Hemodialysis PDF

QUALITY
ASSURANCE
GUIDELINES
for
Hernodialysis
Devices
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health
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HHS Publication FDA 91-4161
Quality Assurance Guidelines for

Hernodialysis Devices
Douglas L. Vlchek, BA, CHT

Sally Burrows-Hudson, MSN, RN, CNN
Dialysis Management Incorporated
Conifer, CO
Nancy Pressly, Project Officer
Office of Training and Assistance
This work was carried out under FDA contract number 223-89-6021
February 1991
U.S. DEPARTMENT OF HEALTH A N D H U M A N SERVICES

Food and Drug Administrat~on
Center for Dewces and Rdd~olog~cal
Health
R o c k v ~ l l Maryland
~,
20857
Foreword
In October 1982, the Food and Drug Administration established the Center for
Devices and Radiological Health (CDRH) by merging the Bureau of Medical Devices and
the Bureau of Radiological Health.
The Center develops and implements national programs to protect the public health
in the fields of medical devices and radiological health. These programs are intended t o
assure the safety, effectiveness, and proper labeling of medical devices, t o control
unnecessary human exposure t o potentially hazardous ionizing and nonionizing radiation,
and t o ensure the safe, efficacious use of such radiation.
The Center publishes the results of i t s work in scientific journals and in its own
technical reports. These reports provide a mechanism for disseminating results of CDRH
and contractor projects. They are sold by the Government Printing Office and/or the
National Technical Information Service.
W e welcome your comments and requests for further information.
Acting Director
Center for Devices
and Radiological Health
Preface
The Center for Devices and Radiological Health's (CDRH) mission under the 1976
Medical Device Amendments and the 1990 Safe Medical Devices Act i s t o develop and
implement national programs t o protect the public from unsafe or ineffective medical
devices.
One important aspect of the Center's activities is the development o f
educational programs for health professionals and consumers in the proper use o f
medical devices.
Hemodialysis is a critical care medical technique which sustains the lives of
thousands of patients who suffer from acute o r chronic kidney failure. However, due t o
the inherent complexity and risk of thc technique, a few patients experience adverse
events which are avoidable. Most adverse events are caused b y u s e r . e r r o r o r a
combination of user error and medical device malfunction. A comprehensive device
quality assurance program would help avoid many of these adverse events.
This publication, "Quality Assurance Guidelines for Hemodialysis Devices," is an
integral part of the Center's educational program in hemodialysis. It discusses quality
assurance for water treatment equipment, equipment used t o evaluate the acceptability
of the dialysate concentrate, dialysate delivery equipment with its associated monitors and
alarms, extracorporeal blood components, dialyzers, dialyzer reprocessing and testing
equipment, and all other equipment associated with the dialysis procedure.
W e hope that this manual will help dialysis facility personnel become more familiar
with quality assurance procedures for dialysis equipment. The manual will assist the
facility i n developing and implementing a facility-specific quality assurance program o r in
refining an existing quality assurance program. Each chapter describes quality assurance
methods and also provides examples of forms which can be adapted for each facility's
specific needs.
In addition t o this manual, the Center has published another manual entitled "A
Manual o n Water Treatment for Hemodialysis" and has produced educational videotapes
o n various aspects of user safety in hemodialysis. The videotapes have been produced as
a cooperative effort among manufacturers, professional associations, and the Center and
were sent free of charge t o each dialysis facility in the United States.
For further information, please contact Ms. Nancy A. Pressly (HFZ-240), Center for
Devices and Radiological Health, 5600 Fishers Lane, Rockville, Maryland
20857.
Joseph S. Arcarese
Office of Training and
Assistance
iii
Acknowledgements
Interim drafts of this manual were reviewed by the following individuals. The authors are indebted
to them for their careful and constructive reviews and many useful suggestions. The reviewers are:
Barbara Bednar, RN, CNN

Renal Treatment Centers
Berwyn, PA
Lee Bland, MS
Centers for Disease Control
Atlanta, GA
George Buffaloe, PhD
CGH Medical, Inc.
Lakewood, CO
Vera Buffaloe
CGH Medical, Inc.
Lakewood, CO
Larry M. Day, BA
Dialysis Management Inc.
Golden, CO
Martin Favero, PhD
Atlanta, GA
Leroy J. Fishbach
MinntechIRenal Systems
Minneapolis, MN
Karen Stalla, RN
Fresenius, Inc.
Concord, CA
Robert Fortner, MD
Bainbridge Island, WA
Frank A Gotch, MD
Ralph K.Davies Medical Center
San Francisco, CA
Consuelo F. Hill, BS, RN, CHN
ESRD Network of New England
New Haven, CT
Martin V. Hudson, CHT
V.A. Medical Center
Palo Alto, CA
Douglas Luehmann
Regional Kidney Disease Program
Minneapolis, MN
Donna Mapes, MSN, RN
Transpacific ESRD Network
Sausalito, CA
Mark Neumann
Nephrology News and Issues
King of Prussia, PA
Acknowledgements (Cont.)
During the initial research phase of this project a number of dialysis facilities, manufacturers, and
other organizations were contacted and contributed information used in this manual. The authors
are indebted to them for their willingness to assist in this project and share their information. These
contributors are:
Health Care Financing Administration
Robert Wood Johnson University Hospital
Joint Commission on Accreditation of
Healthcare Organizations
Mayo Clinic
Medro Systems, Incorporated
Mesa Medical Inc.
Mistebar Computer Consultants
National Association of Nephrology
Technologists
National Kidney Foundation
National Medical Care, Medical
Products Division
National Medical Care, Dialysis
Services Division
Northwest Kidney Center
Occupational Safety and Health
Administration
Organon Teknika Corporation
Oshner Clinic
Polymetrics, Incorporated
Porter Memorial Hospital
Quantitative Medical Systems
Quinton Instrument Company
Renal Physicians Association
Renal Systems, Division of
Minntech Corp.
Renal Treatment Centers
Separation Technology, Inc.
Seratronics, Inc.
Serim Research Corp.
Shiley, Incorporated
Sporicidin International
Surgikos, Incorporated
Terumo Corporation, USA
University of Pennsylvania
Outpatient Dialysis Unit
V.A Medical Center, Palo Alto
Vas-Cath Incorporated
Whittaker Bioproducts
Zyzatech Water Systems, Inc.
Abbott Laboratories
American Nephrology Nurses Association
Amgen, Inc.
Arnuchina
Associates of Cape Cod
Association for the Advancement of
Medical Instrumentation
Automata, Inc.
B. Braun Medical Equipment, Inc.
Baxter Healthcare, Renal Division
Bicarbolyte Corporation
Board of Nephrology ExaminersNursing and Technology
CD Medical, Inc.
Church and Dwight Co.
Clarkson Kidney Center
Cleveland Clinic Foundation
CGH Medical, Inc
(Cobe-Gambro-Hospal)
CompuMod Software
Continental Water Systems Corporation
Culligan International Co.
Dial Medical, Inc.
El Camino Hospital
Emergency Care Research Institute
Enka, AG
Environmental Water Technology
ESRD Networks (all 18)
Filmtec Corporation
Fresenius USA, Inc.
Fresno Community Hospital
W.L. Gore & Associates, Inc.
HemoTec, Incorporated
Charlotte Hungerford Hospital
Impra, Incorporated
Individual State Departments of Health
(all 50 states)
Institute of Medicine
International Standards Organization
Finally, the authors wish to acknowledge the assistance in manuscript preparation by Pamela Jajko
(El Camino Hospital Library & Information Center), Peggy Layton (Dialysis Management Inc.), Joan
W ~(Dialysis
O
Management Inc.), Jason Vlchek (Douglas L. Vlchek & Associates), Patricia Vlchek
(Douglas L. Vlchek & Associates), Colin Beaty, and Darlene Lamun (Executive Secretarial Service).
Abstract
Vlchek, D.L., S. Burrows-Hudson, and N.A. Pressly. Quality Assurance Guidelines for
Hemodialysis Devices. HHS Publication FDA 91-4161 (February 1991)(233 pp).
This manual is designed,to help dialysis facility personnel become more
aware o f quality assurance practices for hemodialysis devices. Device areas
covered include water treatment equipment, equipment used t o evaluate the
acceptability o f the dialysate concentrate, dialysate delivery equipment with its
associated monitors and alarms, extracorporeal blood components, dialyzers,
dialyzer reprocessing and testing equipment, and all other equipment
associated with the dialysis procedure.
This manual can also b e used as a basic guide for designing a new
quality assurance program. The manual includes examples of forms which can
be adapted for each facility's specific needs.
The opinions and statements contained in this report are those of

the authors and may not reflect the views of the Department o f
Health and Human Services (HHS). The mention of commercial
products, their sources, o r their use in connection with material
reported herein is not t o b e construed as either an actual or implied
endorsement of such products b y the Department.
Contents
Page
Introduction .................................................
.......................................
The Basics of Quality Assurance ......................
Water Treatment ...................................
Dialysis Delivery System ............................
Chapter 1: Background
Chapter 2:
Chapter 3:
Chapter 4:
Chapter 5: Dialysate and Dialysate Concentrate ..................

Chapter 6: Hemodialyzers .....................................
.....................
Chapter 8: Anticoagulation ....................................
Chapter 9: Vascular Access Devices .............................
Chapter 10: Hemodialyzer Reuse ...............................
Chapter 11: Infection Control ..................................
Chapter 12: Handling of Toxic Chemicals ........................
Chapter 13: Medical Device Reporting ...........................
Appendix A: Summary of Incidents and Problems .................
Appendix B: Trend Analysis ...................................
Appendix C: Glossary of Terms .................................
Chapter 7: Ancillary Devices and Equipment
Appendix D: List of Tables. Figures. and Forms
...................
Appendix E: Annotated Bibliography ............................
Introduction
Quality Assurance in renal care covers a wide range
of areas and applications. Some of these include:
monitoring appropriateness of therapy; analysis
of resource utilization and pursuing resulting necessary adjustments; assessing patient satisfaction;
measuring morbidity and mortality with the subsequent implementation of attempted solutions; staff
credentialing, and monitoring of technical and clinical processes with suitable modifications when standards are not met.
Since the title of this manual is Quality Assurance Guidelines fir Hemadialysis Devices, the reader
must be aware that only the technical aspects
of hemodialysis are discussed herein. As authors,
we suggest two reasons for this focus.
First, promoting the safe and effective use of medical devices is a mission of the Center for Devices
and Radiological Health, Food and Drug Administration-the contracting agency for this manual.
Second--and probably more importantiassuring
the technical safety in hemodialysis continues to
be one of the most critical facets of renal care. A
number of incidents that result in patient injury
continue to occur every year-incidents that could
be prevented with proper user training, conscientious attention to the manufacturers' instructions
for use and common industry practice, and a wellplanned quality assurance program carried out at
the facility level.
A source of basic background information of the

current risks and hazards associated with the
use of certain devices in hemodialysis today. Suggestions are made as to how to minimize those
risks, as well as how to implement quality assurance
measures used to monitor and control the success
of those actions.
A source of easy-to-use forms, monitoring instruments, and other useful tools that can be immediately utilized in the facility-based quality
assurance program.
This manual is not meant to be:
A complete "cookbookn quality assurance program for the dialysis facility. It does contain
many components of the comprehensive, facility-based quality assurance program. A number of monitoring instruments, forms, and other
tools presented in this manual can immediately
be utilized. However, a truly meaninghl QA
prqgram for dialysis facilities must include areas
that are beyond the scope of this document, including patient care, medical, dietary, social services, patient satisfaction and others.
As authors we wish to convey to the readerluser

of this manual our intent regarding what this p u b
lication "isn and what it "is notn meant to be:
This manual is meant to be:
A first step in assisting the facility to develop

and implement a facility-specific quality assurance approach (or to refine one, if already in
place).
Quality Assurance Guidelines for Hernodialysis Devices
A training manual for the technical aspects of

dialysis. Again, this publication does contain
materials that will help train personnel; but much
more in-depth knowledge of each of these technical areas is essential for most dialysis staff
members. An annotated bibliography appears
a t the end of the manual to assist the facility
in finding other resources needed to complete
that training.
Standards of technical practice for hemodialysis. This manual refers to various "standards"
and "guidelines" that are already in existence.
Some are voluntary standards, others are regulations. This manual should not be construed
as a new set of standards to be followed by the
facility. The facility's own policies and procedures are the basic standards by which its QA
program should be built and functions judged
and monitored. In accordance with Quality Improvement principles, those &cility standards (Policies and Procedures) should continuously be scrutinized and improved upon.
The authors would like to express their gratitude
to all those who have assisted in the preparation
of this manual who are, literally, too numerous to
name individually: the manufacturers who s u p
plied materials and reviewed drafts of individual

sections; dialysis facilities that provided infonnation on their quality assurance programs; physicians, nurses, administrators, and technicians who
provided personal experiences; the regulatory agencies, networks, and other governmental entities that
provided input; and the professional organizations
and voluntary standards associations.
It is our hope that this manual will provide a means
to assist all dialysis facilitiesin improving the quality
of renal care.
Chapter 1
BACKGROUND
CONTENTS
Page
GENERAL
...................................................
1-1
OVERVIEW OF RECENT ACTIVITIES AND

PARTICIPANTS IN QUALITY ASSURANCE ..................... 1-2
Manufacturers
.........................................
1-2
...
1-3
Association for the Advancement of Medical Instrumentation
Joint Commission on Accreditation of Healthcare

Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
...........................
1-3
...............................
1-4
....................
1-4
Health Care Financing Administration
Occupational Safety and Health Administration .............. 1-4

End Stage Renal Disease Networks
.......................
1-5
End Stage Renal Disease Facilities
.......................
1-5
.................
1-5
OVERVIEW OF PROBLEMS AND INCIDENTS
Quality Assurance Guidelines for Hemodialysis Devices
Background
Chapter 1
GENERAL
The ultimate purpose of this publication-Quality
Assurance Guidelines for H e d i a l y s i s Devices-is
to provide generic quality assurance and quality
control procedures for each type of equipment used
in an End Stage Renal Disease facility.
The US. Food and Drug Administration (FDA) has
a history of encouraging the development of quality assurance (QA) programs in facilities that use
medical devices. Wherever medical devices are used,
QA profla& should be established to ensure that
the devices are properly used and maintained.
Incorporating effective QA programs into hemodialysis facilities helps assure safe and effective therapy.
Quality assurance may be defined as those actions that provide adequate confidence that a
facility will administer consistently high-quality
policies, procedures, and practices.
In 1984, the FDA awarded four contracts to study

the practice of hemodialysis. The contractors were
the Health Departments of Ohio, California, Massachusetts, and District of Columbia. Results from
these studies and data from the FDA's Device Experience Network (DEN) system suggest that the
quality of dialysis treatment could be improved by
increasing the utilization of quality assurance in
several areas:
the treatment of water and in the design, operation, and maintenance of water systems;
the handling and dilution of concentrates;
the reuse of disposable components
the operation and maintenance of dialysis delivery systems;
the practice of Universal Precautions to control
the spread of human immunodeficiency virus
(HIV) and hepatitis B virus (HBV);
Quality control, as it relates to medical devices, comprises monitoring, testing, and maintenance.
other areas including patient care, patient education (including home dialysis patients), personnel training, and adequate record keeping.
Qualityadministration comprises management

actions taken to guarantee that quality control
procedures are performed properly, their results
analyzed, and appropriate corrective measures
taken.
The Center for Devices and Radiological Health

(CDRH&a component of the FDA-has had an
educational program geared toward the safe and
effective use of medical devices in hemodialysis facilities. CDRH believes that the overall safety and
effectiveness of the hemodialysis process will be
improved if facilities voluntarily establish and implement QA programs.
Hemodialysis, a therapeutic process in which several medical devices are used, has been an area of
focus for the FDA for many years. In 1978, the
FDA began a study of the problems associated with
dialysis devices, resulting in a report that discussed
the problems associated with all aspects of the system. The FDA's interest continued with active participation in the Association for the Advancement
ofMedica1 Instrumentation (AAMI), Renal Disease
and Detoxification Committee, resulting in voluntary American National Standards for hemodialysis devices.
Assurance Guidelines
The CDRH contracted to have this publicationQuality Assurance Guidelinesfor Hernodialysis Devices-developed and written as guidelines for establishing quality assurance programs in hemodialysis facilities. These guidelines can be helpful in
optimizing patient care and controlling the spread
of infectious diseases in dialysis facilities. This
publication covers the information required to ensure that appropriate equipment is specified, pur-
chased, operated, calibrated, and maintained prop

erly, and that administrative controls are effedively
exearted,the&ycmsminga&and~h~
process.
In a typical hemodialysis facility, the various pieces
ofequipment can be grouped accordingto use,namely:
L Water treatment equipment;
2 Equipment to monitor operation of the water

treatment system;
3. Equipment to evaluate the acceptability of the
dialysate concentrate;
4. Dialysate delivery equipment with its associated
monitors and alarms;
5. Extracorporeal blood components (including blood

access, blood tubing, blood pumps (if appropriate), infusion pumps, and airRoam detectors);
7. Dialyzer reprocessing and testing equipment;
8. Any other equipment associated with the dialysis procedure.

Each piece of equipment requires written quality
control procedures that include maintenance and
calibration procedures. The procedures should include:
1. Selecting appropriate parameters to monitor;
2. Selecting and specifying measurement techniques

(electronic, or manual);
3. Determining appropriate intervals a t which to

monitor (continuous or periodic).
These procedures need to be accomplished periodically to ensure that equipment operates in accordance with the manufacturers' specifications. Some
of the necessary written procedures, particularly
for maintenance and calibration, may accompany
the equipment when it is received from the manufacturer. However, these may need to be modified
and additional procedures may have to be developed for a particular hemodialysis facility. Specific
facility procedures may be needed because:
1. The circumstance of use of the equipment are
unusual (application or type of patient);
2. The equipment is used in conjunction with other

equipment from another manufacturer;
3. Qualifications, credentialling, or training of personnel differ from facility to facility;
4. The original accompanying procedures may be
inadequate (unclear, not detailed enough, too
detailed, etc.).
OWRVIEW OF RECENT
ACTIVITIES AND PARTICIPANTS
IN QUALITY ASSURANCE
Over the years, there have been a number of Quality Assurance and Quality Control activities undertaken. Among the entities involved are: the
manufacturers, the Association for the Advancement of Medical Instrumentation (AAMI), the Joint
Commission on Accreditation of Healthcare
Organizations (JCAHO), the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), the Health Care Financing Administration (HCFA), the Occupational Safety and Health
Administration (OSHA), the ESRD Networks, and
the facilities themselves. Briefly, the contribution
of each:
Manufacturers
The manufacturers are responsible for complying
with Good Manufacturing Practice (GMP) regulations enforced by the FDA These regulations include: written procedures, validation of procedures,
monitoring of performance, documentation of results, review of records, and action implementation. The GMP regulation is intended to assure
that the manufacturer produces devices that are
safe and effective and otherwise compliant with
the federal Food, Drug and Cosmetic Act. The
GMP regulation is described in the Code of Federal
Regulations, Title 21, Part 820, Good Manufacturing Practice for Medical Devices. The GMP is intended to ensure that devices are fit for their intended use. The device GMP is primarily concerned
with the quality of conformance of a device; that is,
the extent to which a device conforms with its design specifications.
Association for the Advancement of

Medical Instrumentation ( A m )
AAMI, a volunteer organization, also assisted significantly in improving the quality assurance and
quality control of dialysis facilities. Since 1980,
AAMI has introduced and published.
The FDA has also been extremely active in assisting, investigating, and ensuring the safety of medical devices through several programs.
The American National Standards for Hemodialysis Systems, which includes standards for concentrate for hemodialysis, hemodialysis systems
equipment, water treatment equipment, dialysate supply systems, and monitors of the blood
circuit.
The AAMI Recommended Practice for Reuse of
Hemodialyzers (incorporated by reference into
the Code of Federal Regulations in 1987).
Standards for First Use Hemodialyzers.
Standards for Hemodialyzer Blood Tubing.
AAMI continues to update and r e h e these standards on an ongoing basis. AAMI also provides a
variety of educational resource materials, training
sessions, technology analysis and review sessions,
and workshops several times yearly. For the past
several years, AAMI has, a t least once per year,
provided courses on hemodialyzer reuse and on water
quality for hemodialysis.
Joint Commission on Accreditation

of Healthcare Organizations
(JCAHO)
(FDA)
The Investigation of Risks and Hazards Associated with Medical Devices. This report
is a result of a study performed under contract
by the Fkgional Kidney Disease Program in Minneapolis, Minnesota. Published in 1980, this
study reviewed water purification, concentrate
used for dialysate preparation, dialysate delivery systems, access to recirculation, blood tubing and accessories,blood pumps, infusion pumps
for anticoagulation, airifoam detectors, dialyze n , and the reuse of dialyzers.
Hemodialysis System Investigation Reports:.
As noted earlier, in late 1984, the FDA issued
contracts which resulted in Hemodialysis System Investigation Reports from California, the
District of Columbia, Massachusetts, and Ohio.
These contractors reported that serious problems existed in various areas of current hemodialysis practice: water treatment systems; dialysate delivery systems and dialysate concentrate;
dialyzers; extracorporeal blood circuits; reuse of
disposables;orientation training programs of staff;
qualification and experience of patient care s W ,
manufacturers' literature; and home dialysis
patients. The recommendations were comprehensive for each area studied.
J C A H 0 - a non-governmental organization primarily involved with accreditation of hospitals--has also

had impact on dialysis facilities in that all dialysis
facilities who are a department of hospitals have
been inspected according to JCAHO "Special Care
Unitsncriteria. Additionally, JCAHO has begun to
require implementation of, and to insped for, incorporation of the "10-Step Process" for quality assurance programs in dialysis facilities, as well as in
other specialty areas within hospitals. Chapter
Two, The Basics of Quality Assurance, provides
the reader with details of this process.
Guidelines for Hemodialysis Devices
Educational Projects. Over the past several

years, the Center for Devices and Radiological
Health Office of Training and Assistance has,
with the assistance of the manufacturers and
several other professional groups, produced educational materials and video tapes including Human
Factors in Hemodiulysis, Water Treatment in
Hemodialysis, Infection Control for Hemodialysis, and Repmssing of Hemodialyzers. Facilities have enthusiastically received these materials, and the importance of the issues handled
therein certainly have been underscored. The
Office of Training and Assistance also published
A Manual on Water Treatment for Hemodialysis
early in 1990.
Other FDA Activities: The FDA also gathers

information through other programs such as the
Problem Reporting Program (PRP) and the Medical Device Reporting Program (MDR). The FDA
is also able to provide important feedback through
the Device Experience Network regarding all of
the device related problems mentioned above.
Centers for Disease Control (CDC)

Since the early 1970's, the CDC has conducted surveillance of hepatitis in hernodialysis centers. Through
a cooperative effort with HCFA, the CDC has been
able to determine and report the frequency with
which hepatitis and other infectious diseases occur
over time, factors associated with the occurrence
of these diseases, and the effect various infection
control measures have had in preventing transmission of disease in hemodialysis.
As a result of these surveillance efforts, the CDC

established initial recommendations for control
measures for hepatitis-B (HBV) in dialysis centers.
Issued in November, 1977, the measures focused
on: serologic testing, record keeping, staff and patient education, control and prevention, housekeep
ing and sterilization, and disinfection. These recommendations have been continuously updated and
revised to reflect current technological practice and
new problems.
The CDC's approach has been to educate and monitor, reporting their findings, each year to the nephrology community. Networks and other organizations adopted the CDC recommendations as standards encouraging facility compliance. As a result,
these precautions, when employed, have demonstrated a significant reduction in the incidence of
HBV infection.
The CDC has M h e r developed their infection control
recommendations to include HIV (human immunodeficiency virus). Utilizing lessons learned from
the dialysis field, the CDC issued the current Universal Precautions for all areas of health care. Because use of serologic testing for HIV is not universally employed, the CDC has focused on the education of all health care workers in the application of
Universal Precautions.
Health Care Financing

Administration (HCFA)
By definition, the Health Care Financing Administration (HCFA) administers the Medicare funds
for reimbursement of End Stage Renal Disease treatc
ment. An important aspect of that function is assuring quality and appropriateness of care associated with that treatment.
In the final rulemaking for the End Stage Renal

Disease (ESRD) program, the June 3, 1976, Federal Register described the further conditions of
coverage of suppliers of ESRD services:
These Health Care Financing Administration
(HCFA) regulations (Part 405 of Chapter N of
Title 42 Subpart U) established the initial standards by which facilities would be allowed to provide services to ESRD patients: network membership; compliance with federal, state, and local laws
and regulations; governing body and management;
patient care planning (long term and short term);
patient rights and responsibilities;medical records;
physical environment; director and staff qualifications; and minimal service requirements.
These conditions of coverage, as interpreted by
HCFA, are used by the state and federal surveyors to evaluate dialysis facilities. These federal standards have been the only guide for all subsequent
quality assurance activities undertaken.
Occupational Safety and Health

Administration (OSHA)
During the past three years OSHA regulationshave
also had a direct impact on dialysis facilities:
In December of 1987 OSHA published a Final Rule
on Occupational Exposure to Formaldehyde which
includes exposure limits, required monitoring, regulated areas, emergency procedures, medical surveillance, special record keeping requirements, communications with and training of employees, and
other actions.
Additionally, OSHA has published a Notice of Proposed Rule Making regarding Occupational Expo-
sure to HIV and HBV. The final rule is to be published in the very near future.
OSHA's Hazard CommunicationStandardalsorecphs
employers to provide information to their employees
about hazardous chemicals used in the work place.
End Stage Renal Disease (ESRD)

Networks
In June, 1976, the final ESRD regulations included
a mandate to the Secretary of Health, Education
and Welfare (HEW) to regulate health care being
provided to persons with ESRD. In order to monitor and regulate the care provided to these patients, the ESRD Networks were established with
the mandate that each Network was to organize its
own medical review program. Some changes have
occurred since that time, but the Network functions established by HCFA are primarily to:
End Stage Renal Disease (ESRD)

Facilities
As the reader will note from the above, dialysis facilities have had to not only learn and grow with
the technological advancements in the field, but
also comprehend and apply the various standards,
guidelines, and recommendations put forth.
Facilities tend to be eager for information, forms,

models andlor programs that will help them with
all aspects of quality assurance. It is the intention
of this manual, Quality Assurance Guidelines for
Hernodialysis Devices, to fill some of that need.
Develop Network goals for placing patients in

settings for selfcare and transplantation;
OVERVIEW OF PROBLEMS
AND INCIDENTS
Encourage the use of medically appropriatetreati

ment settings most compatible with patient rehabilitation;
The past few years have seen an increase in the

concern that quality of care be maintained as the
basic cornerstone of dialysis delivery.
Develop criteria and standards relating to the

quality and appropriateness of patient care;
Events that have seriously jeopardized patient safety

in several different dialysis facilities have occurred
during the past three to four years. These incidents have focused attention on the absolute necessity of completely competent, well-trained, medical, nursing, and technical staffs, and on well-designed use of today's technology and diligent quality assurance programs. Occasionally,incidents have
occurred during this time that have received national media (newspapers, magazines, national television) exposure:
Evaluate the procedures used by facilitiesin assessing patients for placement in appropriate treatment modalities;
Make recommendations to member facilities as
needed to achieve Network goals;
Conduct on-site reviews of facilities as necessary;
I.
cific QA programs. This effort continues to be a

priority for Networks.
Collect, validate, and analyze data.
Each Network has functioned independently of the

. others allowing considerable autonomy and creativity to best meet the HCFA requirements as well
as community need. A significant amount of focus
for the Networks has been those technical aspects
attracting national attention; i.e., water treatment,
infection control, dialyzer reuse, et cetera.
In late September 1987,44 patients in one facility were treated for hemolysis due to chloramine
contamination of dialysate. It was later found
that facility staff lacked adequate information
regarding water treatment and water treatment
system planning. Furthermore, inadequate staff
monitoring, and an overall lack of ongoing performance appraisal contributed to this incident.
In 1984, the HCFA specified that each Network

would encourage the development of facility spe-
A few months later, a serious incident occurred

where injectable lidocaine was confksed with
mannitol. In this incident, one patient died and

another was seriously injured. Proper storage
and labeling techniques, as well a s protocols for
administration of medication, among other issues, were implicated
In early 1989, patient injury occurred when a
germicide and preservative (sodium azide) was
not completely removed tiom a component of a
water beatrnent system (ultrafilter). In this case,
again, improper design and use, as well as inadequate training and monitoring were involved.
In mid-1989,36+ patients were treated for metabolic acidosis in a dialysis facility when acid dialysate concentrate was used with dialysis delivery systems in the acetate mode. The machines were all functioning according to specifications, but the pre-dialysis safety checks specified by the manufacturer were not performed,
and other gaps in quality assurance and quality
control contributed to this incident.
During these periods, the Centers for Disease Control and other federal agencies investigated scores
of other similar incidents which did not appear in
the media: bacterial contamination of water treatment systems, pyrogen reactions, HIV and HBV
exposure, problems with improper use of dialysate
concentrate, other contaminations of water treatment systems and water storage. The list is long
and serious. Further, during this same period of

time, the controversy regarding the reuse of
hemodialyzers continued, and this has been reviewed often in the media.
Appendix A provides the reader the opportunity
to review the hundreds of other incidents that
have occurred in recent years related to device
malfunction. More oRen than not, these were
related to improper use, improper user training,
improper preventative maintenance, and other
issues normally monitored and corrected by a
quality assurance program.
The combination of all of these factors has drawn
significant national attention from the public, legislature, regulatory agencies, and even dialysis
facilities, and health care professionals. The importance of strong and effective quality assurance
programs in an effort to enhance safety and reduce the risk of these sorts of incidents is on
everyone's mind.
Please note that most of the following chaptirs in
this manual, Quality Assurance Guidelines for
Hemodialysis Devices, contain a section on adverse incidents--both pre-1980, as well a s incidents found in the FDA's Medical Device Reporting files. These are offered to the readers as
background for consideration as to whether or
not such incidents could occur in their facility.
Chapter 2
THE BASICS OF
CONTENTS
Page
................................................
2-1
. . . . .. .... .... . . . ..... .. ....

The JCAHO 10-Step Process for Monitoring and Evaluation . . . .
2-1
DEFINITION
QUALITY ASSURANCE METHODS
Comprehensive Quality Assurance Program:

The Smith-Marker "Unit-Based Quality Assurance Model"
Quality Control
2-1
.. . . .
2-4
. .. . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . .... . .
2-5
Continuous Improvement Concepts:

Derning's Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
REFERENCES
...............................................
2-7
. . . . . ... . . .... . . . . . . . .. . . . .. .
2-8
TABLES, FIGURES, AND FORMS
Assurance Guidelines for Hernodialysis Devices
Chapter 2
The Basics of
Quality Assurance
DEFINITION
gates the responsibility of conducting the QA activities to a committee.
Quality assurance is a cyclical process by which

problems and opportunities for improvement are
identified and analyzed, solutions are developed and
implemented, and reassessment occurs. If the cycle
is not completed, that is, if only the assessment
component takes place, quality assurance (QA) will
not occur (see Figure 1).
2. Form a oommittee. Committee members should
include the dialysis unit's medical director, head

nurse, chief technician, dietitian, and social worker.
If the unit is very large and has multiple shifts,
the charge nurses responsible for each shift must
be included. When a QA coordinator is employed
or a staff nurse is assigned the position on a
part-time basis, that person should be involved
and attend each QA committee meeting.
QUALITY ASSURANCE METHODS

Many hemodialysis facilities have successfidly developed and implemented quality assurance programs. Some use quality assurance methods that
they have developed themselves, modifying various
models and plans; some use the Joint Commission
on Accreditation of Healthcare Organizations' tenstep process for monitoring and evaluation; while a
few use specific models developed by other people,
including Carolyn Smith-Marker's, "Unit-Based Quality Assurance Model."
In this manual, the quality assurance cycle previously described, the Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) ten
step process for monitoring and evaluation, the SmithMarker model for quality assurance, and Deming's
continuous improvement concepts are offered to facilitate a comprehensive examination of quality for
the hemodialysis facility. It is recommended that
the references listed at the end of this chapter be
used to provide more comprehensive assistance with
QA programming.
Committee members must be those individuals

that have the authority to make decisions and
implement the necessary actions to assure correction of a problem. A chairperson for the committee must be elected or appointed. The position is usually assigned to the head nurse or
someone who can carry out the various coordinating activities involved.
3. Develop a plan. A plan must describe the
facility's QA program purpose and goals. The
plan should include the scope of the QA program, how to achieve the purpose and goals that
are outlined, and the mechanisms to be used.
The plan also delineates the organization, responsibility and authority of the QA program:
who is to be involved in the QA program, committee membership, the reporting mechanism,
and the ultimate authority responsible for the
QA program for the facility (see Figure 2).
4. Organize and meet. The committee must or-
ganize itself and educate members who are not

familiar with the QA process. The appropriate
resources need to be provided, such as articles,
books, and educational programs.
JCAHO 10-Step Process for

Monitoring and Evaluation
Once organized and prepared, the committee must

meet. To assure a continuous monitoring process and commitment to improving quality, the
committee should meet on a monthly basis.
A Getting Started
1. Assign responsibility, The governing body of
the facility is the ultimate authority responsible
for the QA program. The governing body dele-
5. Minutes. Minutes of all QA committee meetings must be written and handled in a confiden-
Quality Assumnce Guidelines for Hernodialysis Devices
tial manner and should be maintained in a file

that is not within public access. It is highly recommended that each QA committee review their
specific state statute pertaining to the confidentiality of the QA committee minutes.
B. Define Scope of Care

In the first step, critical indicators of care are developed d e h i n g the scope of care provided by the
facility. Table 1provides an example list describing the scope of care in a hemodialysis unit This
list was developed by using the brainstorming technique to answer a number of questions:
1. lSpes of patients served. What are the characteristics of the patient population, such as age,
residence, ethnicity, length of time on dialysis,
or other unique characteristics?
2 Conditions and diagnoses treated. Are specific types of renal diseases treated? Are the
patients' conditions medically complex? Are the
patients all paraplegic? Diabetics? Hepatitis
positive? Do the patients have multiple healthcare problems?
3. Services provided. What treatments or activities are performed in the dialysis unit? All of
the activities that go into the hemodialysis p m ess should be listed: patient orientation, vascular access care, venipuncture, heparinization,
equipment maintenance, reuse, water treatment,
infection control, environmental control, environmental safety, et cetera.
4 The types of practitioners providing care.
Who are the people involved in the care of the
end stage renal disease patient in the dialysis
unit?
5. Sites where the care is provided. Is this an

outpatient facility? An in-hospital facility? Or
an outpatient clinic associated with the hospital? Is it a freestanding facility? Or is it home
dialysis?
6. Times when
is provided. Are there different shifts available for patients?
C. Identify Important Aspects of Care

The next step is to identify the important aspects
of care. These are the things that we do that are
most important. Consider these three aspects:
1. The aspect occum frequently or affects a

large number of patients. In a facility this
particular factor is very important There are a
number of things done that affect large numbers
of patients. Examples include: the hemodialysis
procedure itself; water treatment; reuse; and
venipuncture.
2. .Patientsa m at risk of serious consequences

or a m deprived of substantial benefit if the
care is not provided comtly, in a timely
fashion or as properly indicated. In other
words, if the hemodialysis treatment is not provided adequately or properly the patients may
suffer the serious consequences of uremia or be
put a t risk for other injury.
3. The aspect of care has tended in the past
to produce problems for staff and patients.

In the hemodialysis unit this may include infection control, water treatment, venipuncture, et
cetera. HBV and HIV pose numerous problems
for both staff and patients. Venipuncture is another aspect of care that has produced problems
for both patients and s t . .
High volume, high risk and problem prone areas
that have been identified must be considered the
most important aspects of care and require ongoing monitoring and evaluation.
D. Identzfy Indicators
Indicators are chosen directly from those aspects of
care that have been identified as being most important. Using these indicators, important aspects can then be monitored and evaluated on an
ongoing basis.
Among the indicators that are finally chosen, the
most current standards and regulations, as outlined in Table 2, must be included. Rather than
monitoring each specific entity of a regulation or
standard, only those that are most important and
have direct impact upon a patient should be selected. The monitoring process should be both broad
and selective to provide an overview of the entire
scope of facility operations.
An indicator may also come from the unit's policy

and procedure manual. Policies and procedures that
are current with regulations and standards and
are up-to-date with all the equipment and supplies
used in the unit, can serve as an immediate resource for developing indicators.
2-2
To be comprehensive in this process, the QA committee should monitor a mix of structure, process,
and outcome indicators.
staructure is that which holds the organization
together; i.e., policies, building structure, equipment.
process is that which is performed or provided

by the facility; i.e., the performance of procedures; and,
outcome,the end result of what has been done.

All staff, if not directly involved in the identification of indicators, must be informed and have an
opportunity for input. Monitoring instruments will
be most successll if all staff participate in the
development of and are aware of indicator expectations. Examples of monitoring instruments designed according to these guidelines and the additional information presented below are included in
many of the chapters in this manual, Quality Assumnce Guidelines for H e d i a l y s i s Devices.
E. Establish Thresholds for

Compliance
As indicators are identified and monitoring instruments are developed, the committee must establish thresholds by which the compliance level is
expected. A threshold is simply that percentage of
compliance with the indicators that you expect to
find when monitoring the activities of your facility.
It is recommended that a threshold for action begin at 85%. While highly desirable, a 10Wo threshold is not recommended a t first. Compliance of
100% is not necessarily achievable in the beginning stages of monitoring. Begin at 85% and work
towards continuous improvement.
F. Collect and Analyze the Data

After the indicators have been identified, thresholds established and the monitoring instrument
has been developed, the sources of information that
will be needed should be identified. Table 3 desrribes where a variety of information might be
found. It is important to keep in mind that the
SOUmes must match the required data and that
there are multiple sources already available in the
dialysis unit.
The collection process is also very important. Data

~llectionor the gathering of information must be
conducted in an accurate and speedy manner. The

collection process includes the identification of the
indicator to be monitored, an assignment of the
staff person to do that monitoring, and the appropriate space and time provided. The staff person
should not try to care for a patient at the same
time heishe is reviewing activities of their coworkers or trying to conduct a chart audit.
Once the monitoring activity has been completed
and the data collected, it must be displayed in such
a way as to ensure that the QA committee can read
i t and accurately interpret the findings. Displaying the data is another difficult task to complete;
the Problem Tracking Form shown in Figure 3 can
accurately track problems over time and display
the results of the QA monitoring activities.
G. Evaluate the Results

Problems identified by the monitoring activities (ie.,
failure to achieve expected compliance threshold)
must be analyzed. In some cases, there may not be
a clearly defined problem It is important, however, to assure that areas for improvement are acted
upon. There may be problems that are readily solved.
These actions should be implemented quickly. Some
problems may be extremely complex and long term
in resolution. Decision making must focus on those
pieces of the problem that will have a direct impact upon patient safety. A threat to patient safety
must be tackled swiftly. When time permits, the
oommittee must carefully review the remainingpieces
of the problem.
As problems are identified through monitoring, it

is important that the QA committee document or
"track" the identified problems. One method is
the use of a Problem Tracking Form (Figure 3). By
noting the problems on a tracking form, the committee will be able to track a specific problem, the
activities required, and the person responsible for
assuring that the solution is implemented. Each
time the QA committee reviews the status of a
problem, a notation of the review date should be
made on the form. The detailed committee discussion relating to the problem can be noted in the
minutes. Until the problem is resolved, the committee should make similar notations on the form
a t each meeting. When the problem is finally resolved, the problem can be removed from the form.
Note, however, that the past forms should be retained in the minutes of the QA committee meetings.
lity Assurance Gui&lines fir Hernodialysis Devices
H. Develop Solutions to Problems and

Take Action
Analysis of the problems or areas for improvement
will generate solutions. It is important to consider
the best solution. What is its value? Is it cost
effective? Is it feasible to implement? Are resources readily available to implement this solution? And, will the solution be accepted by staff
and patients alike? StafF and patient involvement
must be considered in the development of solutions.
A plan of action must be developed by identifying

the steps involved in implementing the solution. A
target date for implementation and reevaluation
must also be determined. The person responsible
for implementing that solution must be aware of
the expectations, responsibility, and authority required to carry out the plan. The plan must then
be implemented. If the solution is not implemented
and if all activity stops at this point, the problem
will not be resolved and the assurance of quality
will not occur.
I. Reassess
Reassessment and documentation of improvement
is required to "bring the QA loop to a closen (see
Figure 1). This occurs &r the solution has been
given enough time to make a change or to correct a
problem The reassessment monitoring instrument
should not be significantly different from the one
used to identi@ the original problem. Through follow-up monitoring activity, the QA committee will
be able to determine if the problem has been solved.
The monitoring process should be continued over a
period of time to assure sustained resolution.
J. Communicate
The results of all QA activities need to be communicated to all dialysis staff. It is not enough that
the head nurse, the medical director and the chief
technician and possibly the administrator decide
what to do about certain problems that they have
identified. Further, when problems are resolved
andlor improvement opportunities are acted upon
and resolved, the staff must be made aware of the
outcome and they must be congratulated on a job
well done.
The process described for monitoring and evaluation includes the assignment of responsibility, dehing
scope of care, identifying important aspects of care,
identifyng key indicators, establishing thresholds
for evaluation, collecting and organizing data, evaluating care, taking action, assessing and documenting improvement, and communicating relevant information.
Comprehensive Quality Assurance

Program: The Smith-Marker"UnitBased Quality Assurance Model"
A comprehensive QA program involves all aspects
of unit activity and integrates each under one
"umbrellan. A comprehensive QA program includes
nine activities: development of standards, staff eredentialing, performance appraisal, risk management,
utilization review, concurrent monitoring, continuous and focused monitoring, active problem identification, and continuing education.
A Development of Standards
This includes the use of the professional standards
of practice for medicine, nephrology nursing, social
workers, renal dietitians, and technicians. Federal
and state regulations also form the standards for
many of the technical activities and structural aspects in the dialysis unit.
B. Staff Credentialing
Staff credentialing, by either a professional license
or certification, is an important means of screening
personnel. It provides an assurance that the individual is capable of providing a recognized level of
skill and expertise. This means that for all staff,
where licensure or certification are appropriate, the
dialysis unit administration must assure that the
documentation is current and maintained according to state laws.
Other types of certification renewal or credentialling
are also important to validate and maintain on file.
For example, all direct patient care stafF should be
certified for cardiopulmonaryresuscitation, continu-
~ u a l i Assurance
b
Guidelines for Henodialysis Devices
ing education requirements, preventive back care

orientation, hazardous materials communication,
and other programs required by facility policy.
G. Retrospective monitoring
Performance appraisal must flow from the role description and the QA program. Standards of practice, the role description and the performance appraisal process must tie together and create one
unified method of evaluating professional employee
behavior.
Monitoring retrospectively focuses on that which

has already occurred.Information found in the medical record is most commonly used for retrospective
monitoring. Infection control, special problem focused studies, kinetic modeling, outcome monitoring, mortality review, infections, vascular access
problems, and technical audits can all be performed
retrospectively. There are a number of retrospective monitoring instruments included throughout
this manual.
D. Risk management
H. Active problem identification
Risk management is focused on financial liability

awareness. Risk management activities include
disaster planning, infection surveillance and control, the use of universal precautions, facility structural aspeds such as handrails on the walls and
non-skid floors in the unit. The informed consent
process is also a risk management activity, along
with patient relations, incident reporting, adverse
occurrence reporting, safety and hazardous materials education, and a grievance process for the facility.
Active problem identification flows from the results

of monitoring activities: staff credentialing, performance appraisal, risk management, utilization review, concurrent monitoring, and retrospective monitoring, with the addition of comments and prob
lems presented by patients, s t . , and management
personnel.
C. Performance appraisal
An up-to-date policy and procedure manual is also

an important component of risk management. A
well written manual ensures that the policies and
procedures expected to be used in the delivery of
services follow all current standards, guidelines,
and regulations.
I. Continuing education
Continuing education should focus on the problems
that are identified. Continuing education should
come from and focus on those problems or opportunities for improvement that have been identified
through the ongoing monitoring and evaluation
process.
E. Utilization review
Quality Control
When examining utilization factors related to the

dialysis facility, the QA committee may focus on
repeat dialyses, unscheduled acutes, emergency room
visits, blood utilization, and medication administration.
Control is the process of regulating an adivity to

verify its conformance to a standard. Quality control (QC) is the process for those activities that
measure a product's performance. Quality control
is an important component of quality assurance.
F. Concurrent monitoring
In the hemodialysis unit, the purpose of QC is to

assure that the equipment/devices used are safe
and effective. This goal is met by the application of
a cyclic process; that is, by establishing standards,
measuring performance, and correcting deviations.
Concurrent monitoring is the process of observing

what is happening at the time of its occurence. Examples of this include: observing staff or patients
perform procedures; querying patient satisfaction
or a patient's sense of quality of life; reviewing
treatment and care outcomes, especially functional
*tuS. There are a number of concurrent monitoring instruments included throughout this manual.
A major aspect of quality control is reliability. Rt+

liability is the ability of the product to perform its
intended function over a period of time. A product
that "worksn as it is designed, without mechanical
failure or errors, for a long period of time is a reliable one.

There are four aspects of reliability:
1. The device will not fail during a particular time;
i.e., during dialysis.
2. The device is able to perform those applications
for which it has been designed and as it is expected to perform, i.e., accurately prepare, monitor and deliver dialysate.
3. The device's W e expectancy" is known, and the

device lasts as long as expected.
4. The device will function in an appropriate environment.
Maintenance of all equipment has an important

role in assuring reliability. When maintenance is
performed according to the manufacturer's guide
lines or facility policies and procedures it may save
the dialysis unit substantial dollars in costly repair
or replacement work. Preventative maintenance
also assures a safe and adequate dialytic therapy.
Periodic monitoring and evaluation are required
for prevention programs. They are essential to determine whether or not the equipment is operating
satisfactorily. These periodic monitoring activities
simply review the operation of the device in much
the same manner as monitoring the medical record
or personnel performance. They should be scheduled and performed by the technical personnel who
know how to operate the equipment. The results
of the monitoring activity are, of course, written
and circulated within the dialysis program.
C. Correcting Deviations
Each measurement taken must be evaluated against
an existing standard. These standards may be
found in the manufacturer's literaturdrecornmendations for use or other sources as described in
Table 2. When a deviation from the standard OCcurs,the problem must be analyzed and corrected.
Throughout this manual a number of quality control instruments, procedures and measures will be
described. It is important that quality control be
incorporated into the facility's quality assurance
PW-.
Continuous Improvement Concepts:

Deming's Principles
"Quality must be built into a product or service, it
cannot be inspected in." (Deming, 1982). The t h e
ory of continuous improvement is crucial for successful dialysis unit operations. The following is
offered for consideration in the development of a
facility QA program.
Key points for improving quality:
Top to bottom organizational consistency of purpose towards improvement of senrice.
Find problems. It is our job to work continually
on the system--towardscontinual improvement.
Eliminatk inspections and substitute meaningful measures of quality.
Take immediate action to remove barriers to gualih
service.
A. Establishing Standards
Throughout this manual, standards that are pertinent to the components or devices discussed in each
chapter have been identified. In relatively few cases
do dialysis personnel need to develop new standards. The vast number and scope of standards
and regulations that already exist must be used
(See Table 2).
Institute long-rangeplanning, cease focus on shortterm profits.
B. Measuring Performance
Make use of practical statistical techniques and

tools (control charts, flow diagrams, run charts,
etc.) to facilitate learning and action.
Equipmentldevice performance measurements are

performed pre-dialysis (pH, conductivity, dialysate
flow rate, temperature), during dialysis (blood flow
rate, heparin infusion rate, volumetric controlled
fluid removal rate), and during maintenance and
repair procedures (ohms, volts, amps, flow rates).
Eliminate barriers between staff groups; substitute team work.

Introduce modem training methods.
Recognize achievement.
The careful integration and implementation of various models and methods of quality assurance will
promote and enhance the high quality of care.
~ u a l iAssurance
t~
Guihlines for Hernodialysis Devices
REFERENCES
1. Joint Commission Guide to Quality Assurance. Joint Commission on Accreditation of

Healthcare Organizations (JCAHO), Chicago, IL (1990).
2. Quality Assurance for Nephrology Nursing. American Nephrology Nurses Association,
Pitman, NJ (1989).
3. WALTON, M., The Deming Management Method. Putnam Publishing, New York, NY (1986).
4. SMITH-MARKER, C. Monitoring Professional Nursing Practice. Aspen Publications, 1:3,
Rockville, MD (1987).
5. MICHNICH, M.E., HARRIS, L.J. WILLIS, R.A. and WILLIAMS, J.E. Ambulatory Care
Evaluation: A Primer for Quality Review. UCLA School of Public Health, Los Angeles, CA
(1976).
Note: A list of additional references on this topic can be found in Appendix E a t the end of
this manual. These additional references are included to enable the reader to pursue further investigation for the purpose of training or research on this topic .
(
i
STANDARDS
COLLECT DATA
REASSESS
CHOOSE AND
IMPLEMENT SOLUTION
ANALYZE PROBLEMS AND

GENERATE SOLUTIONS
I. PROGRAM PURPOSE AND GOALS
dialysisAransplant program is to provide high quality

The overall goal of
services in an environment that is safe to both patients and providers and in a manner that will optimally
benefit the patient's well-being. The purpose of the Quality Assurance Program is to objectively, systematically, and comprehensively monitor and evaluate the quality and appropriatenessof patient care,
to reveal opportunities to improve patient care, and to resolve identified problems.
II. ORGANIZATION AND AUTHORITY
is responsiblefor assuring that a planned and sysThe Governing Body of

tematic process for monitoring and evaluating the quality and appropriateness of patient care services
is in place, implemented, and is effective. A Quality Assurance (QA) Committee, consisting of at least
the key members of the multidisciplinaryteam: medical director, head nurse, social worker, dietitian,
chief technician, and a representative from any other service provided, is established to assure
completion of activities consistant with the purpose and functions of the QA Program.
Ill. OBJECTIVES
The QA program shall be:

A. Comprehensive in scope, reflective of the diversity of providers and services.
B. Designedto objectively and systematically monitor and evaluate the quality and appropriateness
of patient care, pursue opportunitiesto improve patient care, and resolve identified problems.
C. Responsiblefor defining effectivemechanisms for reviewing and evaluating patient care, as well
as for an appropriate systemfor respondingto suchfindings that emphasizescorrectionof identified problems.
0.Designed and expected to demonstrate verifiable improvement in patient care and clinical performance.
E. Defined in a written plan that shall be re-evaluatedon an annual basis.
IV. PROGRAM COMPONENTS
A. Data Gathering: the QA program shall facilitate the identification on a regular, ongoing basis of
known or suspected problems in patient care through the establishment of a comprehensive and
Coordinated system of information exchange and record maintenance regarding quality of care
issues. Sources of problem identificationcan be based on either continuous monitorsor on casespecific referrals.
Assurance,Guidelines for Hernodialysis Devices
SAMPLE QUALITY
ASSURANCE
PLAN
6. Problem Analysis: the QA program shall facilitate the collection, analysis, and presentation of
appropriate data. Patient care issuesbroughtto the attention of the QA programshall be screened
and actedupon according to:
1. degree of adverse impact on patients;
2. feasibilty objective analysis; and
3. potential for riskhenefit
C. Reporting: the QA programshall assure the reportingof data resultsto respectiveprovidergroups.

D. Problem Resolution: the QA program shall facilitate and assure an appropriate plan for action
including solution identification and implementation, problem tracking, and reassessment.
V. REPORTING AND CONFIDENTIALIN

Minutes of QA committee meetings shall be recorded. Indicator monitoring results, actions taken, and
follow-up monitoringwill be fully documented. The documentation of all QA activities will be updated
on an ongoing basis and will reflect current status of each identified problem. On a routine basis, a
summary of all QA activities will be reportedto the Governing Body and integrated (as appropriate) into
the organization-wide program. All information, analyses, records, and proceedings of the QA committee shall be protected as confidential records.
VI. PROGRAM EVALUATION

The QA committee will evaluate the QA program at least annually to assure that it meets the quality
assurance needs and goals of the facility. Pre-establishedwritten objectives shall be used and a wriiten
report shall be submitted to the Governing Body.
Reviewed and Approved by:
Date
Director of
Governing Body Representative
Date
Reprinted with permission from ANNA'S Ouality Assurance for Nephrology Nursing, Copyright 1989. American Nephrology
Nurses' Association, Pitman. NJ.
2-10
DATE
PROBLEM
ACTION PLAN
DATES
REVIEWED
1, Chronic Adult Hemodialysis Outpatients with ESRD

Elderly
Non-ambulatory
Drug Abusers
Diabetics
Patients of Various Ages
Nursing Home Patients
Patients with Ethnic/Cultural Diversity

Patients with Various Disabilities
Patients of Low Economic Status
Home Training
Rehabilitation
Transfusions
Family Support
IDPN Therapy
Laboratory Tests
Disaster Planning
Staff Support
Reuse
Universal Precautions
Water Treatment
Entertainment and Socialization
Coordinate Care with Nursing
and Medicine
High Flux Hemodialysis

EPO Therapy
Dietary Counseling
Continuous Therapies
Self Care
Quality Assurance
Comfort Measures
Medication Review
Patient Scheduling
Isolation
Educate Students
Research
Travel Arrangements for Vacations
2. Treatment and Care

Hemodialysis
Conventional Hemodialysis
IV Med Administration
PsychISocial Support
Transportation
Financial Counseling
Patient Education
Staff Inservice
Primary Nursing
Equipment Maintenance
Safety Management
Handling Patient Grievances
Purchasing
Then, subcategories, under #2 above, such as Hemodialysis, can be divided into

"Important Aspects of Care": For example:
Hemodialysis
Venipuncture
Water Treatment
Reuse
Kinetic Modeling
Anticoagulation
Equipment Maintenance
Nutritional Counseling
Ultrafiltration
Patient Monitoring During Treatment
3. Providers
Physicians
Social Workers
Aides
Laboratory Personnel
Business Personnel
Nurses
Renal Nutritionists
Chief Executive Officers
Transport Personnel
Surgeons
LVIPN's
Secretaries
House Keeping Personnel
Volunteers
Technicians (Reuse, Equipment,
Patient Care)
Used with Permissionby Transpacific ESRD Network, Sausalho, CA
2-12
42 CFR Part 405, Subpart U (Conditions for Coverage of End-Stage Renal Disease (ESRD)
Services
HCFAIAAMI Recommended Practice for Reuse of Hemodialyzers (plus Final Rule in

October 2,1987 Federal Register)
HCFA Final Rule: Medicare Program: Protocol for the Reuse of Dialysis Bloodlines
(42 CFR Part 405, Federal Register May 2, 1990, Vol. 55, No. 85, p. 18331-18335)
Standards of Clinical Practice for Nephrology Nursing (ANNA)

American National Standard (ANSIIAAMI) for Hemodialysis Systems
29 CFR OSHA Regulation including: formaldehyde, infections materials, and other chemicals
Various ESRD Network Standards of Patient Care
FDA Safety Alert: Chloramines, 1987
Various State Standards, including:
Minimum Standards to Comply with Existing Federal and State of California Regu
tions ("Chloramines Removal from Renal Dialysis Water Supplies")
California Standard for Water Piping Systems in Hemodialysis
Various Local Statutes

JCAHO Standards
Facility Policies
ManufacturerssInstructionsfor Use
Ass
It is usually not necessary to create new data sources for quality assurance purposes. Existing
sources include:
Medical Record
Dialysis RecordILog Sheets
Patient Care Plans
Hospitalization Record
Laboratory and other Diagnostic Records
Incident Reports
Adverse Occurrence Reports
Equipment Maintenance Reports
Water Quality Monitoring Reports
Culture Reports: Water, Reused Dialyzers, Dialysate, Environmental
Hepatitis Surveillance Reports
Electrical Safety Testing Reports
Reuse Master File
Patient Satisfaction Surveys
State and Federal Survey Reports
Medical Device Alerts
Manufacturers' Recalls
Performance Appraisals
Utilization Review Reports
Chapter 3
WATER TREATMENT
CONTENTS
Page
TECHNICAL DESCRIPTION OF DEVICE
3-1
RISKS AND HAZARDS
......................
.......................................
3-1
.....................................
3-2
...
Policies and Procedures ..................................
Staff Training and Education ............................
Monitoring and Evaluation ..............................
Daily Monitoring .................................
Monthly Monitoring ..............................
Patient Monitoring ................................
Home Dialysis Monitoring ..........................
Other Monitoring .................................
Prevention .......................................
Purchasing Guidelines .............................
3-3
EXISTINGGUIDELINES
QUALITY ASSURANCE FOR WATER TREATMENT SYSTEMS
REFERENCES
;.
3-3
3-3
3-4
3-4
3-4
3-5
3-5
3-5
3-5
3-5
...............................................
3-6
.............................
3-7
TABLES. FIGURES. AND FORMS
ArsU?'ane Guidelines for Hernodialysis Devices
Chapter 3
Water Treatment
TECHNICAL DESCRIPTION OF
DEVICE
incidents or complications can be summarized by

fkmsingonpl.c331emsthatomuredwitheachcomponent
Prior to the 1970ts,chronichemodiaysiswas performed

using tap water to prepare the dialysate. In these
early days, medical instability of the chronic renal
failure patient in combination with the multiple
problems related to other components of the dialysis
therapy tended to mask problems that may have
been due to impurities in the tap water.
As the practice of hemodialysis progressed and the

equipment and other apparatusinvolved in the therapy
improved, it became apparent that various chemical
and microbiological contaminants present in tap
water were indeed responsible for a number of the
deleterious effects seen in the chronic hemodialysis
population. Table 1A presents a list of the most
common contaminantsfound in tap water, and Table
1B presents the clinical effects related to these
contaminants.
Today, virtually all chronic hemodialysis facilities
in the United States employ some type of water
treatment system to purify water before using it to
produce dialysate.
Water treatment systems are a combination of a
variety of components, each with varying roles and
effectiveness in removing contaminants commonly
present in drinking water. Table 2 briefly reviews
the most common water treatment system components
used for producing purified water for hemodialysis.
In 1989 the FDA produced and released a videotape
entitled Water Treatment in Hemdialysis and in
1990 a manual entitled A Manual on Water Treatment for Hemdialysis Both have been distributed
to all dialysis facilities in the United States.
#=KSAND
HAZARDS
prior to 1980 contains reports ofpatient

ons attributed to malfunctions or misuse
water treatment systems in hemodialysis. These
Assurance Guidelines for Hernodidvsis Deoices
Filters Bacterial growth, resulting in pyrogen

reactions; hemolysis, due to elution of formaldehyde from media; particle breakthrough, causing
damage to downstream equipment.
Carbon Absorption: Bacterial growth, causing

pyrogen reactions; chloramine breakthrough, due
to inadequate sizing or exhaustion of the media
resulting in hemolysis; release of carbon fines,
damaging the reverse osmosis RO.)membrane;
inappropriate bypassing of carbon filter.
Softeners: Bacterial contamination, resulting
in pymgen reactions; hypercalcemia and hypermagnesernia, due to inadequate regenemtion, improper
connections, and poor salt quality;hypematremia,
due to mistiming of regeneration while patients
were on dialysis.
Ion Exchange: Bacterial contamination, causing
pyrcgen reactions; elution offloride, toxic residues,
and acidic effluent, due to continued use of exhausted deionization system; elution of chemical
toxins and impurities, due to the use of industrial
grade resins; sloughingofhes, due to poor quality
of resins; patient exposure to toxic chemicals,
due to inadequate rinsing of disinfectant; low
pH, due to acidic effluent; nitrosaxnines from
use without carbon filter.
Reverse Osmosis:Bacterial contamination, due
to inadequate disinfecting or membrane breakthrough; premature failure of membrane, due to
inadequate or improper pretreatment.
Storage: Bacterial contamination, resulting in

pyrogen reactions; zinc toxicity, due to leaching
from storage tank.
Distribution: Bacterial contamination, causing
pyrogen reactions; back-siphoning of germicide
from one machine to another, due to improper
distribution design.
treated as necessary to maintain a continuous

water supply that is biologically and chemically
compatible with acceptable dialysis techniques.
Records of test results and equipment maintenance
are maintained at the facility."
Literature review from 1980 through 1989 and the

more recent MDR files indicate the followingadditional
incidenwproblem areas:
Inadequate removal of aluminum in the water
purification process for dialysis, resulting in
aluminum-inducedfracturing osteodystrophy and
dialysis dementia.
2. The second set of guidelines is contained in the
American National Standards for Hemodialysis

Systems (AAMI: RD5-1981). In this document
the standards are related to the manufacturer
and to the user. A summary of the standards
for the manufacturers is found in Table 3 and a
summary of the standardsfor the user is contained
in Table 4. Recommendations to enable users to
achieve the standards are summarized in Table
5.
Bacteremia and pyrogen reactions, resulting from

improper placement of water heater "downstreamn
of reverse osmosis.
Contamination of water used for the reuse of
dialyzers with non-tuberculous micobacterium,
due to inadequate design andlor disinfection of
water treatment system and distribution piping.
Ethylene glycol intoxication, due to accidental
attachment of air conditioning system to dialysis
water treatment system.
Nitrate induced anemia in a home dialysis patient,
due to inadequate water treatment (sohner only).
Metabolic acidosis, due to improper water bwdment
and low pH of purified water.
Pseudomonas stutzeri bacteremia and pyrogen
reactions, due to contamination of deionizers.
Generation of dimethylnitmsamine (a carcinogen)
in mixed-bed deionizer, due to non-use of precarbon filter.
3. The third standard, in the Code of Federal Regulations 42 CFR Part 405.2150, is related to reuse
of hemodialyzers and other dialysis supplies.
This section adopts, by reference, the AAMI
Recommended Practice for Reuse of Hemodialyzers. Table 6 summarizes this standard.
4. The fourth guideline is the Safety Alert issued

by the Food and Drug Administration (FDASthat
issued recommendations regarding chloramines
and their removal (February 19, 1988). This
document states that the use of granular activated
filters for removal of chloramines should include
the following
Accidental over-fluoridation of municipal (tap)

water combined with inadequate monitoring of
deionization, resulting in use of exhausted tanks
and subsequent toxic patient reactions (including
death) from fluoride contamination.
Many ofthe incidents could have been avoided through
routine testing, observations, a more thorough
understanding of water treatment, proper system
design, and quality control procedures. Although
only a few of these incidents resulted in patient
death, almost all had the potential to cause death.
m T I N G GUIDELINES
There are four standards/guidelines pertaining to
water for dialysis purposes:
1. The Code of Federal Regulations 42 CFR Subpart
U, Part 405.2140 (a) (5) states that Water used
for dialysis purposes is analyzed periodically and
a Whenever a change is made in the exisiting

water treatment system, ascertain the capacity
of the carbon filter to cope with that change
by consulting with a water treatment engineer,
contractor, or consultant who is experienced
in the operation of hernodialysis water treatment
systems. This is to assure that the maximum
expected level of chloramines from the municipal
water supply can be effectively removed with
the carbon filter being used.
b. Use charcoal filters containinggranular activated
carbon (GAC) and replace rather than regenerate
the filters when exhausted. It is recommended
( W o m i a law requires) that the water treatment
system contain two carbon filters in series.
c. Test the water for chloramines as it exits the
first filter at least once per patient shift. If

the level of chloramines exceeds the 0.1 ppm
standard, there should be an immediate test
for the chloramine level in the water used to
prepare dialysate.
3-2
d. Establish a systematic plan for replacing the

filters as they become exhausted. With the
filters in series, the exhausted first filter can
be replaced with the second, and a new carbon
placed in the second position.
e. Whenever a carbon filter is replaced, disinfect
and thoroughly rinse the filter housing before

the new filter is installed.
QUALITY ASSURANCE FOR

WATER TREATMENT SYSTEMS
Policies and Procedures

An essential facility quality assurance activity is
the development, writing, implementation, and evaluation of policies and procedures for the water treatment
system. All standards previously described must
be incorporated into these policies and procedures.
Specifically, the policies and procedures must address
the scope oftreatment, components and related equip
ment and monitors, and testing expectations.
Comprehensive policies and procedures must also
address the interrelationships of each component
of the water treatment system, as well as the various
related components, such as the dialyzer, delivery
system and patient. The risks involved must be
clearly identified and considered, and appropriate
safety measures and preventative systems developed.
Policies and procedures must also address safe and
effective operation of the water treatment system,
including
basic technical operation
use of the equipment
safety checks
preventative maintenance
cleaning and disinfection
scheduled monitoring
troubleshooting and repair
record keeping
patient monitoring.
Asswrance Guidelines
Staff Training and Continuing

Education
Role descriptions should include all personnel
responsibilities for water treatment: supplies and
equipment, testingand monitoring, and other similar
responsibilities. Each responsibility should stem
from a specific policy or procedure.
StafFtraining should be a well-defined and organized
process. Content should be clearly defined for the
learner and be based on behavioral objectives. The
behavioral objectives can be used to accurately and
objectively measure learning. At the end of the
didactic session(s), the instructor should confirm
by a written test andlor return demonstration that
learning has occurred and that the learner is able
to perform the procedure(s) independently without
error. Documentation of testing results should be
placed in personnel files.
Comprehension of the purpose and function of each

component of the water treatment system requires
a basic understanding of normal physiological
concepts, as well as responses associated with uremia
and the hemodialysis therapy. Content should include
principles of dialysis and water treatment, patient
response to therapy and related complications, and
monitoring and evaluation. The interrelationships
of each system component, the delivery system,
dialysate, dialyzer, etc. must be incorporated into
the training process.
Need for further education, such as inservices or
intensive educational sessions, can be determined
from the routine quality assurance monitoring process
(see Form 1,'Water Treatment System Monitoring
Form", used for concurrent quality assurance
monitoring) and the ongoing staff performance
appraisal process. When problems are identified,
staff should be made aware of the problems and be
involved in their resolution. This nearly always
includes problem-specific continuing education.
The medical director of the dialysis facility must
verify that the individual has successfblly completed
the initial education and training program. The
medical director is also responsible for assuring that
an annualperformance evaluation has been performed.
firms that water being delivered from the softener

is at acceptable limits at that time. Some experts
recommend, however, that post sohner hardness
also be tested a t the end of the treatment day in
order to confirm proper softener sizing and
regeneration protocols.
A Daily Monitoring
To continually confirm that water produced by the
system is suitable for hemodialysis purposes as well
as to confirm the integrity and proper functioning
of all system components, an aggressive monitoring
process must be followed. Form 2, Water Treatment
System hg,"provides a useable format 61-the mrding
of these data:
(Please note that this form is provided as a model
only; actuul content may need to be altered to f l the
specific system of the individual facility.)

1. Temperature: Daily confirmationof temperature
should be performed.
2. Pressure Monitoring: Monitoring of pressure levels

and pressure drops across components assures
proper operating conditions.
3. Softener timer check: In installations where a
timer is used to actuate automatic regeneration
of the water softener, a daily check of clock set
time should be performed.
4. Reverse osmosis feed flow and permeate flow:
Substantial reduction in product flow rate is an
indication that there may be problems with a
pretreatment component or the reverse osmosis
membrane may be degrading due to scaling or
other types of membrane failure associated with
inadequate pretreatment.
5. Feed water total dissolved solids CTDS), product

water TDS, percent rejection: AAMI Standards
state that (for new RO. systems) "percent rejection
should be continuouslymonitored." This provides
an indication of the condition of the RO. membranes
as well as helping monitor against any catastrophic
compromise in membrane integrity.
7. Chloraminestesting:Testingfor chlorarnines should

granularbe performed as the water exits the
activated carbon filter. Using the recommended
DPD (N. Ndiethyl-pphenylene diamine)method,
results should always be less than O.lmg;/L. If
chloramine levels exiting the first tank exceed
O.lmg/liter, a test of the effluent of the second
tank should be immediately performed. Dialysis
should not proceed if the water used for production
of dialysate contains more than 0.1 m&
8. Audit: The reader will note the final line a t the

bottom of the Water Treatment Log" indicates
"Auditn On a daily basis, someonewho is knowledge
able about the tests, measurements, and limits
for the water treatment monitoring, as well as
the acceptable limits set forth in the facility's
policies and procedures for each one of those
measurements, should review the results. The
person performing the tests should be aware of
the acceptable limits and should have performed
proper notification and taken appropriate action
if the testdmeasurements performed indicated
results outside of acceptable limits.
B. Monthly monitoring
1. Conductivity meters require recalibration monthly,
following the manufacturers recommendations.
2. Microbiological testing of system components and

the distribution system must be performed monthly
in the following manner:
The performance shall be such that the salt passage

rate (100% minus the rejection rate) does not
exceed two times the salt passage rate of the
equipment a t the time of its initial qualification.
Calculate the salt rejection by the following formula:
6. Post water softener hardness: The AAMI American

National Standard for Hemodialysis Systems also
recommends that post waters oftener hardness

be checked daily before dialysis begins. This con-
a Post cadmn filhtkm AAMI (American National

Standardsfor Hemsystems)recommends
that "carbon tanks be monitored for excess
bacterial levels." Although there is no standard
for bacterial levels exiting a carbon tank, very
high levels may indicate a load so high that
domtxeam components are unable to adequately
remove them.
b. Post reverse osmosis: If a reverse osmosis

system is used as a primary method for attaining
microbiologically acceptable water, bacterial
levels should be assessed immediately aRer
the R.O. to ascertain that this goal is being
achieved.
3-4
c Post storage tank:If a storage tank is used

in the water treatment system, bacterial levels
should be cultured directly from this tank in
order to ascertain proper tank design and
disinfection protocols.
d. Post deionize= If the deionizer is used without

reverse osmosis, or placed post reverse osmosis
without any downstream bacterial or endotoxin
protection (an ukdlter), midological integrity
of the effluent must be confirmed.
e. Post ultrafilter: If an ultrafilter is used as a
final bacteriaVendotoxin filter, integrity and

proper disinfection of the ultrafilter must also
be confirmed.
f End of "return loop": A sample should be

performed a t the end of the "return loop," if
used, a s a final measurement of bacterial
colonization anywhere in the system.
3. Any incident related to the water treatment system

should be handled immediately, and should be
included in monthly quality assurance meetings.
C. Patient Monitoring
The following monitoring activities relate to patient
response as it pertains to water treatment:
1. Routine blood chemistries may indicate improper
inorganic chemical concentrations or organic chemical contaminates.
2. Normal intra-dialytic monitoring of patients and

patient symptomology during the dialysis session
can also provide indications of chemical water
contamination. Symptoms seen with improper
water treatment are presented in Table lA
D. Home Dialysis Monitoring

All of the monitoring procedures described above
should be performed by the home dialysis patient,
home dialysis support personnel, and reviewed by
the medical director, as appropriate.
E. Other Monitoring
' h e following water treatment system monitoring
should be performed on a t least a quarterly basis:
1. Safety supplies. All safety supplies related to
personnel handling of chemical toxins or biological
contaminants should be inspected.
I
2 Trend analysis. A trend analysis comparing

microbial monitoring and system fhction should
be performed. A tool for assisting the facility in

this activity is shown as Form 3.
F. Prevention
1. Audit recordkeeping procedures semiannually.
2. Policies and procedures related to water treatment

and water treatment equipment should be reviewed
annually.
3. Facility standards related to the water treatment
system should be reviewed annually.
4. Maintenance and repair logs related to the water
treatment system should be reviewed annually.
5. Any utility (water, drain, electricity)requirements

related to the water treatment system should be
reviewed annually.
G. Purchasing Guidelines
1. Establish quality specifications for all equipment
used.
2. Estimate quantity requirements; allow for future
growth and possible membrane degradation.
3. Cite applicable standards.
4. Require system validation by the vendor to assure

specifications are met.
5. Require the vendor to test for andfor disclose
adverse conditions/substancesthat may effed the
membrane.
6. R a p & a detailed manual for operation,maintenance,

monitoring, disinfection, and safety.
7. Evaluate need for service contract.

As mmmended by the Food and Drug Administration
in the February 19, 1988 Safety Alert, a qualified
water engineer or consultant familiar with the special
needs of dialysis facilities should be consulted when
designing or installing a new water treatment system
or changing an existing one. Whenever changes
are made, it is essential to re-evaluate the design
of the water system as a whole in order to be certain
that it is adequate. The engineer or consultant,
along with the facility, should be familiar with pertinent chemical and bacteriological standards such
as the A M standard andor local, state, and federal
requirements.
Additionally, the design and specification guidelines
contained in the FDA publication, A Manual on
Water llZaQtment@ HernodiaEysis, should be reviewed.
REFERENCES
1. Association for the Advancement of Medical Instrumentation. American National Standard for
Hemodialysis Systems (AAMI: RD5-1981). Arlington, VA (1982).
2. KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation of Risks and
Hazards Associated with Hemodialysis Systems (Technical Report, Contract #223-78-5046).
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration/
Bureau of Medical Devices, Silver Spring, MD (1980).
3. EASTERLING, R. Mechanical Aspects of Dialysis Including Dialysate Delivery Systems and
WaterforDialysate. inclinical Dialysis. A.R. Nissenson, R.N. Fine and D.E. Gentile, eds. Appleton-Century-Crofts, Norwalk, CT (1984).
4. LUEHMANN, D.A., KESHAVIAH, P.R., WARD, R.A., KLEIN,E. and THOMAS, A. A Manual
on Water Treatment for Hemodialysis (FDA Contract #223-87-6027). U.S. Dept. of Health and
Human Services, Public Health Service, Food and Drug AdministratiodCenters for Devices and
Radiological Health, Rockville, MD (1989).
5. Water Treatment in Hemodialysis (Videotape). Food and Drug Administration (1989).
6. VASQUEZ, L. and McELROY, V.L. Validution Protocols for Hemodialysis Water Systems.
Continental Water System Corp., San Antonio, TX (1988).
Note: A list of additional references on this topic can be found in Appendix E a t the end of this
manual. These additional references are included to enable the reader to pursue further
investigationfor the purpose of training or research on this topic .
TABLE
1A
WATERCONTAMINANTS AND
THE LOWEST CONCENTRATIONS

ASSOCIATED WITH TOXICITY IN THE HEMODIALYSIS SETTING
Contaminants
Aluminum
Chloramines
Fluoride
Copper
Zinc
Nitrate
Sulfate
Calcium/Magnesium
Sodium
Microbial
Lowest Concentration
Associated with Toxicity (mg/L)
0.06
0.25
1.o
0.49
0.2
21 (as N)
200
88 (Ca**)
300
Luehmn. et a1 (1989)
SIGNS
AND
SYMPTOMS AND POSSIBLE WATER

CONTAMINANT-RELATED CAUSES
Sign or
Symptom
Anemia
Bone disease
Hemolysis
Hypertension
Hypotension
Metabolic acidosis
Muscle weakness
Nausea and vomiting
Possible Water Contaminant-Related

Cause
Aluminum, chloramines, copper, zinc
Neurological deterioration
and encephalopathy
Aluminum
Aluminum, fluoride
Chloramines, copper, nitrates
Calcium, sodium
Bacteria, endotoxin, nitrates
Low pH, sulfates
Calcium, magnesium
Bacteria, calcium, copper, endotoxin, lov
magnesium, nitrates, sulphates, zinc
Quality Assurdnce Guidelines for Hernodialysis Devices
Luehmn. et at. (1989)
OPERATORREOUI REMENTS
--
Blending Valve
Mixes hot and cold water to a fixed

predetermined temperature to
achieve optimal performance from
the reverse osmosis device.
Water temperature downstream

of blending valve should be monitored at least daily to maintain
optimum R.O. output, and to protect
R.O. membrane and patients from
excess temperature.
Bed Filter
Sand, multi-media, or diatomaceous

earth filter used to remove suspended matter or colloidal material
before downstream components.
Filter should be backwashed at

frequent intewals. Pressure drop
across filter should be monitored at
least daily.
Carbon Absorption
Activated carbon in tanks used to

remove chlorine, chloramine, and
some organics. Two tanks, each
containing granular activated
carbon in series, are recommended.
Each tank should have an empty
bed contact time of 3 to 5 minutes.
Carbon tanks should be followed by
particle filters to remove carbon
fines from tank effluent. Do not
install bypass piping.
Test water for chloramines after the

first tank before every patient dialysis shift. If chlorarnines are > 0.1
mg/L (AAMI Standard), immediately
test water exiting the second tank.
If these levels exceed AAMl limits,
dialysis should not proceed. When
chloramine levels reach AAMl limit
after first tank, replace carbon tank.
Monitor bacterial levels.
Water Softener
A tank containing insoluble spheres

or beads, called "resin." The resin
exchanges cations (positively
charged sodium ions) to remove
calcium and magnesium from incoming hard water. Most facilities
use "permanent" softeners which
incorporate a brine tank containing
concentrated sodium chloride
solution and a control system to
regenerate the softener at preset
intervals.
Test upstream for baseline. Maintain volume of salt in brine tank.

Test post-softener water for hardness at least once daily. Check
timer from proper setting at least
once daily.
Reverse Osmosis
A membrane separation process for

removing solvent from a solution;
this system pressurizes feedwater
on one side of a membrane. By
creating a pressure high enough to
exceed osmotic pressure, reverse
osmotic flow of water occurs across
a semipermeable membrane, giving
"product water" essentially free of
dissolved solids, microorganisms,
and endoxin.
Periodic and validated disinfection

and cleaning should be performed to
protect the R.O. membrane from
scale deposition, particulate and
colloidal fouling, and bacterial
growth. Feed and product water
pressures, flow rates, and ionic
content (conductivity) should be
monitored according to the manufacturer's recommendations, but
at least daily. Post-R.O. bacterial
levels should be measured at least
Variation in pH and temperature can

affect performance.
rank containing insoluble spheres,

3r resin, which remove all types of
anions and cations and replace
them with hydrogen and hydroxide
ions which combine to form water.
Deionizers may be categorized as
'mixed bed," containing both cation
and anion resin in a single vessel, 01
'dual bed." where each resin type is
in a separate vessel.
Deionizers should be equipped with

continuous monitors (temperature
compensated) indicating water ionic
quality of at least 1 megohmfcm,
and a visual and audible alarm,
should the effluent fall below that
level.
Due to the propensity for bacterial

growth in deionizers, they should be
followed by a downstream compoDue to the possibility of formation of nent which removes bacteria and
endotoxin.
carcinogenic nitrosamines when
chlorine contacts the resin, carbon
filtration should be used upstream
of deionizers.
Monitor bacterial levels of tank
A water tank that stores product
effluent. Disinfect tank and diswater; requiredfdesired in some
installations. A water level detector tribution system at intervals which
have been validated to maintain
controls the R.O.delivery to the
acceptable levels of microbiological
tank and a recirculationpump
contaminants. Monitor proper
maintains adequate flow and
performance of level sensors.
pressure to the distribution loop.
The Centers for Disease Control ha:

recommended against use of storage tanks due to hazards related to
bacterial contamination. However,
a number of facilities have been
able to successfully use storage
tanks that are properly designed
and effectively disinfected at
validated intervals.
Confirm proper tank design: airtight

tank with 0.2177hydrophobic air
filter; constant flow with no stagnanl
areas; able to be adequately disinfected and rinsed (bowl-shaped
bottom with drain); tank material
should not add chemical contaminants. etc.
A low pressure mercury vapor lamp

protected by a quartz sleeve which
emits a bactericidal wavelength ligh
to water flowing past it. It should be
noted, however, that certain bacter,
ial species are resistant to ultraviolet irradiation and that this method
does not remove endotoxins. Biofilm will decrease effectiveness.
Monitor loss of radiant energy output. Perform regular maintenance,

including lamp replacement and
cleaning.
OPERATOR
REOUIREMENTS
COMPONENT
NAYE
Ultrafllter
A membrane filter capable of working solely off of existing circuit

pressure (no special pressurizatibn
pump is required (as with R.O.))
which will remove smaller partides
than depth filters. Ultrafilter membranes can be configured as hollow
fibers or spiral wound flat sheets,
and they can be operated in either a
'dead-end" or "cross-flow filtration"
mode.
Pressure drop and flow rate across

the filter should be monitored on at
least a daily basis. Filter should be
cleaned and disinfected on a routine
and validated intewal. Post-filter
bacterial levels should be monitored.
Ultrafilters are capable of removing

bacteria
and endotoxin.
--
Dlstrlbutlon Loop
The distribution loop includes all

piping from other water treatment
system components, distribution
pumps, pressure tanks, etc.
Current acceptable industry design
suggests:
constant flow through all distribution piping, most commonly
achieved via "recirculating loop"
pipe materials which do not
degrade the chemical or microbiological quality of the water
a minimum flow velocity in piping
of 1.5 ftlsec to discourage bacterial colonization
avoidance of any dead-ends in
piping.
At least monthly monitor bacterial

levels in distribution piping at point
where dialysis delivery systems
connect. Disinfect distribution
system at intervals which have
been validated to maintain acceptable levels of microbiological
contaminants.
TABLE
3
AAMI RJZQUIREMENTS
FOR MANUFACTURERS
GENERAL
Device labeling
Product literature
Initial validation
Materials compatibility
SUPPLIER:
AUTOMATIC
REGENERATION
DEVICES
Shall prevent excess levels of contaminants from entering downstream during
regeneration
SUPPLIER:
CARBON
FILTERS
5p filter downstream
Discard and replace exhausted GAC
SUPPLIER:
DEJONIZATION
Continuous resistivity monitor (>l megohm/cm)
Temperature compensated monitor
Visual and audible alarm

GAC upstream (nitrosamines)
SUPPLIER:
PIPING,STORAGE
TANKS
Shall not contribute contaminants (i.e., copper, zinc, lead, bacterial, etc.)
SUPPLIER:REVERSE
OSMOSIS
Capable of AAMl spec. water

Monitor sall passage (2x initial) (salt passage = 100 - rejection rate)
Audible and visual alarms (at highest rejection coefficient where contaminants
reach unsafe levels)
SUPPLIER:
SEDIMENT
FILTERS
Opaque housings
TABLE
4
AAMI STANDARDS
FOR FACILITIES/USERS
MICROBIOLOGICAL
MONITORING
Should be performed at least monthly
Total viable microbial counts shall not exceed 200lml in water used to prepare
dialysate, or 2000lml in proportioned dialysate exiting the dialyzer.
CHEMICAL
CONTAMINANTS
MONITORING
Should be performed at least yearly if prepared by Dl or RO, more frequently if
preparedwith lesser level of treatment.
AAMl maximum levels of chemical contaminants*:
Contaminant
Suggested Maximum Level (mgIL)
Calcium
Magnesium
Sodium**
Potassium
Fluoride
Chlorine
Chloramines
Nitrate (N)
Sulfate
Copper, Barium, Zinc
Aluminum
Arsenic, Lead, Silver
Cadmium
Chromium
Selenium
Mercury
2 (0.1 mEq/L)
4 (0.3 mEq/L)
70 (3 mEq/L)
8 (0.2 mEq/L)
0.2
0.5
0.1
2
100
0.1 each
0.01
0.005 each
0.001
0.014
0.09
0.0002
The physician has ultimate responsibility for determining the quality of water used for
dialysis.
**
230 mg/L (10 mEq/L) where sodium concentration of the concentrate has been
reduced to compensate for the excess sodium in the water, as long as conductivity
of water is being continuously monitored.
TABLE
5
AAMI RECOMMENDATIONS
FOR USERS
CARBON
FILTRATION
Disposable carton
Monitor for bacteria
Monitor for exhaustion
DEIONIZATION
Don't use "industrial" or process resins

One megohm resistivity minimum quality with temperature compensated monitor
Be aware of preservatives and anti-freeze solutions
Carbon filtration for protection against nitrosamines
DISINFECTION
Good procedures for all equipment and systems

MONITORING
PROGRAM
Periodic water analysis

In-line continuous monitoring
Test kits for daily monitoring
A procedures manual
PIPING,STORAGE,
ETC.
Don7 use copper, galvanized iron, or iron materials

REVERSE
OSMOSIS
Monitor pretreatment
Monitor operation
SEDIMENT
FILTERS
Opaque filters
Monitor pressure drop (AP)
Change filters periodically and/or monitor for bacteria
WATER
SOFENER
Automatic regeneration with bypass during regeneration

Pellet salt designed for softeners
Check timer before dialysis
Check hardness before dialysis
AAMI RECOMMENDED
~ C ' l ' I C EFOR REUSE OF HEMODIAL~ER:
WATERREQUIREMENTS
Must meet requirements (pressure, flow rate, chemical quality, microbiological

quality, etc.) of reprocessing equipment operating under peak conditions.
WATERUSEDFOR RINSINGCLEANING
DIALYZER
The water should have a bacterial colony count of less than 200lml and/or bacterial
lipopolysaccharideconcentrationof less than 1nglml (5EUlml). as measured by the
Limulus amebocyte lysate assay.
The water should have a bacterial colony count of less than 2001ml and/or bacterial
lipopolysaccharideconcentration of less than 1 ng/ml(5EU/ml), as measured by the
Limulus amebocyte lystate assay.
PROCEDURE FOR
WATER TREATMENT SYSTEM
MONITORING FORM (FORM 1)
The purpose of this audit is to monitor technical
staff compliance with standard practices and procedures related to the water treatment system.
When staff are aware of the importance of the
policies and well trained in the procedures,
compliance should be very high.
Perform the Audit
Before the Audit
3. Observe staff for actual performance. Auditor

should not interfere with staff activities, be
obtrusive, or preceptibly obvious.
1. Provide adequate and appropriate inservice to

assure total staff awareness and education of
all components associated with water treatment
for dialysis.
2. Assure staff awareness of all elements of the
concurrent audit and how performance will be
observed and evaluated.
1. On the actual audit sheet, write in the date,

auditor's name, patient shift (or time of day),
and standard.
2. Read each indicator carefully.
4. Under each staff code letter, write Y for yes if

indicator is met, N for no ifindicator is not met,
or N/A for not applicable, not observed.
To achieve a Y (yes, indicator was met), staff

should be observed with complete compliance
for each encounter. For example, for a Y to
appear in the "Post-Softener Hardness Donen
box, the staff member must perform the test
before any patient dialysis is done and perform
the test exactly according to the instructions
for use of the test manufacturer and record the
results as per facility policy.
3. The QA committee specifies the standard (expected percentage compliance) desired for the
audit; begin not lower than 85%.
4. Schedule the audit with appropriate personnel

(head nurse, charge nurse, chief technician).
5. Make copies of the audit for each auditor1

observer.
6. Assign code letters for each staff member to be
observed; for example:
Employee A:
B:
C.
Glenn Close
Tom Hanks
William Hurt
etc.
7. Determine how many staff are to be observed.

It is recommend that one auditor should observe
no more than three to four staff a t one time.
8. Define the length of time for observation. I t is
recommended that the audit be conducted during peak activity times (daily start-up, shift
changeovers, etc.). The time frame should be
long enough to observe each staff member completely perform the listed activity.
9. Assign a staff member to perform the audit.
Auditor should not be assigned to other

responsibilities during the audit.
rlity Assurance Guidelines
5. Complete all observations within timeframe

specified. Assure that each indicator has one
response.
After the Audit

1. Under each employee code letter, add total
number of Ys and Ns; do not count NAs.
2. For each employee, calculate compliance percentage by dividing the total Ys by the total
observations; again, do not count NAs.
3. Calculate total compliance percentage for the

audit by dividing total Ys (all employee Ys) by
the total observations; do not count NAs.
4. For each indicator, calculate compliance per-
centage by using the same method as above;

again, do not count NAs.
5. Report results to QA committee and clinical
management team with additional comments
andlor recommendations.
WATER TREATMENT
SYSTEMMONITORINGFORM
-
Date
Auditor
Patient Shift
DayIDate
Staff Member (initials)
Threshold
DAILY MONlTORlNGlSYSTEM CHECKS

All gauge readings recorded
-
p
p
--
Post-softener hardness done

Pre-softener hardness done
Chloramines tested: Before 1st patient shift
Chloramines tested: Before 2nd patient shift
Chloramines tested: Before 3rd patient shift
Blended water temperature recorded
Feed and Droduct TDS, % rejection recorded
-
Feed and product flow rates recorded

Daily audit of log form done
Threshold
Staff Member
MONTHLY FUNCTIONS
Svstem disinfection loaaed
Bacterial samples donelresults recorded: Site
Bacterial sampl& donelresults recorded: Site

Bacterial sam~lesdonelresults recorded: Site
Bacterial samples donelresults recorded: Site
Q.A. Committee RemmnendedAubn:
% Compliant
Tue
Mon
Thu
Wed
Fr i
Sat
DATE
GAUGE READINGS
Pressure gauge #1 (psi) (pre-mix bed)

AP-mixed bed
Pressure gauge #2 (psi) (pre-softener)
AP-softener
Pressure gauge #3 (psi) (precarb 1)
AP-carbon tank #1
Presure gauge #4 (psi) (pre-carb 2)
AP-carbon tank #2
Softener timer check
I Temperature (OF)
Pressure gauge #6 (psi) (pre-filter)

Pressure guage #7 (psi) (post-filter)
AP-R.O. pre-filter
Feedwater TDS
- Product water TDS

Percent rejection
Feed flow
Permeate flow
Feed pressure
Permeate pressure
WATER TESTS
Pre-softener hardness
Post-softener hardness (p.m.)
7
Post-softener hardness (a.m.)

LOGGED BY
CHLORAMINES
TESTS ( ~ 0 . 1mgL)
Before 1st patient shift (initials)

Before 2nd patient shift (initials)
Before 3rd patient shift (initials)
-AUDIT (initials)
( Jan
DATE
-. .. BACTERIAL SAMPLES
Station #I
Station #2
Station #3
Station #4
Station #5
Station #6
Station #7
Station #8
Station #9
Station #I
0
SOFTENER
CHLORAMINES
City Water
Post GAC 1st shift
Post GAC 2nd shift
Post GAC 3rd shift
Post GAC 4th shift
REVERSE OSMOSIS
Feed flow rate
Product flow rate
Percent recover
Feed TDS
Product TDS
Percent rejection
Feed temperature
k5
'-t
00
I
I
Feb
( Mar
I
I
I
Apr
I
I
May
I
I
Jun
Jul
Aug
Sep
I
--
( Oct
Nov
( Dec
I
I
Chapter 4
Dialysis Delivery
System
TECHNICAL DESCEUPTION OF
DEVICE
Appropriate dilutionlproportioning of concentrate.
The dialysis delivery system (delivery system) s u p

plies dialysate to the hemodialyzer, maintaining
proper concentration, temperature, pressures, and
flow in the dialysate circuit. The delivery system
also monitors various functions related to the dialysate compartment and the blood compartment:
dialysate pressure, ultrafiltration rate, blood leaks
into the dialysate, changes in the pressure of the
blood circuit, air or air foam in the blood, and other
parameters.
Continuous monitoring of conductivity (and in

some machines pH) and interruption of dialysate flow to the dialyzer if these parameters differ
from preset limits.
Single patient, single pass systems discharge dialysate to drain after one passage through the dialyzer and are used to deliver dialysate to one patient a t a time. Dialysate is produced from proportioning dialysate concentrate and water. Normally,
single patient systems, also called "negative pressure systems," maintain a subatmospheric ("negative") dialysate pressure in order to accomplish fluid
removal.
Pumping the blood from the patient through the

dialyzer and back to the patient.
The central delivery system maintains a single

"centralndialysate proportioner which prepares dialysate for a number of bedside consoles or bedside
stations. Both the single patient/single pass systems and the multi-patient/single pass systems require a continuous supply of purified water and a
continuous source of concentrate. "Spent," or "exhausted" dialysate is discarded to the drain after it
has made a single pass through the dialyzer.
Interrupting power to the blood pump in such

situations as blood leaks, incorrectly heated dialysate, incorrect dialysate pressures, incorrect
blood compartment pressures, air in the blood.
The sorbent or regenerative dialysis system involves

reprocessing dial~satethrough a cartridge to remove toxins from the spent dialysate, as well as
adjusting electrolytes to the desired level. The standard volume used in regenerative dialysis is approximately 6 liters. This process does not require
a continuous supply of water or concentrate and
does not drain spent dialysate.
' h e basic functions of a dialysate delivery system
are summarized below:
Heating dialysate to physiological range.
P e a s i n g the dialyzer's dialysate compartment

a t a desired flow rate.
Monitoring desired dialysate circuit pressures.
Controlling andlor monitoring ultrafiltration rate.
Monitoring pressure in the extracorporeal blood

circuit.
Monitoring for blood in the effluent dialysate.
Monitoring for appearance of air in the blood
circuit.
Table 1 provides a Iummary of dialysis delivery

system components.
RISKS AND HAZARDS

The literature prior to 1980 contains a large number of reports of patient complications attributed to
problems with dialysis delivery systems. Included
are those that contributed to serious patient injury
or death:
Dialysate mixing errors
Improper settinghesetting of alarm limits
Proportioning pump failure

Conductivity monitor failue
Temperature alarm failure
Dialysate pressure alarm failure
Blood circuit dysfunction
Incidents reported in the literature or through the
Medical Device Reporting Program since 1980 are
summarized in Appendix A A total of 160 incidents were reported. Sixteen were related to central delivery systems and 144 were related to single
patient delivery systems.
Ofthe 160 incidents, 77 were related to user error.
Of the remaining, 70 included some component of
user error in addition to malfunction of the equip
ment itsew. Unfortunately, some of these problems
resulted in patient death.
Machine operated in bypass mode without attaching concentrate, resulting in hemolysis.

Hemolysis, due to empty concentrate jug concurrent with no alarm or by-pass.
Adverse reaction, due to improper pH, alarm

improperly set or disabled.
Hypercalcemia, due to improperly proportioned
concentrate.
Improper concentrateused concumn@ with h a p
propriately adjusted conductivity circuit, resulting in hyponatrernia and hemolysis.
Hypernatremia, due to high dialysate sodium
(248mEqA) caused by facility personnel reversing plumbing inside of machine.
Hemolysis, due to the machine in bypass during
dialysis and technically altered so water flowed
through dialyzer.
Incidents related to user error, or combination of

user error and machine malfunction included:
Patient death due to hypernatremia after staff

member responded to conductivity alarm by recalibrating c&ductivity circuit while patient was
dialyzing.
Blood Circuit
Blood line clamp not completely occluding blood
line; air introduction into blood circuit, resulting
in air embolism.
Todc Chemicals
Formaldehyde back-siphoned from one machine
to another (one machine set with high negative
pressure while the next machine, not in operation, yet in line on the water distribution system
still contained formaldehyde);resulted in patient
toxic chemical exposure.
Patient injury or death from air embolism, due

to an unarmed or bypassed air/foam detector.
Uncontrolled blood pump operation, resulting in
vascular damage and/or excessive extracorporeal
circuit pressures.
Toxic reactions due to patient exposure to germicide used for disinfectant in delivery system.
Patient bleeding, caused by excess heparin administration due to lack of heparin pump preventative maintenance.
Blciod pump stopped working during dialysis;

condition had occurred previously with no action; caused clotting of extracorporeal circuit
Dialysate Conductivity/Electrolytic
Concentration
Bacterial Contamination
Pyrogen reaction due to contaminated delivery
systems.
Ultrafiltration Control
Machine -lfwlction ~ U S i n g h y p e r ~ noi cr h p

tonic dialysate. Hypematremia due to grossly
malagiusted conductivity. These events resulted
in hemolysis, vomiting, seizure, and death.
Improper ultrafiltration rate due to machine

malfunction concurrent with lack of personnel
intervention, resulting in hypovolemic hypotension.
42
Dialysate Temperature
Flow through dialysate circuit despite temperature alarm or rinse setting resulting in hemolysis.
Dialysate a t 42OC instead of 37C with no alarm;
caused hemolysis.
Equipment failure alone is not necessarily dangerous

if a ~ ~ r o ~ l iuser
a t e monitoring and interventions
are utilized. When inadequate monitoring andlor
inappropriate interventions are implemented, the
malfunction may exacerbate into a lethal situation.
Of particular note, 147 of the incidents could

have been averted had the user followed manufacturer's instructions for use, preventative
maintenance,repair, and/or troubleshooting.
of the delivery system, as well as the various related components, such as dialysate, the dialyzer,
blood lines, and transducer protectors. The risks
involved must be clearly identified, considered, and
appropriate safety measures and preventative systems developed.
effective operation of the delivery system:
basic technical
set up and use of equipment

and related
ponents
safety checks

tmubleshooting and repair
record keeping
EXISTING GUIDELINES
The American National Standards for Hemodialysis
Systems were developed by the Association for-the
Advancement of Medical Instrumentation (AAMI)
and approved by the American National Standards
Institute in May 1982 (see Table 2).
The most complete guideline for the operation of
dialysis delivery systems, however, comes from the
manufacturer's instructions for use. These instructions should be incorporated into the facility's policies and procedures.
patient monitoring.

Education
Role descriptions should include all personnel r e
sponsibilities for operation and use of the delivery
system including preventative maintenance, troubleshooting and repairs, daily or per-treatment safety
and other system checks and recordkeeping. Each
responsibility should stem from a specific policy or
procedure.
Staff training should be a well-defined and organ-

DIALYSIS DELIVERY SYSTEMS
i
s
An essential step in designing the facility's quality

a~suranceprogram is the development, implementation, and evaluation of policies and procedures for
dialysis delivery systems. All standards previously
described must be incorporated into these policies
and procedures. Specifically, the policies and prod-s
must address the scope of care and theraWtic choices, equipment, disposables, and s u p
plies used in the dialysis facility.
ized program. Content should be clearly defined

for the learner and based on behavioral objectives.
The behavioral objectives can be used to accurately
and objectively measure learning. At the end of
the sessiods), the instructor must confirm by a
written test andlor return demonstration that learning has occurred and that the learner is able to
perform the procedure(s) independently without error.
Documentation of test results should be recorded
in the personnel file.
Comprehension of the purpose and h c t i o n of the
dialysis delivery system requires a basic understanding of kidney disease, fluids and electrolytes,
principles of dialysis, infection control, and complications of the hemodialysis treatment. Content
should include theory of operation, pre and post
lity Assurance Guidelines for Hemodialysis Devices
operational procedures, parameters of safety, cleaning and disinfection, electrical safety, emergency
procedures, troubleshooting, and water treatment.
from the ongoing quality monitoring process and
the continuous staff performance appraisal process. When problems are identified, staff should be
made aware of the problem and involved in its
resolution. This nearly always includes problem
specific continuing education.
ascertain that the individual has successfully completed the initial education and training program.
The medical diredor is also responsible for assuring that an annual performance appraisal has been
performed.

The following section provides a summary of recommendations for monitoring that should be performed to enhance safety and reduce the level of
risk of patient injury due to incidents related to
malfunction andlor improper use of dialysis delivery systems:
A. Daily Monitoring
1. Conductivity of the final dialysate being delivered to the dialyzer should be checked before
every treatment. When used, the pH of bicarbonate dialysate should also be confirmed before
each treatment. Conductivity must be within
the manufacturer's stated specifics. If the pH is
below 6.5 or above 7.5, dialysis should not be
started, even when conductivity is within acceptable limits.
2. Temperature should also be within the manufacturer's specifications. Temperature may be

checked with an independent reference meter or
with a reference thermometer. As with pH and
conductivity, the actual numerical readings should
be recorded on the patient's daily dialysis record
and initials of the person performing the test
noted (see Form 1).
3. Absence of residual germicide should be verified
on all delivery systems connected to a single water
treatment qoop" before dialysis begins. Such
testing must be performed with an assay known
to detect the minimum standard level. The test
results should be documented on the patient's
daily dialysis record. The actual result should
be recorded and initials of the person performing the test noted (see Form 1).
4. A test of proper functioning of the airKoam detector should be performed before dialysis is initiated. This test should be a direct test of function of the alarm, causing interruption of the
blood pump and actuation of the blood line clamp,
either by introducing air into the venous level
detector or by removing the tubing so that air is
sensed by the detector-as recommended by the
device manufacturer. Test results should be
documented on the patient's daily dialysis record. The actual result should be recorded and
initials of the person performing the test noted
(see Form 1).
5. The blood detector must be checked for proper

armed status according to the method recommended by the manufacturer. Test result should
be documented on the patient's daily dialysis record. The actual result should be recorded and
initials of the person performing the test noted
(see Form 1).
According to manufacturers' instructions, the

conductivity should be checked with an independent reference meter which is known to be
properly calibrated. The pH can be checked with
a similar meter or pH paper.
6. If the delivery system employed is equipped with

ultrafiltration control, the user should perform
applicable tests of the ultrafiltration control system as prescribed by the manufacturer. Documentation of that testing should be performed
(see Form 1).
These readings should be documented on the

patient's daily dialysis record. The actual numerical readings should be recorded and initials
of the person performing the test should be noted
(see Form 1 for sample recording format).
7. All other alarms must be tested according to the

manufacturer's instructions for use before every
treatment including low and high conductivity
alarm, low and high temperature alarm, dialysate pressure alarm, water pressure alarm, etc.
Quality ~ssuranceGuidelines for Hernodialysis Deuices
Documentation of that testing should be performed (see Form 1).

If the particular delivery system is equipped with
a "self-alarm checkn mode, it is important that
the user understand that, most o h n , it is a
check of the electronic circuitry, and not a confirmation of some of the vital h c t i o n s of specific alarms.
8. Observation of dialysate flow should be made

while the machine is in a "dialyzingf mode. A b
sence of dialysate flow should be confirmed when
the machine is in "bypassn mode actuated by
both manual setting of the machine to bypass or
via any of the alarm functions that will cause
the machine to enter a bypass mode.
(Pm:
3. Preventative Maintenance
Monitoring documentation of all PM should be performed
to assure that it is completed within the scheduled time frame and performed according to the
manufacturer's recommendations (see Form 3).
1. Routine intradialytic monitoring of patient's
physiological parameters and symptoms during
the dialysis treatment can provide indications of
improper delivery system function. A few primary types of symptoms seen are:
B. Monthly Monitoring
1. Micmbiological testing: In accordance with
the AAMI American National Standard for Heme
dialysis Systems and in keeping with accepted
industry standards, water for production of dialysate and actual dialysate proportioned and
exiting the dialyzer should be monitored for bacterial levels on no less than a monthly basis.
Microbiological monitoring is performed to establish ongoing validation of proper disinfection
protocols.
Regular monitoring of a representative sample

of delivery systems will sate once protocols
are validated.
As indicated in the American National Standard for Hemodialysis Systems, the samphg should
be done "at the termination of dialysis a t the
point where dialysate exits the dialyze?. Results for total microbial counts shall not exceed
Nausea, vomiting, and headache may be

related to incorrect electrolyte composition of
the dialysate due to an incorrect dialysate or
improper proportioning of the delivery system.
Hypotension or hypertension may be related to improper ultrafiltration either through

failure of the ultrafiltration controller or improper blood or dialysate circuit pressure.
Pyrogen reaction (shaking chills, increase
in patient temperature of more than 1C during treatment) or septicemia (identified through
blood cultures) may occur from patient exposure to endotoxin or bacteria due to improper
disinfection of the dialysate circuit.
Hemolysis (cherry red blood in venous blood
tubing, chest pain, dyspnea, hypotension, increased serum potassium, decreased hematocrit) may occur due to improper dialysate composition, machine malfunction resulting in water only in the dialysate circuit, or very high
dialysate temperature.
2,000 colony forming units per ml. The facility

must assure that the American National Standard for Hemodialysis Systems assay protocol is
followed.
Acute blood loss (obvious source of blood

spill, shock, vomiting, convulsions) may r e
sult from extreme pressures in the blood circuit causing line separation.
2 Assessing trends: Pertinent information, i.e.,

bacterial levels, conductivity and pH readings,
etc., should be logged on a chart across a page so
that readings can be examined and compared
over an extended period of time. This tool makes
it possible to compare current readings to those
taken during the past several daydweeks/months.
Any untoward trends thus become immediately
2 for sample trend chart).
obvious (see ~ o r m
Air embolism (evidence of air in blood lines,
ity Assurance Guidelines for Hemodialysis Devices
chest pain, dyspnea, coughing, cyanosis, visual problems, confusion, coma, etc.) may result from air entering the blood circuit due to
failure of the air detectiodine clamping system.
Altered mental status (confusion, convulsions, and coma) may occur due to improper
dialysate concentration.

E. Other Monitoring
L At the prescribed recommendations of the manufacturer, or at least quarterly, dialysate flow rate,
blood D
- U ~- Pflow rate. and Drooer calibration of
the heparin pump should be tested d i d Y . Actual
flow rate should be measured over a prescribed
time using precise volume measurements.
An annual review of all policies and procedures
related to dialysis delivery systems should be
performed.
All incidents or adverse occurrences related to
didysis delivery systems should be documented
and reported a t the monthly quality assurance
meetings.
Quarterly monitoring of actual implementation
of dialysis delivery system procedures should be
performed (see Form 4 for sample Pre-dialysis
Checks Monitors and Form 5 for sample Technical Equipment Audit).
F. Prevention
1. Maintenance: Chapter 42 of the Code of Federal Regulations, $405.2140(a)(2) requires that
"All electrical and other equipment used in the
facility is maintained free of defects that could
be a potential hazard to patients or personnel.
There is established a planned program of preventative maintenance of equipment used in dialysis
and related procedures in the facility."
when preventative maintenance is required (see

Form 3 for sample Master Preventative Maintenance Schedule).
A history file of all repairs and maintenance for
each piece of equipment should be maintained
in a separate file. This file describes all technical operations performed on the equipment, including date, parts used, actions taken, tests performed to assure proper functioning before and
&r maintenandrepair, and person performing maintenancdrepair.
A log of all maintenancehepair work for each

piece of equipment should be kept a t the front of
the "history file." This log includes a very brief
description of the maintenancehepair (e.g., "500
h r maintenancen or "adjusted conductivity" or
"repaired inoperable blood pump," etc.), date, and
person performing action. Such a log provides a
trend analysis of any problems related to the delivery system, as well as a quick confirmation of
maintenance being performed according to schedule.
3. Repair & Troubleshooting:Even when dialysis delivery systems are properly designed, monitored, and maintained, the entire system may
unexpectedly fail or a component of the system
mav fail. Althoueh these failures cannot be foreseen and occur very infrequently, when they do
occur, it is important that patients are not a t
risk. The most important aspect of system failure is to have an established and agreed upon
plan of action. This plan should be approved by
the medical director and communicated to all
facility staff.
Each manufacturer provides comprehensive directions pertaining to preventative maintenance

requirements for the entire dialysis delivery system. Maximum time intemals--either in number of hours of operation of the system or in
calendar days-between preventative maintenance
procedures are also specified. The schedules and
procedures established must be followed.
2. Recordkeeping:A master schedule of all preventative maintenance should be developed. Such
a master schedule will list every machine by
serid number or other identifier and identify
Repair and maintenance on a delivery system

should be performed by "qualified personnel."
The definition of "qualified personneln may differ from facility to facility, and that definition is
the final responsibility of the medical director.
Consider the following recommendations:
a Facility personnel trained by another facility
personnel member who has been certified by
the manufacturer as competent to perform
such training, or
b. Facility technical personnel who have successMly completed (certified) the manufacturer's
technical training program, or
c. Manufacturer's technical service personnel.
46
The following is a list of pertinent questions to ask
when purchasing a delivery system:
What are the electrical, water flow, pressure,

and drain requirements?
Has the system proved safe and reliable in other

facilities? Seek and ve* references.
Does the manufacturer provide complete clinical
training in use of the device?

Does the manufacurer provide acceptable technical maintenance and repair? Does the manufacturer provide technical maintenance and r e
pair training to facility personnel?
Does the system comply with existing standards,

i.e., AAMI?
After finding the answers to these questions the
facility should:
1. Choose the two or three different manufacturers'

systems best suited to the facility's current and
future needs and desires, and
2. Request one of the chosen systems from each
manufacturer for an on-site trial of one to four
weeks duration, and
3. Obtain subjective opinion from the technical and

patient care staff, as well as from the patients,
and
4. Obtain objective information from the patient
care and technical staff. Using a form such as
the one included at the end of this chapter may
be helpll (Form 6).
This process will enhance the likelihood of selecting a delivery system which suits the needs of the
medical, clinical, and technical staffs. It also helps
to assure a system that is safe and effective in the
facility's hands.
Q ~ l i tAssurance
y
Guidelines for Hernodialysis Devices
REFERENCES
Hemodialysis Systems (AAMI RD5-1981). Arlington, VA (1982).

Hazards Associated with Hernodialysis Systems (Technical Report, Contract #223-78-5046).US.
Dept. of Health and Human Services, Public Health Service, Food and Drug Administration/
3. SHALDON, S. and LARSSON, L-A Hemodialysis Monitors a d Monitoring, in Replacement of
Renal Function by Dialysis. William Drukker, Frank M. Parsons, and John F. Maher, eds.
Martinus Nijhoff, The Hague, The Netherlands (1988).
in Introduction to Dialysis. MG.

Cogan and M. Garovoy, eds. Churchill Livingston, New York (1985).
4. GOTCH, F. and KEEN, M. Dialyzers and Delivery Systems
5. KEEN, M., LANCASTER, C. and BINKLEY, C. Concepts a d Principles ofHemodialysisinCore

Curriculum for Nephrology Nursing. L.E. Lancaster, ed. American Nephrology Nurses'
Association, Pitman, NJ (1990).
6. Emergency Care Research Institute. Improper Dialysate
in Health Devices Report (1984).
investigation for the purpose of training or research on this topic .
Quality Assurance Guidelines for Henodialysis Devices
Dlalysate Proportioner
Fixed Ratio
Mix dialysate concentrate(s)

and water to produce final
dialysate of predetermined
and precise electrolytic
composition.
Use correct concentrates;

calibrate conductivity circuit;
measure conductivity and pH of
final dialysate before
treatment.
Cylinders of known volume proportion dialysate concentrate

and treated water in exact, predetermined amounts; cyclic
filling and emptying of each
cylinder controlled through a
series of valves.
A control sensor monitors
conductivity of final dialysate
and regulates flow of dialysate
concentrate within specific
conductivity limits. Flow can
be regulated using variable
speed pumps, variable orifice
devices or other mechanisms.
Dialysate Pump
Maintains appropriate dialysate Visually confirm dialysate flow

through dialysate tubing andlor
flow rate through dialyzer.
dialyzer. Confirm dialysate flow
rate per manufacturer's
recommendations.
Blood Circuit Pressure Monitors

"Pre-pump"
Monitors extracorporeal pressure between patient's "arterial"

access and the blood pump.
Alerts operator to collapse in
tubing that has the potential to
cause hemolysis, damage to
vascular access, or partial
collapse in tubing, resulting in
inaccurate blood flow readings.
Monitors extracorporeal pressure between blood pump and
dialyzer. Alerts operator to
tubing separations and tubing
obstructions. Also useful in
calculating transmembrane
pressures (TMP).
'Venous"
Monitors extracorporeal pressure betweer! dialyzer and

patient's "venous" vascular
access. Alerts operator to
tubing separations and tubing
obstructions. Also useful in
calculating TMP.
Q U i t y Assurance Guidelines for Hernodialysis Devices
Before every treatment: test

monitors/alarms to confirm
proper function; confirm that
any limits are properly set,
secure all connections to
blood tubing, transducer
protectors, etc.
Precisely controls amount of

ultrafiltration from the patient's
blood during the hemodialysis
treatment.
Perform predialysis tests of the

irltrafiltration control system
Der manufacturer's instructions
lor use. Immediately investigate proper functioning of this
mmponent if a patient's actual
weight loss varies from expected weight loss by more than
the percentage indicated in the
manufacturer's specifications.
A controlled and measured

amount of dialysate is
removed, generally via a
volumetric pump, from a
closed, fluid-filled, noncompliant dialysate circuit.
Dialysate inflow and dialysate
outflow are precisely measured
using sensitive flow meters.
By subtracting dialysate inflow
rate from outflow rate, a microprocessor calculates ultrafiltration rate and adjusts the
machines' TMP to achieve
desired ultrafiltration rate.
-
Before every treatment: set

A 'Wow through" sensor, with
sensitivity as per manufacadjustable sensitivity that
turer's procedures, confirm
detects the presence of blood
in the effluent dialysate. When proper audible and visual
alarms, as well as blood pump
the amount of blood detected
by the device exceeds the limit and dialysate pump action in
alarm condition.
set during calibration, audible
and visual alarms occur, and
the blood pump stops. In some
systems, bypass of dialysate
flow to the dialyzer also occurs
-
- -- -
Monitors the extracorporeal

circuit for potentially lethal
quantities of air-in either the
venous blood tubing or the
venous bubble trap. Employs
ultrasonic device which measures changes in acoustic
transmission or photo-optical
device which detects change in
optical density between a light
source and a photocell. Upon
detection of a quantity of air,
audible and visual alarms are
activated, the blood pump is
stopped, and the venous blood
tubing is occluded.
Devices
Before every treatment:

confirm proper audible and
visual alarms, as well as blood
pump interlock and venous line
clamp in alarm condition;
confirm that airnoam detector
is armed and that tubing is in
the clamp assembly.
TABIS2
SUMMARY
OF AAMI DEL~VERY
SYSTEM
REQUIREMENTS
(MANUFACTURER STANDARDS)
Devlce Markings
Trade name of device
Manufacturer name and address
Model Number; serial Number
Requirementfor
Identification of
Product Ltterature
List of monitors and warnings regarding that they must be used.
Proceduresfor minimizing bacterial growth.
Warning to check dialysate concentration with independent method.
Accuracy and sensitivity of monitors.
Preset monitor limits.
Statement regarding microbiological isolation of blood circuit pressure monitors.
Time delay to initiationof blood leak alarm.
Specica
foitns
and test methods for deaerator.
Normal pressure drop specifications.
Method of TMP measurement.
Warning to check dialysate concentration (batch systems).
Identification of materials in contact with dialysate circuit.
Specifcations regarding airdoam detector.
Alarm adjustment procedures for maximimizing sensitivity of blood leak detector.
Warning regarding malfunctionsthat could lead to hemolysis and how to react.
Monitorsand Alarms
General (visible to patient; temperature in "C;pressure in mmHg).

Temperature: monitor on-line; maintain range of 36-40 "C;redundant safeties; audible and visual alarms;
alarm condition adivates bypass; automatic heat sterilization prohibits dialysis mode.
Dialysate Pressure: pressure entering dialyzer monitoredf 20%; hightlow limits; audible and alarms.
TMP monitors: accuracy f 20%; higMow limits; audible and visual alarms.
Blood circuit pressure: venous pressure monitoring required; accurxy It 10% of indicated pressure; highnow
limits; audible and alarms; blood pump deactivated in alarm condition; instructions for validation.
Concentration: on-line monitor; audible and visual alarms and bypass if dialysate concentrationf 5%;
redundant safeties; temperature compensated; hghnow limits.
Blood leak detector: required in all machines; meets AAMIdidated blood leak amount parameters; test
functions; calibration ability; audible and visual alarms; alarm condition inactivates blood pump.
AirFoam detector: required on all systems where ingress of air is possible; audible and visual alarms; alarm
condition stops blood pump and occludes venous line; audible and visual warning when not armed; shall not
cause chemical changes to blood.
Safety Requirements
General: safe configuration; monitors minimize false alarms and inadvertent resetting; monitors cannot be
disabled when patient at risk; audible alarms at least 70 decibels and unable to mute for > 180 sec; design
facilitates cleaning.
Electrid Safety: meet "nonisolated" patient connection requirement of ANS, Safe Current Limits for Electromedical Appartatus; electrical ground provided; corrosion resistant metals; electrical circuits separate from
hydraulic circuits and isolated from fluid leaks; main eledrical failure indicated by audible alarm.
t-
Patient Name
Date
DIALYSIS
PRESCRI~
Dilyzer
Time on
Dry weight
Actual time off
Predialysisweight
Rx time off
Desired weight bss
--
Prime
Rx dialysis length
Postdiisis weight
-.
Infusion
Actual dialysis length
UF rate
QB
QD
Heparin Rx:
Time off
Dilysate Rx
Expected cbning time
Actual cbning time
MACHINE
CHECKS
REUSE
B k a l leak alann
Patient ID
A& barn detect (ched)
Use number
Ak faam detect (armed)
Dialyzer strudurelaesthetic
UF check
Germicidedwell
M e n press set
Germicide presence
Machine number
Germicide absence
CI
m - r
II
Jan
II
Feb
I
I
- -- - --- \ - - . . - - r
Mar
I
I
nrv
Machine #I
Machine #5
'
lachine #6
, m ~ h : f47
i~
Mau
111 ICI R I
- Machine #8
- Machine #9
Machine #10
OTHERPROBLEMSSPECI IF^\
I
I
May
II
Jun
II
Jul
Aug
Sep
Oct
Nov
Machine #I
Machine #2
Machine #3
TEMPERATURE
Apr
- -
1
I
Dec
FORM
3
DELIVERYSYSTEMMASTERPREVENTATIVE MAINTENANCE
SCHEDULE
Machine #5
Jan
Feb
Mar
Machine #12
May
XI
Jun
Jul
Aug
Sep
Oct
XI
X1
XI
X1
X1
X1
XI
XI
Dec
XI
XI
XI
X1
XI
XI
Nov
X1
XI
XI
XI
XI
Machine #8
Machine #11
XI
Machine #7
Machine #10
Apr
XI
Machine #6
Machine #9
XI
XI
PROCEDURE FOR CONCURRENT

MONITORING FORM:
PREDIALYSIS TECHNICAL
CHECKS (FORM4)
policies and well trained in the procedures,
compliance should be very high.
Perform the Audit
Before the Audit


all components associated with water treatment for dialysis.

and standard.

indicator is met, N for no if indicator is not met,
or NfA for not applicable, not observed.

appear in the "Post-Softener Hardness Done"
for use of the test manufacturer and record the
results as per facility policy.

5. Make copies of the audit for each auditorfobserver.

Employee A:
B:
C.
Glenn Close
Tom Hanks
William Hurt
etc.

I t is recommend that one auditor should observe no more than three to four staff a t one
time;
8. Define the length of time for observation. It is
Auditor should not be assigned to other responsibilities during the audit.

response.
After the Audit


4. For each indicator, calculate compliance percentage by using the same method as above;

Quality Assuraiwe Guidelines for Hernodialysis Devices
Date
Machine type and no.
Auditor
Serial number
Meter reading
Last maintenance:
Date
TYP
Meter
STAFF RESPONSIBLE: Chief Technician, Medical Director, Head Nurse

OBJECTIVE: To assure that equipment is fully functional and safe for treatment use
A . SURVEY OF EQUIPMENT TECHNICAL RECORDS

YES
1.
Do equipment maintenance records include documentation of an electrical

safety check performed in accordance with interval recommended by
manufacturer?
2. Is the documentation of maintenance on each dialysis machine current and

complete?
3.
Is monthly bacteriologicaltesting of each dialysis machine performed and

the results documented in a permanent record?
4.
Is each dialysis machine disinfected in accordance with unit policy or as

indicated by bacterial testing?
5.
Are the following machine functions calibrated at least every three months?
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
6.
Bbod pump
Heparin pump
Air bubble detectorlline clamp
Blood leak detector
Audiohisual alarms
Temperature
Conductivity
Negative pressureluttrafiltrationpump
Arterial pressure monitor
Venous pressure monitor
Have the screen filters been cleanedlreplaced during maintenance procedures?
7 . Have the internal transducer protectors been changed during maintenance

procedures?
B . EQUIPMENT VISUAL INSPECTION

1
YES
Outside of machlne
a.
b.
c,
2.
d.
e.
f.
Are all the switches, knobs, and the venous clamp functioning properly?
Do the drip chamber level adjust knobdever operate properly?
Is the blood pump roller assembly secured tightly to its shaft, and do
both rollers turn freely?
Is the mechanical zero of the drip chamber meters operating properly?
Are the Hansen connectors free of leaks?
Are the o-rings of the concentrate connectors free of cracks and leaks?
g.
h.
i.
Is the acid concentrate connector free of residue buildup?

Is the bicarbonate connector free of residue buildup?
Is the air bubble detector housing clean?
j.
k.
I.
m.
Is the venous clamp clean?

Is the machine free of blood, salt crystals, etc?
Does the heparin pump carriage move freely?
Are all the lamps functioning?
Inside of machine
a.
b.
c.
d.
e.
Free of water leaks (no puddle at bottom of unit, connections)

Hoses and tubing assembly clear cnd clean
Check valves free of leaks
Fuses 0.k.
Tie-wraps around all hydraulic tubing pressure points
C. GENERAL FUNCTlONSlMAlNTENANCE
1.
Is measured dialysate flow (mllmin) at the drain within the following specifications:
a.
b.
c.
d.
e.
2.
Machine #1 (570 f 50)

Machine #2 (560 f 70)
Machine #3 @ 300
Machine #4 @ 500
Machine #5 @ 800
Is the test alarm battery serviceable:

a.
b.
c.
d.
Machine #l (9.0 f 0.5 V)

Machine #2 (9.0 f 0.5 V)
Machine #3 (1.6 f 0.25 V)
Machine #4 (9.0 f 0.5 V)
3.
Is the no-water alarm functioning?
4.
Is the no-power alarm functioning?
5.
Is the bypass function working?
NO
N/A
DIALYSISEQUIPMENTA U D I T
(cont.)
D . ARE THE FOLLOWING MACHINE FUNCTIONS CALIBRATED

ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS?
1
YES
Values for conductivity and temperature:

a.
b.
c.
Temperature
Na = 1 and Bicarb = 30
(37.0 f 0.5 OC)

(2.65 f 0.1 mmho/cm)
(3.05 f 0.1 mmholcm)
d.
e.
f.
Voltage at TP1
(1.25 V)
Na = 1 and Bicarb = 35 (12.50 f 0.1 mmholcm) (acid and bicarb)
Na = 3 and Bicarb = 35 (13.50 f 0.2 mmholcm)
g.
h.
Na = 3 and on acetate
(14.50 0.2 mmholcm)

(13.50 rt 0.2 mmholcm) (bicarb off)
2.
Was acid rinse procedure performed within the last 1000 hrs of operation?
3.
Has the effluent pump been oiled within the last 1000 hrs of operation?
4.
Are the effluent pump stators serviceable (at least -525 mmHg)?
5.
Is the pressure venffsampling port working properly (positive pressure

dialysate alarm, pressure not in excess of +475 mmHg before venting)?
6.
Is the concentrate pump occlusion 0.k. (at least -550 mmHg)?
7.
Was the stabilizer recharged during maintenance procedures?
8.
Does the four-way bypass valvelfluidic capacitor indicate that there is no leak?
9.
Does the hydraulic leak test indicate that there are no leaks?
10. Visual inspection (inside):

a. Fluidic capacitor free of residue
b. Stabilizer and air bypass lines free of residue
c. Cooling fan free of dust and lint
d. Air vents (top and bottom at back of unit) lint-free
e. pH probe free of residue
f. All cells (conductivity control mixer, monitor conductivity and
temperature, electrode conductivity cell) free of residue
g. Pump segments free of discoloration or flattening
.
h. All pump rotor arm pins correctly aligned
i. Neucleation chamber material clear
Pump header and manifold blocks free of cracks and leaks
j.
Drip
chamber level tubes free of cracks
k.
I. Effluent pump cover vents free of lint
m. Blood leak detector is clean
TOTALS
PROBLEMS IDENTIFIED:
Used wirh permission by Artificial Kidney Center. Palo Alto VA Medical Center, PPab Alto, CA
FORM 6
DELIVERY SYSTEM EVALUATION CHECKLIST

1. CONDUCTIVITY
A) What type proportioning system is used?
0) Can proportions be altered?
C) High and low limits?
D) Can limits be tested?
E) What type of readout (monitor) is used?
F) What type of internal monitoring?
G) Does it have a bypass mode?
H) Will blood pump run in bypass?
I) Can conductivity be falsified?
J) Will machine bypass if probe fails?
2. TEMPERATURE
A) High and low limits?
0) Can limits be easily tested?
C) How is temp adjusted?
D) What type readout? Scale?
E) What type of heating element is used?
F) Redundant monitoring?
G) Utilize bypass?
H) Will pump run in bypass mode?
3. DIALYSATE FLOW
A) Can it be altered?
0) Type readout?
C) Is there a (no water) alarm?
4. ARTERIAWENOUS MONITORS
A) What type readout?
B) What measurements used? Scale?
C) Transducer inlet type?
D) Type of gauge?
E) Sequential alarms?
F) Can limits be moved? Preset?
G) Can limits be tested?
H) Does indicator float with movement?
I) How does the alarm system work?
J)
K)
DELIVERY SYSTEM EVALUATION CHECKLIST tcont.)

5. DEAERATlON
A) How is it accomplished?
B) How effective is it?
C) How is air relieved?
6. BLOOD LEAK DETECTOR

Comparative?
Effects of air? Scum?
Cleaning?
Can limits be tested?
Sensitivity? (adjustalble)
Do limits need to be altered, adjusted each dialysis?
How does alarm system work?
7. AIR DETECTOR
A) Sensitivity
i. Adjustment?
ii. Testing
B) Will it accomadate drip chamber?
C) What type system?
D) How does alarm system work?
E) Line clamp incorporation?
F)
8. BLOOD PUMP
A) Type roller head used? (self occlufing?)
B) How is occlusion set?
C) What type of readout?
D) What scale is used?
E) Cleaning?
F) Cover?
G) Maximum blood flow rate?
9. HEPARIN PUMP
A) Syringe size used?
B) Delivery rate variationlscale?
C) What type pump used?
D) How does system work?
E)
F)
DELIVERY SYSTEM EVALUATION CHECKLIST (cont.)

10. RESET SYSTEM
A) Automatic/correction
B) Protective shield
11. RINSE MODE

A) Can Paitient dialyize in rinse mode?
B) Can it be "fooled"?
C) How does it work? Does bypass get rinsed?
D)
E)
12. EXTERIOR
Simplicity
Breakables
Weight
Portability
Cleaning
Electrical leakage?
13. OPERATOR'S MANUAL

A) Schematics-complete?
B) Understandability?
C) Procedures?
D) Function descriptions?
E) Detail?
F) Service?
G) CautionsNVarnings clear?
14. DlALYZER ADAPTABILITY

(defined by facility's therapeutic intent 8 dialyzer type)
A) Ultrafiltration Control?
i. Principle (Volumetric or Servo-Feed Back
ii. Accuracy (measured with dialyzers to be used)
iii.
8) Dialysate flow adjustable?
15. ISOLATED ULTRAFILTRATION

A) P.U.F. capabilities
B) Altering with venous pressure
C) Can ultrafiltration be measured?
DELIWRY SYSTEM EVALUATION CHECKLIST (cont.)

16. BICARBONATE DIALYSATE
A) What type proportioning system is used?
6) Can proportions be alteredlprogrammed?
C) High and low limits?
D) Can limits be tested?
E) What type of readout (monitor) is used (pH)?
F) What type of internal monitoring (pH)?
G) Will machine bypass if pH probe fails? (if applicable)
17. COMPANY RELIABILITY

A) Service
6) Follow through
C) Availability
18. SPARE PARTS

A) Necessary inventory
6) Cost
C) Availability/delivery time
19. MAINTENANCEIREPAIRS
A) How often what required for P.M.?
6) Special tools required?
C) Machine reliability
D) Training timeleasy for stafflhome patients?
E) Does company provide training? Cost?
20. OPTIONAL FEATURES

A) VariablelProgramable Sodium
6) Self-Diagnostics
C) Computer Interface (machine data, patient data, etc)
0) Blood Pressure Monitoring (patient)
E) Autodisinfect
e\
~ u aityl Assurance Guidelines for Henod ialysis Devices
Chapter 5
DLALYSATE AND
DIALYSATE
CONCENTRATE
CONTENTS
Page
......................
.......................................
5-1
RISKS AND HAZARDS
5-1
QUALITY ASSURANCE FOR DIALYSATE AND
DIALYSATE CONCENTRATE ................................. 5-2

Policies and Procedures .................................. 5-2
............................
Other Monitoring .................................
Prevention .......................................
StaffTraining and Education
REFERENCES
5-3
5-3
5-3
5-4
5-4
5-4
5-5
5-5
..........................................
5-6
.............................
5-7
QualityAssurance Guidelines for Hernodialysis Devices
Chapter 5
Dialysate and
Dialysate Concentrate
DEVICE
Briefly, the problems related to manufacturers included:
Dialysate, or dialysis fluid, is a non-sterile aqueous

solution with an electrolyte composition near that
of normal extracellular fluid. Its electrolyte composition is designed to correct the metabolic imbalance that occurs as a result of uremia.
Mimbial growth in liquid bicarbonate concentrate.
Electrolyte content of dialysate includes sodium,

potassium, chloride, magnesium, calcium, glucose
(optional), and either acetate or bicarbonate as a
buffer. Concentration of these electrolytes in dialysate fluid is shown in Table 1. Dialysate contains
none of the solutes that are eliminated from the
blood during dialysis (urea, creatinine, and other
waste products of nitrogen metabolism).
High levels of aluminum contaminating acetate

concentrate.
Actual electrolyte content of the concentrate was

different than described on the label.
Foreign matter in liquid bicarbonate concentrate.
Incidents related to user error, or machine malb c t i o n include:

Improper sodium concentrations due to miscalibration of or improper proportioning by the dialysis
delivery systems.
Dialysate concentrate is a preparation of salts which,

when diluted with water, yields dialysate for use in
dialysis. Dialysate concentrates are manufactured
commercially in liquid or powder form.
The chemicals present in the dialysate have access, via the dialyzer, to the bloodstream of patients undergoing the dialysis. Therefore, the proper
concentration of all of these chemicals as well as
the quality of the concentrate and the water used
to dilute the concentrate is critical.
The literature prior to 1980contained only one report

of patient complications attributed to concentrate:
a case of hypermagnesemia due to the use of commercially prepared concentrate with a magnesium
concentration ten times greater than specifications.
Incidents reported in the literature and through
the Medical Device Reporting program since 1980
are summarized in Appendix A Of note, 50% of
the 18incidents reported involved problems related
to the concentrate when delivered from the manufacturer. The remaining 50% were related to user
error or machine malfirnctions.
Use of wrong concentrates or improper mixing of

concentrates due to staff misreading labels.
Bacterial problems related to improper disinfection

of storage containers or use of water containing
excess bacteria.
Many ofthe incidents could have been avoided through
fairly simple tests, observations, or quality control
procedures implemented in the dialysis facilities.
Further, although only a few of these incidents resulted in patient death, almost all had the potential to cause death.
EXISTING GUIDELINES
Guidelines currently available regarding dialysate,
or dialysate concentrate, are found in the Association for the Advancement of Medical Instrumentation (AAMI) document, the American National Standards for Hemodialysis Systems (RD5-1981). These
standards can be separated into two areas: (1)
those related primarily to manufacturers' labeling
and literature and manufacturers' specificationsfor
concentrate, and (2) those dealing with microbiological suitability of final, proportioned dialysate.
5- 1
Table 2 summarizes these standards.

In the absence of federal, local, or other voluntary
standards, well accepted "industry" standards, that
is, accepted technique for handling of dialysate and
dialysate concentrate, are available. In 1983 the
Emergency Care Research Institute (ECRI) summarized these and recommended the following steps
as the appeared in Health Devices (1983):
1. Check the actualpH and conductivity ofthe ddysah
with an external meter.
2. Check the conductivity, pH, and temperature alarm
system before each dialysis treatment.
3. Assure that all personnel in the dialysis unit are

well informed of the types of concentrates available,
even if you presently use only one type.
4. Whenever possible, develop and use a system of
labeling,connector types,and matching containers
that prevent or minimize cross-connections or
use of mismatched concentrates.
5. Store and dispense dialysate concentrates as though

they were drugs. Develop a policy for inventory
management and storage system that will
effectively control the mixing and dispensing of
all concentrates. Storing concentrates according
to type, composition, and proportioning ratios
should reduce the risks ofmismatchedconcentrates.
Prohibit access to storage areas and allow only
authorized, specially trained personnel to mix
and dispense concentrates.
QUALm ASSURANCE FOR

DIALYSATE AND DIALYSATE
CONCENTRATE
Policies and procedures concerning dialysate and
dialysate concentrate as it relates to hemodialysis
therapy must be developed, written, implemented
and evaluated. All standards previously described
must be incorporated into these policies and procedures.
Specifically, the policies and procedures should address the different therapeutic prescriptions available in the facility, i.e., high-flux dialysis, high efficiency dialysis, and conventional dialysis. Each of
these differing therapeutic modalities may require
different types of dialysate; for example, sodium
modeling, bicarbonate dialysis, acetate dialysis,
ultrafiltration, or individual patient prescription.
of the dialysate as well as the dialysis delivery
systems. The risks involved must be clearly identified, considered, and appropriate safety measures
and preventative systems developed.
effective dialysate handling:
6. Verify and record actual dialysate composition

on the patient's records to assure that what is
being delivered is appropriate for what has been
prescribed by the physician (see Form 1).
7. Do not dispense concentratesfrom large containers

into smaller ones without a "keyed" dispensing
system. Such a system should include labeling
of the smaller containers as well as color-coded
or key-coded (shape) connections between caps
of containers and uptake tubing on machines.
8. Always dispose of concentrates remaining from
the previous treatment. Do not pour remaining
concentrate into another container or use in the
next treatment. Replace empty or partially full
containers with full ones. Whenever possible,
standardize equipment so that only one bicarbonate
concentrate system is used.
Qua1ity'~ssuranceGuidelines for Hernodialysis Devices
mixing of concentrate additives

mixing of acid and bicarbonate concentrate
labeling
container and delivery system connector systems
sanitary procedures used in handling and mixing
the concentrate, both in large tanks a s well as
individual containers
length of time for storing the concentrate after
mixing
frequency of sanitization of the mixing containers
and the delivery containers; use of a validated
sanitization procedure
measured microbiological condition of the water
used to prepare the bicarbonate concentrate
monitoring of patient reactions during dialysis
and trend analysis.

Education
A. Daily Monitoring
Role descriptions should include personnel responsibilities for handling and testing of concentrate,
ordering, confirmation of proper labeling, testing
and monitoring, and other similar responsibilities.
Each ~sponsibilityshould stem from a specific policy
or procedure.
Staff training should be a well-defined and organized process. Content should be clearly defined for
the learner and based on behavioral objectives. The
sessiods), the instructor should confirm by a written test andlor return demonstration that learning
has occurred and that the learner is able to perform the procedure(s) independently without error.
Test results should be documented and placed in
employee's personnel file.
Comprehension of the purpose and function of dialysate and dialysate concentrate requires a basic
understanding of normal physiological concepts, as
well as responses associated with uremia and the
hemodialysis therapy. Content should include dialysate fluid composition, h c t i o n , preparation,
conductivity and pH, and potential complications
with improper mixes of dialysate.
from the routine quality assurance monitoring p m ess and the ongoing staff performance appraisal
process. When problems are identified, all staff
should be made aware of the problem and be involved in its solution. This nearly always includes
problem specific continuing education.
The medical diredor of the dialysis facility must
ascertain that the individual has successhlly completed the initial education and training program.
The medical director is also responsible for assuring that an annual review has been performed.

To prevent patient injury associated with the use
of improper concentrates, concentrate mix-ups, miscalibrated dialysis delivery systems, and improper
function of the dialysate delivery systems proportioning or conductivity circuit, the following monitoring activities are recommended:
Conductivity of the final dialysate being delivered

to the dialyzer should be checked before every
tmatment The pH and temperakneofthe ddysate
should also be confirmed before each treatment
Conductivity should be within the manufacturel's
stated specifications. If the pH is below 6.5 or
above 7.5 dialysis should not be initiated, even if
the conductivity is within acceptable limits.
Conductivity should be checked with a independent
reference meter which is known to be properly
calibrated. The pH can be checked with a similar
meter, or with pH paper.
Becausetemperaturecan alter conductivityIleading,

the temperature should also be within the
manufacturel's specifications. Temperature may
be checked with a reference meter or with a
reference thermometer.
AU three of these readings should be documented

on the patient's daily dialysis record. The actual
numerical readings should be recorded, not simply
a "check markn or "0.k." Initials of the person
performing the test should also be included (see
Form 1for sample recording format).
Before initiating treatment, confirmation that the
prescribed concentrate is being used and that all
manufacturer's safety devices and features are
being employed should be done. This should
include reading the label on all concentrate containers, correct use of any color-coding andlor
any keycoding, and use of the proper facilitydesignated concentrate containers. This safety
check shouldbe documented on the patients dialysis
treatment record. Dialysis may be initiated when
all of these checks correspond to established
parameters.
If concentrates are mixed from powder in a large
container and then distributed into smaller "jugs,"
each jug should be labeled with the following
information (see Form 2 for sample labeling
formats):
Contents, i.e., A concentrate, B concentrate,
acetate concentrate, etc., plus proportioning
ratio.
Time the solution was mixed and initials of
person(s) mixing the solution.
Time the solution was dispensed and identification of person(s) performing this procedure.
5-3
confirm that the sanitization and handling

procedures for these jugs are also valid.
Other special additives inserted into the

concentrate (i.e., potassium, a potassium "spike,"
calcium, etc.). This information should also
be recorded on the label by the person pexforming
the addition. (Many facilities require that at
least two individuals watch this procedure and
initial the container.)
4. A monitoring andlor coding system should also
be included
the daily ior&ring of rinsing,
sanitizing, or disinfecting procedures for the
bicarbonate mixing tank or "concentrate jugs";
for example:
A daily log for sanitization and rinsing of the

mixing tank should include time performed
and initials of person(s) performing the task.
A daily log might also include proper recording
of any procedures required on "concentrate
jugs". This can more easily be performed if
each jug is identitied with a serial number
(see below for more information on coding of
concentrate jugs).
The daily log should also include results of
any test performed to verify adequate rinsing
(absence) of the disinfectantfgermicide used
so as to prevent any introduction of toxic
substances into the patient.
A culture sampling of the dialysis delivery

systems for dialysate as described in the AAMI
American National Standardsfor Hemodialysis
Systems provides an overview of the efficacy
of all systems for maintaining microbiological
standards.
3. To assesstrends,pertinent infonnation, ia,bacterial
levels, conductivity, pH readings, etc., should be

logged on a chart across a page so that readings
can be examined and compared over an extended
period of time. This makes it possible to compare
current readings to those taken during the past
several days/week&nonths. Any untoward trends
thus become immediately obvious (see Form 3
for sample trend chart).
The following patient monitoring aspects have relationships to dialysate and dialysate concentrate
handling:
1. Routineblood chemisbiesmay provide an indication
of improper use of concentrates. These are further
explained below.
2. Routine intradialytic monitoring and patient
symptoms during the dialysis treatment can also
provide indicationsfor improperly used concentrates
L On at least a monthly basis, calibration of any

reference meters used to perform daily or other
conductivity,pH, and other monitoring of dialysate
should be performed using a reliable Standard
Solution (see Chapter 7 for more information on
use of Standard Solution). Manufacturers may
recommend more frequent confirmation of proper
calibration. Be sure to follow the recommendations of the device manufacturer.
or~.Afewoftheprimarytypesofsym~
seen with incorrect use of concentrates are
summarized below:
Hyponatremia induced by low sodium content

in the dialysak,may result in hemolysis, nausea
and vomiting, and death.
0
2. On at least a monthly basis, validate the handling

and disinfection procedures to prevent microbiological contamination. To do this, the following
is recommended:
Obtain a sample of the bicarbonate concentrate

from any mixing tank. This should be done
on a "worse case" basis, i.e., draw the sample
after the ' --st period since the last disinfection1
sanitization, and after the longest storage time
for concentrate in that container.
A random sample of the concentrate fiom

concentrate jugs should also be performed to
inducedbyimproperfimctioning
dialysis proportioning system or too much
sodium in the dialysate; may result in nausea
and vomiting, seizures, and death.
Acidosis or allraZosisresultingh m improperk
used, or mix-ups in concentrates;will become
apparent by respiratory problems, nausea and
vomiting, headaches, seizures, and death.
Hyperkalemia induced by high potassium

content in dialysate; may result in death.

should be performed by the home dialysis patient
~ u a l i tAssurance
j
5-4
and home dialysis support personnel, and reviewed

by the medical diredor as appropriate.
E. Other Monitoring
Other monitoring includes assuring proper use and
outcome related to dialysate and dialysate concentrate handling:
1. An incoming materials log should be maintained.
Included in this log should be the identification
of the product, delivery date, lot number, and
person receiving the products. Dialysate should
be received, inspected, and released for use only
by authorized personnel who are trained in the
use and expected specifications of the product.
Confirmation that the product is properly labeled
as ordered should be performed. Any product
with labelsthatare not intact or thatare incorrectly
labeled should not be accepted.
2. An annual review of all policies and procedures
related to dialysate and dialysate concentrate
handling should be performed.
should be perfbrmed (seeForm 4 for sample dhlysd~

concentrate safety monitor).
F. Prevention
Follow exactly all of the manufacturer's instnrctions
for use.
Test conductivityand pH with a properly cabakd
independentrefmce meter before every treatment
If final proportioned dialysate is determined to
be not ofthe proper chemical concentration(im&
conductivity, incomct pH, particulate contamination, etc.), do not initiate dialysis.
If a determination is made that the chemical
c o n c e n m is improper after a patient is connected
to a machine, verify that the delivery system is
in bypass mode. Troubleshoot the problem with
the dialysate hoses disconneded from the dialyzer.
Confirm presence or absence of delivery system
malfunction. If the equipment malfunction is
confirmed, the patient should be immediately
disconnected.
3. All incidents or adverse occurrences related to

dialysate or dialysate concentrate handling should
be documented and reported at the monthly quality
assurance meetings.
4. Quarterly monitoring of actual implementation

of dialysate and dialysate concentrate procedures
Maintain a well-validated system of sanitization1

disinfection of all components of the concentrate
andlor dialysate handling system (water treatment
system, dialysis delivery system, mixing tank,
individual jugs,etc.).
Hernodialysis Systems (AAMI RD51981). Arlington, VA (1982).
2. KESHAVIAH, P.,LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation ofRisks and

H m d s Associuted with Hemodialysis Systems (Technical Report, Contract m23-78-5046).
U.S.Dept. of Health and Human Services, Public Health Service, Food and DrugAdministration1
3. Emergency Care Research Institute. Impmper Dialysrrte. Health Devices (October, 1983).
4. FAVERO, M.S. Dialysis Associuted Diseases and Their Control. Hospital Infections, J.V.Bennet
and P.S. Brachman, eds. Little, Brown, & Co., Boston, MA (1985).
6. VLCHEK, D L and BURROWS-HUDSON. QualityAssNephrology News & Issues, 4.9: 14-15(1989).
in Bicarbonate Dialysate Handling.
Note: A list of additional references on this topic can be found in Appendix E at the end of this
manual. These additional references are included to enable the reader to pursue firther
investigation for the purpose of training or research on this topic.
Sodium
Potassium
Calcium
Magnesium
Chloride
Bicarbonate or Acetate
Glucose (mg%)
TABLE
2
Smmwz~
OF AAMI D'IALYSATE
CONCENTRATE
STANDARDS
Manufacturer: Labeling and Documentation
Name and address of manufacturer
Date of manufacture
Lot number (capable of tracing manufactuing history)
Composition (including metric weight)
Ratio of water for mixing for proportioning systems; volume for batch systems
Composition of diluted solution (conductivity, concentration)
Fill volume of container
Trade name of product
For aqueous concentrates:
Storage temperature range
lnstructions for mixing
lnstructions regarding precipitates
- Warning regarding damaged containers
Warning regarding issues related to bacterial growth
- System for readily distinguishing between different solutions
For dry concentrates:
- Storage temperature range
- lnstructions to keep container tightly sealed until use
Manufacturer: Requirements for Concentrate

Physical state: either aqueous or dry
Solute concentration shall be f5% of stated concentration, except sodium & chlorine which must be 2%
"AAMI Quality water" must be used in manufacture of concentrate
Fill volume must be within 2% of labeled volume if for use with batch system
Acidity or alkalinity
- acetate concentrate: pH range 6.0 to 8.0 and require <1 mEq of acid or base to titrate 1 liter to pH of 7.4
- bicarbonate concentrate: include directions for proper mixing and prevention of calcium or magnesium
precipitation
Chemical grade must meet current requirements of USP/National Formulary
Final dialysate arsenic content must not exceed 0.05 mgA
Particulates: aqueous concentrate must be filtered through 1.5 p or finer, non-fiber releasing filter not
containing asbestos
Additives: concentrate must contain no substances other than those listed on label; no indicators or preservatives shall be added
Containers:
- shall not interact chemically or physically with contents that would in any way alter strength, purity, or
quality
- shall have closures that prevent contamination or loss of contents
- shall contain not less than 97% of labeled volume or weight
Water and chemicals used must be non-pyrogenic
User: Requirements for Dialysate

Water used to prepare dialysate:
- total microbial count 1200/ml
- within AAMVANSl maximum chemical contaminant levels
Dialysate:
- total microbial count s 2000/ml
5-8
XYZ DIALYSIS
CENTER
Date
Patlent Name
Dialyzer
Time on
Dry weight
Actual time off
Predialysis weight
Fk time off
Desired weight loss
Prime
Fk dialysis length
Postdialysis weight
Infusion
UF rate
Time off
Expected clotting time
QB
QD
Heparin Rx:
Diaiysate Rx
Actual clotting time
Conductivity
Blood leak alarm
Patient ID
PH
Air foam detect (check)
Use number
Temperature
Air foam detect (armed)
Dialyzer structure/aesthetic
Special Rx
UF check
Germicide dwell
Mixed by
A W e n press set
Germicide presence
Dispensed by
Machine number
Germicide absence
FORM
2
DIALYSATE CONCENTRATE LABELS
Dialysate Concentrate Tank Label
Date
Proportioning Ratio
Time Mixed
Initials
Additives
Initials
Comments
Dialysate Concentrate Jug Label
Date
Proportioning Ratio
Time Mixed
Initials
Time Dispensed
Initials
Additives
Initials
Comments
Jan
DATE
CULTURE SITE
Machine #1
Machine #2
Machine #3
Machine #4
Machine #5
Machine #6
Machine #7
Machine #8
Machine #9
Machine #10
MIXING T A N K
Feb
Mar
Apr
May
Jun
Jul
Aug
Se p
Oct
Nov
Dec

MONITORING FORM:
DIALYSATE CONCENTRATE
SAFETY MOMTOR (FORM 4)
policies and well trained in the procedures, compliance should be very high.
Before the Audit

all componentsassociated with water treatment
for dialysis.

Perform the Audit

and standard.


for use of the test manufacturer a n d record the
results a s per facility policy.

observer.

Employee A:
B:
C.
Glenn Close
Tom Hanks
William Hurt
etc.
Determine how many staff are to be observed.

It is recommend that one auditor should observe
no more than three to four staff a t one time.

specified. Assure t h a t each indicator has one
response.
After the Audit

Define the length of time for observation. It is


Auditor shouldnotbe assigned to otherresponsibilities during the audit.
Calculate total compliance percentage for the

For each indicator, calculate compliance percentage by using the same method as above;
Report results to QA committee and clinical
--
Date
Patient Shift
Auditor
Station Number
--
Staff Member (initials)

PER TREATMENT FUNCTIONS
Prowr concentrate confirmed on patient record
Proper connectors used (color codedkey coded)
Conductivity checkedlrecorded before treatment
1
1
1 I
pH checked and recorded before treatment

Concentrate jug properly labeled
DAILYIWEEKLYIMONTHLY FUNCTIONS
Staff Member
YIN
Most recent mixing tank sanitzation recorded on log

Most recent concentrate jugs sanitization recorded on log
Most recent concentrate iua bacterial culture within limits
Most recent mixing tank bacterial culture within limits
Q.A. Cornittee RecommendedActbn:
Chapter 6
HEMODIALYZERS
:
CONTENTS
Page
......................
.......................................
6-1
RISKS AND HAZARDS
6-2
...................... 6-2
StaffTraining and Education ............................ 6-3
Monitoring and Evaluation .............................. 6-3
Daily Monitoring ................................. 6-3
Monthly Monitoring .............................. 6-4
Patient Monitoring ................................ 6-4
Home Dialysis Monitoring .......................... 6-4
Other Monitoring ................................. 6-5
Prevention ....................................... 6-5
Purchasing Guidelines ............................. 6-5
QUALITY ASSURANCE FOR DIALYZERS
.............................
Qrurlity Assuran:ce Guidelines for H e d i a l y s i s Devices
6-7
Chapter 6
Hernodialyzers
Note: Information specific to reuse of hemodialyzers, as well as some other general discussion regarding dialyzers may also be found in Chapter 12,
Hemodialyzer Reuse.
Ultmfiltmtion is the simultaneoustransfer of a solvent,

with the small amount of solutes that it contains,
across a membrane.
DEVICE
The hemodiulyzer (dialyzer) is a device that permits electrolyte metabolic and fluid exchange between the blood and the dialysis fluid. A semi-permeable membrane separates two compartments;
the patient's blood flows through one and the dialysis fluid, or dialysate, flows through the other.
The solute and fluid removal capabilities of a dialyzer are referred to as performance characteristics.
Other characteristics such as materials of construction, priming volume and compliance, residual blood
volume, fluid dynamic parameters, etc. are referred
to as design characteristics.
Several of these basic characteristics of the dialyzer are described below:
Mass Transfer. Mass transfer is used to calcu-
The rate of ultrafiltration depends on the effective

surface area and the hydraulic permeability of the
membrane, as well as transmembrane hydrostatic
pressure.
In practical terms, solute removal (incorporating
both diffusion and ultrafiltration) from the blood to
the dialysate is most often defined as clearance .
Dialysance describes dialyzer efficiency when solute concentration in the dialysate is not zero, or
the volume of blood cleared of that solute per minute, if the dialysate concentration was zero (see
Table 3).
Dialyzer Membranes
There are three basic membrane types:
1. The conventional cellulosic membrane (Cuprophanq saponified cellulose ester, regenerated
cellulose, cuprammonium rayon, etc.)
late the amount of solute transfer across the semipermeable membrane. Mass solute transfer is the
quantity of a solute transferred from the blood into
the dialysis fluid (or vice-versa) per unit of time.
2. Cellulose acetate, and
Mass transfer across a semi-permeable membrane

includes two basic mechanisms, difiswn and dtrafiltration .
k o m a quality assurance perspective, membranes

must be evaluated prior to use based on their solute transport characteristics, biocompatibility, water removal, reuse, clotting, and membrane integ-
Diftcusion is the passive transfer of solutes across a

membrane in the absence of net solvent transfer.
The amount of solute crossing a membrane by diffusion depends on three factors: (a) the mean concentration ingredient of the solute on either side of
the membrane, (b) the effective dialysis surface
area available for diffiion, and (c) the total dialyzer permeability coefficient.
3. Noncellulosic and high flux (polysulfone, polyacrylonitrile, polymethylmethacrylate,polyamide,

polycarbonate, etc.)
rity.
Design Characteristics
Dialyzer design characteristics may also influence
the facility's selection of a specific dialyzer for a
given patient. These characteristics include the
priming volume and the compliance of the blood
compartment, blood and dialysate compartment

hydraulic pressure drops, the residual blood volume, the uniformity of flow distribution in blood
and dialysate compartments, as well as more subjective characteristics such as size, weight, shape,
etc.
Dialysate leak at dialysate port, resulting in

inadequate dialyzer clearance.
See Table 1 for a summary description of types of

hemodialyzers and their characteristics.
to clotting, due to inappropriate anticoagulant
RISKS AND HAZARDS

The literature prior to 1980 contains a large number of reports and patient complications attributed
to problems with dialyzers. These include problems with the structural design ofthe dialyzer, patient
allergic responses to the membrane material andl
or the chemical used to make or sterilize the membrane, and human errors.
Incidents reported in the literature and through
the Medical Device Reporting system since 1980
are summarized in Appendix A
A total 342 incidents were reported; apparent dialyzer hypersensitivity reactions comprised 205 of
these. Of the remaining incidents, many included
some component malfunction of the device, due to
manufacturer quality control error.
Incidents related to user error or a combination of
user error and device malfunction included:
F'yrogen reaction and sepsis, indicating bacterial contamination of dialyzer due to poor setup technique.
Dialyzer hypersensitivityreaction when dialyzer
was not primed according to manufacturer's recommendations.
Extreme blood loss, due to broken blood port on
dialyzer, blood line separation, cracked dialyzer
header, or fiber rupture with no blood detector
alarm.
Membrane leaks on dialyzm secon* to damaged

dialyzer housing, &r a case of dialyzers was
dropped without being reported.
Large plate dialyzer membrane leak secondary
administration and monitoring.
Many of the incidentscould have been avoided thrugh
fairly simple tests, observations, or quality control
procedures as specified in the manufacturer's instructions for use. Further, although only a few of
these incidents resulted in patient death, almost
all had the potential to cause death.
EXISTING GUIDELINES
Guidelines currently relavent to dialyzers are the
International organization for Standardization (IS01
Document 8637, International Standard for Hemodialyzers, Hemofilters, and Hemoconcentrators, and
the American National Standard for First Use
Hemodialyzers (ANSUMMI: RD16-1984) developed by the Association for the Advancement of
Medical Instrumentation (AAMI). Both of these
documents are, primarily voluntary standards for
manufacturers of hemodialyzers.
Table 2 summarizes AAMI's American National
Standards for First Use Hernodialyzers.

DIALYZERS
Air embolus, due to improper blood linddialyzer

connection.
An essential step in designing a facility's quality

assurance program is the development, implementation, and evaluation of policies and procedures
for hemodialyzers. All standards previously described must be incorporated into these policies and
procedures. Specifically, the policies and procedures must address the scope of care and therapeutic choices, equipment, disposables, and s u p
plies used in the dialysis facility.
Inadequate dialyzer clearance, associated with

poor priming technique and incomplete removal
of air.

address the interrelationship of each component of
the hemodialyzer, as well as the various related
Clotting of extracorporealcircuit, due to improper

anticoagulation monitoring.
6-2
components, such as the dialysate, delivery system, blood lines and transducer protectors. The
risks involved must be clearly identified and considered, and appropriate safety measures and preventative systems developed.
Policies and procedures must also address the safe
and effectivehandling and use of the hemodialyzer:
1. Storage conditions
2. Inspection of dialyzer before use
3. Priming of blood and dialysate path

4. Intra-dialytic monitoring of blood circuit pressure
5. Intra-dialytic monitoring of dialysate pressure
complications management and troubleshooting,

patient monitoring, and documentation.
Need for further education such as inservices or
intensive educational sessions can be determined
the continuous staff performance appraisal process. When problems are identified, all staff should
be made aware of the problem and be involved in
its solution; this nearly always includes problem
ascertain that an individual has successfblly completed the initial education and training program.
The medical director is also responsible for assuring that an annual performance appraisal process
has been performed.
6. Intra-dialytic monitoring for dialyzer blood leak
7. Technique for termination of dialysis
8. Anticoagulation
9. Management and troubleshooting of complications
10. Patient monitoring"

Education
Role descriptions should include all personnel responsibilities for general handling and use of the
hemodialyzer, treatment safety and record keep
ing.
Staff training should be a well-defined, organized

program with content clearly defined for the learner
based on behavioral objectives. The behavioral
objectives can be used to accurately and objectively
monitor and measure learning. At the end of the
session(s), the instructor must confirm by a written
test andor return demonstration that learning has
occurred and that the learner is able to perform
the procedure(s) independently without error.
Comprehension of the purpose and function of the
hemodialyzer requires a basic understanding of
kidney disease, fluids and electrolytes, principles of
dialysis, infection control, and complications of the
hernodialysis treatment. Content should include
dialyzer principles and function, dialyzer related
procedures, aseptic technique, parameters of safety,

risk of patient injury. These recommendations will
also ensure that the dialysis being received by the
patient is as prescribed by the physician.
A. Daily Monitoring
1. Physical inspection of the dialyzer for appropri-
ate labeling, undamaged packaging, intact caps,

and any other obvious defects should be performed.
2. Confirm that the dialyzer prescribed by the physician for the patient's treatment is being used.
3. Confirm that the dialysate flow rate and blood

flow rate prescribed by the physician are actual
delivery rates. Clarify that equipment settings
conform with prescription. Any reduction in
blood or dialysate flow rate must be documented
with rationale (see Form 1).
4. Confirm that actual dialysis duration is that
prescribed by the physician. Any departure from
the prescribed treatment time (in minutes) should
be explained on the record.
5. Test and document results of all components of

the dialysis delivery system, including:
Quality Assurance.Guidelines for Hernodialysis Devices
the ultrafiltration control system

the blood leak detector
arterialhenous pressure alarms; setting

limits
blood cultures), from patient exposure to an

improperly sterilized dialyzer or a break in
aseptic technique.
Acute blood loss, which may be the result of
extreme pressures in the blood circuit, causing dialyzer membrane rupture, blood leaking through the actual dialyzer housing, or
bloodline separation from the dialyzer.
6. Blood flow through the dialyzer as well as dialysate distribution and flow through the dialyzer should be observed a t the beginning and
throughout the treatment.
7. Monitoring and recording of anticoagulation

therapy must be performed to assure that the
delivery rate is as prescribed.
8. Special events such as blood leaks, pyrogen reactions, cracked dialyzers or other complications
should be recorded on the patient's record.
The performance of the above tests and observations should be recorded on a daily patient dialysis
record. The initials of the person performing the
test and the specific machine number should a p
pear on that record (see Form 1).
3. Routine monitoring and evaluation of anticoagulation therapy needs to be conduded for both
patient and dialyzer clotting times. Real andlor
potential complications related to anticoagulation need to be addressed and documented in
the patient record.
4. When treatment delivery is not as prescribed, it
is recommended that the patient's vascular access be evaluated for recirculation.
5. First Use Syndrome signs and symptoms include chest pain, anxiety, shortness of breath,
and back pain.
Any case of First Use Syndrome (FUS),or Dialyzer Hypersensitivity Reaction, should be addressed immediately. Signs and symptoms of
these reactions include asthmatic reaction, respiratory arrest, pruritis, urticaria, erythema, peripheral and facial edema, hypertension, hypotension, and cardiac arrythmia. The reactions
range from very mild to very severe, including
death. The following should be done in the case
of a suspected FUS reaction:
An essential component of assuring adequacy of

the dialysis treatment is to confirm that the dialyzers and the way the dialyzers are being used are in
compliance with facility expectations and national
standards. A welldesigned urea kinetics program
will enable the facility to monitor adequacy of treatment The patient should have one or more of the
following measured on, at least, a quarterly basis:
pdpost BUN reduction
KTN urea (delivered or actual)
Immediately discontinue dialysis on the patient without returning the contents of the
extracorporeal circuit. Provide medical treatment for any resulting symptoms.
prdpost creatinine reduction

Individual characterization of the dialyzers may also
be performed.
Many experts recommend that the same dialyzer type not be used on the patient, if possible. If the same dialyzer must be used, be
sure to rinse diligently according to the manufacturer's recommendations prior to use.
1. Routine monitoring of BUN as described above.
2. Routine intradialytic monitoring of the patient's
physiological parametersand symptomscan provide
indications of improper dialyzer function. A few
of the symptoms seen are:
Hypotension or hypertension, related to gross

dialyzer performance error, especially in the
absence of an ultrafiltration controller.
F'yrogen reaction (shaking, chills, increase in
patient temperature of more than 1C during
treatment) or septicemia (identified through
Note: A positive history of hypersensitivity reaction is an indication for careful monitoring for
such signs and symptoms during dialysis.

E. Other Monitoring
entire dialysis delivery system. The established

schedules and procedures must be followed.
1. Using the prescribed recommendations of the

manufacturer, dialysate flow rate, blood pump
flow rate and proper calibration of the heparin
pump should be tested directly. Actual flow
rates should be measured over a prescribed time
using precise volume measurements.
2. Water and dialysate must be tested and evaluated to assure at least minimum compliance
with AAMI standards.
2. An annual review of all policies and procedures
related to hemodialyzers should be performed.

Assure that current standards andfor regulations are incorporated as appropriate.
The following is a list of pertinent questions to ask

when purchasing hemodialyzers.
Does the dialyzer meet the facility's definition
of adequacy?
3. All incidents or adverse occurrences related to

hemodialyzers should be documented and reported a t the monthly quality assurance meetings. To assess trends that may compromise
patient safety, adverse occurrences associated
with the dialyzer should be recorded on a "flow
chart" so that the information can be examined, analyzed, and compared over an extended
period of time by the quality assurance committee. Any trends thus become immediately
obvious and appropriate action can be taken.
See Form 2 for a sample trend analysis format.
What are the performance characteristics of the

dialyzer? How do these performance characteristics fit in with the facility's and physician's
therapeutic intent?
What are the specific equipment needs related
to the use of this dialyzer?
4. Quarterly monitoring of actual implementation
What are the graphic representations of "in-vim"

expectations of performance according to the
therapeutic parameters that will be used in the
faility?
of hemodialyzer procedures should be performed.

See Form 3 for sample "Dialyzer Usen monitoring instrument.
Has the specific dialyzer been proven safe, reliable and effective in other facilities?
F. Prevention
1. Each manufacturer provides comprehensive directions for the preventative maintenance of the
These questions will enhance the likelihood of selecting a hemodialyzer that best suits the need of
the patient. It will also help to assure a treatment
that is safe and effective.
REFERENCES
1. Association for the Advancement of Medical Instrumentation. American National Standard,
First Use Hemodialyzers (AAMI: RD16-1984). Arlington, VA (1984).
Hazards Associated with Hemodialysis Systems (Technical Report, Contract #223-78-5046).
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration/Bureau of Medical Devices, Silver Spring, MD (1980).
3. SARGENT, J.A. and GOTCH, F.A. Principles and Biophysics of Dialysis in Replacement of
Renal Function by Dialysis. William Drukker, Frank M. Parsons and John F. Maher, eds.
Martinus Nijhoff, The Hague, The Netherlands (1988).
4. HOENICH, N.A., FROST, T.H. and KERR, D.N.S. Diulyzers inReplacement of Renal Function
by Dialysis. William Drukker, Frank M. Parsons and John F. Maher, eds. Martinus Nijhoff, The
Hague, The Netherlands (1988).
5. SHINABERGER, J.H., MILLER, J.H. and GARDNER, P.W. Characteristics of Available

Diulyzers in Clinical Dialysis. A .R. Nissenson, R.N. Fine and D.E. Gentile, eds. AppletonCentury-Crofts, Norwalk, CT (1984).
6. DHEW. Evaluation of Hemodiulyzers and Dialysis Membranes (report of a study group of the
Artificial Kidney-Chronic Uremia Program, E. Klein, Chairman. DHEW Pub. No. (NIH)771294). US. Department of Health, Education and Welfare, Washington, DC (1977).
7. VLCHEK, D.L. and BURROWS-HUDSON S. Quality Assurance Challenges in Short Dialysis.
Nephrology News & Issues, 5 , l : 12-14 (1990).
8. GOTCH, F. Kinetic Modeling in hemodialysis. Clinical Dialysis. AR. Nissenson, R.N. Fine
and D.E. Gentile, eds. Appleton and Lange, Norwalk, CT (1990).
9. KEEN, M., LANCASTER, C. and BINKLEY, L. Concept and Principles ofHemodialysis. incore
Curriculum for Nephrology Nursing. L.E. Lancaster, ed. American Nephrology Nurses'
Association, Pitman, N J (1990).
manual. These additional references are included to enable the reader to pursue further investigation for the purpose of training or research on this topic.
Membrane Type
Transport
Ultraflltratlon
Conventional Membrane
(Cuprophan, Regenerated Cellulose, SCE,
etc.)
Cellulose Acetate
Non-Cellulosic and
Key
+
++
+++
= Effective
= VeryEffective
= Extremely Effective
Blocompatlblllty
TABL~
2
AAMI DIALYZER
REQUIREMENTS
(MANUFACTURER
STANDARDS)
LABELING AND DOCUMENTATION

Device Markings
Manufacturer name and address
Product trade name and generic name
Catalog number
Lot number
Sterilization date
Identification of blood and dialysate ports
Unit Container
Sterilization Date
Statement regarding "sterile and nonpyrogenic"
Special conditions of storage and handling
Statement: "Caution: Federal law restricts device to
sale by or on order of a physician"
A warning that the device must be rinsed before use
Maximum TMP
Statement: " Caution: See Directions for Use before
using this device"
Other descriptive information, warnings, etc.
Warnings regarding flow maldistribution under
certain conditions
Warning ifultrafiltration rate is not linear with
relation to TMP
Package lnsert/lnstructions for Use
Instructions for priming, operating parameters,
monitoring, termination, etc.
Warranty for first use
Dialyzer description/specifications
Indications for use
Adverse Reactions
Recommendations regarding anticoagulation
Contraindications
Warning regarding conditions for backfiltration
Method of sterilization
Any particular features
Ranges for blood flow rate, dialysate flow rate,
TMP, temperature, etc.
Characteristics (UF coefficient, clearances, pressure drops, blood compartment volume, etc.
Names of materials in contact with blood or dialysate

Common chemicals and processes with known
adverse effects on dialyzer materials
Statement that the following is available upon
request: detaills of test methodologies, results
of clinical performance tests, number of particulates in effluent, results of toxicological tests.
PERFORMANCE REQUIREMENTS
Ultrafiltration Rate
*lo% of stated
Solute Clearance
f10% of stated
Pressure drop across the hemodialyzer measured
Blood compartment volume and compliance
measured
Residual blood volume measured
MECHANICAUSTRUCTURALINTEGRITY
REQUIREMENTS
General
Able to withstand pressure 1.5 x recommended
Membrane integrity tested
Packaging integrity to minimize damage during
shipping
DEVICE CLEANLlNESSlREQUlREMENTSFOR
MATERIALS
Must be sterile and nonpyrogenic
All materials in contact with blood must be biocompatible
Residual EtO must be within federal limits
TUBING CONNECTORS
Blood port shall meet IS0 (International Standards
Organization) requirements for design
Dialysate port shall meet IS0 requirementsfor
design
CLEARANCE
In practical terms, solute removal (incorporating both diffusion and ultrafiltration)
from the blood to the dialysate is most often defined as clearance (K).
K, (C,
- )C,
Q,
Q, C
,
(for the blood side of the dialyzer)

where:
C, is solute concentration entering the dialyzer,
C
, is solute concentration exiting the dialyzer,
Q, is blood flow rate, and,
Qf is ultrafiltration rate
And, similarly,
(for the dialysate side of the dialyzer)
Dialyzer efficiency when solute concentration in the dialysate is not zero (such as
recirculating dialysate systems). Dialyzer dialysance(Dd describesthe volume of blood
cleared of that solute per minute if the dialysate concentration is zero.
PATIENT
DAILYDIALYSIS
RECORD
XYZ DIALYSIS
CENTER
Date
Patient Name
Time on
Dry weight
Actual time off
Predialysis weight
Rx time off
Desired weight loss
Prime
Rx dialysis length
Postdialysis weight
Infusion
UF rate
Time off
Dialyzer
QB
QD
Heparin Rx:
Dialysate Rx
Conductivity
Blood leak alarm
Patient ID
PH
Use number
Temperature
Special Rx
UF check
Germicide dwell
Mixed
ArtNen press set
Germicide presence
Dispensed
Machine number
Germicide absence
Jan
Feb
Mar
Apr
May
Jun
Jul
DATE
--
Model #5
Model #6
BLOODLEAKS
(HOUSING)
Model #1
Model #2
Model #3
Model #4
Model #5
Model #6
UF RATE D VS EXPECTED 220%
Model #1
Model #2
Model #3
Model #4
Model #5
Model #6
Other DialyzerPnoblems:
Aug
Sep
Oct
Nov
Dec
PROCEDUREFORCONCURRENT
MONITORING FORM:
DIALYZER USE MONITOR
(FORM 3)
Perform the Audit
Before the Audit



and standard.

indicator is met, N for no ifindicator is not met,

before any patient dialysis is done and perform the test exactly according to the instructions for use of the test manufacturer and
record the results as per facility policy.
4. Schedule the audit with appropriate personnel (head nurse, charge nurse, chief technician).
observer.

response.

After the Audit
Employee A:
B:
C.
Glenn Close
Tom Hanks
William Hurt
etc.

I t is recommend that one auditor should
observe no more than three to four staff a t one
time.
recommended that the auditbe conducted during peak activity times (daily start-up, shift
long enough to observe each staffmembercompletely perform the listed activity.



Chapter 7
ANCILLARY DEVICES
AND EQUIPMENT
CONTENTS
Page
.................................
7-1
........................................
7-2
.....................................
7-2
TECHNICAL DESCRIPTIONS
RISKSANDHAZARDS
EXISTINGGUIDELINES
QUALITY ASSURANCE ...................................... 7-3

StaffTraining and Education ............................ 7-3
..............................
Blood Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transducer Protectors .............................
Single Needle Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conductivity Meters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Home Dialysis ....................................
.............................
7-3
7-4
7-4
7-5
7-5
7-5
7-6
Chapter 7
Ancillary Devices
and Equipment
Blood Tubing'
Blood tubing is the conduit through which blood is
taken from the patient, delivered to the dialyzer,
and returned to the patient during dialysis therapy. Blood tubing sets include various combinations of special purpose components in addition to
the tubing itself Common components of a blood
tubing set may include:
Patient Connectors. Both arterial and venous
end pieces of the blood tubing are used to conned
the tubing to the fistula needle, catheter, etc. These
connectors include both simple h e r connectors as
well as h e r locking connectors.
Dialyzer C o ~ e c t o r s . The connection between
the arterial and venous blood lines and the dialyzer itself may be a "soR connector" made of pliable plastic or a "rigid h e r connector."
Other C o ~ e c t o r s .Various other connectors may
be attached to the blood tubing including: heparin
line, pressure monitoring lines, solution administration lines, and other ports. As with the dialyzer connectors and the patient connectors, these
"service line connectors" can either be straight h e r s
or "her lock connectors."
Injection Sites. Also called "access ports," these
are comprised of a "sleeve" around the tubing itself
(composed of latex or a similar material) or a small
similar port attached to another primary component of the blood tubing, such as a bubble trapldrip
chamber. A needle can be directly inserted for the
purpose of administering medications, fluids, obtaining a blood sample, or other purposes. Most
injection sites are (and should be) equipped with
Some sort of hard plastic protection device to guard
against accidental needle sticks to the patient care
staffwhen inserting needles through the injection
site.
Q&irr Assurance Guidelinesfor Hernodialysis Devices
Drip Chambers o r Bubble Traps. These components are used primarily for removing any air
that may have inadvertently entered the extracorporeal circulation. Most dialysis delivery systems
also monitor for air andfor foam in the blood at the
'Genous bubble trap." This is accomplished by ultrasonic or optical sensors which are placed at or
near the bottom of the bubble trap to alert the user
if bubbles are present.
Bubble traps also serve the purpose of "pressure
buffers" in the extracorporeal blood circuit since
there always is some air near the top of these components. Wide pressure variations in the extracorporeal circuit due to variability in vascular access,
the blood pump, or single needle dialysis can be
minimized as compression and expansion of the air
at the tops of these bubble traps occurs.
Blood Pump Segment. The blood bump segment is a short piece of the arterial blood tubing
that is inserted into the roller section of the blood
pump. It is generally made of durable material
(most often polyvinyl chloride (WC) but in some
cases silicone) in order to withstand the constant
mechanical stress placed upon it.
Clamps. Some blood lines are equipped with their

own dedicated clamping devices on the arterial and
venous tubii, heparin administration lines, solution administration lines, monitoring service lines,
and other areas.
Service Tubing. A variety of "service lines" or

"accessory tubing" also appears on most blood tubing sets. These are used for such h c t i o n s as administration of heparin or heparin infusion, solution administration, pressure monitoring, and other
functions.
BIood Tubing. Finally, the tubing itself acts as
the primary conduit of the blood from the patient
to the dialyzer and back to the patient.
Transducer Protectors
The purpose of these devices is to isolate the interior of the blood tubing and protect the pressure
sensor within the dialysis delivery system. Pressure monitoring creates a direct and open channel
between the sterile internal surfaces of the blood
tubing and the non-sterile components of the dialysis delivery system. An impermeable flexible diaphragm or a submicron filter must be placed at
this interface.
Single Needle Devices

"Single needle systemsn accomplish hemodialysis
with only one venipuncture, the flow through the
needle alternating between flow from the patient
to the dialyzer (arterial or fill phase) and flow from
the dialyzer back to the patient (venous or return
phase). While this can also be accomplished with
"dual lumen" catheters, the following discussion is
limited to single lumen, single needle systems.
Single needle systems are comprised of:
a single, intermittently operated blood pump
and a single clamp (venous) or
a single, continuously operatingblood pump and
two clamps (arterial and venous) or
two intermittently operating blood pumps with
no clamps, with pump occlusion providing the
necessary clamping action with the pump off.
Conductivity Meter (Independent Reference Test Meter).

Basically, the independent reference conductivity
meter operates under the same principle as the
conductivity measurement system in the dialysis
delivery system. A variety of such meters are currently available in the United States, however, not
all of these meters are temperature compensated,
which may present measuring problems for the user.
The principle of checking mechanical dilution of
concentrate is an indirect one which depends upon
the specific conductivity of the total ionic content of
the dialysis fluid. Temperature changes influence
measurement by about 1.7% per OC in the range of
38C. Two electrodes are immersed in the dialysis
fluid and an alternating current of high frequency

pulses through the fluid. When changes in temperature are compensated, the only variable will
be the electrical resistance of the dialysis fluid which
will cause an alteration in the current passing between the electrodes which may be read on a meter.
Many of these independent reference conductivity
meters also enable the user to measure other parameters with relation to the dialysate, including
temperature, pressure, and pH.
RISKS AND HAZARDS

Literature prior to 1980 contains a number of reports of patient complications attributed to prob
lems with blood tubing, transducer protectors, single
needle devices, and conductivity meters. Problems
are usually related to manufacturer.'^ error in product design or manufacturing quality control, inappropriately calibrated equipment, user error in ham
dling the devices, or a combination of user error
and design/operation malfunction.
Incidents reported in the literature between 1980
and 1989 are summarized in Appendix A Many
of these incidents could have been avoided by strict
adherence to the manufacturer.'^ instructions for
use, preventative maintenance, repair protocols, as
well as ongoing monitoring and evaluation activities.
Blood lines. There are three guidelines that address blood lines.
The first two, the Association for the Advancement
of Medical Instrumentation (AAMI) American National Standard for Hemodialyzer Blood Tubing
(RD17-1984) and the International Organization
for Standardization (ISO) Standard for Blood Tub
ing and Dialyzer Connectors, both are directed to
the manufacturers of blood tubing.
A third standard is the HCFA Final Rule: Medicare Program: Protocol for the Reuse of Dialysis
Blood Lines (42 CFR Part 405, Federal Register,
May 2,1990, VoL 55, No. 85, p. 18331-18335). This
rule requires that if a facility reuses blood lines, it
must reuse only a blood line for which the FDA
7-2
has accepted the manufacturer's protocol for reuse

of that particular blood line. Additionally, the facility must reuse blood lines only in accordance
with that protocol.
In the absence of any other standards of practice or
use for dialysis facilities and personnel, we will disCUSS proper use and handling later in this chapter.
Manufacturers' instructions for use serve as the
best standard.
Transducer protedors. Manufacturers' instructions for use will serve as the best standard. The
Centers for Disease Control and Health Care F'inancing Administration stipulate that transducer
protectors should not be reused.
Single needle control. Single needle control
devices are included in the AAMI American National Standard for Hemodialysis Systems as well
as in the IS0 Standard for Hemodialysis Systems.
Manufacturers' instructions for use may serve as
the best standard to follow.
Independent reference meters. Two standards
refer to conductivity reference standards including:
the National Institute of Standards and Technology (N.I.S.T.); and the Organization of Legal Metrology (a European bureau similar to the N.I.S.T.).
The standards relate to specific aqueous electrolytic conductance.
QUALITY ASSURANCE

Policies and procedures concerning ancillary equip
ment and supplies as they relate to the hemodialysis therapy must be developed, written, implemented
and evaluated. All standards previously described
must be incorporated into these policies and procedures.
Specifically,the policies and procedures should address
purpose and function of each device, use, maintenance, safety factors, troubleshooting and repair,
and related documentation. The risks involved must
be clearly identified and considered, and appropriate safety measures and preventative systems developed. Specifically, the procedures must address
storage and inventory control, usehandling, disposal, complication management, and repair.

Education
Role descriptions should describe all personnel responsibilities for handling and use of ancillary s u p
plies and equipment, ordering, confirmation of proper
labeling, testing and monitoring, and other similar
responsibilities. Each responsibility should stem
Staff training should be a well defined and organized process. Content should be clearly defined for
sessiods), the instructor should confirm by a written test andlor return demonstration that learning
has occurred and that the learner is able to perform the procedure(s) independently without error.
Testing results should be documented and placed
in the employee's personnel file.
Comprehension of the purpose and function of each
piece of equipment or supply requires a basic understanding of normal physiological concepts, as
well as responses associated with uremia and the
hemodialysis therapy. Content should include principles of dialysis, patient response to therapy and
related complications, aseptic technique and inventory control. The interrelationships of each device
and the delivery system, dialysate, dialyzer, etc.
must be incorporated into the training process.
Need for W h e r education, such as inservices or
from the routine quality assurance monitoring process and the ongoing staff performance appraisal
process. When problems are identified, all staff
should be made aware of the problem and be involved in its solution. This nearly always includes
problem specific continuing education.
authorize that the individual has successfidly completed the initial education and training program.
The medical director is also responsible for assuring that an annual performance evaluation has been
performed.

To assure patient safety through the proper use of
ancillary equipment and supplies as well as test
instruments, the following monitoring activities are
recommended.
Blood Tubing
A. Daily Monitoring
On a per-treatment basis, patient care staff should
confirm that the blood lines are compatible with
the delivery system and dialyzer, and that packaging and all caps on the blood tubing sets are intact,
ensuring that the manufacturer's intent for a sterile, non-pyrogenic extracorporeal circuit is maintained.
A physical check of all blood line connectors (dialyzer, accessory ports, heparin syringe, etc.) should
be confirmed before attachment to the patient and
starting the blood pump. Arterial and venous pressure alarms should be appropriately set to detect
excess pressures that could cause line separation.
A pyrogen reaction (shaking chills, increase in

treatment) or septicemia (identified through blood
cultures) may be the result of an improperly
sterilized blood line.
Air embolism (evidence of air in blood lines and
.entering patients, chest pain, dyspnea, coughing, cyanosis, visual problems, confusion, coma)
that may be the result of the disconnection of
specific connectors in the blood line set or air
entering through a damaged component.
C. Other Monitoring
An incoming materials log should be maintained.
Included in this log should be the identification of
the product, delivery date, lot number, and person
receiving the products. Confirmation that the product is labeled as ordered should be performed. Any
product with labels not intact or incorrectly labeled
should not be accepted.

related to blood tubing handling should be performed.
All incidents or adverse occurrences related to blood

A visual inspection of the blood tubing and blood
tubing connectors for damage, leaks, and whole or
partial occlusions, etc., should be performed.
Assure that the aidfoam detector is in the proper
position and armed.
tubing should be documented and reported at the

monthly quality assurance meetings.
D. Prevention
Follow exactly all of the manufacturer's instructions for use.
At the time of setup, all connectors and lines should

be inspected by the staff member to ensure absence of kinks, partial occlusions, or other physical
damage.
Transducer Protectors
All connections should be double checked for secure fitting.
A Daily Monitoring
B. Patient Monitoring
Visually confirm that the packaging and caps are

intact before use.
The following should be part of regular intradialytic monitoring and may be related to malfunction
or improper use of blood lines:
Visually confirm that the transducer protector does

not contain water or blood a t the beginning of treatment and periodically throughout treatment.
Acute blood loss (obvious source of blood spill,

shock, vomiting, convulsions) that may be the
result of extreme pressures in the blood circuit
or poor connections, resulting in disconnection
of connectors or other leaking from the blood
lines.
Assure that the transducer protectors are compatible with specific dialysis delivery systems.
Double check that connections of the transducer

protector to the dialysis delivery system and to pressure monitoring tubing of the blood tubing set are
secure.
Before use, the staff member setting up the system

should confirm that the transducer pmtedor does
not have occluded ports, cracks, or any other physical damage-
B. Other Monitoring
An incorning materials log should be maintained.
This log should include the idenacation of the
delivery date, lot number, and person remiving the product, confirmation that the product
is labeled as ordered should be performed. Any
products with labels that are not intact or that are
incorrectly labeled should not be accepted.
An annual review of d l policies and procedures
related to transducer protectors should be performed.
All incidents or adverse occurrences related to transducer protectors should be documented and reported
at the monthly quality assurance meetings.
ing function, patient safety, and treatment effectiveness.
Conductivity Meters (Independent

Reference Meters)
A. Daily Monitoring
Most conductivity meters include a "self-test" function of electronic circuitry and battery. If the user's
meter is equipped with this fimction, the "self-test"
should be performed before every use.
Before using a meter to recalibrate a dialysis delivery system, the conductivity meter should be checked,
according to manufacturer's instructions, with a
standard conductivity solution. That conductivity
should be entered on a regular conductivity meter
log (see Form 1a t the end of this chapter).
C. Prevention
Manufacturers of some conductivity meters recommend that proper calibration of the meter be confirmed with standard solution daily.
Follow exactly all of the manufacturer's instructions for use.
SingleNeedle Equipment
A Daily Monitoring
During setup, check that the blood clamp andlor
blood pump occludes tubing and interrupts flow.
Confirmation that pressure alarms are set according to manufacturer's specifications.
Calculate the stroke volume at the beginning of
treatment and confirm that the stroke volume fits
within the prescription and the manufacturer's recommendations.
On no less than a monthly basis, conductivity meter calibration should be confirmed using a Standard Conductivity Solution following manufacture&
instructions. That conductivity reading should be
entered onto a Conductivity Meter Log (Form 1).
To ensure that all monitoring described above is
performed, systems checks should be included on a
"Daily Patient Treatment Record" (see Form 2) or
a "Daily Dialysis System Checklist" (see Form 3)
which requires that the staff members setting up
the dialysis delivery system check off all vital functions of the procedure on a specific form before initiation of treatment.

related to single needle equipment should be performed.
Review all logs and monitoring instruments relating to these pieces of equipment a t the monthly
quality assurance meeting. Any data outside of acceptable limits must be addressed. Trend analysis
(see Form 4) of parameters related to the instruments' function should be a part of this review.
All incidents or adverse occurrences related to single

needle equipment should be documented and reported at the monthly quality assurance meetings.
Home Dialysis Monitoring
C. Prevention
All preventative maintenance required by the
manufacturer must be performed to assure ongo-

Today's
Date
Date
Last Checked
Meter
Serial Number
Standard Solution
Conductivity
Meter
Conductivity
PATIENTDAILYDIALYSISRECORD
XYZ DIALYSIS
CENTER
Date
Patient Name
Time on
Dly weight
Actual time off
Predialysis weight
Rx time off
Desired weight loss
Prime
Rx dialysis length
Postdialysis weight
Infusion
UF rate
Time off
Dialyzer
QB
QD
Heparin Rx:
Dialysate Rx
Conductivity
Blood leak alarm
Patient ID
pH
Use number
~emperature
Dialyzer structurelaesthetic
Special Rx
UF check
Germicide dwell
Mixed
ArVVen press set
Germicide presence
Dispensed
Machine number
Germicide absence
~ssurance.
~uidelines
for ~ e r n a l i a l ~ s~ies v i c e s
PreDialysis
Correct concentrate (check label)

EAdequateantity of concentrate in jug
Correct conductivity confirmed

Correct pH confirmed (if applicable)
Dialysate flow confirmed
Bubble trap levels set
Blood leak detector checked
Bypass mode checked
o
-r
checked
=detector
armed
Arterial and venous pressure limits set

UF controller checked (if applicable)
Weight recorded
Ultrafiltration calculated and set
Vital signs done and recorded
I Dialysate temperature
Post-Dialysis
Weight recorded
E
s done and recorded
I Unusual events charted

Machine cleaned and disinfected
Patient Name
Machine type
I
Date
Machine No.
This checklist is meant as a reminder to the patient care giver to perform the
vital functions necessary for safe and effective hemodialysis. It does not
replace any ordinary records or charting which should be done (i.e., daily
dialysis reoords7Iow sheets, system logs, etc.).
Jan
CONDUCTIVITY
METER TRENDANALYSIS
I Feb I Mar I Apr I M a y 1 Jun I Jul 1 Aug 1
DATE
Sep
Oct
Nov
Dec
CONDUCTIVITY
Meter #1
Standard solution conductivity
Meter conductivity
Standard solution pH
Meter pH
Actual temperature
Meter temperature
Recalibration required
Matar P2
...-.-.
"-

Meter conductivitv
1I
1
I
II
Meter #3
Meter conductivity
Meter pH
A d ~ ~tnmnwraturn
al
I
I
1
1
Meter temperature
INCIDENTS
I
I
Chapter 8
ANTICOAGULATION
CONTENTS
Page
BACKGROUND
...............................................
8-1
.......................................
8-1
.............
Policies and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitoring and Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Daily Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monthly Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Home Dialysis Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . .
Other Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8-2
RISKS AND HAZARDS
QUALITY ASSURANCE FOR ANTICOAGULATION
.............................
8-2
8-2
8-3
8-3
8-3
8-3
8-3
8-3
8-3
8-6
Chapter 8
Anticoagulation
BACKGROUND
Hemodialysistreatment is dependent upon the
free flowof blood over the dialysis membrane and
through the arterial and venous blood tubing.

Blood, however, has a normal tendency to clot
when it comes in contact with a foreign surface
such as the extracorporeal circuit of the artificial
kidney. It is necessary to prevent this clotting
during dialysis. The purpose of anticoagulation
duringhemodialysis is to prevent blood clottingin
the extracorporeal circuit.
There are a variety of anticoagulation techniques
that are employed for hemodialysis:
Systemic: Systemic heparinization prolongs the
patient's clotting time, preventing thrombus formation in the extracorporeal circuit. This is
achieved by continuous or intermittent infusion of
heparin throughout the dialysis treatment. A
heparin loading dose, or bolus, is usually given
prior to the initiation of dialysis. During dialysis,
heparin is injected into the arterial blood line
using either an infusion pump to deliver a continuous amount of heparin throughout the dialysis, or periodic intermittent injections of heparin
into the extracorporeal circuit.
Regional Heparinization: This method of anticoagulation is used when the patient is a t risk for
hemorrhage or where systemic anticoagulation is
contraindicated by the patient's condition. Regional heparinization is the continuous infusion
of heparin into the the arterial bloodline assuring
anticoagulation of the extracorporeal circuit. At
the same time, protamine sulfate solution is infused into the venous bloodline. This neutralizes
the effectofheparin before the blood is returnedto
the patient. l%sadvantages associated with regional heparinization include the difficulty of
simultaneous dosage determination for both
heparin and the protamine sulfate as well a s the
potential for post-therapy heparin-rebound,
resulting in hypercoagulability.
Quality h s ~ r n w eGuidelines for Hernodialysis Dovices
Low Dose Heparinization: An alternative to

regional heparinization is minimal, controlled,
tight or low dose heparinization. The objective is
to administer, either continuously or intermittently, just enough heparin systemicallyto slightly
elevate the patient's clotting time so that the
dialyzer does not clot. This requires close monitoring by frequent clotting time measurements.
R e g i o n a l C i t r a t e A n t i c o a g u l a t i o n : This
method of anticoagulation infuses sodium citrate
into the arterial bloodline to complex calcium and
prevent clotting in the extracorporeal circuit.
Calcium is infused into the venous bloodline to
restore serum calcium to normal limits. The
dialysate used must be calcium-free. The patient
must be closely monitored for hypocalcemia and
citrate toxicity.
Heparin-free: Using high blood flow rates and
intermittent saline flushes of the dialyzer throughout dialysis, dialysis can be achieved using no
heparin or other anticoagulant.
There are also a variety of techniques for monitoring anticoagulation. They are:
Activated clotting time (ACT)
Lee-White clotting time (LWCT)
Whole blood activated partial thromboplastin
time (WBFTT)
Plasma partial thromboplastin time ~P'I"l')
To determine an effective anticoagulation regimen for the patient, three key patient parameters
must be assessed: normal or baseline clotting
time, response and sensitivity to heparin, and
elimination rate of heparin.
RISKS AND HAZARDS

The most common complication reported in the
literature pertinent to anticoagulation therapy is
hemorrhage. The incidence of post dialysis bleed-
ing secondary to dialysis-related heparinization

h a s been reported to be a s high as 21%.
The risk of hemorrhage is so significant that heparin infusion is contraindicated in patients with
pre-existing bleeding tendencies such a s hemophilia, jaundice, post-operative oozing, threatened abortion, bacterial endocarditis, suspected
intracranial hemorrhage, inaccessible ulcerative
lesions especially of the gastrointestinal tract,
heparin hypersensitivity, and shock.

address the interrelationships of anticoagulation,
the patient, and the dialyzer. The risks involved
mustbe clearly identified and considered, and ap
propriate safety measures and preventative systems developed.
Several factors such as fever, drugs like digitalis

and tetracycline, nicotine, and antihistamines
affect the activity of heparin. One might even
expect that the same patient may react differently
a t different times to the same dose ofheparin. The
variables inherent in the drug also effect patient
response including commercial source, molecular
weight, and potency from lot to lot. The effectiveness of heparin can be altered when in contact
with pH levels (dialysate) exceeding a normal
range. It has also been reported that heparin
tolerance varies not only in different individuals,
but in the same individual during surgical procedures.
Policies and procedures must also address safe

and effective operation of the equipment used to
deliver and monitor anticoagulation during dialysis:
*2
"i
'
drug inventory, handling, and use

complication management
basic technical operation
set up and use of the equipment and related
components
safety checks
routine patient monitoring
troubleshooting and repair
EXISTING GUIDELTNES
record keeping
patient education
The best guidelines to follow must be those of the

manufacturer's instructions for use. This includes instructions for use of the drugs as well as
the equipment related to drug administration and
anticoagulation monitoring. Current literature,
including anticoagulation research, must be reviewed and facility policies and procedures updated accordingly.

ANTICOAGULATION
An essential step in designing the facility's quality assurance program is the development, implementation, and evaluation of policies and procedures for hemodialysis anticoagulation. All
standards previously described must be incorporated into these policies and procedures. Specifically, the policies and procedures must address
the scope of care and therapeutic choices, equipment, disposables, and supplies.

Education
Role descriptions should include all personnel responsibilities for handling and use of anticoagulants, infusion pumps, monitoring devices, daily
or per-treatment safety and other system checks,
recordkeeping pertinent to anticoagulation, and
other similar responsibilities.
Staff training should be a well-defined and organized program. Content should be clearly defined
for the learner and based on behavioral objectives.
The behavioral objectives can be used to accurately and objectively measure learning. At the
end of the session(s), the instructor should confirm by a written test and/or return demonstration that Ieaminghas occurred and that the learner
is able to perform the pmcedure(s) independently
without error. The results of the testing process
shouldbe documented and placed in the ernplo~@*~
personnel file.
comprehension of the purpose and function of

anticoagulationrequires a basic understanding of
normal
concepts, a s well a s responses
a s w c i a t d with uremia and the hemodialysis
therapy. Content should include principles of
dialysis, patient response to therapy and related
mmplicati~n~,
aseptic technique, monitoring, care
and patient education.
the continuous staff performance appraisal process. When problems are identified, all staff should
its solution; this nearly always includes problemspecific continuing education.
authorize that the individual has successfully
the initial education and training program. The medical director is also responsible for
assuring that an annual review has been performed.

risk of patient injury due to incidents related to
malfunction andlor improper use of equipment
related to anticoagulation:
A. Daily Monitoring
1. Confirm anticoagulation goals as prescribed.
2. Confirm vial contents and strength.
3. Confirm the use of aseptic technique in han-
dling the device.

4. Inspect syringes and connectors for damage,
6. Monitor the anticoagulation level until stabilized. After stabilization, monitor a s per physician directive or whenever problems are
suspected.
1. Confirm proper calibration of the monitoring
device using standard provided by the manufacturer.
2. Confirm proper calibration of infusion pumps
following the manufacturer's recommendations.
3. Complete monitoring documentation ofall preventative maintenance to assure that it is

performed within the scheduled timeframe
and according to the manufacturer's recommendations.
C . Patient Monitoring
The anticoagulation regimen should be based on
the clotting time results, patient's condition, patency of the extracorporeal circuit, and response to
previous anticoagulation. The patient should be
assessed by reviewing hematocrit, clotting studies, and history of complications per facility policy. Anticoagulant administered and results of
monitoringshouldbe documented on the patient's
daily dialysis record (see Form 1).

the medical director a s appropriate.
E. Other Monitoring
1. Trend monitoring and analysis of various
complications, including incidents or adverse
occurrences related to anticoagulation should
be conducted.
leaks, and whole or partial occlusions. All connections should be double checked for secure
fit.
2. Trend monitoring and analysis of monitoring

equipment can be documented using Form 2.
5. Administer the drug within the time frame

specified by the manufacturer or as close to
syringe preparation as possible. The individual preparing the drug for infusion must administer the drug.
The patient should be advised as to the side effects

of heparin therapy and should be encouraged to
report any unusual changes prior to the initiation
of each dialysis. The patient should also be informed of how to prevent hemorrhaging or bleed-
Quality ~ s s u m n c eGuidelines for Hernodialysis Devices
F. Prevention
ing after dialysis and after the patient has lea the
dialysis unit. The patient should be informed of
the rationale for anticoagulation therapy including its purpose, route, dosage, side effects, and
monitoring procedures. The patient should un.

derstand the signs and symptoms andlor con&.
tions to report regarding complications of coagu.
lation therapy.
Quality Assurance Guidelinesfor Hernodialysis Devices
REFERENCES
1. KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation ofRisks and
Hazards Associated with Hernodialysis Systems (Technical Report, Contract m23-78-5046).
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration/Bureau of Medical Devices, Silver Spring, MD (1980).
2. LINDSAY, RM. Practical Use ofAnticoagzthnts.inbplacernent of Renal Function of Dialysis.
William Drukker, FrankM. Parsons, and John F. Maher, ede. Martinus Hijhoff,The Hague, The
Netherlands (1988).
Note: Additional references on this topic can be found in Appendix E at the end of this manual.
These additional references are included to enable the reader to pursue further investigation
for the purpose of training or research on this topic
PATIENT
DAILYDIALYSISRECORD
XYZ DIALYSISCENTER
Patlent Name
Date
Time on
Dry weight
Actual time off
Predialysis weight
Rx time off
Desired weight bss
Prime
Rx dialysis length
Postdialysis weight
Infusion
UF rate
Tlme off
~lcpecredclotting t h e
Dialyzer
QD
QB
Heparin Rx:
Dialysate Rx
Conductivity
Blood leak alarm
Patient ID
PH
Use number
Temperature
Dialyzer structurelaesthetic
Special Rx
UF check
Germicide dwell
Mixed
ArtNen press set
Germicide presence
Dispensed
Machine number
Germicide absence
Quulity Asswam Guidelinesfor Hemadialysis Devices
,-
, - -
FORM2
ACTIVATED CLOTTING TIME METER CALIBRATION LOG
Date
Meter
Serial No.
High
Standard ACT
Quality~ssuranceGuidelinesfor H e d i a l y s i s Devices
Meter
Low ACT
Low
Standard ACT
Meter
Low ACT
Chapter 9
VASCULAR ACCESS
DEVICES
CONTENTS
Page
.....................
9-1
.......................................
9-1
.....................................
9-2
....
Policies and Procedures ..................................
Monthly Monitoring ...............................
Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Home Dialysis Monitoring ...........................
Other Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9-2
...............................................
9-5
TECHNICAL DESCRIPTION OF DEVICES

RISKS AND HAZARDS
EXISTING GUIDELINES
QUALITY ASSURANCE FOR VASCULAR ACCESS DEVICES
REFERENCES
9-2
9-2
9-3
9-3
9-3
9-3
9-3
9-3
9-4
Chapter 9
Vascular access, for purposes of hemodialysis, is

the patient's life-line. I t has been stated that
each time there is a real or potential threat to
the patient's access, the patient experiences a
sense of impending death. (Lundin, 1989). For
patients with multiple vascular access problems,
this experience can be extraordinarily stressful,
limiting the sense of well being, quality of life,
and certainly rehabilitation.
DEVICES
To perform long-term hemodialysis, reliable access to the blood circulation is required. A fully
functional and patent access is imperative.
Access can be achieved in a number of ways.
For each of the following accesses, there are various modifications, types and brands.
External Arteriovenous Shunt. This consists

of two rigid Teflon@ tips implanted in an artery
and a vein with Silastica tubing attached to
the Teflon tips in the vessels. Each piece of the
Silastic tubing is brought to the outside of the
skin and connected together for continuous blood
flow. When used for hemodialysis, the two Silastic tubings are separated and attached to the
two bloodlines leading to and from the dialyzer.
Although not commonly used today, the shunt
can be used a s a temporary access while the
patient is awaiting maturation of an internal
fistula, or for acute or reversible renal failure.
Internal Arteriovenous Fistula. The fistula

is created with a surgical anastamosis between
an artery and a vein. This allows increased blood
flow through the vein, causing engorgement and
enlargement. When the vein has had an opportunity to mature, large bore needles are inserted
into the vein to provide blood access for hemodialysis. The fistula is the ideal access for longterm hemodialysis.
Vascular Access
Internal Arteriovenous Graft. This is the
surgical implant of a biologic or artificial graft.
The ends of the graft are surgically attached to
an artery and a vein. Large bore needles are inserted into the graft to provide blood access. The
graft can be used for long-term hemodialysis.
There are various configurations of the surgical
anastomoses.
Temporary Access. A catheter can be used on
a short term or temporary basis for vascular access. It is frequently used while a more permanent access can be created or when the patient
may be waiting for a different type of renal replacement therapy such as transplantation.
Long-term use of the temporary access is not
uncommon today. The locations for placement
of these catheters are usually the subclavian
vein, the femoral vein, and occasionally the jugular vein.
RISKS AND HAZARDS

The literature has reported several problems associated with vascular access types and devices.
It has been noted that the primary reason for
hospitalization of the hemodialysis patient is
related to the vascular access.
The risks and hazards identified in the literature can be classified into the following categories:
MechaniCaYtechnique. These are the incidents

which pertain to the cannulation or venipuncture techniques used and the reports regarding
performance of the various devices used for access, including flow and long term durability.
Infectious complications. There are numerous incidents related to various microbiological
organisms that have resulted in serious infections and are related to surgical techniques, venipuncture or handling techniques.
Qmlity Assurance Guidelines for Hernodialysis Devices
In the manufacturer's literature and the medical device reporting system, the incidents related to vascular access devices can be divided
into three categories:
Mechanical. Reports pertaining to mechanical

risks or hazards are related to hubs, lines andl
or connectors separating from each other before,
during, and after treatment. These unexpected
disconnections create numerous problems with
bleeding, excess vessel trauma, and even death.
Also reported are cracks in connectors or tubing, causing blood loss or air inhsion leading to
air embolus. Other incidents are reported that
pertain to kinking of tubing, faulty packaging,
etc.
Infection. There are numerous reports of various organisms that have caused patient morbidity or access failure. These organisms were analyzed and found to be due to improper technique
in either the handling or use of the device.
Physiological complications. Incidents include aneurysms, thrombus, hemothorax, pneumothorax, infection and sepsis, fibrin deposition,
dermatitis from the device material, excessive
bleeding around the access site (during and after dialysis), and injury and loss of access due to
inappropriate administration of drugs.
EXISTING GUIDELINES
The best guidelines to follow are the manufacturer's instructions for use. Current research
related to each particular vascular access device
in use within the facility must be reviewed and
evaluated for use a s a new or modified facility
standard.

VASCULAR ACCESS DEVICES
Policies a n d procedures concerning vascular
access devices and supplies as they relate to the
hemodialysis therapy must be developed, written, implemented and evaluated. All standards
previously described must be incorporated into
these policies and procedures.
The policies and procedures should address the

purpose and function, use, safety factors, monitoring, preventive measures, patient education,
and related documentation. The risks involved
must be clearly identified and considered, and
appropriate safety measures and preventative
systems developed. Specifically, the procedures
must address storage and inventory control, use/
handling, complication management, anticoagulation therapy, and care post operatively, as well
a s before, during and after the dialysis treatment.

Education
Role descriptions should describe all personnel
responsibilities for handling and use of vascular
access devices. Each responsibility should stem
Staff training should be a well-defined and organized process. Content should be clearly defined for the learner and based on behavioral
objectives. The behavioral objectives can be used
to accurately and objectively measure learning.
At the end of the session(s), the instructor should
confirm by written test andlor return demonstration that learning has occurred and that the
learner is able to perform the procedure(s) independently without error. Test results should be
documented and placed in employee's personnel
file.
There needs to be comprehension of the purpose
and function of each vascular access device being
used within the facility and a basic understanding of normal physiological concepts, as well as
responses associated with uremia and the hemodialysis therapy. Content should include principles of dialysis, patient response to therapy and
related complications, aseptic technique, and, for
each access device type, indications for use, advantages and disadvantages, monitoring, care,
complications, anticoagulation, patient education
and venipuncturehandling technique. The interrelationships of each device and the delivery
system, dialysate, dialyzer, etc. must be incorporated into the training process.
9-2
from the routine quality assurance monitoring

process and the ongoing staff performance appraisal process. When problems are identified,
all staff should be made aware of the problem
and be involved in its solution; this nearly always includes problem specific continuing education.
authorize that the individual has successfully
completed the initial education and training
program. The medical director is also responsible for assuring that a n annual performance
evaluation has been performed.

To assure patient safety and device effectiveness, the following monitoring activities are recommended:
A. Daily Monitoring
Recirculation may be calculated by direct measurement according to the following formula:

% recirculation =
P
'A 100
P- v
where,
P = peripheral concentration (BUN)
A = sample from arterial blood line (BUN)

V = sample from venous bloodline (BUN)
1. Complications associated with venipuncture.
2. Hospitalizations associated with vascular access infections, revisions, or other related

complications.
Continuous assessment for signs and symptoms
of vascular access complications:
1. Occlusion, mechanical failure
1. Inspect the device and connectors for damage, leaks, and whole or partial occlusions,
etc. All connections should be double checked
for secure fitting.
2. Thrombosis
2. Verifj. access patency and flow direction.
4. Skin erosion
3. Confirm the use of aseptic technique in handling the access device.
5. Dislodgement
4. Monitor anticoagulation therapy until stabilized.
7. Aneurysm; psuedoaneurysm
5. Monitor arterial and venous pressures.

6. Monitor blood flow rate.
7. Assess for signs and symptoms of complications.
8. It may become apparent that the prescribed

treatment is not being delivered as evidenced
by:
.a. Increase in patient's blood chemistries such
as BUN, creatinine, potassium, etc.

b. Percent reduction in urea significantly less
than prescribed.
c. Apparent change in flow andfor pressure.
In such a case the patient's vascular access

should be evaluated for recirculation.
3. Infection
6. Hemorrhage
8. Arterial insufficiency, steal syndrome

should be performed by the home dialysis patient, home dialysis support personnel, and reviewed by the medical director as appropriate.
E. Other Monitoring
1. Trend monitoring and analysis of various
complications, including incidents or adverse
occurrences related to venipuncture.
2. Trend monitoring and analysis of hospitalizations due to vascular access devices.
3. Trend monitoring and analysis of the reliability of a vascular access device.
I?. Prevention
1. Follow all of the manufacturer's instructions
for use and all facility policies and pr0C.edures.
2 Conduct and validate patient and staff educa-
tion.
administration
3. Develop p m ~ l for
s
using vasucular access devices.
Quality Assurance Guitlelines for Hernodialysis Devices
REFERENCES
Hazards Associuted with Hemodialysis Systems (Technical Report, Contract #223-78-5046).

U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug AdministrationfBureau of Medical Devices, Silver Spring, MD (1980).
2. BELL, P.RF. and VEITCH, P.S. Vascular Access for Hemodialysis in Clinical Dialysis. AR.
Nissenson, RN. Fine and D.E. Gentile, eds. Appleton-Century-Crofts, Norwalk, CT (1990).
3. HARTIGAN, M . Circulatory Access for Hemodialysis in Core Curriculum for Nephrology
Nursing. L.E. Lamaster, ed. American Nephrology Nurses' Association, Pitman, NJ (1990).
4. LUNDIN, P. Personal Communication. 1980.
Hemodialysis Devices
Chapter 10
HEMODIALYZER REUSE
CONTENTS
Page
....................
10-1
.......................................
EXISTINGGUIDELINES .....................................
10-1
TECHNICAL DESCRIPTION OF PROCESS

RISKSANDHAZARDS
10-1
QUALITY ASSURANCE FOR HEMODIALYZER REUSE ......... 10-2

Policies and Procedures ................................. 10-2
Staff Training and Education ............................ 10-2
..............................
10-3
.................................
Prevention .......................................
Purchasing Guidelines .............................
10-4
Other Monitoring
10-3
10-3
10-4
10-4
10-4
10-4
REFERENCES ............................................... 10-6

Guidelines
.
.............................
10-7
Chapter 10
PROCESS
Hemodialyzer reuse is the practice of using the
same dialyzer for multiple dialyses without replacement of membranes or other surfaces in contact
with blood. This is accomplished utilizing restoration techniques including cleaning the blood surfaces, followed by disinfection or sterilization.
Dialyzer reprocessing can be performed manually
or through use of an automated, c o m m e d l y available "reprocessing system." Most automated reprocessing systems automatically rinse the dialyzer
of residual blood and blood products, perform some
manner of "cleaning" process, test the dialyzer for
leaks and performance parameters, and fill the dialyzer with an appropriate concentration of a germicide. Some automated systems also provide data
storage and labeling functions automatically.
A variety of materials are commonly used in dialyzer reprocessing including cleaning agents, germicidal agents, and purified water used to dilute
both of the above. Commonly used cleaning agents
include hydrogen peroxide, sodium hypochlorite, reverse ultratiltration of water from the dialysate compartment into the blood compartment and out through
the blood ports, and pressurized water. Germicides used for the high level disinfection required
for dialyzer reuse include formaldehyde, peroxyacetic acid (trade name Renalinq, glutaraldehyde
(trade names Sporicidin@,Nephre*, Cide*) and
others.
In 1990 the FDA produced and released a vide
otape entitled Reprocessing $HemOdialyzers which
has been distributed to all U.S. dialysis facilities.
RISKS AND HAZARDS

The literature prior to 1980 includes reports of patient
complications attributed to problems with dialyzer
Ruse. The problems were due to user error with
Hemodialyzer
Reuse
an established procedure or the use of an inappropriate procedure. The literature describes patient
experiences with pyrogen reactions, boluses of toxic
chemicals, decreased adequacy of dialysis,blood loss,
and potential immunological problems.
The 20 incidents that have been reported since 1980
are summarized in Appendix A
Fifteen incidents were related to pyrogen reactions andlor bacteremia, due to inappropriate
water treatment. The causes included use of
endotoxin-contaminated water and too low a
concentration of germicide used to disinfect the
dialyzers.
Four incidents involved patient reactions to residual germicide.
One case was related to excessive ultrdltration rate.
Many of the incidents could have been avoided through
simple tests, observations, and/or quality control
procedures implemented in the dialysis facilities.
EXISTING GUIDELINES
Unlike many other technical areas of hemodialysis,
hemodialyzer reuse has comprehensive standards
of practice. The practice is regulated by HCFA according to 42 Part 405.2150. The regulation, incorporating the Association for the Advancement of
Medical Instnunentation(AAMI)Recommended Practice for Reuse of Hemodialyzers, contains standards
and conditions for safe and effective hemodialyzer
reuse and reprocessing, enforceable as conditions
of Medicare coverage.
Table 1reviews the AAMI Recommended Practice
for Reuse of Hemodialyzers. The Recommended
Practice addresses facility requirements, reuse equip
ment, cleaning and disinfection methods, labeling,
preparation for multiple use, controls, and patient
aspects.
Several states, including California, Colorado, Georgia, and Washington DC,also have regulations pertinent to the reuse of hemodialyzers.
QUALITY ASSURANCE

Policies and procedures concerning the reuse of
hemodialyzers must be developed, written, implemented, and evaluated. All standards and regulations previously described must be incorporated into
these policies and procedures. Spedcally, the policies and procedures must address disposables, equip
ment, personnel, practice, and the patient
address the interrelationships of reuse, the dialyzer,
and the delivery system. The risks involved must
be clearly identified and considered, and appropriate safety measures and preventative systems developed and incorporated.
Specifically, policies and procedures must assure
the safe and effective operation of a reuse program:
Reprocessing Equipment:
Equipment operation
Basic technical operation
Setup and use of the equipment and related
components
Safety checks
Preventive maintenance
Cleaning and disinfection
Troubleshooting and repair
Mixing and storage of cleaning agents and germicides.
Testing for presence or absence of germicide;
effectiveness of germicide.
Labeling.
Recordkeeping.
Storage of reprocessed dialyzers.
H Dialyzer performance validation.

I. Patient monitoring.

Education
Role descriptions should include all personnel responsibilities for the operation, preventative maintenance, repairs of reprocessing equipment, daily
safety andlor system checks, appropriate recordkeep
ing, acceptance of incoming supplies and inventory
control, performance and safety checks of reprocessed dialyzers, and other similar responsibilities.
Each responsibility should stem from a specificpolicy
or procedure.
the learner and based on behavioral objectives. These
measure learning. At the end of the session(s), the
instructor should confirm by written test andlor
return demonstration that learning has occurred
and that the learner is able to perform the procedure(s)
independently without error. Test results should
be documented and placed in employee's personnel
file.
Comprehension of reuse principles and practices
requires a basic understanding of normal physiological concepts, as well as the basic principles of
hemodialysis therapy. Content should include the
facility's specific reprocessing procedures, documentation requirements, aseptic technique, collection
and handling of specimens, risks and hazards of
multiple use, consequences of not performing tasks
correctly, risks and hazards associated with toxic
substances used in the reprocessing procedure,
emergency actions, and principles of infection control.
Need for fiuther education such as inservices or intensive educational sessions can be determined from
the routine quality assurance monitoring process
and the ongoing staff performance appraisal process (see Forms 1, 2, and 3). When need for improvement or problems are identified, all staff should
solution identification and implementation. This
nearly always includes problem specific continuing
education.
Preparation of the reprocessed dialyzer for use.
The medical director must approve the written

curriculum for training. The medical director of
the facility, or his or her designee, must verify
that the individual has successfXly completed the
initial education and the training program. The
medical director is also responsible for assuring
that an annual performance appraisal has been
performed.
Verify by the time and date the dialyzer was

filled with germicide, noted on the dialyzer label, that the "dwell time" for the germicide has
been a t least the minimum recommended by
the manufacturer (see Form 5).
Prior to initiating dialysis, staff, and the patient when possible, should confirm that the
dialyzer about to be used is the patient's dialyzer. This can be accomplished by comparing
patient name and medical record number (or
other secondary identification) on the dialyzer
label with the same information on the patient's
chart (see Form 5).

This section provides a summary of recommendations for monitoring and evaluation that should be
performed to enhance the safety and reduce the
level of risk of patient injury due to incidents related to the reuse of hemodialyzers, and to assure
the efficacy of dialyzers that have been reprocessed.
StafF should test that the level of residual germicide (absence of germicide) aRer "rinse out"
and before clinical use of the dialyzer is a t or
below acceptable levels (see Form 5).
Any tests recommended by the manufacturer to

confirm proper functioning of the reuse system
must be performed (see Form 1).
k Daily Monitoring
Dialyzer performance must be validated during
the reprocessing procedure by total cell volume
0
andor membrane resistance as determined
by in vitro ultrafiltration rate. Alternatively, if
the facility performs urea kinetic modeling the
"actual dialyzer clearance" data from the kinetic modeling program may be correlated with
TCV. Documentation of the information/test
results is required (see Form 4).
1. Confirm that all water used in the reprocessing
program (dialyzer rinsing and cleaning, dilution of germicides and cleaning chemicals) meets
AAMI microbiological requirements. Not more
than 200 colony-forming units per ml of water
andlor not more than 1ndml bacterial lipopolysaccharide (endotoxin), as measured by Limulus amoebocyte lysate assay (LAL), should be
present.
2. A test of membrane integrity (leak rate) for each

dialyzer need be done only if the leak rate of
the reprocessed dialyzers is greater than the
leak rate of new dialyzers. If the reprocessing
equipment includes such a test, it should certainly be a routine monitoring activity (see Form
4).
3. The person performing the dialyzer reprocessing, the staff member setting up a reprocessed
dialyzer and, when possible, the patient, should
verify that the dialyzer does not appear to be
physically damaged, the reuse label on the dialyzer is complete and legible, the headers ofthe
dialyzer do not contain any large quantities of
dotted blood or other materials, and that the
hollow fibers appear to be relatively free of any
blood product (see Forms 4 and 5).
4. A statistically significant number of dialyzers
should be checked for concentration of germicide adequate for effective high level disinfection before "rinse out" prior to clinical use (see
Form 5).
It should be noted that the choice as to which

test (bacterial counts or LAL) to perform is one
that should be carellly evaluated. For example,
with certain water treatment system configurations, performing only bacterial counts may yield
acceptableresults, while utilizing concurrent LAL
testing would indicate a potential problem. The
simpler bacterial count methodology may not
always identify a problem, and could place patients at risk.
2. If formaldehyde is used in the dialyzer reprocessing program, formaldehyde vapors should be
monitored a t least monthly and whenever indicated by discomfort of personnel or patients.
Additionally, OSHA has set mandatory maximum

formaldehyde levels:
8-hour time weighted average CrWA) exposure

limit = 1ppm
Trend analysis, performed by the quality assurance committee, should include patient adverse
reactions such as fever, chills, improper ultrafiltration, unexpected changesin BUN and matinine,
incident reports, small molecule clearances, levels of toxic chemicals, other dialyzer failures
(leaks, structural damage, etc.), equipment maintenance, and repair logs (see Form 6).
15 minute short-term exposure limit (STEL) =

2 PPm
Action level (AL) = 0.5 ppm in 8 hour TWA
See Chapter 12 for a hrther dicsucssion on OSHA
Regulations.
1. Routine blood chemistries may provide an indi-
cation of the effectiveness of the reuse procedure and subsequent dialyzer performance.
2. Routine intradialytic monitoring of the patient's
physiological parameters and symptomotology
during the dialysis treatment can provide indications of adverse events related to reuse. A
few of the symptoms seen are:
a Hypotension or hypertension, related to improper ultrafiltration due to change in dialyzer performance characteristics.
b. Pymgen reaction (shaking chills, increase in
treatment) or septicemia (identified through
blood cultures), from improper disinfection of
the dialyzer or endotoxin in the dialyzer.
c.
Acute blood loss (obvious source of blood spill,

shock, vomiting, convulsions),from membrane
damage related to dialyzer reprocessing
d Pain around vascular access site, respiratory

symptoms, and other indications of toxic or
allergic reaction, caused by incomplete removal
of the germicide from the dialyzer before use.
e. Increase in the patient's requirements for
anticoagulation, related to excess clotting in

reused dialyzers.

When reuse is performed at home, all of the monitoring procedures described above should be performed by the home dialysis patient, home dialysis
support personnel, and reviewed by the medical
director.
3. ~e;formanceappraisal of all personnel participating in the reuse program should be performed.

4. An annual review of facility policies and procedures for applicability to current best practices
and current standards and regulations must be
completed.
F. Prevention
All equipment must be free of defects that may be
a potential hazard to patients or personnel. An established preventative maintenance program must
be implemented and evaluated.
Before equipment is placed back in use (following
maintenance or repair), confirmation must assure
that all aspects of the device are functioning according to manufacturers' specificationsand procedures.
Water quality for all aspects of the reuse process
must be tested and evaluated to assure compliance
with AAML standard and federal regulation.
All components of the reprocessing equipment must
be tested and safety parameters set prior to use.
Any dialyzer reprocessing system being considered
for use should comply with the federal regulations.
which incorporate the AAMI Recommended Practice for Reuse of Hemodialyzers. Any state or local
regulations which apply for the specificfacility should
also be met.
1. Equipment
E. Other Monitoring
1. All safety equipment and supplies (protective
equipment and clothing, emergency equipment,
spill control supplies, etc.) should be inspected
to confirm usability and proper condition (see
Form 4).
~ u a l i tAssurance
y
Complete instructions for use must be available.

Instructions for preventative maintenance and
repair of the equipment are required.
Training for facility personnel in equipment use
is essential.
The system should be equipped with indicators

that show proper function.
Specifications for utilities must be met, including water pressure, flow rate, chemical quality,
bacterial and pyrogenic quality, electrical and
drain requirements.
that are included in the Material Safety Data

Sheet (MSDS) for the particular chemical.
b. Germicides
Design of the reprocessing system should assure ease of disinfection.

Upon installation and prior to clinical use, validation of dialyzer performance test methods and
tests of concentration of germicide must be performed.
The system should be designed to minimize any
exposure to potentially toxic substances, i-e.,
closed exhaust system for venting toxic fumes,
systems to minimize skin or eye contact with
toxic liquids, etc.
2. Chemicals
Two types of chemicals are commonly purchased

for dialyzer reprocessing, cleaning agents and germicides.
a Cleaning Agents
The facility should validate that a specificcleaning agent does not substantially alter the performance or safety characteristics of the dialyzer.
All cleaning agents must be compatible with
the membrane, the potting material, and the
casing of the dialyzer, as well as with all components of the automated dialyzer reprocessing system or manual reprocessing system.
The facility should obtain or establish, for all
cleaning agents used, safe handling practices
Guidelines
The facility should assure that the germicide,

when used according to the manufacturer's
instructions, is a t least as effective in killing
microbial contaminants as 4% formaldehyde
with a minimum contact time of 24 hours
and a temperature of at least 20C.
The germicide used should be shown to be
compatible with the dialyzer membrane, the
dialyzer potting material, and the casing, as
well as all components of the manual or automated dialper reprocessing system.
The manufacturer of the germicide should provide andlor the facility should develop policies and procedures for minimizing risk related to airborne toxicity, as well as direct
skin or eye contact. The Material Safety Data
Sheet for the chemical should be obtained.
Instructions should be obtained for inspection
of the chemical upon receipt to assure that it
is being delivered in a manner that will render it effective for its intended use.
Storage and environmentalrequirements should
be specified.
Information regarding compatibilitywith other
chemicals (other germicides, cleaning agents,
etc.) should be obtained.
Appropriate tests or test kits for determining
the concentration of the germicide in solution, as well as the relative presence of the
germicide and absence of the germicide, should
be developed or secured.
REFERENCES
1. Association for the Advancement of Medical Instrumentation. Recommended Practice:Reuse of

Hemodialyzers. (AAMI ROH-1986). Arlington, VA (1986).
2. KESHAVIAH, P., LUEHMANN, D., SHAPIRO, F. and COMTY, C. Investigation ofRisks and
H d s Associated with Hemodialysis Systems. (Technical Report, Contract t223-78-5046).
U.S.Dept. of Health and Human Services, Public Health Service, Food and Drug AdministratiodBureau of Medical Devices, Silver Spring, MD (1980).
3. Proceedings of the National Workshop on Reuse of Consumables in Hemodialysis. J.H. Sadler,
ed. Kidney Disease Coalition, Washington, DC (1984).
4. Hemodialyzer R e w : Issues & Solutions (an AAMI Analysis and Review). Association for
Advancement of Medical Instrumentation, Arlington, VA (1985).
5. Reprocessing of Hemodialyzers (Videotape). Food and Drug Administration. (1990).
No&: A list of additional references on this topic can be found in Appendix E at the end of this
QUU&
TABLE
1
AAMI RECOMMENDED
PRACTICE: REUSEOF HEMODIALYZERS
Records
Master record
Reprocessing record
Equipment maintenance and material quality
record
Personnel health monitoring records
Complaint investigation records
Quality assurance and quality control records
Personnel Qualifications and Training
Qualifications (adequate education and background; repairs by qualified technicians)
Written curriculum
Documentation of successful completion of
training course
Patient Considerations
Medical issues: written policies and procedures
relative to special patient medical conditions
Legal review of any lnformed Consent; if used,
lnformed Consent belongs in medical record
Open physicianlpatient relationship
Equlpment
Appropriate design, construction, and validations
Water Systems
Meet specificationsof reuse equipment operating
at peak load
Proper disinfection
Water quality testing
Reprocessing Systems
Utility requirements specified and followed
Validation testing initially and periodically
Written preventative maintenance schedule and
hl
Repairs by qualified personnel; test equipment
function before reinstituting use
Environmental Control and Safety Equipment
Validation of adequate function initially, periodically, and after any repair
Written preventative maintenance schedule and
log
Safety equipment inspected and maintained according to manufacturer recommendations
Physical Plant and Environmental Safety
Considerations
Reprocessing area clean and sanitary; ventilatio
maintains acceptable level of toxicity
Specific storage area requirements for new and

reprocessed dialyzers
Tests that do not require special facilities may be
done in reprocessing or treatment area
Personnel protection: gloves. protective clothing,
eyeprotection, eyewash stations, spill control
equipment, etc.
Environmental safety: evaluate chemicals for safe
storage and handling; written procedures; comply
with OSHA and other regulatory requirements.
Reprocessing Supplies
Speafications and testing: certification by supplier
or appropriate testing; proper documentation
Incoming supply control: log results of quality tests
Inventory control: first in, first out; prdper log
Hemodiaiyzer Labeling
Use reprocessed dialyzer on same patient;
patient's name on label
Label prior to first use; update with each reprocessing
Label and markings should withstand reprocessing
and dialysis procedures; should not obscure
manufacturer's label or disallow inspection of
interior of dialyzer
Required information on label: patient's name,
number of previous uses, date of last reprocessing
Reprocessing
Handle and transport dialyzers in a clean and
sanitary manner
Rinsing and cleaning: written time limits; effective
procedures; water quality requirements; cleaning
agents must not adversely affect dialyzer
Both dialysate and blood sides should be free of
visible clotted blood except for a few clotted fibers
and small clots around periphery of header
Performance Measurements
In-vitro small molecule clearance should be actual
rejection criterion
Total cell volume is allright, but validation of correlation with clearance (inital and periodic) is
required
In-vitro uttrafiltration should not change f 20%
manufacturer's specifications (initial and periodic
validation)
Blood path integrity should be validated initially
and when any changes are made in process
Leak tests on all dialyzers not required if leak rate
is equal to or less than that for new dialyzers
TABLE
1 (cont.)
AAMI RECOMMENDED
PRACTICE:
REUSEOF HEMODIALYZERS
Germicide
Capable of high-level disinfection when tested
against highly resistant water microorganisms
If formaldehyde is used: 4% for 24hrs at 20C or
demonstrated equivalent
Do not mix reactive materials
Minimum water quality (microbiological) requirements for dilutent
Dialyzer should be filled with disinfectant until
effluent is within 10% of original concentration
Use disinfected or new caps
Testing of concentration of germicide
Exterior of dialyzer: clean and use low-level
germicide
Inspection
Dialyzer jacket free of visible blood or foreign
material
No leaks or cracks
No more than a few clotted fibers
Headers free of all but a few small peripheral clots
Blood and dialysate ports capped with no leakage
Label properly filled-out and legible
Disposition of Rejected Dialyzers
Policies
Proper contamination prevention (of blood-borne
pathogens) procedures
Storage
If greater than one month, validation of safety and
effectivess of dialyzer
Preparation for Dialysis and Testing for
Potentially Toxic Residues
Visual inspection of dialyzer and label for safety
and efficacy
Verification of patient identification (two people)
Testing for presence of germicide on at least
random sample
Validation of proper germicide concentration
(initially and periodically)
Priming procedure and elution of germicide (documented procedure)
Testing for residual germicide: written procedure;
assure level is below maximum recommended
level
'
Rinsing should prevent rebound to inappropriate

level (validate)
Set-up procedures: maximum waiting time to
prevent bacterial problems; verification of germicide dwell time
Validated and documented test of residual germicide
Monitor patient and dialyzer for complications
during dialysis; record any problems
Symptoms
Measure temperature before and after dialysis;
evaluate reprocessing if patient shows fever, chills
Evaluate reprocessing if other sypmtoms such as
pain in access arm or other unexplained symptoms
"Special Incident Report" if problems
Dialyzer failures (leaks, excessive deviations from
expected performance, etc.) should be documented, investigated, and placed in complaint file
Quality Assurance and Quality Control
QA personnel should:
Review and audit master record at least annually
Audit complaint invesitgation file and perform trend
analysis at least quarterly
Audit job descriptions, training materials, and
documentation of training at least annually
Audit compliance with informed consent policy at
least annually.
Be involved in equipment and supplies specifications and purchases
Audit written policies and procedures at least
annually, and whenever problems
Audit written maintenance and repair policies at
least annually
Audit physical plant and environmental safety
parameters at least quarterly
Audit parameters related to reprocessing supplies
at least semiannually
Audit parameters related to hemodialyzer labeling
at least quarterly
Audit compliance with actual reprocessing technique at least monthly initially, and at least semiannually later; trend analysis should be performed
at least quarterly.
Audit written procedures regarding QA and QC
and verify their implementation at least quarterly
Audit results of performance validation
MONITORING FORMS:
REUSE LABELING AND
RECORDKEEPING (FORM 1)
REUSED DIALYZER PREPARATION FOR USE (FORM 2)
REUSE PHYSICAL PLANT AND
ENVIRONMENTAL SAFETY
MONITOR (FORM 3)
Before the Audit


long enough to observe each staffmember completely perform the listed activity.
Perform the Audit


and standard.

indicator is met, Nfor no ifindicator is not met,
or NIA for not applicable, not observed.

record the results a s per facility policy.
specified. Assure that each indicator h a s one
response.
After the Audit
5. Make copies of the audit for each auditor/

observer.


Employee A:
B:
C.
Glenn Close
Tom Hanks
William Hurt
etc.

It is recommend t h a t one auditor should
time.
8- Define the length of time for observation. It is

4. For each indicator, calculate compliance percentage by using the same method a s above;

andfor recommendations.
REUSE
FORM 1
LABELING
AND RECORDKEEPING MONITOR
Threshold
Log record completed

Dialyzers properly labeled
Dialyzers properly stored
Predialysis dialyzer check done and recorded
Predialysis TBV check done and recorded
Q. A. Comnfttee Recommended Adbn:
% Compliant
hb w a m e Guidelines for Hernodialysis Devices
REUSE PHYSICALPLANTAND ENVIRONMENTAL

SAFETYMONITOR
=F=l
Threshold
MSDS for toxic substances posted

Spill control procedures posted
Spill control materials available
Exhaust fan operating during reprocessing
Environmental testing meets OSHA standard
Q. A. Cornittee RecommendedAction:
% Compliant
PATIENTDAILYDIALYSISRECORD
XYZ DIALYSIS
CENTER
Date
Patient Name
DIALYSIS
PRESCRIPTION
Time on
Dry weight
Actual time off
Predialysis weight
Rx time off
Desired weight loss
Prime
Rx dialysis length
Postdialysis weight
Infusion
UF rate
Time off
Dialyzer
QB
QD
Heparin Rx:
Dialysate Rx
DIALYSATE
MACHINE
CHECKS
REUSE
Conductivity
Blood leak alarm
Patient ID
PH
Use number
Temperature
Special Rx
UF check
Germicide dwell
Mixed
ArtNen press set
Germicide presence
Dispensed
Machine number
Germicide absence
Chapter 11
INFECTION CONTROL
+
CONTENTS
Page
BACKGROUND
.............................................
11-1
QUALITY ASSURANCE ...................................... 11-4
.................................
StaffTraining and Education ............................
11-4
11-4
11-5
REFERENCES ............................................... 11-6
Guidelines for
.............................
Devices
11-7
Chapter 11
Infection Control
BACKGROUND
H e d i a l y s i s which has been distributed to all dialysis facilities in the United States.
Infection control is a mechanism by which the adherence, colonization, or invasion of an infectious

organism is prevented. Infection control is used in
dialysis units to prevent patients from acquiring
infections specific to the dialysis unit. The purpose
of infection control is to ensure the prevention of infections through appropriately applied policies and
procedures. Continuous surveillance and other monitoring and evaluation activities assist in identi@ing factors that may influence the occurrence of infections.
Although the risk to patients and staff in a hemodialysis unit for contact with viral and bacterial infections is quite high, the use and monitoring of
carefully developed procedures can significantly limit
the degree of risk involved. The Center for Disease
Control (CDC) has reported that from 1980 to 1985
attention to infection control has systematicallydecreased the incidence of Hepatitis B among dialysis
patients and staff alike. Infection control procedures in hemodialysis today require isolation of HBV
patients. The CDC notes that isolation of HIV patients is not necessary.
Further, the CDC has noted that infections due to
contaminated water, dialysate, andlor dialyzers have
been significantly reduced as a result of appropriately applied surveillance and control efforts. Infection control-oriented procedures for vascular access
venipuncture and other direct invasions to the patients
circulatory system have been shown to successfully
Protect the patient from exposure to infection.
Each manufacturer describes the infection control
strategies that are to be employed for their particular medical device in the directions for use. Within
this manual, infection control is addressed for each
Of these devices in the respective chapters. This
Particular chapter will focus on the control of bloodborne infections.
In D ~ m b e of
r 1989 the FDA produced and re-
&a
videotape entitled Infection Control for
EXISTING GUIDELINES
Throughout the years the CDC has issued and u p
dated blood-borne infection control strategies and
precautions (including universal precautions) for the
renal dialysis community as well as other health
care agencies. The dialysis community has complied with the CDC recommendations over the years
as a voluntary standard. Now the Occupational
Safety and Health Administration (OSHA)has regulations that would enforce the use of universal precautions as well as other infection control s t r a k
gies for all of health care.
Federal OSHA Regulation, Subpart Z of 29CFR
Part 1910.1030, addresses control of blood-borne
pathogens. The regulation specifies facility infection control strategies as follows.
1. Written Plan
It is expected that each employer having employees whose anticipated duties may result in occupational exposure to infectious agents shall establish
a written infection control plan designed to minimize or eliminate employee exposure. The plan
shall include a determination of that exposure, and
the schedule for and method of implementation for
each of the following requirements. The plan shall
be reviewed and updated as necessary to reflect
significant changes in tasks or procedures. The
plan shall be made available for inspection by federal and state surveyors.
a Universal precautions shall be followed
b. Certain control measures shall be examined and

maintained or replaced on a regular schedule to
ensure effectiveness. For example, employees
shall wash their hands immediately or as soon
as possible after the removal of gloves or other
personal protective equipment and after hand
contact with blood.
when visibly soiled, torn, or punctured. They

shall not be washed or disinfected for reuse.
Utility gloves may be disinfected for reuse if
the integrity of the glove is not compromised.
c. All personal protective equipment and clothing shall be removed immediately upon leaving the work area and shall be disposed in an
appropriately designated area or container for
storage, washing, decontamination or disposal.
Masks, eye protection and face shields shall be

worn whenever splashes, sprays, droplets or
aerosol of blood or other potentially infectious
materials may be generated and there is a potential for eye, ear, nose or mouth contamination. Gowns, aprons, and other body clothing
shall be worn when the employee has a potential for occupational exposure. The gowns,
coats or aprons shallbe worn if there is a potential for soiling of clothes with blood or other
infectious materials. Fluid-resistant clothing
shall be worn if there is a potential for splashing or spraying of blood or other potentially infectious materials.
d. Used needles and other sharps shall not be

sheared, bent, broken, recapped or re-sheathed
by hand. These needles shall not be removed
from the disposable syringes and they shall be
discarded in puncture-proof and color-coded
containers.
e. Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are
prohibited in the work area.
f. Food and drink shall not be stored in refrigerators, freezers, or cabinets where blood or other
potentially infectious materials are stored.
g. All procedures involving blood or other potentially infectious materials shall be performed
in such a manner a s to minimize splashing,
spraying and aerosolization of these substances.
2. Personal Protective Equipment

a. When there is a potential for occupational exposure, the employer shall provide and ensure
that employees use appropriate personal protective equipment such a s but not limited to
gloves, gowns, fluid-proof aprons, laboratory
coats, face shields or masks and eye protection.
b. The employer shall assure that the appropriate personal protective equipment in the appropriate sizes is readily accessible a t the work
site or issued to employees. Hypo-allergenic
gloves shall be readily accessible to employees
who are allergic to gloves normally provided.
c. The employer shall provide for the cleaning,
laundering, or disposal of personal protective
equipment.
d. The employer shall repair or replace required
personal protective equipment a s needed to
maintain its effectiveness.
e. Gloves shall be worn when the employee has
the potential for hands to have direct skin contact with blood or other blood products, mucous membranes, non-intact skin and when
handling items or surfaces soiled with blood.
Gloves shall be replaced a s soon a s possible
3. Housekeeping
a. Employers shall ensure that the work site is
maintained in a clean and sanitary condition.
There will be a written schedule for cleaning
and methods of disinfection based upon the location within the facility, type of surface to be
cleaned, type of soil present, and tasks and
procedures being performed.
b. All equipment and environmental and working surfaces shall be properly cleaned and disinfected after contact with blood or other potentially infectious materials. Work surfaces
shall be decontaminated with an appropriate
disinfectant when surfaces are overtly contaminated after completion of procedures or
immediately after any spill ofblood and a t the
end of the work shift. Equipment that may
become contaminated with blood or other potentially infectious materials shall be checked
routinely and prior to servicing or shipping
and shall be decontaminated as necessary. All
bins, pails, cans and similar receptacles intended for reuse that have a potential for becoming contaminated with blood shall be inspected, cleaned and disinfected on a regularly
scheduled basis. If the contamination is evident they should be cleaned and disinfected
immediately. Broken glassware shall not be
picked up by hands. It shall be cleaned up
using mechanical means. Specimens of blood
or other potentially infectious materials shall
be placed in a closable, leak-proof container,
labeled andlor color-coded accordingly.
Quality.Assurance Guidelines for Hernodialysis Devices
11-2
an explanation of the employer's infection contJ.01 pragram;
4. Infectious Waste Disposal

All infectious waste destined for disposal shall be
placed in closable, leak-proof containers or bags
that are color-coded or labeled as required If outside contamination of the container or bag is likely
to occur, then a second leak-proof container or bag
which is closeable and labeled or color coded shall
be placed over the outside of the first and closed to
prevent leakage during handling, storage and trans
port.
an explanation of the appropriate methods for

recognizing tasks and other activities that may
involve exposure to blood and other potentially
infectious materials;
an explanation of the use and limitations of
practices that will prevent or reduce exposure
to blood borne pathogens including appropriate
engineering controls, work practices and personal protective equipment;
All disposal of infectious waste shall be in accordance with applicable federal, state and local regulations. Immediately after use, sharps shall be
disposed of in closeable puncture-resistant disposable containers which are leak-proof on the sides
and bottom and are labeled or color-coded accordingly. These containers shall be easily accessible
to personnel and located in the immediate area of
use. They shall be replaced routinely, not allowed
to overfill, nor be reused.
information on the types, proper use, location,

removal, handling, decontamination andlor disposal of personal protective equipment;
an explanation of the basis for selection of personal protective equipment;
information on the Hepatitis B vaccine including information on its efficacy, safety, hazards
(potential side effects),and the benefits of being
vaccinated;
5. Laundry
Laundry that is contaminated with blood shall
handled as little as possible with a minimum of
agitation. Contaminated laundry shall be bagged
at the location where it was used and shall not be
sorted or rinsed in patient care areas. Contaminated laundry shall be placed and transported in
bags that are labeled and color coded. The employer shall ensure that laundry workers wear protective gloves and other appropriate personal protective equipment to prevent occupational exposure.
information on the appropriate actions to take

and persons to contact in an emergency;
an explanation of the procedures to follow if an
exposure incident occurs including the method
of reporting the'incident and the medical follow-up that will be made available;
information on the medical counseling that the
employer is providing for exposed individuals
and an explanation of the signs and labels andl
or color coding required by the various standards within thisregulation.
6. Training Program
The training program of the employee shall be provided at the time of initial employment or within
ninety days &r being hired. At least annually
thereafter the employer shall ensure that all employees with occupational exposure participate in
the training program. The material should be a p
Propriate in content and vocabulary to the educational level, literacy and language background of
the employees The training program shall contain
the following elements:
a a copy of the OSHA regulations and an explanation of its contents;
b. general explanation of the epidemiology and symp

toms of blood-borne diseases;
an explanation of the modes of transmission of

blood-borne pathogens;
Guidelines
A copy of the facility's universal precautions pro,cedure.
Medical Records
The employer shall establish and maintain an accurate record for each employee. The record shall
include the name and social security number of the
employee, a copy of the employee's Hepatitis B vaccination records and medical records relative to the
employee's ability to receive vaccine or the circumstances of an exposure incident. A copy of all results of physical examinations, medical testing and
followup procedures as they relate to the employee's
ability to receive vaccination or to postexposure
evaluation following an exposure incident should
also be included in the medical record.
The employer's copy of the physician's written opinion and a copy of the information provided to the
physician as required by the various standards in
this regulation are to be included in the medical
record. The employer shall assure that the employee medical records are kept confidential and
are not disclosed or reported to any person within
or outside the work place except as required by
law. The employer shall maintain this record for
at least the duration of the employment plus thirty
years in accordance with Federal Regulation 29CFR
1910.20.
8. Training records
Training records shall include the following information: the dates of the training sessions, the contents or a summary of the training session; the
names of persons conducting the training, and the
names of all persons attending the training sessions. These records shall be maintained for five
Y.The employer shall assure that all records required
to be maintained by this section shall be made
available upon request. The employee training records required shall be provided upon request for
examination and copying to employees, employee
representatives, and any state or federal surveyors.
QUALITY ASSURANCE

Policies and procedures pertaining to infection control must be developed, written, implemented, and
evaluated. All standards and regulations previously described must be incorporated into the policies and procedures.
Comprehensive policies and procedures must address the interrelationships of the equipment, the
people involved and the environment. The risks
must be clearly defined and considered, and preventative systems developed and incorporated.
Policies and procedures must assure safe and effective practices:
Universal precautions
Housekeeping practices
Infectious waste disposal
Laundry disposition
Medical recordkeeping
Employee records
Education
Role descriptions should describe all personnel responsibilities for infection control practices. Each
responsibility should stem from a specific policy or
pmedure.
measure learning, At the end of the sessioxds), the
instrudor should confirm by a written test a d o r
return demonstration that learning has occurred
and that the leamer is able to perform the p d u r e ( s )
independently without error. Test results should
be documented and placed in personnel file.
Comprehension of the purpose and function of infection control principles and procedures requires a
basic understanding of normal physiological concepts, as well as responses associated with uremia
and the hemodialysis therapy. Content should include the specific areas spelled out in the OSHA
regulation previously described.
Need for further education such as inservices or intensive educational sessions can be determined from
the routine quality assurance monitoring process
and the ongoing staff performance appraisal process. When problems are identified, all s t -should
its solution; this nearly always includes problem
verify that the individual has successhlly completed
the initial education and training program. The
medical director is also responsible for assuring that
an annual review has been performed.

On a periodic basis, quality assurance monitoring
of facility personnel's compliance with policies and
procedures should be perfonned A concurrent monibring instrument may be used for this purpose
(see Form 1).
Guidelines
All policies and procedures must be reviewed and

updated annually to reflect changes in regulations
andlor standards.
Trend analysis, performed by the quality assurance
committee, should include incident reports and surveillance monitoring results.
REFERENCES
1. Centers for Disease Control. Recommendations for Prevention of H N Transmission in Health

Care Settings. MMWR, 36 (Supplement no. 251,pp. 144-185(1987).
2. Occupational Safety and Health Administration. Occupational Exposure to Blood Borne Pathogens H N and HBV Notice of Proposed Rule Making, 29 CFR Part 1920,Federal Register,
May 30, 1989.
3. Infection Control for Hernodialysis (VideoTape). Food and Drug Administration. (1989).
4. Centers for Disease Control. Protection Against Viral Hepatitis. MMWR, 39 (1990).
5. ALTER, M.J.and FAVERO, M.S.National Surveillance of Dialysis-Associated Diseases in

the United States, 1987. Centers for Disease Control, Atlanta, GA (1988).

AUDIT:
UNIVERSAL PRECAUTIONS
MONITOR (FORM 1)
Before the Audit

Perform the Audit

and standard.


appear in the "Post-Softener Hardness Donen
before any patient dialysis is done a n d perform the test exactly according to the instructions for use of the test manufacturer and
record the results a s per facility policy.

observer.

response.

After the Audit
Employee A:
B:
C.
Glenn Close
TomHanks
William Hurt
etc.

It is recommend that one auditor should
time.
8. Define the length of time for observation. I t is




andfor recommendations.

A s s'U?
--
Guidelines
I i i
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Chapter 12
HANDLING OF
TOXIC CHEMICALS
CONTENTS
Page
BACKGROUND .............................................. 12-1
E
TS
T ...................................... 12-1
Hazard Communication
12-1
.................................
Occupational Exposure to Formaldehyde . . . . . . . . . . . . . . . . . . .
12-3
...........................
12-5
MONITORING AND EVALUATION

Daily Monitoring
......................................
Monthly Monitoring ....................................
Other Monitoring ......................................
R E F E N C E S ...............................................
TABLES, FIGURES, AND FORMS
Guidelines
.............................
12-5
12-6
12-6
12-7
12-8
Chapter 12
Handling of
Toxic Chemicals
Formaldehyde
Glutaraldehyde
Sodium Hypochlorite (Bleach)
Hydrogen Peroxide
Povidone Iodine Solution
Chlorhexidine Gluconate
Hexachlorophene
Ethyl Alcohol
Ethyl Chloride
Benzalkonium Chloride
BACKGROUND
The average dialysis unit has a number of toxic
or hazardous chemicals present. They are used
a s cleaning and disinfecting agents, janitorial
supplies, and for other purposes. A list of the
common chemicals present in a dialysis facility
include, but are not limited to:
Acids
BasesICaustics
Cleaning Agents
Degreasing Agents
Disinfectants
Flammables
Greases
Paints
Solvents
Surfactants
Water Treatment Agents
Sterilants
Bactericidal Agents
Janitorial Supplies
Although i t is impossible to avoid all risk associated with use of these toxic chemicals, the facility can significantly reduce that risk by following some practical quality assurance measures. The first step is to be aware of the chemicals found in the unit. A chemical that meets
the criteria of a hazardous substance may be:
Corrosive to living tissues; carcinogenic; toxic
when administered orally, cutaneously, or
through inhalation; irritant; sensitizer; toxic to
target organs including the liver, kidney, central nervous system, blood, lung, reproductive
system, or eyes. Some of the chemicals that
meet this definition that are commonly found in
the dialysis facility include:
Acetic Acid
-* Peracetic Acid
Chlorine Dioxide
EXISTING STANDARDS
Three Occupational Safety and Health Administration (OSHA) standards are especially relevant to the dialysis community and must be incorporated into policies and procedures and clinical practice:
1. hazard communication
2. occupational exposure to formaldehyde, and
3. occupational exposure to blood borne pathogens.

A separate chapter in this manual, Chapter 11,
entitled Infection Control, discusses the occupational exposure to blood-borne pathogens standard.
Hazard Communication Standard

This standard requires employers to provide information to their employees about the hazardous chemicals used in the work place through
the development and the implementation of a
"hazard communication program."
Compliance with this rule can be achieved
through a four step process as described below.
@ Amwance Guidelines for Hernodialysis Devices
Step 1 List the hazardous chemicals in the facility. In general, these chemicals will have a
label warning of a potential hazard such a s eye
irritation.
Step 2. Obtain the Material Safety Data Sheets
(MSDS) for all chemicals identified. The MSDS,
prepared and supplied by the manufacturer of
the chemical, contains information including:
identification (trade name, chemical name,
chemical family, formula);
hazardous ingredients (components, specific
chemical identity, common name);
physicaVchemica1 characteristics (boiling
point, vapor pressure, vapor density, solubility in water, appearance and odor, specific
gravity, melting point, evaporation rate);
fire and explosion hazard data (flash point,
extinguishing media; special fire fighting procedures, flammable limits, unusual fire and
explosion hazards);
reactivity data (stability, conditions to avoid,
incompatibilities, materials to avoid);
Additionally, a list of all toxic chemicals used in

the facility and all of the MSDS's should be in
one file. This file must be available to all employees. Finally, the facility is required to provide a copy of a MSDS upon the request of any
employee, designated representatives of employees, emergency personnel, and to OSHA
Step 3. All toxic chemical containers must be
appropriately labeled. The label must contain
the product name, a s well as appropriate warnings regarding use. Upon delivery of these
chemicals, proper labeling should be confirmed
and employees should be instructed not to remove labels under any circumstances. Empty
containers from toxic chemicals should be immediately discarded and not reused for other
purposes.
Step 4. A written hazard communications program must be developed and implemented. Such
a program should be included in the initial training of all staff members, and during annual
review. The program should include a t least
the following.
hazardous decomposition or bioproducts (hazardous polymerization); health hazard data

(routes of entry: inhalation, skin, ingestion);
health hazards (acute and chronic) carcinogenicity, signs and symptoms of hazardous
exposure, medical conditions generally aggravated by hazardous exposure, and emergency
first aid procedures;
precautions for safe handling and use (steps
to be taken in case the material is released
or spilled, waste disposal method, precautions
to be taken in handling and storing, other
precautions);
control measures (respiratory protection), ventilation (total exhaust, special, etc.), protective gloves, eye protection, other protective
clothing or equipment, and workhygienic
practices.
The MSDS for specific chemicals should be
posted in any area where that chemical is used.
This is done to assure the staff direct access to
information about the risks involved with the
chemicals, proper handling procedures, and information required in case of an emergency.
Discussion of the contents of all regulations

related to handling of hazardous chemicals.
Discussion of the contents on Material Safety
Data Sheets of all hazardous chemicals in
the facility.
Description of any medical surveillance programs related to hazardous chemicals available in the facility.
Description of potential health hazards related to exposure of any hazardous chemicals and description of signs and symptoms
of that exposure.
Instruction to immediately report any adverse
signs or symptoms that the employee suspects are attributable to hazardous chemical
exposure.
Description of all operations within the facility or procedures where potential exposure
to a hazardous chemical is present.
Purpose for, proper use of, and limitations of
all personal protective clothing and equipment related to hazardous chemical use.
Instructions for handling of spills, emergencies, and clean-up procedures.
12-2
An explanation of the importance of any engineering andlor work practice controls for
employee protection and necessary instmction in the use of these controls.
California
Connecticut
Hawaii
Indiana
Iowa
Kentucky
Maryland
Michigan
Minnesota
Nevada
A review of emergency procedures including

specific duties or assignments of each employee in the event of a hazardous chemical
emergency.
Whenever a new hazardous chemical is introduced, training must be understaken and completed.
Upon completion of the training program, the
employer should verify and document employee
comprehension. This should be repeated on an
annual basis and be incorporated into the performance appraisal process. I t is recommended
that documentation of successful completion of
the program be included in the employee's personnel file.
The facility should also have written policies
regarding hazard communication for any outside contractors. Should any outside contractor
bring hazardous materials into the dialysis facility, that contractor should provide the facility
with an MSDS along with written procedures as
to how the material will be used, monitored,
and eliminated. An example may be a water
treatment vendor bringing materials to disinfect or clean water treatment system components.
The facility is required to complete and maintain OSHA Form 200 reporting all occupational
injuries and illness. The form must be recorded
within six months of occurrence. A copy of the
total number of occupational injuries and illnesses must be posted in each facility in a place
where employee notices are posted on an annual basis.
To obtain a copy of the OSHA hazard communication standard, specify Federal Register 52
(163): 31852-31886, August 4, 1987.
Certain states and territories have "approvedn
Programs that meet the requirements of the
federal regulation but also have additional laws
a d regulations. These states and territories
include:
Alaska
Arizona
New Mexico
New York
North Carolina
Puerto Rico
South Carolina
Tennessee
Utah
Vermont
Virgin Islands
Virginia
Washington
Wyoming
If your facility is located in a state with a OSHAapproved plan, you must comply with the Hazards Communications Requirements of that
state.
Occupational Exposure to
Formaldehyde
The OSHA standard for Occupational Exposure
to Formaldehyde stipulates:
A. Exposure Limits
1. Permissible exposure limit: the employer
shall ensure that no employee is exposed to

an airborne concentration of formaldehyde
that exceeds one part formaldehyde per million parts of air (1 ppm), a s an.8 hour timeweighted average (TWA).
2. Short term exposure limit: the employer shall
ensure that no employee is exposed to an air
borne concentration of formaldehyde which
exceeds two parts formaldehyde per million
parts air as a 15 minute short term exposure
limit (STEL).
3. Action level equals 0.5 parts per million (ppm)

in a 8 hour time-weighted average (TWA).
B . Required Monitoring
1. Initial monitoring shall identify all employ-
ees who may be exposed a t or above the action level or above the short term exposure
limit and accurately determine the exposure
of each employee so identified.
2. Unless the employer chooses to measure the
exposure of each employee potentially exposed
to formaldehyde, the employer shall develop
a representative sampling strategy and measure sufficient exposures within each job clas-
sification of each work shift. The purpose of

this is to correctly characterize and not underestimate the exposure of any employee
within each exposure group.
4. Employees have the right to observe monitoring procedures.
3. The initial monitoring process shall be repeated each time there is a change in production, the equipment process, personnel,
or control measures which may result in new
or additional exposure to formaldehyde.
These are areas where airborne formaldehyde

exceeds 8 hour time weighted average or short
term exposure limit.
C. Periodic Monitoring
1. A notice regarding the danger and hazard

must be posted.
1. The employer shall periodically measure and

accurately determine exposure to formaldehyde for employees shown by initial monitoring to be exposed at or above the action level
or a t or above the short term exposure limit.
2. If the last monitoring results reveal employ-
ees exposure a t or above the action level, the

employer shall repeat monitoring of the employees a t least every six months.
3. If the last monitoring results reveal employee
exposure a t or above the short term exposure limit, the employer shall repeat monitoring of the employees a t least once a year
under worst conditions.
D. Termination of Monitoring
The employer may discontinue periodic monitoring for employees if results from two consecutive samples, taken a t least seven days apart,
demonstrate that the employee exposure is below the action level and the short term exposure
limits. This must be a statistically significant
sample.
E. Other Monitoring Information

1. Monitoring shall be accurate a t the 95% confidence level to within plus or minus 25% of
airborne formaldehyde concentration a t timeweighted exposure and short term exposure
limits and to within plus or minus 35% for
action level.
2. Monitored employees must receive the results
of the monitoring within 15 days.
3. If employee exposure exceeds the 8 hour time

weighted average or the short term exposure
limit, the employer shall develop and implement a written plan to reduce employee exposure to or below either (both) and give written notice to employees.
F. Regulated Areas
In these areas:
2. Access to these areas must be restricted to
authorized personnel who have been trained

as described earlier.
3. Respiratory protection must be provided
(permanently) if engineering or workplace
practice cannot reduce employee exposure to
acceptable limits, or temporarily in the interval until feasible engineering or workplace
practice changes are made to correct exposure levels.
4, Protective clothing must be worn and work
practices performed.
5. Employee training programs in hazards and
proper handling must be provided.
6. Proper housekeeping (preventative maintenance, proper storage, spill contingency plans)
must be implemented and practiced.
G. Emergency Procedures
For all areas where there is a possibility of an
emergency involving formaldehyde, the facility
must assure that appropriate procedures are
adopted to minimize injury. Appropriate procedures must be implemented in the event of any
such emergency.
H. Medical Surveillance
The facility must institute a medical surveillance
program for all employees exposed to formaldehyde a t concentrations equal to, or exceeding,
the action level. Also medical surveillance must
be performed when concentrations exceed the
short term exposure limits, as well as for any
employee developing signs or symptoms of formaldehyde overexposure. Such surveillance and
any examinations must be performed by or under the supervision of a physician and provided
without cost, loss of pay, and a t a reasonable
time and place.
12-4
The facility must also administer a medical disease questionnaire to any employee prior to being
assigned to a job where formaldehyde exposure
is a t or above the action level or above the short
term exposure limit including: work history,
smoking history, any evidence of eye, nose or
throat irritation, chronic airway problems, hydroactive airway disease, allergic skin conditions,
dermatitis, respiratory problems. This questionnaire must be administered annually. I t should
also be given to employees experiencing signs
and symptoms indicative of possible over exposure to formaldehyde. Assuming that the facility has already instituted all possible engineering control measures, the physician must determine on the basis of this questionnaire, his examination, and other information whether the
employees are required to wear respirators to
reduce exposure to formaldehyde.
I. Medical Examinations
Medical examinations are to be given to any employee if the physician feels, based on information in the medical disease questionnaire, the
employee may be a t risk from hazardous exposure to formaldehyde. This requirement for
physical examination also pertains to employees exposed during an emergency situation. The
physician's opinion must be documented.
J. Employee Training and Information

1. Training must be provided to all employees
assigned to work places with a health hazard.
2. Training must be provided a t the time of initial assignment and whenever new hazards
from formaldehyde are introduced into the
work place.
3. Training must be provided a t least annually

for all employees a t or above the action level
or the short term exposure limit.
4. The training program shall be conducted in
a manner that all employees are able to understand and must include:
Proper formaldehyde handling

Proper use of protective equipment
Spill contingency plans
Use of engineering environmental controls
Emergency procedures
Proper use of each type of eyewash station
in facility.
5. All employees must be informed of the location of the written training materials. These
must be available to the employees a t no cost.
K. Recordkeeping
Recordkeeping must include:
1. Results of all scheduled and unscheduled airborne formaldehyde exposure measurements.
2. Objective documentation if the employer has

determined that no measurements are necessary (no employee is exposed to formaldehyde a t or above the action level).
3. An accurate record of each employee who is
subject to medical surveillance under this
standard.
4. Records regarding fit testing of all respirators.

5. All records must be retained for 30 years after employment ends and all records must
be available for OSHA inspection (Federal
Register, December 4, 1987, 29 CFR Parts
1910 and 1926, Volume 52, Number 233,
Pages 46168 to 46312).
MONITORING AND EVALUATION

The following are recommendations for monitoring that should be performed to enhance the
safety and reduce the level of risk to patients or
staff. These recommendations are in addition
to those previously described.
Contents of the regulation and of the MSDS

Medical surveillance program purpose and
description
Potential health hazards (how to identify
and what to do)
Daily Monitoring
A. Test for the absence of clinically significant
levels of germicide or cleaning agents (toxic
0ther Monitoring
chemicals) in clean/sanitized/disinfected dialysis delivery systems.
A Emergency equipment should be inspected

for proper functionhondition according to the
manufacturer's instructions or facility policy.
B. Test for the absence of clinically significant

chemicals) in clean/sanitized/disinfectedwater treatment systems.
B. A trend analysis of incidents and/or regular

monitoring pertaining to use of toxic chemicals should be performed. Performance appraisal of all personnel responsible for handling tmic chemicals should also be performed
(see Form 1).
C. Test for the absence of clinically significant

chemicals) i n cleanlsanitizedldisinfeded reprocessed dialyzers before clinical use.
C. All incoming supplies and records should be

inspected periodically for completeness.
Monthly Monitoring
A. If formaldehyde is used a s the disinfectant
in reuse of hemodialyzers, the AAMI Recommdnded Practice for Reuse of Hemodialyzers
states that "formaldehyde vapors should be
monitored a t least monthly, and whenever
indicated by the discomfort of personnel."
B. Incident reports related to use of toxic chemicals should be reviewed and analyzed by the
quality assurance committee.
'
D. All policies and procedures related to handling of toxic chemicals must be reviewed annually.
E. Performance appraisal process for all personnel responsible for handling toxic chemicals
and facility review should be completed annually (see Form 2).
REFERENCES
1. Occupational Safety and Health Administration (OSHA) Standard. Hazard Communication

Standard. Federal Register, 52 (163): 31852-31886, August 4,1987.
2. Occupational Safety and Health Administration (OSHA) Standard. Occupational Exposure to

Formaldehyde. Federal Register, 52 (233): 46168-46312, December 4,1987.
3. BEDNAR, B. Meeting OSHA Hazard Communication Standards. Nephrology News & Issues.
4,6: 14-15, 1989.
investigation on this topic for the purpose of training or research.
FORM1
TOXIC CHEMICALSHANDLING TRENDANALYSIS
Jan
DATE
MONITORING:
AIRBORNE
LEVELS
Location #I
Location #2
Location #3
Location #4
Location #5
Location #6
Location #7
Location #8
SPILLS
Location #1
Location #2
Location #3
Location #4
ACCIDENTAL
EYECONTACT,
EX.
Location #1
Location #2
Location #3
Location #4
Other:
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
MONITORING FORM:
TOXIC CHEMICAL HANDLING
(FORM 2)

Perform the Audit


and standard.

Before the Audit




record the results as per facility policy.
response.

observer.
After the Audit


Employee A:
B:
C.
Glenn Close
Tom Hanks
William Hurt
etc.

It is recommend that one auditor should
time.


k ! p d Aylpel led se p e ~ o ppua peleqel sleqweqo qxol IIV
Chapter 13
MEDICAL DEVICE
REPORTING
+
I
CONTENTS
Page
BACKGROUND
................................. ............
13-1
PROBLEM REPORTING MECHANISMS . . . . . . . . . . . . . . . . . . . . . . . 13-1

Medical Device and Laboratory Problem Reporting Program . . . 13-1
. . ... . . . . . .. . .. . . ... . ..... .

Guidelines for Not Reporting . . . . . . . . . . . .............
Required Information for Reporting . . . . . . ............
How the Program Works . . . . . . . . . . . . . . . . . . . . . . . . . . .
Medical Device Reporting Regulation . . . . . . . . . . . . . . . . . . . . . .
Safe Medical Devices Act of 1990 . . . . . . . . . . . . . . . . . . . . . . . . . .
Guidelines for Reporting
A FACILITY'S RESPONSIBILITY FOR REPORTING
. . . . . . .. . . ..
13-1
13-2
13-2
13-3
13-3
13-4
13-4
TABLES, FIGURES, AND FORMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6
tY Assurance Guidelines for Hernodialysis Devices
Chapter 13
In Appendix A the reader will find a complete analysis of all Medical Device Reporting (MDR) files pertaining to hemodialysis devices for the period from
January 1,1980 through December 31,1989.
Medical Device
Reporting
2. The "Medical Device Reporting" regulation,
3. The Medical Device Amendments of 1976, as

amended by the Safe Medical Devices Act of
1990, and
4. Manufacturers' Complaint investigation files.
BACKGROUND
As has been noted elsewhere in this manual, a
large number of these incidents are related to user
error or to inappropriate or inadequate maintenance
Medical Device and Laboratory

Problem Reporting Program
and repair of the devices. Other incidents may

have been less severe had the user acted in accordance with the manufacturer's instructions. Another large segment of these incidents involves some
degree of device or equipment malfunction.
The Problem Reporting Program, or PRP, is f i ~ d e d

by the Food and Drug Administration, Center for
Devices and Radiological Health, and coordinated
by the United States Pharmacopeia (USP). One of
the USPs objectives is to improve product quality
and to inform industry and government about the
health hazards caused by medical devices. The
PRP provides healthcare practitioners and other
medical device users with an effective and expedient way to report problems related to the safety
and efficacy of medical devices.
The primary protection that providers and patients

have to ensure that unsafe or ineffective devices do
not remain on the market is provided by the Food
and Drug Administration (FDAI. The FDA performs routine inspections of manufacturers' facilities and recordkeeping systems to ensure compliance with "Good Manufacturing Practices."
Another method by which safety is maintained is
by the FDA's investigation of problems reported in
the use of the devices. Thus, the absolute importance of all users reporting any problemdincidents
related to use of the devices is underscored. Essentially, if dialysis personnel do not inform the FDA
of problems related to devices, it may take longer
to become aware that a device may be unsafe or
ineffective.
A Guidelines for Reporting

The PRP encourages users to report incidents of:
Death,
Serious injury, or
Malhctions that could result in hazards or
injuries.
Problems with medical devices, in-vitro diagnostic
equipment, and radiological health products should
also be reported:
PROBtERl REPORTING
MKmANrsMs
mere are basically four mechanisms by which prob
lems related to hemodialysis can be reported:
The "Medical Device and Laboratory Problem
Reporting Program,"
When there is user error. It is important to

determine if the design of the device contributes to user error or if incomplete labeling
may have contributed to the event.
When a decision is made to no longer use a
piece of equipment due to a malfunction which
has occurred or recurred It is better to report the event rather than just discard the
13-1
ers are experiencing the same problem, contacting the facility's centralized reporting area,
such as the Biomedical Engineering, Purchasing, or Risk Management departments, may
be helpful before deciding not to report an
isolated occurrence.
device, place it in storage, or return it to the

manufacturer.
When repeated repairs do not solve the problem.
When a manufacturer's design or repair changes
to the product adversely affect the performance, safety, or efficacy in the opinion of the
practitioner.
When the problem indicates poor quality control by the manufacturer.
When a problem of incompatibility between
devices of differentmanufacturers results in a
serious hazard or injury.
C. Required Information for Reporting

Reporters are encouraged to supply as much information as possible when reporting. A copy of the
Product Problem Reporting Program Form is included at the end of this chapter. The report can
be submitted in writing or by telephoning a tollfree number: 1-800-638-6725(in Maryland call coll e d 301-881-0256).
When a malfunction results in medical treatment, hospitalization, repeat surgical procedures, or readmission.
When reporting, it would be helpful to include the

following.
Even when a problem has occurred only once, if

the practitioner believes that the possibility for recurrence may exist, the problem should be reported.
The USP informs both the manufacturer and the
FDA Analyses of other "isolated incidentsn that
may have occurred and a trend analysis are then
performed. It is possible that a single problem
reported from one facility may be seen to fit into a
pattern of incidents reported by many facilities and
therefore be more significant than might first a p
pear.
Identification numbers (lot number, model number, serial number, etc.). These numbers can
help to identify if problems are recurring in
one particular lot or involve one particular
model and enable the FDA and the manufacturer to rapidly solve the problems.
B. Guidelines for Not Reporting
Whether it is a disposable device that has

been reused.
If the device involved does not have the potential to

cause or contribute to a death or serious injury, it
probably should not be reported. These include:
Changes to a product that are only cosmetic
in nature and do not affect, or have the potential to affect, the performance, safety, or
efficacy of the device. This includes personal
preference for a device.
Normal wear and tear of a device or routine
service complaints where no performance prob
lems exist such as consumer senrice complaints,
nonresponsiveness of the firm, unavailable service
manuals, or parts and replacements not readily supplied.
Isolated occurrences where the problems occur only once, the chance of recurrence is, in
the practitioner's opinion, either zero or highly
unlikely, and there is no potential for death
or injury. If interested in determining if oth-
Complete name of the device and the manufacturer name that appears on the label.
Whether the same firm or another firm is
identified as the distributor and/or manufacturer.
If the directions for use were properly followed; if not, could the directions have been
improved.
Indicate whether a sample of the device(s)
has been retained. If possible and practical,
it is important to retain a sample of the device, as well as other devices that may have
been related to the particular problem.
Identify the location of the event (i.e., hospital, clinic, home, transport, etc.).
Include the title or practice specialty of the
practitioner (physician,nurse, technician, etc.)
who was using the device when the problem
occurred.
Include a complete description of the problem
including any actual or potential adverse effects upon the patient or practitioner. Include any results of physical examinations or
13-2
laboratory tests performed in conjunction with

the problem in assistance or treatment of diagnosis or that can otherwise assist in understanding the problem
D. How the Program Works

USP is an independent, nongovernmental body
composed of approximately 300 representativesfrom
associations and colleges of pharmacy, nursing and
medicine. Once the PRP is notified by submitting
the problem on the reporting form or by calling the
toll-free telephone number, copies of the report are
forwarded to the FDA on the day that it is received. The USP also sends a copy to the manufacturer so that it is aware of the problem and your
concern. The USP will acknowledge receipt of the
report and provide additional reporting materials
for future use.
Reports submitted to the USP are subject to the
Privacy Act. The USP will delete the reporter's
name on the manufacturer and/or FDA copy of the
report if requested. However, it should be noted
that the manufacturer and the FDA may be limited in the amount of follow-up that can be done if
the reporter's name is not available. In addition,
FDA will delete the hospital, patient, and physician names (or any other data that can be used to
identi& them) prior to public release of s report
under the Freedom of Information Act.
If a name is given, the reporter may be contacted
by the FDA, the manufacturer, or both for additional information or to inform the reporter about
their evaluatibn of the report. Manufacturers have
other responsibilities regarding the investigation,
evaluation, and reporting of device-related problems ("complaint investigations" according to Good
Manufacturing Practices, Medical Device Reporting regulations, etc.).
The PRP form (see Form 2) a t the end of this chap

ter summarizes actions for the problem reporting
program. It is recommended that this form be phe
tocopied and posted in a prominent place in the dialysis center, head nurse's office,medical director's
office, and chief technician's office.
Medical Device Reporting

Regulation
Note: The following information on the Medical
Device Reporting rule applies to manufacturers of medical devices only. It is included
in this manual solely for informational purposes.
The Medical Device Reporting (MDR) final rule,
dated December 13, 1984, requires manufacturers
to report information to the FDA when one of their
devices may have caused or contributed to a death
or serious injury or when a malfunction may contribute to death or serious injury. The MDR regulation is intended to ensure that the FDA is informed promptly of all serious or potentially serious problems associated with marketed medical devices.
Under the Good Manufacturing Practices (GMP)
regulations, a manufacturer is required to review,
evaluate, investigate, and maintain a failure record of its devices.
The MDR regulation requires the manufacturer to
notify the FDA as follows:
Although the primary purpose of the PRP system

is to improve the products utilized in healthcare, it
is also a vital means of quickly bringing health
hazards to the attention of officials in government
and industry. In this way, appropriate action may
be taken, either in the f o m of product improvements or recalls.
mh Wtem is not designed to replace any rePorting requirement8 that the institution m a y
WY
haw. Remember to also use any mrmat fmility reportirg procedures such as in&nt mports.
%Y ~ s u r a n c eGuidelines for Hernodialysis Devices
In case of a death, the manufacturer must

submit the report to the FDA by telephone as
soon as possible, but no later than five calendar days of receipt of the information and must
file a written report within 15 days of receipt
of the information.
In the case of serious injury or a malfunction
that is likely to cause or contribute to a serious injury or death if it recurs, a report should
be made to the FDA as soon as the necessary
information for making the report is obtained,
but no later than 15 working days after initial receipt of the information. The manufacturer must report to the FDA each time it
becomes aware of a reportable event or malfunction.
Safe Medical Devices Act of 1990

On November 28,1990, President Bush signed into
law the "Safe Medical Devices Act of 1990," which
amends the Federal Food, Drug, and Cosmetic Act.
Several of the provisions of this new legislation have
an impact on the requirements of reporting medical
device problems. The new law will impose reporting
requirements on users for the first time. Certain
device user facilities, including hospitals, nursing
homes, ambulatory surgicalfacilities,and outpatient
treatment facilities that are not physician's offices,
will be required to report deaths related to medical
devices to the FDA They are also required to submit
reports of serious illnesses or injuries related to
devices to the manufacturer or to the FDA if the
manufacturer is not known. These provisions of the
law will go into effect upon publication of the h a 1
regulations or 12months from the date of enactment
(November 28, 1991), whichever is earlier.
Other provisions ofthis law include that distributors
of medical devices will be required to provide copies
ofMDRreportsto the manufacturer ofthe device and
that manufacturers, importers, and distributors who
make MDR reports will be required to certify the
number of reports submitted to the FDA in a year.
Also, manufacturers of permanently implantable or
life-sustainingandlife-supportingdevicesused outside a device user facilityand that are reasonably
likely to have serious adverse health consequences
will be required to establish tracking systems for
these devices.
A FACILITY'S RESPONSIBILITY
FOR REPORTING
In the event of a death or serious injury related to
the use of a medical device or in the event of a malfhction of a medical device that is likely to cause
or contribute to death or serious injury if it recurs
the facility may report to the manufacturer as well
as the PRP. Once the new law goes into effect (no
later than November 28, 1991), facilities will be
required to report deaths to the FDA and serious
injurylserious illness to the manufacturer or the
FDA if the manufacturer is not known. These are
important reporting mechanisms for the swveillance of products by both the manufacturer and
the FDA It is only through such reporting that
serious product defects or other problems can be
discovered, investigated, and resolved.
Reportable events also include improper labeling,
defective components, performance that does not
meet the specificationsof the product, poor packaging, incomplete or confusing instructions, and erroneous information. This information may be filed
as a complaint with the manufacturer as well as
with the PRP.
All facility staff members should be trained in the
problem reporting process. This should be a component of the initial training of new employees and
reviewed annually.
FORM 1
Fonn Approved: OMB No. 08104143
DATE RECEIVED
ACCESS NO
I
Lot Number(s) and Expiration Date@)(If applicable)
PRODUCT IDENTIFICATION:
Name of Product and Type of Device
(Indude sires or othec identifying characteristics and attach labeling, If available)
Serial Numbefls)
Manufacturer's Name
Manufacturer's City, State. Zip Code
Is this a disposable item?
YES
Manufacturer's Product Number andlor Model Number
NO
2. REPORTER INFORMATION:
Your Name
Today's Date
Title and Department

Facility's Name
Street Address
City
3.
State
Zip
Phone(
Ext: -
PROBLEM INFORMATION:
Date event occurred
This event has been reported to: Manufacturer
Pkue Indicate how you want your ldentlty publlcly disclosed:
Other
No public disclosure
If requested, will the actual product involved in the event be available for evaluation by the manufacturer or FDA?
To the manufact~rerldistributor
YES
FDA
[7
NO
Tothe manutacturer/distributor and to anyone who requests a

of the report irgm the FDA
Robkmnotedorouopectd (Describethe event In as much detail as necessary. Attach additional pages if required. lnclude how and where
the product was used. Include other equipment or products that were involved. Sketches may be helpful in describing problem areas.)
REfURN TO
Unlted States Pharmacopeia
12601 Twinbrook Parkway
Rockville, Maryland
20852
Attention: Dr. Joseph G. Valentino
OR
#ur FDA Zl9f (3/85)
%'Assurance Guidelines for Hemodialysis Devices
CALL TOLL FREE ANYTIME
800-638-6725.
IN THE CONTINENTAL UNITED STATES
'In himyland. call collect (301) 881-0258
be9:00 AM and 4 3 0 PM
FORM 2
WHAT TO REPORT?
Anythlng you conslder t o be a problem with a device:
When a device problem causes serious hazard, injury, or death (even I user error was involved)
Repeated device repairs are required and problem is not solved
Incompatibility in two products could or did create a hazard and you were not warned of this
possibility by the manufacturer
Improper labeling
Defective components
Performance failures
Poor packaging
Incomplete or confusing instructions
Erroneous information
Again, anything you consider to be a problem with a device!
2.
WHATTO HAVE READY WHEN YOU MAKE THE CALL OR FlLL OUT THE FORM:
Your name and title
Facility name, address, telephone number
Product name
Lot number, model number, serial number, product expiration date
Manufacturer's name and address (also Distributor's if notes both)
Problem noted:
Was a disposable device reused?
Were instructions for use followed (could they be improved?)
Has a sample of the device been retained?
Identify location of the event
Identify titlelpractice specialty of person using device at time of problem occurence
Include complete description of problem including any actual or potential adverse effects upon the
patient or practitioner
3.
MAKE THE CALL!
(OR FlLL OUT THE FORM AND SEND IT)
CALL TOLL FREE ANYTIME

800-638-6725
(in Maryland call collect (301) 881-0256 between
4.
9:ooAM and 4:30PM)
PERFORM ANY OTHER REGULAR REPORTING PROCEDURES REQUIRED BY

FACILITY POLICY.
Appendix A
Summary of Incidents/Problems
Appendix A (Cont.)
a i t y Assurawe Guidelines for Hernodialysis Devices
Summary of IncidentslProblems
CATEGORY
DATE
DESCRIPTION
POTENTIAL HAZARWRISK
ACTION REWIRED
Fadliy podalysls checks;
Del Sys-Sngl R
2/18/86
Air embolus; details unkmwn; suspecl air detector not armd
Air embolus; death
Del Sys-Sngl R
3/21/86
High sodium; pt sodum.187; d a m d a @ ~ s t e by

d fadlity
Hypematreria; mslvorn; selmes; death Check c o n & M V befao d i w i s ; proper mmmPpairXX: p o c o d u s
Del Sys-Sngl R
4/10/86
Exmss UF due to ? equipmnt mlfundon; posdMe user u r w
Hypvderria; hypotendon
Fadlity tdlow maM1( ImtwcUons; Menu( action 7
Del Sys-Sngl R
4/18/86
Addods due to low bkabpH; lmpoper mnmmate used
Addods; death
Fadlly h a t conc as drug (pocd); pH and mnd chedt before dldysls
Del Sys-Sngl R
4/22/86
Hemdysis due to enpty concentrate)ug; no darm
Hypnatrenia; n m k o m ; hemolyds
Proper pocedues; m n u t adon
Del Sys-Sngl R
488/86
Fyrogen reactions 2" to gross machine baaerial cantanindon
Pyrogen reactions; sepsis
Roper dldnfecllonpomdves, water Ueatmm badefial mnitodng
Del Sys-Sngl R
4/28/86
Pyrogen readions 2 O to gross water system baaerld contamination
Pyrogen reactions; sepsis
Roper didnfedon p o m u e s , water reatmem bacterial mrindng
Air embolus; death
Fadliy pedalyds checks;

Roper water treatment; proper machine dntenanm
p
-
Del Sys-Sngl R
4/29/86
Potentid air embolus; detdls unknown; suspect user error
Del Sys-Sngl R
56/88
Heater overheated due to din in water
Hemclyjs
Del Sys-Sngl R
7/18/86
High d l d p t e sodun( 234); alarm and pmporcloningmdadjusted ly fadI4kj
Check m n & m b l u e d i w s ; proper m m P p a i r m promdues

Hypnuemia; m L m ; s e i ~ e sdeath
;
Del Sys-Sngl R
Del Sys-Sngl R
86/86
High didysate sodurn; details unkmwn
Hypernauemia; nars&om; seimes; death Check mn&c+MV
8/13/86
Appar. pyogen rxn; Renallnpoorwater ueatment; p w . baMner (high flux)
Pyrogen reaction; sepsis
Del Sys-Sngl R
9/19/86
Blood p n p mFped w k l n g dulng ddysis; also d d pedidysis (gmed)
lneffecdvedalysis; potemid of dotllng
Manut adon; poper machine d n t e n m W p e d l d y d s checks
Excess UF due to 7 equipment mltundon
Hypvdenia; hyptension
Manut adon
Del Sys-Sngl R
Del Sys-Sngl R
11/17/86
UF due to 7 equip meHundon; user w
before dialysis; proper m$lmPpairlO(: promdues
Proper water tmnt design 6 disinfect; p r o w miaoUol modlor 6 germidde dllulion
d cdib requirermm
118/87
Ex-
2/11/87
Punp operaled at rnax speed (700) despite sening; control mahtunclion
Excessive Mood now
Manuf adon; fadliy pedalysis checks
Maruf adon
Del Sys-Sngl R
2/12/87
Excess UF due to ewpment mdfundon
Hypvdenia; hypotendon
Dd Sys.Sngl R
2118187
R gained weight 7 2 O to positrve didysate pess; no predidysls mach checks
Hypervolemia; hypertendon
Roper fadlky pocedures; mand d o n
P u p Operated at accelerateds p e d despite setting; control maltundon
~xcessiveblood now
Manut adon; fadlity pedalysis checks
Hypematremia; ws)vorn; seimes; death Check mnd before dhlysis; paper rrtWrepdr/O(: pocedures
Del Sys-Sngl Pt
3/2/87
Del Sys-Sngl R
3m7
Stan used machine despite knowledge of mnductMty poblem; high sodium
Del Sys-Sngl R
4/13/87
Punp operated at acceleratedsped despte setting; control maltundon
-PI
Excessive Mood now
Manutamer action; fadlity pedidysls checks
Patient recsived smdl electrical s h 5 due to wiring poblem
EleclrMon
Proper mMepalr pomdves; elec checks; QC procedues
Potentid i r embolus: Ud p m p continred to run 8 no damp despite 5r darm
Air embolus; death
Fadlity peddysis checks; mfr action
Del Sys-Sngi
4R4/87
Del Sys-Sngi PI
Del Sys-Sngi R
4/29/07
4RO187
Potentid air embolus: Md p m p m n t i w d to run & no damp despite rir alarm
Air embolus; death
Fadllty p e d d y d s checks; mfr action
Del SpSngi R
5/1/87
Potentid ar embolus: Md pump m n t i w d to run a no dampdespite dr darm
Air embolus; death
Fadlity peddysis checks; mh action
Dd Sys-Sngi Pt
511187
Potentid air embolus: Md p m p continred to run a no damp despite dr d a m
Air emb~lus;death
Fadlity p e d d y d s checks; mh action
Del Sys-Sngl R
6/12/87
Air embolus; mdfunclion of reset switch dsaued a l r m
Air embolus; death
Fadlity p e d d y d s checks; mfr action
Del Sys-Sngi PI
6/23/07
Formldeyde exposure due to backsiphon from upstream mchim
Toxic rxn; death
And siphon valves; paper pocedures
Del Sys-Sngl PI
6/25/87
Excess UF due to equip malf; user dd rot follow rntr's promdues
Hypvolenia; hypotension
Fadlity fdlow mfr I ~ s ~ N ~ o ~ s ;

Fadlity peddysis checks; follow mih repairlmtncpocd; OC
Pot. air erbdus: Md p m p mnt to run 8 ro danp despite air alrrm; inprop repair
6/25/07
Del SysSngi PI
p
Del Sys-Sngi PI
6130187
Air embolus; ar detector stuck in reset position
Air embolus; death
Fadlity peddysis ch*
Dd Sys-Sngl PI
7/1/87
Pot. air emtdus: Md pump mnt to run 8 no danp despite air alrm; poor mnc
Air embolus; death
Fadlity p e d d y d s checks; fdlow nih repairlmtncpocd; (X:
Del Sys-Sngl PI
7/16/87
Art & ven pressure darm but no Mood pump stop;
Problems assac with excess pessure
Fadllty peddysis checks; mfr action
Del SyrSnd PI
7/17/87
Excessive UF cased dalo memb ~ p t u r emaif

; due to poor fadlity w i p rtnc
b o d loss; l p t e n d o n ; sepsis
Proper mdntenanmhepalrpromdues; (X: pomdues
Del Sya-Sngi R
7131187
Excess UF due to equipment mdtunclion
Hypvdenia; hypotendon
Manufachrer action
Del Sys-Sngl R
8/11/87
Punp operated at accel speed despite sening; m m d mdtutunclion
Excessive Mood now
Manufamu action; fadlity pedidyJis checks
mfr action
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Appendix A (Cant.)
Quality-Assurance Guidelines for Hemodialysis Devices
Summary of Incidents l Problems
CATEGORY
IDATE
~DESCRIPTION
Dl*-
7nOB1
~POTENTYL
HAZARDIRBK
ACTION REWIRED
-
Ipmpr sodum mnc (low); inproper dlludon of concantate by user
Hyponalrenia; ncuslvom: hemotpis
ManufacaJ.oh d o n ; chedc condixhity befue dialysis

Fdlow t m ~ f a c b l o hpocedues;chedc mnd before datysis
a*-
liMW
lpmpr sodummncenhllon (low)
Hypwrenia; n ~ ) v o mhemdyds
;
Dl*-
8UB4
lnpmper potassium content low and high)
NausWvomhing;cardac poMems
Manutaatrw% d o n
Dl*-
11BB4
pH of add mncontrate too high
Alkylods; m d a c pmtlems
Manufacaroh d o n ; chedc pH befwe dalyds
ow-
5IlM
lnprqmr sodumconc (high); 7 fadlky oqJp callb
Hypomaremla; na~sWm;selme; death
Manufaduer's d o n ; chedc mndue(vl hy
8BB5
Inproper Potassium mntem; fadMy staff niroad label
Nausmoriflng; w d a c poblems
Manuf cducodo l W s ; fadl teal mnc as drug (poce&res)
before d i w s
Lw'W
817B6
Maatial gwth in tlquid mncenuate; recall
Pyrogen readions;sepsis
Manutamoh d o n ; fadlity miwtioioglcd mnllorlng
Dl*-
lOn4B6
Maoblal q M In liquid concentate; r e d
Pyrogen reaalons;sepsis
Manufachlroh d o n ; fad(ty mlwblologid mnitodng
?*-
lORgm6
M a a t i d q M In Hquid cOnMhte; recall
Pyrogm reactions; sepsis
Manufacaroh d o n ; fedtty mlwtiologlcA mnltodng
or*a*a*-
11/5/88
Maatial g M In Hqid mcemrate; r e d
Pyrogen reactions; sepds
Manufacarer's d o n ; fadky mlmblological mniiorlng
3/16/87
Used inproper mnc;p mqhrod medical imrvomlon
Hypernauenia; mh)vom; winre; death
Mh cdorcode labek;fadl teat mnc as h g bocd); 4
7RlB7
Sodum content on label was m n g (off by 100%)
Hypemaremla; na~h)vom;seime; death
Manufachrrehd o n ; chea condwwty M a e d i m s

Manufacarer's d o n ; fadtty mlwtiologicd mnltorlng
before dial
Dl*-
8rZO8.3
M a a t i d q M In Wquld mcanaato; recall;
Pyrogen reactions;sepsis
pijv-
Qn2/80
Inproper Potassium content; fadlity staff nisread label
Nausmomhing; cardac poblems
Manuf cola-code labels; fadlity troa concantate sc dNg bocedures)
Didysate
5MM
23 pts dldzd with add lnstd of mtateconc on acetate mech;stall e n u
Addods; death
FadMy mat mnc as dug (poce&res); chedc mndlpH before daysis
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Appendix A (Cont.)
qua lit^ Assurance
Summary of Incidents /Problems
w '*q
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Appendix B
Trend Analysis
Recommendations that trend analysis be performed

on various aspects oftechnical data have been included
in several sections throughout this manual. Trend
analyses can be performed in a variety of different
ways, using many formats. To assist the reader in
understanding how to perform and use trend analysis
as a quality assurance tool the following case history is presented.
It is recommended that all hemodialysis facilities
perform certain ba&riological monitoring on a monthly
basis. These should include at least water bacterial levels and dialysate bacterial levels to confirm
compliance with AAMI Standards.
Most hemodialysis facilities draw cultures monthly;
and, when results are received back from the laboratory, many stack the actual lab reports in a threering binder or drawer &r checking that the results are within AAMI limits.
Although such a practice gives the facility some
assurance that the water and dialysate are microbiologically acceptable for dialysis, a few additional
actions will provide more helpful information. They
may also prevent problems, long before they occur.
In addition to simply looking at the laboratory report

form and filing it, the facility should also record the
results on a spreadsheet.
Sample Case History

Trend Analysis of Delivery System Dialysate
Bacterial Levels
An anecdote about an actual occurence reported in
a hernodialysis facility indicates the value of such
a recordkeeping system. The name and location of
the facility has been changed.
Mt. Evans Dialysis Facility in Conifer, Colorado

contacted the authors in November 1989 complainpatients were experiencing
W g e n reactions. Upon interview with facility
Personnel, it was found that one delivery system's
k that two of their
bacterial culture results showed > 30,000 colonies1

ml in Odober.
The facility had not been charting bacterial levels,
but simply filing the lab slips in a manner similar
to that described above. To investigate and solve
the problem, the initial step taken was to array all
culture results obtained in 1989, for all six of the
facility's machines on one spreadsheet. The results
are presented in Figure 1.
Using a line chart further enhances the visibility of
trends. In Figure 2 the constantly increasing level
of bacterial colonization in machine #2 is obvious.
A simple rule of thumb is that any value which

shows three consecutive increases or decreases in
such a line chart indicates a trend. Thus, if the
Mt. Evans Dialysis Facility had been using a line
chart, they would have realized that an unacceptable trend was occuring when they charted the
July results on machine #2. July was the third
consecutive month with a significant increase in
colony count. Since no changes had been made in
disinfection protocols, or any other policies or procedures that would affect bacterial growth, they
could have anticipated that the month-to-month
increase in colony count would continue.
In the end, the problem was determined to be a
buildup of biofilm in the inlet water line of the
machine. This part of the system was not subject
to the routine disinfection performed at the Mt.
Evans facility.
Thorough disinfection and cleaning, through the
water distribution loop eliminated the problem. No
permanent patient injury occurred.
The purpose of the anecdote is to illustrate the usefulness of trend analysis in anticipating problems,
and in solving them before serious consequences do
occur. Tools and methods such as those described
in this appendix section should be used in any of
the areas discussed in this manual where trend
analysis is recommended.
Qmlit~
Appendix B (Cont.)
Trend Analysis
Figure 1
Delivery System Dialysate Culture Results

Jun
Jul
Aug
Sep
Oct
Nov
MACHINE #
Figure 2
Machine #2 Dialysate Culture Results
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Month (1989)
B-2
Appendix C
Glossary of Terms
Automated hemodialyzer reprocessing system: A device that automatically rinses the

dialyzer of residual blood and blood products,
performs some manner of "cleaning" process,
tests the dialyzer for leaks and performance
parameters, and fills the dialyzer with an appropriate concentration of a germicide.
Depth filter (or sand filter or multi-media

filter or diatomaceous earth filter): A tanktype filter, usually including a backflushing system, which is used as a first stage treatment to
remove suspended matter, colloidal material or
silt from the water before introduction to other
downstream water treatment components.
Blending valve: A device, generally a t the beginning of the "pre-treatment," that mixes warm
and cold water to achieve an optimum temperature for operation of the reverse osmosis membranes.
Dialysance: Describes dialyzer efficiency when

solute concentration in the dialysate is not zero
(such a s recirculating dialysate delivery systems); the volume of blood cleared of that solute
per minute if the dialysate concentration is zero.
Carbon filter (or granular activated carbon filter): A cylindrical tank containing an
activated carbon filter medium with a central
drainage core. This type of filter is used primarily to remove chlorine and chloramine, as
well as some organics.
Dialysate (or dialysis fluid ): A non-sterile

aqueous solution with an electrolyte composition near that of normal extra cellular fluid.
Central dialysate delivery system: A system that utilizes a single "centraln dialysate proportioner which prepares dialysate for a number of bedside consoles or bedside stations.
Clearance: Describes the performance of the
dialyzer for solute removal; the amount of blood
completely cleared of a solute by the dialyzer
per minute expressed in ml/min.
Concurrent monitoring: The process of observing or measuring something a t the time it
is occuring.
Deionizer (or deionization tank or DI): A
tank of insoluble spheres or beads, called resin,
which exchanges all types of cations and anions
and replaces them with hydrogen and hydroxide ions which combine to form water. Deionizers may be categorized as "mixed bedn, containing both cation and anion resin in a single vessel, or "dual bedn, where each resin type is in a
Separate vessel.
Dialysate concentrate: A preparation of salts

which, when diluted with water, yields dialysate for use in dialysis. These concentrates are
manufactured commercially in liquid or powder
form.
Dialysis delivery system: A device that delivers dialysate to the hemodialyzer maintaining proper concentration, temperature, pressures, and flow in the dialysate circuit. The
dialysis delivery system (delivery system) also
monitors various functions related to the dialysate compartment and the blood compartment:
dialysate pressure, ultrafiltration rate, blood
leaks into the dialysate, changes in the pressure
of the blood circuit, air or air foam in the blood.
Dialyzer: The device where the exchange between blood and the dialysis fluid takes place; a
semi-permeable membrane separates two compartments, one in which flows the patient's blood,
and the other the dialysis fluid, or dialysate.
Diffusion (or conductive transfer): The passive transport of solutes across a membrane in
the absence of net solvent transfer.
Glossary
Appendix C (Cont.)
Endotoxin: Bacterial lipopolysaccharide found

in the bacterial cell wall. I t is a pyrogenically
active material
Fixed-ratio proportioning system: A delivery system in which cylinders of known volumes
are used to proportion dialysate concentrate and
treated water in exact amounts, and through a
series of valves control the cyclic filling and emptying of each cylinder.
I m p o r t a n t aspects of care: Those things that
are performed or provided in a health care setting that are most important. These aspects
tend to be high volume, high risk or problem
prone.
Kinetic modeling: A means of quantifying and
individualizing dialysis treatment and nutritional plan.
Langelier s a t u r a t i o n index: A calculation of
the propensity of a reverse osmosis membrane
for scaling with calcium carbonate crystals performed by using total dissolved solids, total alkalinity, calcium concentration, pH, and temperature of the R.O. reject stream.
R e v e r s e osmosis: A membrane separation

process for removing solvent from a solution. In
an RO system feed water is pressurized on one
side of a semi-permeable membrane. The pressure is high enough to exceed the osmotic pressure and cause reverse osmotic flow of water.
Sediment filter: A cylindrical cartridge filter
used to remove particulates.
Servo-controlled proportioning systems: A
delivery system that uses a control sensor to
monitor the conductivity of the dialysate and
regulate the flow of the dialysate concentrate
within the specific conductivity limits. Flow can
be regulated using variable speed pumps, variable orifice values, or other mechanisms.
Servo-feedback ultrafiltration control system: A delivery system where dialysate inflow
(Q,) and outflow (Q,) are measured constantly,
using sensitive flow meters. By subtracting Q,
from Q, the system measures ultrafiltration flow
rate (Q,).
Once that value is known, the microprocessor (in which a desired Q, has been
programmed by the user) automatically adjusts
the machine's TMP so that desired Q,,
- equals
measured Q.,
*
Limulus amoebocyte lysate assay: A laboratory test for p~rogenicitywhich employs a mat k a l derived from the blood of the horseshoe
crab.
Mass solute transfer: The quantity of a solute transferred from the blood into the dialysis
fluid (or vice-versa) across the semipemeable
membrane of the dialyzer per unit of time.
Pyrogen: A fever-producing substance.
Pyrogen reaction: A patient reaction characterized by shaking chills and fever.
Quality assurance: A cyclical Process by which
problems and opportunities for improvement are
identified and analyzed, solutions are developed
and implemented, and reassessment occurs.
Q u a l i t y control: The process by which a
product's performance is measured.
Retrospective monitoring: The process of
measuring something that has already occurred.
Sieving coefficient: A mathematical expression that describes the fraction of specific solute
retained by a membrane during ultrafiltration
(c&,w>.
Silt density index: A measurement of the

membrane-fouling and filter-plugging characterisitics of tap water.
Single patient, single pass dialysate delive r y sys&ms: A system-where dialysate is delivered to one patient at a time; also called
"negative pressure systems."
S o r b e n t ( o r regenerative) dialysis system:
A delivery system that involves the reprocessing of dialysate through a cartridge to remove
uremic toxins from the spent dialysate, as well
a s adjusting electrolytes to the desired level.
Threshold f o r compliance: A percentage of
compliance with the indicators that are expected
to be found when monitoring the activities of
the facility.
Appendix C (Cont.)
Toxic substance: Any chemical that is corrosive to living tissues; carcinogenic; toxic when
administered orally, cutaneously, or through
inhalation; irritant; sensitizer; toxic to target organs.
Ultrafilter: A membrane filter that will remove smaller particles (10,000 to 50,000 MW
cutoff) than depth filters.
Ultrafiltration: The process by which plasma
water is removed from the blood due to a pressure gradient between the blood and dialysate
compartments; expressed in mVmin, mVhr, or
Uhr.
Ultraviolet radiation: A means of disinfecting hemodialysis water that utilizes radiant
energy for the destruction of bacteria. UV light
Glossary
is produced by means of a low pressure mercury
vapor lamp that emits the majority of its light
a t a bactericidal wave length. Water passing
through an ultraviolet radiator typically flows
over and around a quartz sleeve and does not
contact the lamp itself.
Volumetric ultrafiltration control system:
A delivery system that employs a fluid-filled,
closed, non-compliant dialysate circuit from
which a controlled and measured amount of fluid
(dialysate) is removed, generally, via a volumetric pump, from a closed circuit.
Water softener: A tank of insoluble spheres or
beads, called resin, which exchange cations in
removing calcium and magnesium from incoming hard water.
Appendix D
List of Tables, Figures, and Forms
Chapter 2: The Basics of Quality Assurance
Figure 1
The Quality Assurance Process
Sample Quality Assurance Plan
Figure 2
Quality Assurance Problem Tracking Form
Figure 3
Scope of Care
Table 1
Regulations, Guidelines, and Standards
Table 2
Data Sources
Table 3
Chapter 3: Water Treatment
Table lA
Water Contaminants
Table 1B
Signs and Symptoms and Possible Water Contaminant-Related Causes
Water Treatment System (summary of components)
Table 2
AAMI Requirements for Manufacturers (summary)
Table 3
AAMI Requirements for FacilitieslUsers (summary)
Table 4
AAMI Recommendations for Users (summary)
Table 5
AAMI Recommended Practice for Reuse of Hemodialyzers
Table 6
Water Requirements (summary)
Water Treatment System Log
Form 1
Water Treatment System Monitoring Form (concurrent monitor)
Form 2
Water Treatment System Trend Analysis
Form 3
Chapter 4: Dialysis Delivery System
Table 1
Dialysis Delivery System (summary of components)
Table 2
Summary of AAMI Delivery System Requirements
(Manufacturer Standards)
Form 1
Patient Daily Dialysis Record
Form 2
Delivery System Trend Analysis
Form 3
Delivery System Master Preventative Maintenance Schedule
Form 4
Predialysis Technical Checks Monitor (concurrent monitor)
Form 5
Dialysis Equipment Audit
Form 6
Delivery System Evaluation Checklist
Chapter 5: Dialysate and Dialysate Concentrate
Table 1
Typical Ranges of Dialysate Fluid
Table 2
Summary of AAMI Dialysate Concentrate Standards
Form 1
Form 2
Dialysate Concentrate Tank Label and
Dialysate Concentrate J u g Label
Form 3
Dialysate Cultures Trend Analysis
Form 4
Dialysate Concentrate Safety Monitor (concurrent monitor)
Chapter 6: Hemodialyzers
Table 1
Dialyzerhlembrane Characteristics
Table 2
AAMI Dialyzer Requirements (Manufacturer Standards) (summary)
Table 3
Some Useful Formulas in Working with Dialyzers
Form 1
Form 2
Dialyzer Problems Trend Analysis
Form 3
Dialyzer Use Monitor (concurrent monitor)
wit^ &~wanceGuidelines for Hernodialysis Devices
Appendix D (Cont.)
List of Tables, Figures,& Forms
Chapter 7: Ancillary Devices and Equipment

Conductivity Meter Calibration Check Log
Form 1
Form 2
Form 3
Dialysis Systems Checklist
Conductivity Meter Trend Analysis
Form 4
Chapter 8: Anticoagulation
Form 1
Automated
Clotting Time Meter Calibration Log
Form 2
Chapter 10: Hemodialyzer Reuse
M I Recommended Practice: Reuse of Hemodialyzers (summaly)
Table 1
Reuse Labeling and Recordkeeping Monitor (concurrent monitor)
Form 1
Reused Dialyzer Preparation for Use Monitor (concurrent monitor)
Form 2
Reuse Physical Plant and Environmental Safety Monitor
Form 3
(concurrent monitor)
Dialyzer Reprocessing Log
Form 4
Form 5
Reuse Problems Trend Analysis
Form 6
Chapter 11: Infection Control
Universal Precautions Monitor (concurrent monitor)
Form 1
Chapter 12: Handling of Toxic Chemicals
Toxic Chemicals Handling Trend Analysis
Form 1
Toxic Chemicals Handling Monitor (concurrent monitor)
Form 2
Chapter 13: Medical Device Reporting
Form 1
Problem Reporting Form
Problem Reporting Program Summary
Form 2
Appendix E
Annotated Bibliography
Contents
The Basics of Quality Assurance
Water Treatment
Dialysis Delivery System
Dialysate and Dialysate Concentrate
Hemodialyzers
Anticoagulation
Vascular Access Devices

HemodialyzerReuse
NOTE TO TNE READER

In performingthe research necessary to produce this
document,Q ~ a l i t ~ ~ s s u m~uidelinesfor~emodince
alysis Devices, an extensive literature search was
performed. Although afew ofthe principle references
for the material provided are included a t the end of
each oftheindividualchapters, significantadditional
citations were reviewed prior to writing the manual.
wit^ AssuraIU:e Guidelinesfor HernodialysisDevices
In order to allow the reader to hrther review the

literature availablebetween 1980and 1989on these
topics, this section, Appendix E, contains an additional annotated bibliography related to the devices
included in the above subject areas.
This appendix is also included to allow the reader to
pursue additional study of these areas and to assist
the facility as a training tool.
Appendix E (Cont.)
Annotated Biblwgmphy
Chapter 2
Techncal~entsforrapidhigh-efEciencytherapies. Guthke, R, Gunther, K, Stein, G. and Knorre, W.A

Keshaviah, P., Luehmann,D., Ilstrup,K andcollins,
ComputPqpumsBiomed, 19(%3),pp.189-95(1985).
A Artif Organs, 10 (3), pp. 189-94 (Jun 1986). The
Four parameters of a two-pool model are evaluated
by an iterative method using the explicit solutions of
key technical elements necessary for such implementation include high blood flow rates, higher effithe linear differential equations.
ciencydialS7zers/~ters,ultrafiltration~0n~l~s,
Insufficient documentation of the hemodialysis preand bicarbonate as the buffer source. In addition,
scription: delaying the definition of adequate dialyhemodiafiltrationrequires schemesto ensure sterilsis. Lundin, AP., Tarras, M. and Friedman, E.A
ity and nonpyrogenicity of the infusion fluid and apNephron, 37 (3), pp. 200-2 (1984). The authors anapropriate balancing of the rates of ultrafiltrationand
lyzed 953 articles published in three established
reifision.
nephrology journals to select those pertaining to
A digital computer model for optimal programming
treatment with hemodialysis. A total of 152 papers
of hemodialytic treatment. Lamberti, C., Sarti, E.,
were selected on the criteriathat the reported results
Santoro,A , Spongano,M.,Zucchelli,P. andRossi,M.
might have been affected by variation in the dialysis
prescription. Only a small proportion of the papers
Int J Artif Organs, 11(4), pp. 23542 (Jul1988). A
studied (11.8%)detailed the complete dialysis premathematical model of hydroelectrolyte exchanges
scription including type of dialyzer, blood flow rate,
and arterial pressure regulation in the human body
during dialysis has been set up. It is conceived as a
and duration and frequency of dialysis. A surprising
29% of papers provided no details of the dialyzer
tool for a new dialysis unit which will be able to
"interpret" the signals supplied by suitable instruemployed. Other potentially important variables
ments connected to the patient and modify the masuch as the type of blood tubing or method of water
chine set-pointsin real time in order to obtain clinical
treatment used were rarely mentioned. Compararesults defined by the physician.
tive studiesof the course and outcome of hemodialysis regimens require specification of exactly how
An advanced, user-friendly microcomputer program
dialysis was performed. It is suggested that manufor hemodialysis kinetics. Buur, T. A& Exp Med
scripts provide this information as a condition of
Bwl, 223, pp. 23944 (1987).
suitability for publication.
Relative importance of membrane Limulus amebocyte lysate-reactivematerial and ethyleneoxide in
hypersensitivity reactions. Pearson, F.C. Contrib
Nephrol, 59, pp. 134-44 (1987).
Evaluation report: dialysis and ancillaryequipment.
JMed Eng Technol,10(3),pp. 141-7(MayJ u n 1986).
Report of the continuingprogramme of evaluation of
medical equipment sponsored by the UK Health
Departments, the evaluation of dialysis and ancillary equipment camed out within the University of
Sheffield,under the direction 0fPmfessorM.M. Black.
'Health Equipment Information' Number 148, published in December 1985, carries full reports. Twopool model analysisof data in hemodialysisbymeans
of programmable pocket calculator TI 59.
Quality of treatment issuesin maintenancedialysis.

Stewart, J.H. Med JAust, 2 (9), pp. 430-3 (Oct 30
1982).
The dialysis nurse's role in an interdisciplinary program. Hopper, S A J Am Asxx Nephml Nurses
Tech, 6 (I), pp. 204 (1979).
Adjustment and +ty
ofpatient-nurse interaction
among dialysis patients, Tucker, C.M., Mulkerne,
D.J., Panides, W.C. and Ziller, R.C. Nephrd Nurse,
3 (2),pp. 26-32 (Jan-Feb 1981).
Implementation of ANA's quality assurance program for clientswith end-stagerenal disease. Bruce,
G.L, Hinds, P., Hudak, J., Mucha, A , Taylor, M.C.
and Thompson, C.R ANS, 2 (2), pp. 79-95 (Jan
1980).
E-2
Appendix E (ContJ
Anndated Biblwgmphy
The change from h c t i o n a l to primary nursing.
Dean, L.P. Nurs Clin North Ant, 14 (2), pp. 357-64
(Jun 1979).
Nursingmanagement of multiple dialysisunits: roles
andresponsibilities. Momssey, Z.M. Nephrd Nurse,
1(11, pp. 43-5 (Jan-Feb 1979).
Satisfaction with health care of hemodialysis patients. Ferrans, C.E., Powers, M.J. and Kasch, C.R
Department of Medical-SurgicalNursing, College of
Nursing, University of Illinois, Chicago 60680. Res
Nurs Health, 10 (61, pp. 367-74 (Dec1987). The purpose of this study was to assess the satisfaction with
care of hemodialysis patients, and to explore the r e
lationships between satisfactionwith care, quality of
life, and background variables. No generalizations
can be made.
Minimum performance standards for double-lumen
subclavian cannulas for hemodialysis. Bregman, H.,
Miller, K and Berry, L. ASAIO Trans, 32 (I), pp.
500-2 (Jul-Sep 1986).
Technology assessment. How effective is medical
care? Hazelton,AE. Clin GeriatrMed, 2 (3), pp. 4.8190 (Aug 1986). Technology assessment helps the
physician by determining which technologies are
most apt to benefit the patient, allowing the physician to recommend a prudent course of action. Technology assessment should encourage skepticism of
new technology, causing the clinician to be more
rigorous about accepting the latest invention. By
shunning the useless technologies, physicians can
prevent rationing of the useful techniques and avoid
being caught in the ethical dilemma of doing what is
best for the patient but is detrimental to society.
Quality hemodialysis: a "gold standard" treatment
for survival. Lundin, AP. Kidney Int, Suppl, 17, pp.
S12-4 (Dec 1985).
Investigation of the Karnofsky Performance Status
as a measure of quality of life. Grieco, A and Long,
C.J. Health Psychol, 3 (21, pp. 129-42 (1984). The
Karnofsky Performance Status appears to be the
most widely used scale for objective assessment of
medical patients' quality of life. Evidence for its
reliability and validity is reviewed and new data
Presented. Tests of inter-rater reliability,concurrent
validity, and discriminant validity indicate that,
with standardized observational procedures based
0x1 a mental status exam, the Karnofsky scale is
Veptably reliable and valid as a global measure but
tdoes not adequatelycapturethe conceptualdomain
O f ~ t ofylife.
w i t ~ ~ s s u r a n Guidelines
ee
for Henodialysis Devices
Chapter 2

Mortality, morbidity, and life satisfaction in the very
old dialysis patient. Westlie, L., Umen, A, Nestrud,
S. and %ellstrand, C.M. Trans Am SocArtifIntern
Organs, 30, pp. 21-30 (1984). Discussion ofmortality,
morbidity and life satisfaction of 157 patients 70
years of age and above. The authors conclude that
older patients are excellentdialysis candidates and it
is wrong not to consider them for dialysis.
Assessing the quality of nursing care in a dialysis
KL., Feltman, B.A and Smeltzer, C.H.
unit. &J=,
ANNA J, 12 (11, pp. 11-5,53 (Feb 1985).
Aprotest movement in a private clinic: an analysis of
a patient strike. Waissman, R. Soc Sci Med, 20 (21,
pp. 129-32 ( 1985). Behind this protest movement
among chronic patients on dialysis was a dispute
between the specialist who headed the service and
the director of the clinic. This dispute eventually
involved the patients, who felt that the quality of care
was a t stake. Their 'therapy strike', as exceptionalas
it is in the world of illness, brings to mind forms of
action used by the consumer movement or by labour
unions. The reasons that this small group ofpatients
interrupted treatment are analysed in terms of their
relations to medicine and their conceptions of illness.
Monthly home patient checklist: a dialysis assessment tool. Rhodes,V.S. JNephrol Nurs, 2 (1), pp. 289 (Jan-Feb 1985).
The computerin medicine. Its application to medical
practice, quality control, and cost containment. Pollak, V. JAMA, 253 (I), pp. 62-8 ( J a n 4,1985).
The liaison psychiatrist and the outpatient hemodialysis unit. Part I: Reliability and validity of stafF
assessments ofpatient compliance on a hemodialysis
unit. Manley, M. Clin Exp Dial Apheresis, 7 (41, pp.
349-56 (1983). Staffratings for global impressionsof
patient compliance are collected in an outpatient
hemodialysis unit, inter-rater reliability is calculated, and the rating averages are correlated with three
biological markers. Ahigh degree of exact inter-rater
agreement is found and correlation of ratings with
inter-dialysis weight gain, mean BUN, and mean K
are determined.
Reliability and validity of a quality assurance instrument for a renal dialysis unit. Molzahn-Yanitski,
AE. Nephrol Nurse, 5 (6), pp. 8-12 (Nov-Dec1983).
A statistical review of variables predictive of adjustment inhemodialysispatients. Olsen, C.A Nephrd
Nurse, 5 (6),pp. 16-27 (Nov-Dee 1983). Document
Type: Review (68 refs.).
Appendix E (Cont.)
hnnotated Bibliography
Effect of an algorithm and patient information on
serum phosphoms levels. Deimling, A , Denny, M.,
Harrison, M., Kerr, B., Mayfield, M., PelleShearer,
M., Seaby,N. andTownsend S. AANNTJ, 11(11, pp.
35-8,50 (Feb 1984).
Assessment ofrehabilitationoutcomesamongchronic
dialysis patients. Kutner, N.G. and Cardenas, D.D.
Am JNephml, 2 (31, pp. 128-32(1982). The physical
status of 137 chronic dialysis patients was assessed
by both objectiveand subjectivemeasures; education
and employment statuses were also determined.
Below normal grip strength characterizedthe majority of patients; slowed nerve conduction and subjective fatigue were also observed among a subset of patients. However, patients demonstrated good to
normal muscle strength and relatively normal pinch
strength, and activities of daily living presented no
problems for the large majority of patients. Employment probability was directly related to educational
status. Despite dialysis requirements and other
employment disincentives, 42% of non-diabetic men
aged 21-59 were employed.
Monitoring standards instead of problems. Hexum,
J.M. J Nurs Qua1Assur,l(3), pp. 8-13 (May 1987).
The computer in quality control of hemodialysis
patient care. Pollak, V.E., Peterson, D.W. and Flynn
J. QRB, 12 (6), pp. 202-10 (Jun 1986). Describes a
computerized,custom-designedmedical information
system (MIS)that has been used for more than eight
years in the care ofpatients with chronic renal failure
treated by hemodialysis in a medical center. Application of the MIS in the day-bday management of
patients in one limited-caredialysisclinic is detailed,
with particular attention to its capacity to contribute
to the quality of care of the individual patient.
Morbidity and mortality oflong-termhaemodialysis:
areview. Gabriel, R J R Soc Med, 77 (7), pp. 595-601
(Jul1984). Document Type: Review (90 refs.).
Selected health care maintenance policies in chronic
dialysis centers. Dillingham, M.A and Anderson,
R.J. Am J Kidney Dis, 6 (4), pp. 23740 (Oct 1985).
f i r a survey approach, the authors postulate that
prospective studies to determine optimal methods of
health caremaintenancein the chronicdialysiscenter
are indicated.
Risks and hazards associated with dialyzers and
dialysate delivery systems. Keshaviah, P.R. and
Luehmann, D.A Cn't Rev BiomedEng, 9 (3),pp. 20144 (1983). Document Type: Review (83 refs.).
Quality Assurance Guidelinesfor HernodialysisDevices
Chapter 2
Fadors influencing survival of patients on chronic
hemodialysis: implications for nursing. Rogers, K,
Tzamaloukas, AH. and Avasthi, P.S. J Nephrol
Nurse, 3 (3), pp. 1014 (May-Jun 1986).
Sudden death in hemodialysis patients. Cohle, S.D.
and Graham, M.A JForensic Sci, 30 (I), pp.158-66
(Jan 1985). Hemodialysispatients may die suddenly
and unexpectedly from a number of causes. These
deaths may be divided into those due directly to and
occuningduringhemodialysis,those occurringwhile
the patient is not undergoingdialysis, and those that
may occur at any time. The first groupincludesbrain
herniation, air embolism, acute hemorrhage as a
result of machine malfunction or fistula rupture,
electrocution,cardiac arrhythmia caused byhypokalemia, complicationsof subclavianintra-venouscatheter insertion, thirddegree heart block as a result of
triglyceride emulsion, and disseminated intravascularcoagulation(D1C)orhyperkaIemiacausedby~eated
dialysate. The second group includes deaths due to
pericardial tamponade because of effusion and suicidalcausesofdeath(exSangcLinati~n,electro~imbalance
as a result of excessive intake of salt, fluid, or potassium) as well as more conventional methods of suicide. The last category includes people dying of
arterio-sclerotic cardiovascular disease, hypertensive cardiovascular disease, and internal hemorrhage. Investigation of these deaths, including pertinent historical, laboratory, and autopsy data and
investigation of dialysis equipment is discussed.
An unsuspected cause of acute hemolysis during

hemodialysis. Francos, G.C., Burke,J.F. Jr, Besarab,
A, Martinez, J., Kirkwood, R.G. and Hummel, L.A
Trans Am Soc Artif Intern Organs, 29, pp. 140-5
(1983).
Computermodellingofhaemodialysis/ultrafiltration
explaining the pathogenesis of the disequilibrium
syndrome. Dawids, S.G. and Caspersen, AH. P m
Eur Dial Transplant Assoc, 19, pp. 360-5 (1983).
Based on the hypothesisthat rapid correctionsofpH,
Na+ and osmolalitygive rise to disequilibrium (DES)
during efficient haemodialysis (HD), a 14 compartment model has been designed for dynamic analysis
oftheinduced fluid shifts and the resultinghaemodynamic reactions. The model reactions correlated remarkably with clinical findings and indicatehow far
a patient's haemodynamic compensation can prevent circulatory collapse and hypovolaemia, mainly
through lowering the mean pressure in a major
portion of the capillaries. Steady weight dialysis
causes reduction of blood volume up to 65 percent
before circulatory collapse occurs.
E-4
Appendix E (Cont.)
Mortality risk factors in patients treated by chronic
hemodialysis. Report of the Diaphane collaborative
study. Degoulet, P., Legrain, M., Reach, I., Aime, F.,
Devries, C., Rojas, P. and Jacobs, C. Nephron, 31 (2),
pp. 103-10(198). A survival analysis was applied to
1,453patients treated between 1972 and 1978in 33
French dialysis centers and prospectively followed
up in the computerized Diaphane Dialysis Registry;
198 deaths (overall mortality (OM) were registered,
of which 87 (43%) were secondary to cardiovascular
complications(cardiov8SCUIarmortality=CVM)).Risk
factors for OM and CVM (p values less than 0.05)
were age, male sex, nephroangiosclerosis or diabetic
nephropathy as the primary renal disease, elevated
systolic and diastolicblood pressure and two weekly
dialysis rather then three. In contrast with the
results observed for the general population, a high
body mass index and elevated cholesterol, triglycerides and uric acid were not found to be associated
with significantly increased CVM or OM. On the
contrary, low body mass index (less than 20 kg/m2),
low cholesterol (less than 4.5 mmoV1) and low mean
predialysis blood urea (less than 4.6 mmoV1) were
associated with increased OM and CVM, and more
especially with high stroke mortality. Results for
urea but not for cholesterol remain significant &r
adjustment for age, sex, weekly dialysisscheduleand
body mass index. They suggest that, in addition to
elevatedblood pressure, apoor nutritional state and,
or low protein intake may be important factors for
explaining the high cardiovascular mortality, particularly for strokes, observed in dialyzed patients.
The Joint Commission Guide to Quality Assurance.
JCAHO, Chicago, IL (1988). An indepth presentation of the "10-StepMonitoring and Evaluation process" providing explanations of each step and examples on how to accomplish each phase.
Standards of Clinical Practice for Nephmlogy Nursing. AmericanNephrologyNur~esAssociation:

Pitman,
NJ, (130 pp.) (1988). Acomplete set of structure, process, and outcome standards for clinical nephrology
nursing practice.
QualityAssurance for Nephmlogy Nursing. AmeriC8n Nephrology Nurses Association; Pitman, NJ
(1989). A guide for the application of the quality

assurance process in nephrology nursing. Follows
the JCAHO 10-Step process and presents clinical/
Practical examples for all areas of nephrology nurs"lg.
Chupter 2
Core Curriculum for Nephmkgy Nursing. L. Lancaster Cedl. American Nephrology Nurses Association; Pitman, NJ (1990). Designed to provide afoundation from which the professional nurse can apply
the nursing process to the care of renal patients,
prepare for certification, and continue the study of
nephrology nursing practice.
Evolution of a QualityAssurance Program. SeabyN.
Nephrdogy News & Issues, 2 (8), p. 34 (1988). A brief
step-by-stepdescription on how to put together a QA
program for a dialysis facility.
Quality Assurance: You Can Do It Too! Seaby, N.,

Bower, M. and Burrows-Hudson, S. ANNA Journal,
14(1), pp. 15-21 (1987).
QualityAssurance for Dialysis. Burrows-Hudson,S.

ESRD Network #3: Sausalito, CA (89 pp.) (1984).
Quality assurance vs. cost containment: "damned if
you do, damned if you don'tw Schron, S.R AANNT
J, 9 (2), pp. 13-23(Apr 1982).
Control and prevention of infection on hemodialysis

units. Clarke, B.H. Nurs Clin North Am, 15 (4), pp.
883-90 (Dec 1980). An approach is presented which
illustratesthat&ectivecontrolandpreventionmea~u~e~
evolve from an organized method of identifying the
pertinent data, definingthe problems, creatingworkable and reasonable control measures, implementing the measures, and then evaluating their effectiveness. Since infection control and prevention
measures affect them directly, nurses must assume
a predominant role in the development, application,
and evaluation of these measures.
Home monitoring of diabetes: a comparison of four
fieldmethodsfor analysingglucoselevels. Baumgart,
R, Cregan, D., France,M.W. and Dnuy,M.I. Ir Med
J, 74 (ll), pp. 319-20 Wov 1981).
Tracking Problems. Stoten, S. ANNA J,14,5, p. 328
(Oct 1987). Aproblem-trackingmodelwas developed
to identify and resolve problems that existed in a
dialysis facility and serve as a communications link
among unit coordinators, physicians, and staff. The
article presents a tool for recording topic, date, suspected problem, investigation results, cause, action
needed, and date resolved.
Appendix E (Cont.)
Chapter 3
Water Treatment
Effect of water deionisers on 'fracturing osteodystrophy'anddialysisencephalopathyinPlymouth.Leather,

H.M.,Lewin, I.G., Calder, E., Braybrooke,J.and Cox,
RR Nephron, 29 (1-21,pp. 80-4 (1981). When water
deionisers were not used routinely, a bone disease
with multiple fractures, 'fracturing osteodystrophy,'
and dialysisencephalopathyoccurredin a sign5cant
number of patients. When water deionisers were
used commonly, fracturing osteodystrophy and dialysis encephalopathy occurred extremely infiequently. Duration of dialysis without a water deioniser appeared to be the most important factor in the
development of these two conditions. The use of
water deionisersusually led to healing of fractures in
patients with fracturing osteodystrophyand also led
to improvement in 4 of the 11patients with dialysis
encephalopathy. Neither condition has occurred in
any patient using a water deioniser from the first
dialysis. Water deionisers, therefore, appeared to be
effective in both the treatment and prevention of
fracturing osteodystrophyand dialysisencephalopa-
thy.
Surgeon General's advisoryontreatment of water for
use in dialysis. FDA Drug Bull, 11 (I), p. 3 (Mar
1981).
FDA safety alert: sodium azide contamination of
hemodialysis water supplies. ANNA J, 16 (41, p. 273
(Jun 1989).
Bacterial contaminationofdialysatein dialysis-associated endotoxaemia Watzke,H.,Mayer, G., Schwan,
H.P., Stanek, G., Rotter, M., Hirschl, AM. and Gra,
H. J Hosp Infect, 13 (21,pp. 109-15 (Feb 1989).
Bacteriological investigations and endotoxin (ET)
determinations were performed during a routine
haemodialysis session for six patients. Inspection of
the dialyzer machines revealed that air-traps and
heater-unit for the incoming (untreated) tap water
before mixing with the dialysate concentrate were
the only sites where high bacterial release was feasible,as this part of the machine escaped disinfection
due to the construction of these devices. Regular
disinfection of all parts of a dialyzer machine is rec-
ommended, including heating units, air traps and

valves.
Serum nickel concentrations in hemodialysis patients with environmental exposure. Hopfer, S.M.,
Fay, W.P. and Sunderman, F.W. Jr. Ann Clin Lab
Sci, 19 (3), pp. 161-7 (MayJun 1989). Nickel was
apalyzed by electrothermal atomic absorption spectrophotometry in serum specimens from 22 healthy
hospital workers and 30 patients with end-stage
renal disease treated by extracorporeal hemodialysis, who resided in Sudbury, Ontario, Canada, a city
with extensivenickel mines and smelters. This study
confirms the presence ofhypernickelemiainhemodialysis patients, but does not suggest thathemodidysispatients have sigdicantly increasedrisk ofnickel
toxicity in Sudbury, compared to Hartford, despite
the high nickel concentrationsin Sudbury tap water.
The outcome is attributed to the efficient deionization of water used to prepare hemodialysis solutions
in Sudbury.
Correctionofmicrocytosisfollowingelimination of an
occult sourceofaluminumcontaminationofdialysate.
Abreo, K, Brown, S.T., Sella,M. Am JKitEney Dis, 13
(61, pp. 465-8 (Jun 1989). A higher prevalence of
aluminum-associatedmicrocytic anemia was noted
in hemodialysis unit A (n=67) compared to unit B
(n=39). This h d i n g could not be explained by differences in the aluminum content of reverse osmosis
(RO) water or intake of antacids containing aluminum by patients in the two units. Because contamination was missed in spite of water testing a t the RO
site, these findings underscore the importance of
measuring water aluminum and TDS content a t the
dialysis stations. Frequent water testing a t dialysis
stations, familiarity with the design of water treatment facilities, and recognition of aluminum overload can lead to early detection and correction if
similar types of aluminum contamination should
occur.
Uptake of trihalomethanes by patients during

hemodialysis. Cailleux,A, Subra,J.F., Riberi,P. and
Allain P. Clin Chim Acta, 181 (I), pp. 75-80 (Apr 28
E-6
Appendix E (ContS
1989). Trihalomethanes CTHM)present in tap water
were also found in dialysis fluid because they were
not eliminated by water treatment. THM, absorbed
through the dialyser membranes, increased considerably in blood and in expired air of patients on
hemodialysis during the dialysis sessions. The u p
take of THM during each dialysis session was about
1mg.
Aluminium and fluoride in the water supply and
their removal for haemodialysis. Cameron, A.P.,
Drury, P.J., Harston, G.A, Ineson, P.R. Sci Total
Environ,76 (l),pp. 19-28( Sep 15,1988). Aluminium
and fluoride in the water supply and their removal
for haemodialysis were investigated in the Trent
Region, U.K, and wide variations noted. A comparison ofnew andolderwatertreatment systemsshowed
that there is a deteriorationin performance with use.
However, some cases poor removal may be due to the
installation of unsuitable equipment or, more probably, due to a change in the waters used to supply the
different homes. Thus, adequate maintenance of
equipment and frequent sampling of both untreated
and treated waters are required in order to maintain
the provision of waters suitable for the preparation of
dialysate.
Aluminum and chronic renal failure: sources, absorption, transport, and toxicity. Wills, M.R and Savory, J. CRCCrit Rev ClinLab Sci,27 (I), pp. 59-107
(1989). Document Type: Review. An increasedbr@n
content of aluminum appears to be the major etiological factor in the development of a neurological syndrome called either "dialysis encephalopathy" or
"dialysis dementia," an increased bone content, causing a specific form of osteomalacia. An excessof aluminum also appears to be an etiological factor in a
microcytic, hypochromic anemia that occurs in some
patients with chronic renal failure on long-term
treatment with hemodialysis.
Prevalence of non-tuberculous mycobacteria in water supplies of hemodialysis centers. Carson, L . k ,
Bland, L.A,Cusick, LB., Favero, M.S., Bolan, G A ,
Reingold, AL. and Good, C. AppZ Environ Microbial,
54 (121,pp. 3122-5 (Dec 1988). This study was a n d ~ t e d t determine
o
the prevalence ofN'I'h4and other
bacteria in water samples collected over a 13-week
Period from 115 randomly selected dialysis centers in
the United States. The results of this study support
-commendations to use 4% HCHO or a chemical
germicidal equivalent for disinfecting dialyzers that
to be reused.
Chapter 3
Water Treatment
FDA safety alert: chloramine contamination of
hemodialysis water supplies Detterl. Am J Kidney
Dis,11(51, p. 447 (May 1988).
Ethylene glycol intoxication due to contamination of
water systems. MNWR, 36 (36), pp. 611-4 (Sep 18,
1987).
Aluminiium-relatedoste0malacia:responsetoreverse
osmosis water treatment. Smith, G.D., Winney, RJ.,
McLean, A. and Robson, J.S. Kidney Int,32 (11, pp.
96-101 ( Ju11987). Those patients in whom bone
mineralization status improved developed hyperparathyroidism aRer reverse osmosis water-treatment, w h e w the staticpatientsremainedeuparathymid. The results suggest that resolution of aluminium related osteomalacia may occur with reduction
in dialysis fluid aluminium, and that parathyroid
hormone plays a role in the healing of aluminium
related osteomalacia The therapeutic implications
are twofold: attempts to remove all traces of hyperparathymidism may be detrimental to the bone
mineralization status; and stimulation of the parathyroid glands by means of a mild reduction in
dialysisfluid calcium may be ofvalue in the management of those caseswith persistent osteomalaciaand
low bone turnover.
Bacterial colonizationand endotoxincontentofanew
renal dialysiswater systemcomposedofacrylonitile
butadiene styrene. du Moulin, G.C., Coleman, E.C.
Jr. andHedley-Whyte,J. ApplEnviron Microbwl, 53
(61,pp. 1322-6 (Jun 1987). The authors measured
endotoxin and bacterial levels in tap water, in water
purified by reverse osmosis,and in dialysate samples
over a 4-month period in a new 10-bedrenal dialysis
unit. Even &r disinfection ofthe system,there was
no significant decrease in culturable bacteria from
the water even though endotoxin levels were lower.
Speciesisolated from the renal dialysis system were
predominately pseudomonads, whereas species isolated from the tap water were Bacillus and Flavobaderium species.
Water quality-a neglected problem in hemodialysis. Bommer, J. and Ritz, E. Nephron, 46 (11, pp. 16 (1987). Document Type: Review (25 refs.).
Aluminum in the dialysis fluid Rahman, H., Channon, S.M., Parkinson, I.S., Skillen,AW., Ward, M.K.
and Kerr, D.N. ClinN e p h d , 24 Suppl 1, pp. S78-83
(1985). D o m e n t Type:Review (44Refs.) The major
source of aluminum in patients with chronic renal
Appertdir E (Cont.)
Chapter 3
Water Treatment
failure treated by hemodialysis is the hemodialysis

fluid. The aluminum is derived from both the water
and the chemical concentrate usedinthe preparation
of the hernodialysis fluid. Due to the complex physico-chemistry of aluminum in water and dialysis
fluid,both the total aluminum concentration and the
proportion of aluminum species able to cross the
hemodialysis membrane may vary from water supply to water supply and from day to day within a
supply.
by a single centre: evidence for "safe" upper limit of

aluminium in water. Platts, M.M., Owen, G. and
Smith, S. Br Med J [Clin Resl, 288 (6422), pp. 96972 (Mar 31,1984). The authors discuss the fact that
when aluminium was removed from water by deionisation the incidence of fractures diminished during
the next year and no patient developed dialysis
encephalopathy. Theirfindingsshowthat 1.Ornumoll
L is a safe maximum concentration of aluminium in
water for use in home haemodialysis.
Hemodialyzer reuse: practices in the United States

and implicationfor infectioncontrol. Bland, L., Alter,
M., Favero, M., Carson, L. and Cusick, L. Nontuberculous mycobaderia were isolated from the water in
83% of 115hernodialysis centers surveyed across the
United States and could constitute a potential infection risk because of the organisms' greater germicide
resistance than most other naturally occurringwater
bacteria. Two percent formaldehyde is not an effective germicide for high level disinfection of hemodialyzers. Reprocessed hemodialyzers should be disinfected with 4% formaldehyde or an equivalent disinfectant.
Granularactivatedc a h n usage inchloramineremoval

from dialysis water. Meyer, M.A andKlein, E. Artif
Organs, 7 (4), pp. 484-7 (Nov 1983). This is a report
on the bench-scale testing of five kinds of GAC from
three manufacturers. The experimentalresults were
used to estimate the capacity of a 9" diameter,45" tall
column of the best carbon. These scale-up estimationsindicatethatthissorbentmaysafelylast through
156 5-h.
Nitrate induced anaemia in home dialysis patients.

Salvadori,M., Martinelli, F., Cornparini,L., Bandini,
S. and Sodi A. Proc Eur Dial Transplant Assoc Eur
Ren Assoc, 21, pp. 321-5 (1985). Many home dialysis
patients in Florence and the surrounding area suddenly showed an unusual anaemia. All used a so&ener for water treatment. They demonstrated
methaemoglobinaernia, Heinz bodies and reduction
in plasma haptoglobin, indicating Hb oxidation. Tap
water analysis showed excessive nitrates. The substitution of the softeners with deionisers solved this
important and unusual clinical problem.
Aluminium-induced anaemia in haemodialysis patients. McGonigle, R.J.and Parsons, V. Nephron, 39
(11, pp. 1-9 (1985). Evidence has accumulated that
aluminium is the most likely ion responsiblefor memia, but other ions, trace metals in excess or deficiency, and potentially toxic substances cannot be
excluded yet.
The use of ion exchange to remove aluminum from
water used in hemodialysis. Petrie, J .J.,Fleming,R ,
McKinnon, P., Winney, R.J. and Cowie, J. Am J
Kidney Dis, 4 (11, pp. 69-74(Jul1984). A discussion
of a modified ion exchange resin for the removal of
aluminum.
Water purification and the incidence of fractures in
patients receiving home haemodialysis supervised
Heparin inactivation, acidosis and copper poisoning

due to presumed acid contamination of water in a
hernodialysis unit. Eastwood, J.B., Phillips, M.E.,
Minty, P., Gower, P.E. and Curtis,J.R. ClinNephrol,
20 (4), pp. 197-201 (Oct 1983). An accident in a
hemodialysis unit involving 13 patients is reported.
Circumstantial evidence suggeststhat acid contamination of the water supply to the unit resulted in inactivationofheparin with widespreadextracorporeal
clotting and secondary copper intoxication which
proved fatal in one patient. Serum copper concentrations were raised in 6 of the11 patients and whole
blood copper concentrations were raised in four patients. Results of serum ceruloplasmin, whole blood
lead and zinc analyses are reported, together with
tissue analyses for copper in the fatal case. The
majority of the patients showed evidence of a metabolic acidosis.
Generation of dimethylnitrosarninein water p d cation systems. Detection in human blood samples
during hemodialysis. Simenhoff, M.L., Dunn, S.R,
Fiddler, W., Pensabene, J.W. and Smiley, J. JAMA,
250 (15), pp. 2020-4 (Oct 21,1983). Dimethylnitrosarnine (DMNA),a carcinogen, was detected at levels
up to 32 microgramsfl; in dialysate from 5 of 16
dialysis units surveyed. Blood drawn from patients
at one oftheseunitsin which DMNAwasraised in the
dialysate showed asignificantincreasein the amount
of DMNA in the patient's blood when predialysis
levels were compared with 15-minute intradialysis
levels. The presence of a mixed-bed deionizer without an antecedent carbon filter appeared tobe necessary for DMNA production.
E-8
Appendh E (Cont.1
Chapter 3
Water Treatment
Heinz-body haemolysis in haemodialysed patients

caused by chloramines in Sydney tap water. Cater-
son, RJ.,Savdie, E.,Raik,E., Coutts, D. andMahony,

J.F. Med JAust, 2 (81, pp. 367-8 (Oct 16 1982). In
August 1981, there was an outbreak of Heinz-bodypositive haemolytic anaemia among patients who
were undergoing dialysis in Sydney Hospital. This
appeared to be due to excessive chloramines in, and
inadequate carbon filtration of, the water used for
haemodialysis. &r improvement of the carbon filtration system, there were no M e r cases of anaemia
Water supply aluminium concentration, dialysis
dementia, and effect of reverse-osmosiswater treatment. Davison, AM., Walker, G.S., Oli, H. and Lewins, AM. Lancet, 2 (83021, pp. 785-7 (Oct 9,1982).
Dialysis dementia appeared in 18 of 258 patients
treated by haemodialysis. All cases developed in
patients treated by home dialysis (150) and none in
patients treated exclusivelybyhospitaldialysis(108).
Analysesofthedomesticwater supplyfor each month
on dialysis showed that dementia occurred only in
those whose water supplyhadahigh aluminium concentration (greater than 80 microgramdL). Reverse
osmosis treatment satisfactorily removes aluminium and many other substances from water. Its
application had a beneficial effect on 7 of 9 patients
previously exposed to dialysate prepared from water
with a high aluminium content and prevented the
appearance of dementia in 24 patients whose water
was so treated from the start of haemodialysis.
Ionic and nonionic fluoride in plasma (or serum).
Singer, I,. and Ophaug, R. Crit Rev Clin Lab Sci, 18
Review (113
(21, pp. 111-40(1982). Document
refs.).
m:
Bone aluminum deposition in maintenance dialysis

patients treated with aluminium-freedialysate:role
of aluminium hydroxide consumption. Heaf, J.G.,
Podenphant, J., Andersen, J.R. Nephron, 42 (31, pp.
210-6 (1986). It is concluded that bone aluminium
deposition occurs despite the use of aluminium-free
dialysate and is associated with total and present
ahninium hydroxide consumption; heavy aluminium depositionis associated with severe and symptomatic osteomalacia, but can also be observed in the
Presence of predominant hyperparathymidism.
Side effectsin bicarbonate dialysis due to low dialymte pH. Wagner, L., Schindler, B., Marhoffer, W.,
vanE~l,O., Strauch, M. P m Eur Dial Tmnsplant
h s ~19, pp. 346-50 (1983). In six commercially
-%'
fharance Guidelinesfor H e d i a l y s i s Devices
available bicarbonate-containingdialysates,pH and

pC02 were determined. Side effects resulted from
low pH and high pC02. Use of two of the six dialysates was associated with fatigue, muscle cramps
and somnolence.
Bone disease in patients on maintenance haemodialysis using softened or deionized water. Hudson,
G.A,Milne,F.J.,Oliver,N.J.,Reis,P.,Murray,J.and
Meyers, AM. SAfrMedJ, 56 (ll), pp. 439-43(Sep 8,
1979). The results showed that symptomatic osteomalacidosteopenia occurs more frequently in the
units using softened water, which has a higher aluminium content, than in the deionized water unit.
The patients dialysed on soRened water also have
significantly higher serum calcium and phosphorus
levels. It is suggested that in Johannesburg, water
softeningalone is inadequate, and that the high aluminium levels in our water may be responsiblefor accelerated osteomalacidosteopenia.
Acute nickel intoxication by dialysis. Webster, J.D.,
Parker, T.F., Alfrey, AC., Smythe, W.R., Kubo, H.,
Neal, G. and Hull, AR. Ann Intern Med, 92 (51, pp.
631-3(May 1980). Nickel intoxication was observed
in a group of dialyzed patients when leaching of
nickel-plated stainless steel water heater tank contaminated the dialysate. Symptoms occurred during
and after dialysis a t plasma nickel concentrations of
approximately 3 m&. Symptomsincluded nausea,
vomiting, weakness, headache, and palpitation. Remission of symptoms occurred spontaneously, generally 3 to 1 3 hours after cessation of dialysis. The
evidence indicated that the nickel became bound in
the plasmaafter crossingthemembrane, resultingin
a higher concentration in the plasma than in the
dialysate and preventing its removal by dialysis.
Dialysisdementia:therole ofdialysatepHin altering
the dialyzability of aluminum. Gacek, E.M., Babb,
AL.,Uvelli, D.A, Fry,D.L. andscribner, B.H. Trans
Am Soc Artif Intern Organs, 25, pp. 409-15 (1979).
Bacterialcolonization andendotoxin content ofanew
renal dialysiswater system composedofacrylonitrile
butadiene styrene. duMoulin, G.C., Coleman, E.C.
Jr. and Hedley-WhyteJ. Appl Environ Microbial, 53
(6), pp. 1322-6 (Jun 1987). The authors measured
endotoxin and bacterial levels in tap water, in water
purifiedbyreverse osmosis, and in dialysate samples
over a 4-month period in a new 10-bedrenal dialysis
unit. Even after disinfection of the system, there was
no significant decrease in culturable bacteria from
the water even though endotoxin levels were lower.
Appendix E (ContS
Chapter 4
Dialysis Delivery System
Shear-inducedformation ofaggregatesduringhemodialysis. Leonard, E.F.,VanVooren, C., Hauglustaine,

D. and Haumont, S. Contrib Nephml, 36, pp. 34-45
(1983).
to determine the safety of prolonged reductions in

dialysate flow rate. Authors conclude that QD 300
does not impair dialysis efficiency for most small
molecules and saves $1-38per patient per dialysis.
The current status and future of the artificialkidney.

Funck-Brentano,J.L. Artif Organs, 9 (2), pp. 119-26
(May 1985). Document Type: Review ( 32 refs.) Discussion of the technology, use and determination of
adequacy and related cost.
Mechanical Aspects of Dialysis Including Dialysate

Delivery Systems and Water for Dialysate. Easterling, R ~JJClinical Dialysis. AR. Nissenson, RN.
Fine and D.E. Gentile [edsl. Appleton-CenturyCrofts, Norwalk, CT,pp. 53-96 (1984). Excellent indepth overview of water treatment basics and components operation as well as on operation of dialysis
delivery systems.
Comparative analysis of two volumetrical ultrafiltration monitors for hemodialysis. Berden, J.H.,
Wokke, J.M. and Koene RA. Int JArtif Organs, 9 (3),
pp.163-6 (May 1986). Controlled ultrafiltration (UF)
duringhemodialysismay prevent dialysis associated
hypotension. A prerequisite for controlled ultrafiltration is an accurate measurement of ultrafiltration. Volumetric measurement is the best currently
available method for this purpose. In this study the
authors compared in a clinicalsettingtwo volumetric
ultrafiltration monitors. Volumetric monitoring of
UF is accurate and reliable, but its accuracy is
dependent on the type of dialyzer used.
Technical aspects of high-flux hemodiafiltration for
adequate short (under 2 hours) treatment. Miller,
J.H., von Albertini, B., Gardner, P.W. and Shinaberger, J.H. Trans Am Soc Artif Intern Organs, 30,
pp. 377-81 (1984). The efficiencyofhemodialysis can
be more than doubledby usingmuchhigher than normal blood and dialysate flows, employing dialyzers
with greater surface area and permeability, bicarbonate dialysate, and an apparatus capable of rigid
volumetric control ofthe dialysate. Coupled with the
better treatment tolerance described elsewhere in
this volume, this self-containedand automated technique, providinghigh diffusiveand convectivetransfer,permits drastic reductionsin treatment timeover
conventional dialysis: to under 6 hrdwkin this study.
Long-term hemodialysis a t reduced dialysate flow
rates. Kirchner, KA, White, AR., Kiley, J.E. and
Bower, J.D. Am J Nephrol, 4 (I), pp. 7-12 (1984).
Twenty stable hemodialysis patients were maintained on adialysate flow rate of 300mVmin(QD 300)
Quality Assurance Guidelines for HemodiulysisDevices
Staying Tuned into the High-Tech World Part Two:

Dialysis Delivery Systems. Vlchek, D. Dial &Tnznsplant, p. 453 (Aug 1989). A review of ultrafiltration
control principles,risks and hazards associated with
dialysate, variable sodium, and other considerations
necessary for today's advanced dialytic techniques.
Inadequacy of Heat Alone for Dialysis Machine Disinfection. Francos, G.C., Murphy, S.A, Jungkind,
D.L. and Bondi, J.M. Dialy & Transplant, p. 438
(Aug1987). Heavy bacterial overgrowthis described
of each dialysis machine in a facility that chemically
disinfectedmonthlyandheatdisinfecteddaily. Weekly
chemical disinfection and daily heat deinfection was
finally the protocol that was able to maintain acceptable baderial levels.
Hemolysis and consumption coagulopathy due to
overheated dialysate. Tielemans, C.L., Herbaut,
C.R, Geurts, J.O. and Dratwa, M. Nephron, 30 (21,
pp. 190-1 (1982).
Overview of renal assist systems. Smith, J.W. Ann
Biomed Eng, 8 (4-61, pp. 473-86 (1980).
Volumeticmimmputer-based ultrafiltration monitor
for hemodialysis. Wokke, J.M.P., Berden, J.H.M.,
Slegere,J.F.G. and Koene, R.AP. Int JArt Org, 8,1,
pp. 33-6 (1985). This article describes the UFM (ultrafiltration monitor) which uses twomicro-ovalflowmeters that measure the flow rate of the diaysate
entering and leaving the dialyzer. It showed an
E-10
Appendix E (Cont.)
Chapter 4
Dialysis Delwery System
accuracy of 90% using a conventional cuprophan

membrane dialyzer.
On the Origin and Control of Rust-Colored Precipitates in Bicarbonate Dialysate Lines. Stephens, D.
Dial & Transplant, 15,5, pp. 250-4 (May 1986). Due
to the particular chemistry of the solution involved,
bicarbonate dialysates are particularly pmnebpm
cipitation of iron in the delivery system. These
precipitates are not only unsightly, but can result in
machine malfunction if allowed to accumulate. The
article discusses methods of avoiding and eliminating such an accumulation.
Guidelines
Devices
Disinfection of Hernodialysis Machines. Townsend,

T.R, Wee, S.B. and Bartlett J. Dial & Transplant,
14,5(May1985). The article notes that none ofthree
disinfectants tested (3.7% formaldehyde, 1 3 4 dilution Cidex HD, or 1:34 dilution of Sporicidin) was
effectivein disinfecting a Psuedomonas aeruginosa
contaminated dialysis machine when contact time
was 5,10, or 15 minutes. However, after 24 or 72
hours, the formaldehyde and the Cidex were effective.
Appendix E (Cont.)
Chapter 5
Bacterial contamination of dialysate in dialysis-associatedendotoxaemia.Watzke,H.,Mayer,G.,Schwam,

H.P.,Stanek,G.,Rotter,M.,Hirsch1,AM. andGra,H.
JHosp Infect, 1 3(21,pp. 109-15(Feb 1989). Bacteriological investigations and endotoxin (El') determinations were performed during a routine haemodialysis session for six patients. Inspection of the
dialyzermachinesrevealed that air-trapsandheaterunit for the incoming (untreated) tap water before
mixing with the dialysate concentrate were the only
sites where high bacterial release was feasible, as
this part of the machine escaped disinfection due to
the construction of these devices. Regular disinfection is recommended of all parts of a dialyzer machine, including heating units, air traps and valves.
Correctionofmicrocytosisfollowingelimination ofan
occult sourceof aluminum contamination ofdialysate.
Abreo, K , Brown, S.T. and SellaM. Am JKidneyDk,
1 3 (6), pp. 465-8 (Jun1989). A higher prevalence of
aluminum-associated microcytic anemia was noted
in hemodialysis unit A (n=67) compared to unit B
(n=39). This finding could not be explained by differences in the aluminum content of reverse osmosis
(RO) water or intake of antacids containing aluminum by patients in the two units. Because contamination was missed in spite of water testing at the RO
site, these findings underscore the importance of
measuring water aluminum andTDS content a t the
dialysis stations. Frequent water testing at dialysis
stations, familiarity with the design of water treatment facilities, and recognition of aluminum overload can lead to early detection and correction if similar types of aluminum contamination should occur.
Easy production of sterile, pyrogen-free dialysate.
Erley, C.M., vonHerrath, D., Hartenstein-Koch, K ,
Kutschera, D., Amir-Moazami, B. and Schaefer, K
ASAIO Trans, 34 (31, pp. 205-7 (JulSep 1988).
Hemodialysis (HD) hypotension is frequently encountered during conventional acetate HD. The data
obtainedin this study showthat the filtered dialysate
was alwayspyrogen-free when tested with alimulusamebocyte-lysate assay. In addition, in 80%of cases
no bacteria were detected aRer the sterilizing filter.
Quulity~AssuranceGuidelines for Hemodialysis Devices
Almost no febrile episodes were observed when sterile dialysate was used.
The role of dialysate in the stimulation ofinterleukin1production duringclinicalhemodialysis. Port, F.K,
VanDeKerkhove, KM., Kunkel, S.L. and Huger,
M.J. Am JKidney Dis, 10(2), pp. 118-22(Aug1987).
Authors conclude that IL-1 is produced during clinical HD and that endotoxin or its fragments play a
role in the stimulation of IL-1 production, probably
through monocytes adhering to the dialysis membrane. In addition to this dialysate factor, IL-1 production appears also to be stimulated by a bloodmembrane interaction.
Aluminum in the dialysisfluid. Rahman, H., Channon, S.M., Parkinson, I.S., Skillen,AW., Ward, M.K
and Ken, D.N. Clin Nephml, 24 Suppl 1, pp. S78-83
(1985). DocumentType: Review (44refs.) The major
source of aluminum in patients with chronic renal
failure treated by hemodialysis is the hemodialysis
fluid. The aluminum is derived from both the water
and the chemicalconcentrateused in the preparation
of the hemodialysis fluid. Due to the complex physico-chemistry of aluminum in water and dialysis
fluid,both the total aluminum concentration and the
proportion of aluminum species able to cross the
hemodialysis membrane may vary from water supply to water supply and from day to day within a
supply. A "safe" level of aluminum in dialysis fluid,
which will prevent aluminum transfer from dialysis
fluid to blood, and promotes aluminum removal from
blood, has yet to be determined.
Effect of an optimum dialysis fluid calcium concentration on calcium mass transfer during maintenance hemodialysis. Carney, S.L. and Gillies, AH.
ClinNephml, 24 (I), pp. 28-30 (Jul1985). The effect
of an optimum dialysis fluid calcium concentration
(1.625mmoM) on calciummass transfer from dialysis
fluid to patient was assessed in patients on routine
hemodialysis. A significant correlation was noted
between the mass transfer of calcium and the dialysis
fluid calcium concentration (e0.834, p less than
0.01) which was found to vary by at least 5%. This
E-12
Appendix E (Cont.)
variation was due to a manufacturing variation and
not due to inaccurate dilution of the dialysis fluid
concentrate. These data suggests that such a manufacturingvariationmay exposemaintenancehemodialysis patients to periods of excessive calcium loss or
gain and thereby favor renal osteodystrophy or soft
tissue calcification.
Sodium modeling during hemodialysis: a new approach. Petitclerc, T., Man,N.K and Funck-Brentano, J.L. Artif Organs, 8 (4), pp. 418-22 (Nov 1984).
Sodium volume modeling during hemodialysis encounters severaldifficulties. First, the actual sodium
distributionvolume isthe extracellularwater, whereas
the ultrafiltration flow reflects the variation of total
body water. Thus, a two-pool model must be considered. This will complicate the model by increasing
the number of parameters and boundary conditions.
An alternative is to consider the total body water as
the apparent distribution volume of loaded or removed sodium, which leads to a single-pool model.
Second, convective sodium transfer induced by ultrafiltration is not negligiblecompared with difbive
sodium transfer. Therefore, sodium transfer modeling must simultaneously take into account the diffusive and the convective part, with the coupling part
related to both processes. Third, the Donnan effect,
due to nondiffusible anionic plasma proteins, modifies the sodium transfer through the membrane.
Pseudomonas stutzeri bacteremia associated with
hemodialysis. Goetz, A , Yu,V.L., Hanchett, J.E. and
Rihs, J.D. Arch Intern Med, 143(lo), pp. 1909-12(Oct
1983). Pseudomonas stutzeri bacteremia developed
in six patients undergoing hemodialysis. Fever,
shaking chills, nausea, and vomiting were observed.
All patients recovered, although only two received
specific antibiotic therapy. The infections occurred
sporadically over a period of nine months. Pseudomonas stutzeri was subsequently isolated from the
dialysate. The ultimate source was the deionized
water. The emphasis on handwashing, strict compliancewith disinfection procedures,and eliminationof
prolonged sitting times for the filled machine after
disinfection resulted in no firrther cases of P stutzeri
infection.
The untoward effects of the anions of dialysis fluids.

Veech, RL. Kidney Int, 34 (5),pp. 587-97 (Nov1988).
Areview containing124references.Dialysisfluidsin
current use contain unphysiological amounts of the
Bnions, acetate and D-lactate, both of which may
induce specific toxic syndromes. Use of bicarbonate
in place of acetate may: improve control of cellular
energy status, improve ion and water distribution
Q a i @Assurance Guidelines far Hernodialysis Devices
Chapter 5
across plasma a mitochondria1membranes, and decrease most of the untoward reations now associated
with dialysis, while at the same time improving the
sense of well being in patients.
Potential bacteriologic and endotoxin hazards associated with liquid bicarbonate concentrate. Bland,
L A , Ridgeway, M.R., Aguero, S.M., Carson, L.A
and Favero, M.S. ASAIO Trans,33 (3), pp. 542-5
(Jul-Sep1987). Usingliquidbicarbonateconcentrate
from two commercial sourcesand one facility source,
bacterialcontaminationand excessiveendotoxinlevels
were found in all cases. This contamination was
amplified in dialysis fluid to levels well in excess of
AAMI's Recommended dialysate standard.
Microbiologic contamination of liquid bicarbonate
concentrate for hemodialysis. Ebben, J.P., Hirsch,
D.N., Luehmann, D. A, Collins, AJ. and Keshaviah,
P.R. ASAlO Trans, 33 (3), pp. 269-73(JulSep1987).
With the growing use of bicarbonate dialysate, caution must be paid to microbiology of dialysate. The
following precautions are suggested: (1) avoid prolonged storage ofliquidbicarbonate concentrate(LBC),
(2)perform W sterilization ofRO water and LBC, (3)
thoroughly clean storage and mixing containers, (4)
disinfectdialysismachines at least twice weekly, and
(5)when performingbacterial cultures, use standard
plating techniques with a medium supplemented
with NaCl (e.g., commercially available trypic soy
agar).
Pressure controlled single needle hemodialysis usinghigh fluxdialysers and volume regulated ultraf2tration: the problem of dialysate back flow. Zbinden,
M. and Binswanger, U. Life Support Syst, (England)
3, Suppl 1(1985).
Dialysate concentrate: a potential source for lethal
complications. Brueggemeyer, C.D. and Ramirez, G.
Nephron, 46 (4), pp. 397-8 (1987). Report of two incidents where patients were dialyzedwith acid concentrate on an acetate machine. Recommends that
placement of dialysate concentratebe regarded as an
important medical task with concomitant care and
liablility for the responsible individuals that set up
the machines. Any additional available safeguards
should be used.
Rapid high-efficiency bicarbonate hemodialysis.
Keshaviah, P. and Collins, A ASAIO Trans, 32 (I),
pp. 17-23(Jul-Sep 1986). A dialysis time of approximately 2.5 hours was achieved by using blood flow
rates of approx 400 mVmin and large surface area
dialyzers in order to achieve BUN clearances of
Appendix E (Cont.)
approx280 mlhnin. Rapid bicarbonatehemodialysis
was associated with lower incidence ofhypotension,
nausea, and vomitingthan rapid acetate or standard
acetate therapies.
Stableliquidbicartwnatehemodialysate(LBD).N i i s o n ,
A R , Ackerman, RA., Meyers, S A and Birdsall,
S.K TransAm Soc ArtifIntern Organs, 30, pp. 6304 (1984). Normally bicarbonate concentratemust be
prepared shortly before dialysis to prevent destabilization before or during dialysis and also requires a
dual pump proportioning system. This paper d e
scribes a trial ofaliquid bicarbonate concentratethat
is stable over a 2.5 year period, and has been shown
to be safe and easy to use.
Hypoxemia during hemodialysis: effect of different
membranes and dialysate compositions. DeBacker,
W A , Verpooten, G.A, Borgonjon, D.J., VanWaeleghem, J.P., Vermeire, P A and DeBroe, M.E. Contrib
Nephrol, 37 pp. 134-41 (1984). Comparing AN69
membrane, cuprophan membrane, acetate dialysate, and bicarbonate dialysate, it is found that the
degree of dialysis-related hypoxemia increases in
severity as follows: combination of AN69 and bicarbonate shows little hypoxemia; AN69 and acetate, as
well as cuprophan and bicarbonate, show intermediate results; and acetate and cuprophan the most
significant drop. Indications are that there are two
componentsto the dialysishypoxemia: a membranerelated component, and a dialysate buffer component.
Side effects in bicarbonate dialysis due to low dialysate pH. Wagner, L., Schindler, B., Marhoffer, W.,
vanEyl, 0. and Strauch, M. Proc Eur Dial Trmnsplant Assoc, 19, pp. 346-50 (1983). In six commercially available bicarbonate containing dialysates
pH and pC02 were determined. Side effectsresulted
from low pH and high $02. Use of two of the six
dialysateswas associatedwith fatigue,musclecramps
and somnolence. The importance of bicarbonate
dialysate with a higher pH (7.48) and low pC02 (c60
mmHg) in alleviating patient syrnptomology is conhed.
Pancreatic affection aRer acute hypotonic hemodialysis. Paus, P.N., Larsen, E.W., Sodal, G. and
Erichsen, A Acta Med S c a d , 212 (1-21, pp. 83-4
(1982). Four male outpatients, all on stable longterm hemodialysis, wereby accident simultaneously
exposed to hypotonicdialysate. Three of them developed increased serum amylase values and one died
from the consequences of a fulminant pancreatitis,
which had been verified by laparatomy.
Chapter 5
Dialysate and Dialysate Concentmte
Hemolysis and consumption coagulopathy due to
C.R, Geurts, J.O. and Dratwa, M. Nephron, 30 (2),
pp. 190-1(1982). A patient on chronic hemodialysis
was accidentally accidentally exposed to overheated
dialysate (52C) for 100 minutes due to the audible
and visual alarms not being activated due to human
error (the systemcontained a freely adjustable alarm
range of 0" to 60' C which had not been set to the
proper range of 35- 2 "C) and a malfunctioning of the
heater. This resulted in acute hemolysis and consumption coagdapathy.
Reversal of aluminum-inducedhemodialysisanemia
by a low-aluminum dialysate. O'Hare, J.A. and
Murnaghan, D.J. N Eng2 JMed, 306 (ll), pp. 654-6
(Mar 18,1982).
Acetate vs. bicarbonate dialysis. Lesch. EM.Nephrol Nurse, 2 (5), pp. 14-7(SepOct 1980). Life threatening hypokalernia during hemodialysis. Wiegand,
C., Davin, T., Raij, L and &ellstrand, C. Duns Am
Soc Artif Intern Organs, 1979,25, pp. 416-8. The
serum potassium concentration can be dependent on
acid-base status of the patient's serum. Even with a
dialysate concentration of potassium 42% higher
than that of the serum, the authors report ofdecrease
in serum potassium. If a patient is in metabolic
acidosis, they recommend a dialysate potassium of
6.3 mE&.
Dialyskdementia: the role ofdialysatepHin altering
the dialyzability of aluminum. Gacek, E.M., Babb,
A L , Uvelli, D.A., F'ry, D.L and Scribner,B.H. Trans
The pH can alter dialyzabilityof aluminum. If the pH
is between 6.5 and 7.6 there is negligible dialyzability; if lower or higher, the clearance is sigdicant
Trace metal changes in dialysis fluid and blood of
patients on hemodialysis. Salvadeo, A, Minoia, C.,
Segagni, S. and Villa, G. Int JArtif Organs,2 (I), pp.
17-21 ( Jan 1979). Discussion of trace metals in dialysate which can dialyze across the membrane and
result in harmful effectsor harmful accumulation in
the patient.
Haemolytic anaemia caused by overheated dialysate. Lynn, KL., Boots, M.A , Mitchell,T.R Br Med
J , 1 (6159), pp. 306-7 (Feb 3,1979). Home patient
admitted with hemolysis several times. Finally, the
patient noted that the blood lines were "hot" during
dialysis. Upon investigation it was found that the
dialysate temperature was 58OC due to a defective
heater and defective temperature gauge.
E-14
Appendix E (Cont.)
The mechanisms of arterial hypoxemia during

hemodialysis. Romaldini, H., Rodriguez-Roisin, R ,
Lopez,F.A,Ziegler,T.W., Bencowitz,H.Z andWagner,
P.D. Am Rev Respir Dis, 129(5)pp. 780-4(May 1984).
The findings suggest that the hypoxemia observed
duringhemodialysis is primarily due to a decreasein
alveolar ventilation and respiratory quotient associated with removal of metabolic C02 in the dialyzer.
Secondary factors affecting arterial PO2 were the
slight improvement in ventilation-perfusion relationships, tending to increase it, and the decrease in
cardiac output tending to decrease it. There was no
evidencefor diffusion impairment because the measured VA/Q inequality accounted for the degree of
hypoxemia.
Calcium carbonate precipitation in bicarbonate
hemodialysis. Klein, E., Ward, R A and Harding,
G.B. Artif Organs, 10 (31, pp. 248-50 (Jun 1986).
Sparging of the bicarbonate-containingconcentrate
with carbon dioxide converts any carbonate to bicarbonate,thus avoidingthe formationofprecipitateson
addition of calcium ions.
Dialysis-induced hypoxemia and hypotension are
not causallyrelated Keshaviah,P., Carlson, L,Contantini, E. and Shapiro, F. TransAm Soc ArtifIntenz
Organs, 30, pp. 159-62(1984).
Dialysis leukopenia, hypoxemia, and anaphylatoxin
formation: effect of membrane, bath, and citrate
anticoagulation. Wiegrnann,T.B.,MacDougall,M.L.
and Diederich, D.A Am JKidney Dis, 11(5)pp. 41824(May1988). The findingsindicate that leukopenia
is directly and exclusivelyrelated to membrane composition while hypoxemia only relates in .part to
membrane effects.
Sodiumfluxes duringhemodialysis. Bosch, J.,Ponti,
R,Glabman, S.and Lauer, A Nephron, 45(2),pp. 8692 (1987). Three sets of experiments were performed
to determine the effect of the dialysate sodium concentration on the sodium balance of patients undergoing maintenance hemodialysis. First, we demonstrated that the pretreatment plasma sodium concentration was independent of the sodium concentrationofthe dialysate used. Second,the plasma sodium
ancentration availablefor diffusion duringthe treatment was calculatedhmthe plasma sodium concenh t i o n and the plasma proteins. Third, the sodium
fluesusing a hypernatremic or hyponatremic dialysatewerecalculatedfor1OOml of plasmagoingthrough
U e dialyzer. At steady state, no significant difierences in net sodium fluxes were demonstrated beheen hyper- and hyponatremic dialysis.
wit^ ~sswanceGuidelinesfor HernodialysisDevices
Chapter 5
Acetate dialysate versus bicarbonate dialysate: a
continuing controversy. Diamond, S.M. and Henrich, W.L.Am JKidney Dis, 9(1),pp.3-11(Jan1987).
Document Type: Review (91 refs.). The use of bicarbonate dialysate as thebdfer during routine dialysis
is growing. This discussion reviews several of the
comparativetrials in which bicarbonate and acetate
buffers have been tested. Patients who seem most
likely to benefit from bicarbonate dialysate include
those with a reduced muscle mass in whom a high
sodium dialysate has not prevented hypotension.
Benefits of bicarbonate dialysis. Mastrangelo, F.,
Rizzelli, S., Corliano, C., Montinaro, AM., DeBlasi,
V., Alfons, L,Aprile, M., Napoli, M. and Laforgia, R
Kidney Znt, Suppl, 17, pp. S188-93 (Dec 1985).
A mechanism of hypoxemia during hemodialysis.

Consumption of C02 in metabolism of acetate. Oh,
M.S., Uribarri, J., Del Monte, M.L,Heneghan,W.F.,
Kee, C.S., Friedman, E.A and Carroll, H.J. Am J
Nephrd, 5 (5), pp. 366-71(1985). The present study
is an investigation of the role of acetate metabolism
in dialysis-induced hypoxemia and of the relative
roles of acetate metabolism, bicarbonate loss, and
C02 gas (g)loss in causation of hypoxemia. The
results indicate that acetate metabolism can lead to
reduction in respiratory exchange ratio and hypoxe
mia and suggestthat the same mechanismis responsible for hypoxemia during hemodialysis using acetate dialysate.
Effects ofhigh sodium dialysate during maintenance
hemodialysis. Cybulsky, AV., Matni, A. and Hollomby, D.J. Nephron, 41 (I), pp. 57-61 (1985). The
effects of high sodium 144 mmoVl (mEqA) dialysate
were studied in normotensive, hypertensive and
anephric chronic hemodialysis patients. High sodium dialysate is beneficial for normotensive and
anephric patients in reducing dialysis-inducedhypotension and was not associated with any deleterious
effects on long-term blood pressure control. In hypertensive patients, the benefit is less clear, and
hypertension may increase.
Comparisonofhigh and low sodium bicarbonate and
acetate dialysis in stable chronic hemodialysis patients. Bijaphala,s.,Bell, AJ.,Bennett,C.A, Evans,
S.M. and Dawborn, J.K ClinNephml, 23(4),pp.17983 (Apr 1985). Eight stable center dialysis patients
completed four, 10-week study periods in which
either acetate or bicarbonate dialysis was used, each
with high or low sodium concentration. Duringhigh
sodium dialysis,blood pressure wasbetter controlled,
weight loss more easily tolerated and dialysis was
E-15
I
Appendix E (Cont.)
mostsatisfactoryfromthe patient's point ofview with
regard to dialysis-associated symptoms. Careful
choice of dialysate sodium concentration appears to
be important in lessening dialysis side-effects. Substitution of bicarbonate for acetate in chronic stable
dialysispatients has comparatively little benefit and
the choice can legitimately be made on the basis of
cost and technical considerations.
Effect ofvariations in dialysate temperature on blood
pressure duringhemodialysis.Sherman,RA,Faustino,
E.F., Bernholc, AS. and Eisinger, RP. Am JKidney
Dis, 4 (I), pp. 6 6 8 (Jul1984). The effect on BP of
alteration in dialysate temperature was studied in
150 hemodialysis treatments in 17 patients using a
randomized, double-blind protocol. Each patient was
treatedusingdialysateat 35.6"C, 36.7"C, and37BC.
Dialysate cooler than that routinely employedhas a
beneficial effect while warmer dialysate has a detrimental one on intradialytic BP. The use of dialysate
at least 1C cooler than "isothermic" levels may be
appropriate.
Cold as cardiovascular stabilizing factor in hemodialysis: hemodynamic evaluation. Coli, U., Landini,
S.,Lucatello,S.,Fracasso,A,Morachiello,P.,Righetto,
F., Scanferla, F., Onesti, G. and Bazzato, G. Trans
Am Soc ArtifIntern Organs, 29, pp. 71-5(1983). Vascular instability represents the most frequent intradialytic complication of uremic patients. Catecholamine impairment, changes in plasma sodium or
osmolality and, more recently, temperature Q of
dialysate have been proposed to explain this phenomenon. Our hemodynamic study confirms the
important role played by T on intradialytic vascular
stability and may explain the better control observed
duringhemofiltration compared to standard W-HD.
Luehmann, D.A Crit Rev Biomed Erg,9 (3),pp. 20144 (1983). Document Type: Review (83 refs.).
Increment in dialysate sodium with sodium chloride
or bicarbonate addition. Raja, R.M., Fernandes, M.,
Kramer, M.S., Rosenbaum,J.L. and Barber, K. Artif
Organs, 7 (21, pp. 154-8 (May 1983). Hemodialysis
was performed in 12patients for 2 weeks each utilizing acetate dialysate containing 134 mE@ sodium
anddialysatecontaining143mEq/Lsodium, achieved
by the addition of sodium chloride or sodium bicarbonate to Che acetate dialysate. Intradialytic morbidity was lower, dialysis hypoxemia less marked, and
Quality Assurance Guidelinesfor Hemodialysis Devices
Dialysate and Dialysate Concentmte

predialysis blood pH higher with the bicarbonate
than with the chloride-added dialysate.
Advantages ofbicarbonatehemodialysis. Hampl, H.,
Klopp, H., Wolfgruber, M., Pustelnik, A, Schiller,R ,
Hanefeld, F. and Kessel, M. Artif Organs, 6 (4), pp.
410-6 (Nov 1982). During acetate dialysis the patients showed a frequent onset of sudden hypotension and arrhythmia with concomitant symptoms of
the so-calleddisequilibriumsyndrome, whereasthese
symptoms were nonexistent in the same patients
during bicarbonate dialysis.
The role of acetate in the etiology of symptomatic
hypotension. Keshaviah, P.R. Artif Organs, 6 (41,pp.
378-87 (Nov 1982). Studies comparingcardiovascular stability during acetate and bicarbonate dialysis
indicate that bicarbonate dialysis is beneficial only
when the fall in serum osmolality during dialysis is
significant. If the fall in serum osmolality is blunted
either with a high-sodium dialysate or mannitol
f i s i o n s , there is little difference between acetate
and bicarbonate. From a practical viewpoint, highsodium dialysis is technically less complex and expensive than bicarbonate dialysis.
The untoward effects of the anions of dialysis fluids.
Veech, RL. Kidney Int, 34 (51, pp. 587-97(N0~1988).
A review containing 124 references.
Hemodialysiswithlow-temperaturedialysate:alongterm experience. Marcen, R., Quereda, C., Orofino,
L., Lamas, S., Ternel, J.L., Matesanz, R and Ortuno,
J. Nephron, 49 (I), pp. 29-32 (1988). This study
shows that dialysis a t a lower dialysate temperature
(35C) as compared to the normal (37C) offered a
reduction of some intradialytic symptoms including
symptomatichypotension. Lower temperature also
assisted in stabilization of predialysis systolic blood
pressure (SBP) at a lower level and was associated
with a higher ultrafiltration.
Hypoxemia during hemodialysis: a critical review of
the fads. Cardoso,M., Vinay, P.,Vinet, B., Leveillee,
M., Prud'homme, M., Tejedor, A , Courteau, M.,
Gougoux, A , St-Louis, G., Lapierre, L; et al. Am J
Kidney Dis, 11(4), pp. 281-97 (Apr 1988). The literature describingthe fall in Pa02 during dialysisis intensively and critically reviewed. This phenomenon
is related to both the type of membrane used (cellulosic v noncellulosic membrane), and to the composition of the dialysate (acetate us. bicarbonate), which
results in hypoventilation and is the major cause of
hypoxemia (92 refs.).
12
9
Appendix E (Cont.)
Potential bacteriologic and endotoxin hazards associated with liquid bicarbonate concentrate. Bland,
L.A, Ridgeway, M.R., Aguero, S.M., Carson, L.A
and Favero, M.S. ASAIO Trans, 33 (31, pp. 542-5
(Jul-Sep 1987).
Microbiologic contamination of liquid bicarbonate
concentrate for hemodialysis. Ebben, J.P., Hirsch,
D.N., Luehmann, D.A, Collins, A J. and Keshaviah,
P.R. ASAIO Trans, 33 (31, pp. 269-73(JulSep 1987).
Hernodialysis associated hypotension and dialysate
temperature. Quereda, C., Marcen, R, Lamas, S.,
Hernandez-Jodra, M., Oroho, L., Sabater J., Villafruela,J. and Ortuno, J. L$eSupportSyst, 3, Suppl
1, pp. 18-22(1985). Incidence of intradialytic symp
tomatic hypotension was significantly reduced by
lowering dialysate temperature from 37C to 35OC.
This improvementseems not to be mediated by temperature-inducedchangesin membrane biocompatibility, sinceleukocytes,platelets and complementactivation were similar in both situations.
Dialysate concentrate: a potential source for lethal
complications. Brueggemeyer, C.D. and Ramirez,G.
Nephron, 46 (41, pp. 397-8 (1987).
Hypersensitivity reactions related to acetate dialyzate and cellulose acetate membrane. Caravaca, F.,
Pizarro,J.L., Arrobas, M., Cubero,J.J.,Antona, J.M.
and Sanchez, E. Nephron, 45 (2), pp. 158-9 (1987).
Rapid high-efficiency bicarbonate hemodialysis.
Keshaviah, P. and Collins, A RSAIO Trans, 32 (I),
pp. 17-23(Jul-Sep 1986).
The role of glucose in hemodialysis: the effects of
glucose-free dialysate. Ramirez, G., Bercaw, B.L,
Butcher, D.E., Mathis, H.L,Brueggemeyer, C. and
Newton, J.L. Am JKidney Dis, 7 (51, pp. 413-20(May
1986). Glucose-freedialysate has been traditionally
used in patients on chronic hemodialysis, reportedly
without any side effects. Although hypoglycemia is
not produced, several other metabolic changes must
occur to maintain the euglycemic state. This study
looks at patients on chronic hemodialysis usingboth
a glucose-free bath and a glucose bath. Abnormal
EEG changes were observed after dialysis without
glucose that were not present or were minimal with
a glucose bath.
Bone aluminum deposition in maintenance dialysis
patients treated with aluminium-free dialysate: role
~faluminiumhydroxide consumption. Heaf, J.G.,
Pdenphant, J.,Andersen, J.R. Nephron, 42 (31, pp.
210-6 (1986). It is concluded that bone aluminium
Chapter 5
deposition occurs despite the use of aluminium-free
dialysate and is associated with total and present
aluminium hydroxide consumption; heavy aluminium depositionis associated with severe and sympb
matic osteomalacia, but can also be observed in the
presence of predominant hyperparathymidism.
Influence of blood temperature on vascular stability
during hemodialysis and isolated ultrafiltration.
Maggiore, Q., Pizzarelli, F., Zoccali, C., Sisca, S. and
Nicolo, F. Znt JArtif Organs, 8 (4), pp. 175-8 (Jul
1985). It is concluded that the temperature changes
in blood flowing through the extracorporeal circuit
largely account for the differing vascular stability
between isolated UF and simultaneous ultrafiltration-hemodialysis.
Amelioration of hemodialysis-associated hypotension by the use of cool dialysate. Sherman, RA,
Rubin, M.P., Cody, RP. and Eisinger, RP. Am J
Kidney Dis, 5 (2), pp. 124-7(Feb1985). Cool dialysate
reduced the frequency of symptomatic hypotension.
In addition, the rate of fall of mean BP during
treatment was substantially slowed with the reduction in dialysatetemperature. Cooldialysate (34.4"C)
substantially ameliorates hemodialysis-associated
hypotension.
Carbon dioxide removal in acetate hemodialysis:
effectson acid base balance. Bosch, J.P., Glabman,
S., Moutoussis, G., Belledonne, M., vonAlbertini, B.
and Kahn,T. Kidney Int, 25 (5), pp. 830-7(May 1984).
Studies were performed in patients on maintenance
acetate hemodialysis to assess the quantity and
processes involved in the removal of carbon dioxide
((202) during the treatment. The data presented
suggest that multiple factors related to the removal
of C02 during acetate dialysis may be responsiblein
part for the low plasma bicarbonate observed in
patients on chronic maintenance hemodialysis.
A report of data acquired under varying conditions

and a review ofthe literature. Sherlock,J., Ledwith,
J. and Letteri, J . Am J Nephrol, 4 (3), pp. 158-68
(1984). The major reason for hypoxemia during
acetate dialysis is a decrease in alveolar oxygen
tension due to changesin metabolism and a decrease
in pulmonary C02 excretion when C 0 2 is lost from
the dialyzer. The increasing pH may contribute to
the metabolic change during acetate dialysis and the
hypoventilation during bicarbonate dialysis. There
is little evidence to support an effect of pulmonary
capillary obstruction or changes in oxy-hemoglobin
associationonthe decreasein arterial oxygen tension
observed
Appendix E (Cont.1
Long-term hemodialysis a t reduced dialysate flow
rates. Kirchner, KA., White, A R , Kiley, J.E. and
Bower, J.D. Am J Nephrol, 4 (I), pp. 7-12 (1984).
Twenty stable hemodialysis patients were maintained on a dialysate flow rate of 300mVmin (QD 300)
to determine the safety of prolonged reductions in
dialysate flow rate. Authors conclude that QD 300
does not impair dialysis efficiency for most small
molecules and saves $1.38 per patient per dialysis.
Bacterial contamination of the blood compartment
originating from the dialysate in haemodialysers.
Kolmos,H.J. JHosp Infect, 5 (l), pp. 70-5(Mar 1984).
Microorganisms originating from the dialysate compartment invaded the blood compartment ofahodial
RP6' 2.5 percent of the time. Analysis of the data
suggested that the probable access of bacteria to the
blood compartment was by way of minor defects in
the dialysis membrane. The patients experiencedno
obvious symptoms or signs of sepsis which could be
ascribed to the presence of microorganisms in the
blood compartment
A difference in complement and neutrophil activation. Ivanovich, P., Chenoweth, D.E., Schmidt, R.,
Klinkmann, H., Boxer, L A , Jacob, H.S. and Hammerschmidt, D.E. Contrib Nephrol, 37 pp. 78-82
(1984).
Side effects in bicarbonate dialysis due to low dialysate pH. Wagner, L., Schindler, B., Marhoffer, W.,
vanEyl, 0. and Strauch, M. P m Eur Dial Tmnsplant Assoc, 19, pp. 346-50 (1983). In six commercially availablebicarbonate containingdialysatespH
and pC02 were determined. Side effects resulted
from low pH and high $02. Use of two of the six
dialysateswas associatedwith fatigue,musclecramps
and somnolence.
Contrasting alterations in pulmonary gas exchange
during acetate and bicarbonate hemodialysis. Eiser,
AR., Jayamanne, D., Kokseng, C., Che, H., Slifkin,
RF. and Neff, M.S. Am J N e p h l , 2 (3), pp. 123-7
(1982). Our studies revealed that oxygen consump
tion increased significantly during acetate dialysis,
while it decreased slightly during biwbonate dialysis. SinceC02 production decreasedwith bothbaths,
therespiratoryexchangeratioderreasedduringacetate
dialysisbut did not change d u r i n g b i c h n a t e dialysis. We conclude that hypoxemia during dialysis
relates to decreases in minute ventilation and that a
greater decrease during acetate dialysis is a consequence of enhanced oxygen consumption and its
effect on respiratory exhangeratio. Bicarbonate dialysis does not increase oxygen consumption.
Q d i t y Assurance Guidelinesfor HernodialysisDevices
Chapter 5
Electroencephalograminvestigationsofthe disequilibrium syndrome during bicarbonate and acetate
dialysis. Hampl,H., Klopp,H.W.,Michels,N., Mahiout,
A , Schilling, H., WoIfgruber, M., Schiller, R, Hanefeld, F. and Kessel, M. Proc Eur DiaC Transplant
Assoc, 19, pp. 351-9 (1983). Continuous long-time
electroencephalographic (EEG)monitoring was perfbrmedduringacetateandbicarbonate~.
Persisting
normal basic activity of the EEG without neurological symptoms was found only during the course of
bicarbonate dialysis. The decrease in PaC02 and the
deterioration in EEG activity in the patients during
acetate dialysis was concomitant with severe neurological alterations, e.g., the typical symptoms of socalled 'disequilibrium' causing a cessation of dialysis
in three patients.
Danger of haemodialysis using acetate dialysate in
combinationwithalatge surfaceareadialyser. Viljoen,
M. and Gold, C.H. SAfr Med 4 56 (5),pp. 170-2(Aug
4,1979). Large surface area, high mass transfer dialysers have recently come into widespread use,and
it has been shown that they promote the loss of large
amounts of bicarbonate when acetate is used in the
dialysate. In the chronic dialysis patient in a steady
state, these effectsmay be inconsequentialbut, in an
acutelyill patient, the combinationofa dialysate containing acetate and a high-efficiencydialyser may be
extremelyhazardous. Areturn to the use ofbicarbonate as the source of base would avoid such hazards
and would promote the more physiologicalcorrection
of the metabolic acidosis of renal failure.
Acute nickel intoxication by dialysis. Webster, J.D.,
Parker, T.F., Alfrey, AC., Smythe, W.R, Kubo, H.,
Neal, G. and Hull, A R Ann Intern Med, 92 (5), pp.
631-3(May 1980). Nickel intoxication was observed
in a group of dialyzed patients when leaching of
nickel-plated stainless steel water heater tank contaminated the dialysate. Symptomsoccurred during
and after dialysis a t plasma nickel concentrations of
approximately 3 m&. Symptomsincluded nausea,
vomiting, weakness, headache, and palpitation. Remission of symptomsoccurred spontaneously,generally 3 to 13 hours after cessation of dialysis. The
evidence indicated that the nickel became bound in
the plasma aftercrossingthe membrane, resultingin
a higher concentration in the plasma than in the
dialysate and preventing its removal by dialysis.
Life threatening hypokalemia during hemodialysis.
Wiegand, C., Davin, T., Raij, L.and @ellstrand, C.
Trans Am Soc Artif Intern Organs, 25, pp. 416-8
(1979).
Appendix E (Cont.)
Trace metal changes in dialysis fluid and blood of
patients on hemodialysis. Salvadeo, A , Minoia, C.,
Segagni,S.andvilla, G. Int JArtifOrgans, Jan 1979,
2 (I), pp. 17-21.
A Clinical Test of a New Device for On-line Preparation of Dialysis Fluid from Bicarbonate Powder: The
Gambro BiCart. Delin, K, Attman, P.O., Dahlberg,
M. and Aurell, M. Dial & Transplant, p. 468 (Sep
1988).
Issues in Dialysis: Reuse, Dialysate Toxicity, Short
Dialysis. Vlchek, D. Dialy & Transplant, p.127
(March 1988). Areview of an ASN conferenceon the
three title topics. The benefits and limits of each of
these highly topical factors in dialysis are discussed.
A double-blind controlled trial of acetate versus bicarbonatedialysate. Uldall, P.R, Kennedy,I.,Craske,

H., Porrett, E., Aid, J., Woods, F. and Levine D. P m
Clin Dial Transplant Forum, 10,pp. 220-3 (1980). A
significantlylower incidence ofdialysis-relatedsymptoms has been shown during dialysis with bicarbonate rather than the previouslyused acetate. The level
of well-being in the intervals between dialysis was
not appreciably affected by the dialysis mode. It is
suggested that bicarbonate dialysis should be made
availableto all patients receivingregular hemodialysis for end-stage renal failure provided that this can
be done reliably and safely.
Hemolysis and consumption coagdopathy due to
C.R.,Geurts, J.O. and Dratwa, M. Nephron, 30 (21,
pp. 190-1(1982).
Acute haemolysis due to concentrated dialysis fluid.

Mulligan, I., Pafiey, P., Phillips, M.E., Brown, E.A
and Curtis, J.R. Br Med JCClin Resl, 284 (63231,PP.
1151-2 (Apr 17,1982). Fatal acute haemolysis occurred in a 65-year-old man undergoing regular
home haemodialysis for terminal renal failure. Circumstantial evidence indicating that the haemolysis
resultedhm exposureto concentrated dialysis solution was supportedby in-vitrostudies. Frank haemolysis in blood samplesoccurreda t adilution ofgreater
than or equal to 112of dialysisfluid. Osmoticfragility
tests of survivingred blood cells showed 47%haemolysis at a dilution of 1/2and greater than 90%haemolysis at a dilution of lh. Urgent design modifications
to the proportioning machine are being undertaken
to Prevent such an accident recurring.
Dialysate aluminium concentration and renal bone
disease. Walker, G.S., Aaron, J.E., Peacock, M.,
Chapter 5
Robinson, P.J. and Davison, AM. Kidney Int, 21 (21,
pp. 411-5 (Feb 1982). Bone fractures were significantly more common in patients exposed to high
dialysate aluminium concentrations. The histologic
indices of osteomalacia were significantly related to
the prevailingdialpate aluminium concentration,in
such a way that higher aluminium levels were associated with more osbmalacia. These findings suggest that aluminium is a toxic agent associated with
a mineralizing defect in the bone of renal failure
patients.
"Physiologid*and"pharmacologicalndialy~te
sodium
concentrations. Bocatelli, F., Pedrini, L., Ponti, R,
Costanzo, R.,DiF'ilippo, S., Marai, P., Pozzi, C. and
Bonacina, G.P. Int JArtif Organs, 5 (I), pp. 17-24
(Jan 1982). Using "physiological" and "pharmacologically high" sodium dialysate,the removal of water
and sodium by convection improvesthe cardiovascular stability and the patient's well-being, without
bringing about the feared long-term cardiovascular
side effects, if an appropriate dry body weight is
achieved, because of better correction of the cellular
overhydration.
Severe hypokalemia induced by hemodialysis. Wie
gand, C.F., Davin,T.D., Raij,L. and Kjellstrand, C.M.
Arch Intern Med 141(2), pp. 167-7O(Feb1981). During dialysis, it is assumed that the serum electrolyte
levels asymptoticallyapproach the concentration in
the dialysate. In five patients, we observed an average 20% fall in serum potassium level, although the
dialysate contained 42% more potassium than the
predialysis serum. The cause of the hypokalemia
was a rapid shift of potassium from the extracellular
to the intracellular space secondary to correction of
acidosis. All patients entered dialysis with a h i s m
suggestingprolonged potassium loss, marked acidosis, and moderate hypokalemia; thus, the dialysate
potassium concentration should be higher than normal, and frequent determinations of the serum potassium level should be performed. Therapy resulting in rapid correction of acidosis in uremic patients
undergoinghemodialysismay cause large transcompartmental shifts of potassium. Potassium transfer
across the dialysis membrane may be inadequate to
compensate for such shifts, and life-threatening
hypokalemia may occur.
A Short Study on the Sodium Controller. Murray,
M.K. J.Nephml Nursing, pp. 106-8(SeptlOct, 1984).
The device is safe and effective and provides the following benefits: fewer medications required to control hyovolemic hyotension, incidence of complica-
Appendix E (Cont.)
tions reduced with higher sodium dialysate, no a p
preciable M e r e n t of blood pressure or weight gain
on higher sodium, and weight losses increased with
fewer attendant complications.
SodiumBalance. Fleming,S. Dial & Transplant, pp.

55-65 (Jan 1988). The article discusses the cation,
sodium, as the principal osmotic component of the
extracellular fluid. It gives an overview of the inappropriate fluid movement between the intraocclular
compartment and the extracellular compartment
that can cause blood pressure changes, hydrational
imbalances, edema, and other pathoIogicconditions.
Measurement of the effective dialyzer Na diffusion
gradient in vitro and in-vivo. Gotch, F A , Evans,
M.C. and Keen, M. Trans Am Sm Artif Intern
Organs, 31, pp. 354-8 (1985).
W i t y Assurance Guidelinesfor H e d i a l y s i s Devices
Haem*&-induced~spiratorychanges.
Faww
S.,Hoenich, N A , Laker,M.F., Schorr, W. Jr.,Ward,
M.Kand Ken;D.N. NephdDial Zhnsplant, 2 (3),
pp. 161-8 (1987). Amelioration of hypoxaemia may
be achieved by the use of bicarbonate, but its caw
is multifadorial, with contributionsfrom h m m t i lation secondary to dialyser C02 losses and pubo.
nary dysfunction due to leucostasis. These obsemtions suggest that the treatment ofpatients whohave
compromised cardiovascular function is most optimal with the use of biocompatiblemembraneswhich
induceminimalleucopenia,usedin conjunction with
dialysate that utilises bicarbonate as the base re
placement.
Appendix E (ContS
Annotated Bibliogrmphy
Chapter 6
Hemodialyzers
A study on limulus amebocyte lysate (LAL) reactive

materialderivedfromdialyzers.Yoshioka,T.,Ikegami,
K, Ikemura, K, Shiono, S., Uenishi, M., Sugimoto,
H. and Sugimoto,T. Jpn JSurg, 19 (I), pp. 3841 (
Jan 1989). The amebocytesofhorseshoe crab (Limulus)hemolymphcontain a coagulation systemhighly
sensitive to bacterial endotoxins. Limulus amebocyte lysate (LAL) reactive material derived h m
cuproammonium membranes, however is not an endotoxin and acts as a pathway in the coagulation
cascade found in Limulus amebocyte lysate. This
study confirmed these factsby using the coagulation
system of Limulus without factor G, which is a
substrate of the alternative pathway.
Beta 2micmglobulinkineticsin maintenancehemodialysis: a comparison of conventional and high-flux

dialyzersandthe &eds ofdialyzerreuse, DiRaimondo,
C.R, Pollak and V.E. Division of Nephrology, University of Cincinnati Medical Center and Dialysis
Clinics, Inc. An JKidney Dis, 13(5), pp. 390-5 (May
1989).To definethe kineticsofbeta2M duringhemodialysis and the effects of dialyzer reprocessing, serum beta 2M, plasma C3a, and neuhphil counts
were measured immediately predialysis; 15,90, and
180minutes&r beginningdialysis;and 15minutes
postdialysis in ten chronic hemodialysis patients.
Complement activation and neutropenia during
dialysis were significantly more marked with cuprammonium, but were not affected by reprocessing
of either dialyzer. In-vitro adsorption of 1241-beta
2Mtopolysulfonefiberswas greater than to cuprammonium; adsorption was not influenced by dialyzer
reprocessing.
Interleukin-1-its multiple biological effectsand its
association with hemodialysis. Dinarello,C.A Blbod
%f,
6 (3), pp. 164-72 (1988). Document Type:
Review (29 refs.). The conclusion was made that
PYrogens, solutes, complement components and the
ph~sicalnature of the dialysis membrane itself contribute to monocyte activation and cytokine release.
w o n of endotaxin-like interleukin-1-inducing
during in-vitro dialysis. Lonnemann, G.,
' ~ 1 , M.,Floege, J., Koch, KM., Shaldon, S. and
?@&hsurance Guidelinesfor Hemaliulysis Deuices
Dinarello, C A Kidng, Int, 33 (I), pp. 29-35 ( Jan

1988). In order to study the integrity ofdialysismembranes to pyrogens, the dialysate side of a closed loop
hemodialysis (HD)circuitwas challenged with E, coli
microfiltrate containing500ngfmlendotoh. These
studies demonstrate that: (a) in the presence of
plasma, 1Ll-inducing factors pass into the blood
compartment of a dialysis system challenged with
bacterial pyrogen; and (b)MNC production of IL-1 is
enhanced in the presence of plasma.
Foreign particles contaminatinghemodialyzers and
methods of removing them by rinsing. Inagaki, R,
Hamazaki, T., Kuroda, H. and Yano, S. Nephron,
1987,46(41, pp. 343-6. Foreign particles contaminating hemodialyzers constitute a risk of rnicroembolism and allergic reactions in hemodialysis patients. Authors investigated the size distribution of
particles, and the efTects of strikingheadersof dialyzers and flow rates ofrinsing saline on the elimination
offoreign particles from dialyzers. To rinse dialyzers
effectively, at least 1,000 ml of saline are necessary,
and strikingthe headers of dialyzers throughout the
rinsing procedure is important.
The possible role of Limulus-amebocyte-lysate-reactive material in hemodialysis. First-use syndrome.
Pearson, F.C.BkwdPu~fi5 (2-31, pp. 115-22(1987).
In this chapter,current knowledge about LALRMis
presented and integrated with the major mechanisms generally recognized to induce hypersensitivity-type reactions. These mechanisms include: classical induction of allergyby IgE and classical complement activation by IgG and IgM.
Ultrafiltration to reject human interleukin-l-inducingsubstancesderivedfrombcterialcultures. Dinarello,
C A , Lonnemann, G., Maxwell,R and Shaldon, S. J
CZin Microbid, 25 (7), pp. 1233-8 (Jul 1987). The
results indicate that: the IG1-inducing material(s)
present in bacterial culturesof gram-negativeorganisms is rejected by a factor of 100 to 100,000by molecular size exclusion and by absorption;rejection is
sustainedfor at least 32 liters of fluid;the rejection of
Limulus-reactivematerialby theultraflter is greater
for purified endotoxin than for native endotoxins deE-21
Appendix E (Cont.)
Annotated Bibliogmphy
rived from live bacterial cultures; and nonendotoxin
IL1-inducingtoxins (molecularweight, 24,000)from
Staphylococcusaureus are not rejected or absorbed.
No evidence for endotoxin transfer across high flux
polysulfone membranes. Bommer, J., Becker, KP.,
Urbaschek, R., Ritz, E., and Urbaschek B. Clin
Nephrol, 27 (61, pp. 278-82(Jun 198).Toevaluate the
safety of high-flux polysulfone dialyzers, an in-vitro
recirculation system was examined. It was concluded that LPS and lipid A do not pass from either
side through the filter system used when saline was
recirculated for more than 10 h on both sides of the
membrane.
Acute anaphylactoid reactions during hemodialysis .
in France. Foret, M., Kuentz, F., Meftahi, H., Milongo, R, Hachache, T., Elsener, M., Dechelette, Eand
Cordonnier, D. Artif Organs, 11(2), pp. 168-72(Apr
1987). A retrospective survey of anaphylactoidreactions during dialysis in France was conducted. The
presence of cellulose-derivedparticles in the rinsing
fluid of such dialyzers and the possible increased incidence of reactions &r the long (weekend) interdialytic interval suggest that allergy to cellulosederived particles eluted from cellulosic dialyzers
may contribute to dialyzer hypersensitivity reactions.
Effect of dialyzer reprocessing methods on complement activation and hemodialyzer-related symptoms. Dumler, F., Zasuwa, G. and Levin, N.W. Artif
Organs, 11(2), pp. 128-31 (Apr 1987). The effects of
differentdialyzerprocessingmethods and ofreuse on
complement activation and dialyzer-related symp
toms were studied in 96 maintenance hemodialysis
patients. The percentage of patients without symp
toms during dialysis was significantly greater with
reused dialyzersthan with new dialyzers. The severity oftotalsymptomscorrelated signifimntly(p=0.0004)
with complement activation. The results suggest
that total symptoms during dialysis are correlated
with the degree of complement activation. However,
trends in the data pertaining to chest pain suggest
that factors other than complement activation may
be important in the pathogenesis of some dialyzerrelated symptoms.
Technical requirements for rapid high-efficiency
therapies. Keshaviah, P., Luehmann, D., Ilstrup, K
and Collins, A Artif Organs, 10 (31, pp. 189-94(Jun
1986).The key technical elements necessary for such
implementation includehigh blood flow rates, higher
efficiency dialyzerddiafilters, ultrafiltration control
systems, and bicarbonate as the buffer source. In
Chapter 6
Hedialyzers
addition,hemodidtration requires schemesto ensure
sterility and nonpyrogenicityofthe infusionfluid and
appropriate balancing of the rates of ultrafiltration
and reinfbsion.
The current status and b r e of the artificialkidney.
Funck-Brentano,J.L. Artif Organs, 9 (2),pp. 119-26
(May 1985). Document Type: Review (32 refs.). Discussion of the technology, use and determination of
adequacy and related cost.
Role of dialyzer contaminants in the allergic epiphenomena ofhemodialysis. Ward, R.A, Feldhoff, P.W.
and Klein E. Artif Organs, 8 (3), pp. 338-49 (Aug
1984). Cuprophan hollow-fiber dialyzers contain
carbohycontaminants includingl,2,3-propanetriol,
drates, Limulus amebocyte lysate-reactivematerial,
and particulates. In a clinical study, the role of these
substances in the allergic-typeresponse seen in some
hemodialysispatients was examined. Dialyzerpreparation had no effect on predialysis eosinophil counts
or IgE levels. All patients demonstrated transient
leukopeniaand complement activation during dialysis, the magnitudes of which were unaffected by the
type of dialyzer preparation. At the levels found in
the dialyzers studied, it was questioned whether
water-soluble extractables or particulates play any
role in the allergic epiphenomena of hemodialysis.
Anaphylactoid reactionsduetohaemodialysis,haemofiltration, or membrane plasma separation. Nicholls,
AJ. andPlatts,M.M. BrMed J[Clin Resl,285 (63551,
pp. 1607-9( Dec 4,1982). A previously undescribed
anaphylactoid reaction to haemodialysis, haemofiltration, or membrane plasma separation occurred in
15 patients receiving regular dialysis. The illness
varied in severity from urticaria, sneezing, and watering ofthe eyes to severebronchospasm and cardiovascular collapse, and began within aminute ofblood
being returned from the dialyser or filtration device
to the patient. Reactions developed only when a
dialyser sterilised with ethylene oxide was used for
the first time and never after sterilisation with formalin. Several patients had more than one reaction
while three had a reaction each time a new dialyser
was used. Incorrect priming of the dialysers maybe
a partial explanation of these attacks, but the exact
reason for their occurrence is unknown.
Beta 2-microglobulinkineticsin maintenancehemodialysis: a comparison of conventional and high-flux

dialyzers and the effects of dialyzer reuse. DiRaimondo, C.R. andPollak,V.E. Division ofNephrology,
University of Cincinnati Medical Center and Dialysis Clinics, Inc. Am J Kidney Dis, 13 (5), pp. 390-5
E-22
Appendix E (Cont.)
(May 1989). To define the kinetics of beta 2M during
hemodialysis and the effectsof dialyzerreprocessing,
serum beta 2M, plasma C3a, and neutrophil counts
were measured immediately predialysis, 15,90, and
180minutesafterbeginningdialysis, and 1 5minutes
postdialysis in ten chronic hemodialysis patients.
Complementactivationandneutmpeniaduringdialysis
were significantly more marked with cuprammonium, but were not affectedby reprocessing of either
dialyzer. In-vitro adsorption of 1241-beta 2M to
polysulfone fibers was greater than to cuprammonium; adsorption was not influenced by dialper
reprocessing.
Biocompatibility of artificial organs: an overview.
Henderson, L.W.and Chenoweth, D. B l d Pruif, 5
(2-3), pp. 100-11 (1987). Review (41 refs.).
Cellulose acetate hemodialysis membranes are better tolerated than Cuprophan. A difference in complement and neutrophil activation. Ivanovich, P.,
Chenoweth,D.E.,Schmidt, R, Klinkmann, H., Boxer,
L A , Jacob, H.S. and Hammerschmidt,D.E. Contrib
Nephrd, 37, pp. 78-82 (1984). The newer cellulose
acetate membranes show lower degree of complement activation and a smaller drop in neutrophil
count during the first 30 minutes of dialysis than do
the cuprophan dialyzers. It is suggested that patients with intradialytic symptoms related to membrane biocompatibility will tolerate the procedure
better on these newer membranes.
Hypoxemia during hemodialysis: effects of different
WA, Verpooten, G.A, Borgonjon, D.J., Vermeire,
P A , Lins, RR and DeBroe,M.E.Kidney Int, (51, pp.
738-43 Way 23, 1983). Comparing AN69 membrane, cuprophan membrane, acetate dialysate, and
bicarbonate dialysate, it is found that the degree ofdialysis-relatedhypoxemia increases in severity as follows: combination of AN69 and bicarbonate shows
littlehypoxemia;AN69 and acetate as well as cuprophan and bicarbonate showingintermediate results;
and acetateand cuprophan the most significantdrop.
Indicationsare that there are two componentsto the
dialysishypoxemia:a membrane-relatedcomponent,
md a dialysate buffer component.
Bacterial endotoxin in new and reused hemodialyzem:a potential cause of endotoxemia. Petersen, N.J.,
L.A. and Favero, MS. TransAm Soc A d f
C-n,
Organs, 27, pp. 155-60(1981). New dialyzers
may contain an LAGreactive material, but it is not
mgenic. However, if reuse dialyzers are reprocessedand storedwith a disinfectant that containsen~ssuranceGuidelines for Hemdialysis Deuiees
Chapter 6
Hedidyzers
dotoxin, that pyrogenic material may stay in the
membrane even &r rinseout of the disinfectant
Methods for avoiding introduction of this endotoxin
to the patient include discarding the recirculating
solution to waste. Water used for dilution ofgermicide should be endotoxin-free.
Neutrophil behavior during hemodialysis. Role of
membrane contact. Neveceral, P., Markert, M. and
Wauters, J.P. ASAIO Trans, 34 (3), pp. 5647 (JulSep 1988). The in-vivo effect of membrane contacton
oxygen radical productionandchemotaxisofdialyzed
neutrophils isolated simultaneously from the arterial and venous sites during dialysis with cuprophane, polycarbonate, polysulfone, and polyacrilonitrile membranes was studied. Cells remaining in
circulation aRer 15minutes of dialysis showed defective responses only when collected at the venous site
of the cuprophane dialyzer, in spite of a similar
leukopeniaa t the venous and arterial sites. With the
other membranes tested, no defects in neutrophil
h c t i o n s were evidenced. These results suggestthat
down-regulationoccurs within the dialyzer and that,
besides complementactivation,the membrane plays
an additional role.
First-use syndrome in patients treated with hollowfiber dialyzers. Villarroel, F. B l d Purif, 5 (2-3),pp.
112-4 (1987). A two-year survey on first-use syndrome (FUS) in hemodialysis showed that there
were an average of 181 FUS reactions per year.
Nearly 39% of the patients who experienced a FUS
reaction had experienced previous FUS reactions. A
strong correlation was found with respect to the age
and race of the patients. The fact that a patient
recently starteddialysistreatmentorhasbeentreated
with dialysis for some time appears to have no
bearing in the risk of experiencing a FUS reaction.
Hypersensitivity to hemodialysis: the United Kingdom experience. Nicholls, AJ. Artif Organs, 11(21,
pp. 87-9 (Apr 1987). A survey of all U.K hemodialysis centers was conducted to investigate the prevalence ofhypersensitivityin the first use of disposable
dialyzers. A total of 117 patients with 243 separate
reactions were identified, suggestingthat 1in 20 to 1
in 50patientsmay be susceptibletoan anaphylactoid
reaction to a new hemodialyzer at some time, while
the risk of reaction occurringwith any singlehemodialysis is approximately 1in 1,000 to 1in 5,000. No
particular brand or type of hemodialyzer nor any
identifiable technique of priming procedure was
associated with reactions, but in those few patients
who suffered repeated reactions, further problems
were avoidedbyincreasingthe volume ofsaline in the
Appendix E (Cont.)
initial rinse of the hemodialyzer or by changing to
another brand of hemodialyzer.
Effect offirst and subsequent useofhemodialyzerson
patient well-being the rise and fall of a syndrome
associated with new dialyzer use. Charoenpanich,
R., Pollak,V.E., Kant, KS., Robson,M.D. and Cathey,
M. Artif Organs, 11(2), pp. 123-7 (Apr 1987). In a
single large dialysis unit in which dialyzers are
routinely subjected to multiple use, the incidence
rates of intradialytic symptoms during first use and
reuse were compared. The results of this investigation suggest that subjecting dialyzers to an automated reuse processing system before first use can
markedly diminish the incidence of first-use syndrome.
Effect offirst and subsequent useofhemodialyzerson
patient well-being. Analysisofthe incidence of syrnp
toms and events and description of a syndrome associated with new dialyzer use. Robson, M.D., Charoenpanich, R., Kant, KS., Peterson, D.W., Flynn,J.,
Cathey, M. and Pollak, V.E. Am JNephrd, 6 (2), pp.
101-6 (1986). To determine the effect of multiple
dialyzer use on intradialytic symptoms, data from
26,592 successivedialyses on 147patients were analyzed. Over the 26-month period of study 4,933 new
dialyzers were used. All symptoms, considered together, occurred 1.3 times more frequently during
the initial than during the subsequent use of the
dialyzer. No symptom occurred more frequently in
the second or subsequent use ofthe dialyzer. Concurrent chest and back pain were 41 times more frequent when the dialyzer was used for the first time.
A syndrome associated with the first use of the
dialyzer is described.
A survey on hypersensitivity reactions in hemodialysis. Villarroel, F., Ciarkowski, A A Artif Organs, 9
(3), pp. 231-8 (Aug1985).This survey was conducted
from 1982 through 1984 by a cooperative effort
among the Health Industries Manufacturers Association, seven dialyzer manufacturers, and the Food
and Drug Administration. This article presents an
analysis of the 1982-83survey data and a summary
of the 1984 data.
Anaphylatoxin formation during hemodialysis: effects of different dialyzer membranes. Chenoweth,
D.E., Cheung,A K andHenderson, LW. Kidney Int,
24 (6), pp. 764-9 (Dec1983). MeasurabIecomplement
activation resulting in the formation of both C3a and
C5a anaphylatoxins was observed in 12 patients
undergoingmaintenance dialysistreatment with cuprophan hollow fiber dialyzers. The authors surmise
Quality Assurance Guidelinesfor Hernodialysis Devioes
Chapter 6
Herrwdialyzers
that their observations provide direct evidence that
anaphylatoxin formation during hemodialysis is a
transient phenomenon and indicate that the biocompatibility of dialysismembranes, as reflectedbytheir
complement activating potential, may be significantly different
Nursingmanagement of the new dialyzer syndrome.
Butsick, E.A, Clyde, C.A, Hudson, P.C., Manion,
B A and Smith, L.J. AANNTJ , 10 (7), pp. 35-9 (Dec
1983).
Long-term results of dialysis therapy with a highly
permeable membrane. Chanard, J., Bnmois, J.P.,
Melin, J.P., Lavaud, S. and Toupance, 0. Artif
Organs, 6 (3),pp. 261-6 (Augl982). Afive-year study
of short-term dialysis using highly permeable polyacrylonitrilemembrane AN 69 was started in March
1973to compare the &eds of AN 69 and Cuprophan
membrane (CM). The dialysis sessions were significantly better tolerated with AN 69 than with CM,
however, the main advantage of using AN 69 is the
shortening of dialysis time. The duration of dialysis
was 9.5 k0.2 hours per week with AN69 andl6.4kO.2
hours per week with CM. Shortening of dialysistime
permits better social rehabilitation of the patients.
The shorter dialysis was not associatedwith any recognizable side effects that could be demonstrated by
routine clinical and biological analysis.
Hemodialysis-associatedcomplicationsdue to sterilizingagentsethyleneoxideandformaldehyde.Kessler,
M., Cao-Huu,T., Mariot, A and Chanliau J. Contrib
Nephrd, 62, pp. 13-23 (1988). Document Type: Review (57 refs.).
Allergy in long-term hemodialysis 11: Allergic and
atopic patterns of a population of patients undergoing long-term hemodialysis. Bousquet, J., Maurice,
F., Rivory, J.P., Skassa-Brociek, W., Florence, P.,
Chouzenoux, R, Mion, C. and Michel, F.B. JAlEergy
Clin Zmmunol, 81 (3), pp. 605-10 (Mar 1988). Patients did not have serum-specific IgE against the
released chemicals. Five of 17 patients who had a
pruritus during dialysis had either positive RAST to
released chemicals or skin tests to the effluent. Five
of 8 patients who suffered from anaphylaxis had
positive RAST to released chemicals, but only those
whohad apositive RASTpresenteda severereaction.
Ethylene oxide in dialyzer rinsing fluid: effect of
rinsing technique, dialyzer storage time, and potting
compound. Ansorge, W., Pelger, M., Dietrich,W. and
Baurmeister, U. Artif Organs, 11(2),pp. 118-22(Apr
1987). Ethylene oxide (ETO) is recognized as one of
E-24
Appendix E (ContS
the main causes of dialyzer-associated hypersensitivity reactions. The authors results suggest that the
dose of ETO administered to the patient at the outset
of dialysis can be minimized by rinsing the dialyzer
with 2 L offluid at 37C and by avoiding administration of rinsing fluid that has been allowed to remain
in contact with the dialyzer for more than several
minutes. Use of a long storage interval and use of
dialyzers containing reduced amounts of potting
material will also reduce the ETO load.
Mediation of hypersensitivity reactions during
hemodialysis by IgE antibodies against ethylene
oxide. Lernke, H.D. Artif Organs, 11(21, pp. 104-10
(Apr 1987). We conclude that ETO causes most
severe hypersensitivity reactions by an IgE-mediated mechanism. On the other hand, the pathogene
sis of mild (type I)reactions is less clearly associated
with ETO allergy. The results also suggestthat other
potentially allergenic substances in dialyzers (e.g.,
IPM, 2-chloroethanol) rarely induce specific IgE
antibodies in dialysis patients.
Extractable ethylene oxide from cuprammonium
cellulose plate dialyzers: importance of potting compound. Ing, T.S. and Daugirdas, J.T. ASMO k s ,
32 (l), pp. 108-10(Jul-Sep1986). The results suggest
that ethylene oxide retention aRer sterilizationis increased in cuprammonium cellulose plate dialyzers
containingpotting compound. In contrast, cuprammonium cellulose plate dialyzers without potting
compound were characterized by a rapid disappearance of retained ethylene oxide after sterilization.
Whether these findings explain the low incidence of
SARD with cuprammoniumcellulose plate dialyzers
that do not contain potting material is a matter for
continued study and experimentation.
Association of ethylene-oxide-induced IgE antibodies with symptomsin dialysispatients. Rumpf, KW.,
Seubert, S., Seubert, A, Lowitz, H.D., Valentin, R,
Rippe, H., Ippen, H. and Scheler, F. Lancet, 2 (8469701, pp. 1385-7(Dec 21-28 1985). High RAST values
were commonly associated with anaphylactoid reacti~nsdurin~dial~sisandwithchronicasthma
Ethylene
oxide antibodies should be sought routinely in patients presenting with these symptoms and the necessity of ethylene oxide sterilisation of disposable
dialysis equipment should be re-evaluated.
Dialyzer hypersensitivity syndrome: possible role of
d k g y to ethylene oxide. Report of four cases and
review of the literature. Caruana, R.J., Hamilton,
RW.and pearson, F.C. Am JNephrd, 5(4), pp. 27140985). Document Type: M e w (12refs.). Dialyzer
wit^ Assurance Guidetine for Hemodialysis Devices
Chapter 6
Hemodialyzers
hypersensitivity syndrome presents as an acute anaphylactoid reaction, the symptoms of which may
range from mild to life-threatening in severity. The
cause of this syndrome is unknown, but affected patients appear to have a high incidence of positive
radioallergosorbent tests to a conjugate of human
serum albumin and ethylene oxide, suggestingthat
ethylene oxide, a substance used to dry sterilize artificial kidneys, may be an offending allergen.
Severe reactions duringhemodialysis. Rault, R and
Silver, M.R.Am JKi&nqDis, 5 (21, pp. 128-31 (Feb
1985). Severe reactions during dialysis occurred in
1.7%of hemodialysispatients. Respiratorydistress,
agitation, pruritus, and alterations in BP were the
dominant clinical findings, and one patient suffered
arespiratoryarrest. Current evidenceimplicatesthe
dialyzer as the most likely culprit, and experience
suggests that none of the commonly used dialysis
membranes are truly biocompatible.
haphylatoxin formation during hemodialysis:
comparison of new and re-used dialyzers. Chenoweth, D.E., Cheung, A K , Ward, D.M. and Henderson, L.W. Kidney Znt,24 (6), pp. 770-4(Dec 1983).
Hemodialysis of 11 endstage renal failure patients
with new cuprophan hollow fiber dialyzersproduced
signifjcant leukopenia as well as increased plasma
levels ofboth C3a and C5a antigens during the initial
phases of the procedure. These observations suggest
that C3b deposition on the cellulosic membrane surface during first use markedly diminishes the complement-activatingpotential of cuprophan dialyzers
when they are subsequently reused.
Luehmann, D.A Crit Rev Biomed Eng, 9 (31, pp, 20144 (1983). Document Type: Review (83 refs.).
Hypersensitivity reaction on first-time exposure to
cuprophan hollow fiber dialyzer. Key, J., Nahmias,
M. and Acchiardo, S. Am JEdney Dis, 2 (6),pp. 6646 (May 1983). The cause of the hypersensitivityreaction is unknown. It could be due to substances used
in the sterilizationprocedure, to the membrane itself,
or to substances that leach out of the potting compound or membrane. Hypersensitivity reaction
during hemodialysis has been reported to be very
severe or even fatal. Personnel delivering direct
patient care should be aware of the symptoms and
react quickly with proper treatment. Patients suspected to have this reaction should be changed to a
dialyzer without a cuprophan membrane.
Appendk E (ContS
Severe reactions to Cuprophan capillary dialyzers.

Popli, S., Ing, T.S., Daugirdas, J.T., Kheirbek, A.O.,
Viol, G.W., Vilbar, R.M. and Gandhi, V.C. Artif
Organs, 6 (3),pp. 312-5(Aug1982). Five severe reac--'
tions occurred in four maintenance hemodialysis patients 1to 5minutes aRer initiating dialysiswith Cuprophan capillary dialyzers. All reactions were lifethreatening and one resulted in death. Inadequate
rinsing of the dialyzers was probably the cause of the
reactions. The severe reactions were managed by
immediate discontinuation of dialysis and the institution of supportive treatment. Antianaphylactic
measures were also attempted, but their therapeutic
effectivenessremains to be determined.
Hemodialysis-associated neutropenia and hypoxe
mia:the effectofdialyzerrnembrane~~mterials.
Hakim,
R.M. and Lowrie, E.G. Nephron, 32 (I), pp. 32-9
(1982). The fall in white blood cells (WBC)and arterial oxygen pressure that occurs during hemodialysis
was investigated as a b c t i o n of different dialysis
membranes and different sterilization methods. No
significant differences were seen in pH, PC02 or bicarbonate. The results indicate differences in biocompatibility between Merent membranes. Clinical implications are discussed.
Bacterial contamination of the blood compartment
originating from the dialysate in haemodialysers.
Kolmos,H.J. JHosp Infect, 5 (11,pp. 70-5(Mar 1984).
Microorganisms originating from the dialysate compartment invaded the bloodcompartmentofahodial
RP6' 2.5 percent of the time. Analysis of the data
suggested that the probable access ofbacteria to the
blood compartment was by way of minor defects in
the dialysismembrane. The patients experienced no
obvious symptoms or signs of sepsis which could be
ascribed to the presence of microorganisms in the
blood compartment.
Hypoxemia during hemodialysis: effect of Merent
W.A, Verpooten, G.A, Borgonjon, D.J.,VanWaeleghem, J.P., Vermeire, P A and DeBroe, M.E.Contrib
Nephrol, 37, pp. 13441 (1984).
Dynamic behavior of plasma phosphate in chronic
dialysis patients. Sugisaki, H., Onohara, M. and
Kunitomo,T. TransAm Soc ArtifIntern Organs, 28,
pp. 302-7 (1982). (1) Change in the plasma P concentration during intra- and interdialytic phases is
notably different fiom that for BUN, CR and UA
Reduction rate for P depends on its pretreatment
concentration. Plasma Pis apt to level off or rebound
Quality Assurance Guidelinesfor HernodialysisDevks
Chapter 6
Hemodialyzers
even during a treatment and quickly returns to the
pretreatment level after it is terminated. (2)In shortterm evaluations, occurrence of P rebound during a
treatment does not correlate with factors such as
meal, A l gel, dialyzer type, dialyzer membrane and
therapeutic mode, but with the pretreatment P concentration. Onceitreachesathresholdlevelinherent
to each patient, plasma P seems to rebound. (3) Re
treatment P concentration in eachpatient seemedto
be controlled in a relatively narrow range. (4) While
apparent generationrates (GIestimatedwith asingle
compartmental kinetic model are stable during intra- and interdialytic phases as to BUN, CR and UA,
Gfor P seemsto be significantlyenhanced, especially
during the latter period of the treatment and immediately &r the termination of the treatment.
A clinical study on different cellulosic dialysis membranes. Falkenhagen, D., Bosch, T., Brown, G.S.,
Schmidt, B., Holtz, M., Baurrneister,U., Gurland, H.
and Klinlanann, H. Nephrd Dial Transplant, 2 (6),
pp. 537-45 (1987). A comparison of dialysis membranes made of modified cellulose (Hemophan)with
classical regenerated cellulose (Cuprophan). The
efficacy of the modified cellulosic membrane with
respect to urea and creatinine clearance was shown
to be comparable to that of regenerated cellulose and
celldoseacetate. However,modified celluloseshowed
an increased clearance for inorganic phosphate, significantly different from that demonstrated by both
regenerated cellulose and cellulose acetate. Demonstrated that in comparison to regenerated cellulose,
modified cellulose resulted in significantlyless complement activation and WBC reduction, and appears
to be due to the substitution of hydroxyl groups of
regenerated cellulose.
Compartmental distribution of complement activation products in artificial kidneys. Cheung, AK,
Chenoweth, D.E., Otsuka, D. and Henderson, L.W.
Kidney Znt, 30(1), pp. 74-80 (Jull986). Hemodialysis
membranes may differ with regard to their complemenbactivating potential as well as their ability to
remove circulating anaphyla-toxins fiom the blood
path. Clinical measurements ofanaphylatoxh p*
duction during hemodialysis reflect these dynamic
events.
Direct calculation of KIN. A simplified approach to
monitoringofhemodialysis. Barth,RH. Nephron, 50
(31, pp. 1916(1988). A simpleformulafor calculation
of KTN fiom pre, post- and mid-dialysis blood urea
nitrogen is presented. An evaluation by measure
ment of total dialysate urea revealed that urea ki-
E-26
Appendiv E (ContJ
netic modeling consistently overestimated V and K,
and that KTNderivedhm the simpleformulamore
precisely estimated true KTN.
A study on hemodialysis leukopenia using various

dialyzers. Shin,J.,Matsuo, M., Shinko,S., Fujita,Y.,
Inoue, S., Sakai, R and Nishioka, M. JDial, 4 (I), pp.
51-62 (1980). Hemodialysis leukopenia was studied
using various dialyzers and membranes. The authors found that dialyzerswith cellulosicmembranes
caused marked leukopenia, but in recentlydeveloped
non-cellulosic membranes, its occurrence was significantly less. Additionally, the results showed a
newly developed cellulose acetate membrane to correlate well with the non-cellulose membranes r e
gardingleukopenia, in spite of it being a derivative of
cellulose.
Absence ofbacteremia and endotoxemiadespite contaminated dialyzate. Bernick, J.J. and Port, F.K.
ClinNephrd, 14(1), pp. 13-7(Jul1980). Feversassociated with hemodialysishave been attributed to the
transfer of relatively large endotoxin molecules andl
or bacteria from contaminated dialyzate across the
dialyzingmembrane. In this study, due to amalfunction, dialysisfluids containedbacteria and endotoxin
a t levels previously reported to be associated with
pyrogenic reactions. Neither endotoxin nor bacteria
was detected; venous and arterial blood specimens
were collected a t the termination of hemodialysis.
Temperature elevations did not occur. In an extended study, 20 dialyzers were collected aRer single
patient use and the dialyzate compartment wasfilled
with highly contaminated dialyzate, while the blood
compartment was filled with sterile pyrogen-free
saline. Following 5 to 7 days incubation, bacteria
were present in the blood compartments of4 of 20 dialyzers, probably due to contamination during dialyzer handling. However, the much smaller endotoxin molecule could not be detectedin the absence
of bacterial contamination. These results indicate
that the intact cellophane membrane is an effective
barrier to endotoxin and bacteria under clinical conditions.
Comparison of solute permeability and rejection
characteristicsof normal and flux cellulosehaemodialysis membranes. Klein, E., Holland, F.F. and
Eberle, K. P m Eur Dial Transplant Assoc, 16, pp.
198-204 (1979). Permeability and rejection properties of new, high flux cellulose membranes and fibres
have been compared with Cuprophan. The greater
solute and water flux is explained in terms of larger
"pores," which permit greater transport of large
molecules.
QualityAssurance Guidelines for HernodialysisDevices
Chapter 6
Hedialyzers
Bacterial and endotoxin permeability of hemodialysis membranes. Bernick, J.J., Port, F.K, Favero,
M.S. and Brown, D.G. Kidney Int, 16 (4), pp. 491-6
(Oct 1979). Dialysis fluids containing at least l a 7 1
bacteria per milliliter and as much as 12,500ngofendotoxin equivalents per milliliter were dialyzed and
ultrafiltered with three types of disposablehemodialyzers. Neither bacteria nor endotoxin, as measured
by the Limulus lysate assay, was detected in the
sterile compartment despite ultrafiltration. Under
these favorable conditionsfor endotoxin transfer, the
maximum transfer rate was calculated to be less
than 3.5 ngofendotoxinequivalents per hour. At this
rate, it is unlikely that pyrexia during hemodialysis
is due to the transfer of endotoxin across an intact
dialyzing membrane. Provided that the integrity of
the dialyzingmembrane is maintained, this investigation indicates that the risk of endotoxemia or
bacteremia associated with the use of contaminated
dialysis fluids is negligible.
Chapter six: clinicalevaluation. Evaluation ofhemodialyzers and dialysismembranes. Report of a study
group for the Artificial Kidney-Chronic Uremia ProgramNIAMMDD-1977. Klein, E., Autian, J., Bower,
J.D., Buffaloe, G., Centella, L.J., Colton, C.K, Darby,
T.D., Farrell, P.C., Holland, F.F., Kennedy, R.S.,
Lipps, B. Jr, Mason, R,Nolph, KD., Villarroel, F.
and Wathen, R.L Artif Organs, 3 (1), pp. 47-61 (Feb
1979).
Mannitol and maintenance hemodialysis. Swamy,
AP. and Cestero, RV. Artif Organs, 3 (21, pp. 116-9
(May 1979). The extensive use of mannitol during
maintenance hemodialysis prompted a study of
mannitol kinetics. Despite an apparently adequate
clearance rate, mannitol administered during dialysis is incompletelyremoved. Repeated use of mannito1 during dialysis leads to mannitol accumulation.
Clinical significance of the residual mannitol levels
needs further evaluation.
Characteristics of Available Dialyzers. Shinaberger,
J.H., Miller, J.H. and Gardner, P.W. in Clinical Dialysis. AR. Nissenson, R.N. Fine, and D.E. Gentile,
[edsl. Appleton-Century-Crofts,Nowalk CT,pp. 5398 (1984). Methods for characterization of dialyzers
and performance characteristics of many dialyzers
used.
Issues in Dialysis: Reuse, Dialysate Toxicity, Short
Dialysis. Vlchek, D. Dial & Transplant, p. 127
(March 1988). Areview of an ASN conference on the
three title topics. The benefits and limits of each of
these highly topical factors in dialysis are discussed.
E-27
Appendix E (Cont.)
Staying Tuned into the High-TechWorld (Part One).
Vlchek, D. Dialy & Transplant, p. 305 (Jun 1989). A
review of treatment modalities used in the late
1980's with descriptionsof each, dialyzers and dialysis membranes, includingfUnctiona1characteristics.
Volumetrically controlled ultrafiltration. Current
experiences and future prospects. Roy, T., Ahrenholz, P., Falkenhagen, D. and Klinkmann, H. Int J
Artif Organs, 5 (3),pp. 131-5(May 1982). Exact control of ultrafiltration (UF) is a prerequisite for high
flux dialysis and hemodiafiltration. Volumetric dialysate balancing is the best current method for the
use of dialyzers with high water permeabilities. The
precision of UF control by volumetric dialysate balancing is in agreement with all medical requirements. A positive influence of volumetric UF control
on patients undergoing chronic hemodialysis can be
shown by the frequencies of dialysis side effects.
Volumetric UF control is only a first step towards an
intelligent UF module to correlate water removal,
solute removal and sodium balance.
Dialyzer ultrafiltration coefficients: comparison between in-vitro and in-vivo values. Keshaviah, P.R.,
Constantini, E.G., Luehmann, D.A, Shapiro, F.L.
Artif Organs, 6 (I), pp. 23-6 (Feb 1982). This study
describes a simple, convenientmethod for the in-vivo
measurementoftheultrafiltrationcoelicientofhemodialyzers. The method is based on a scheme of isolated
ultrafiltration, i.e., ultrafiltration without dialysate
flow through the dialyzer. Results with this method
indicate that it is more accurate than the conventional bed scale technique. Measurements on three
different dialyzers demonstrate that the in-vivo
ultrafiltration coefficientisonlybetween l%and 10%
lower than the correspondingin-vitro value. This is
in contrast to the rule of thumb used by some manufacturers that in-vivocoefficientsare 30%lower than
in-vitro values. The deviation of the in-vivo value
from the in-vitro one seems to be higher with higher
dialyzer ultrafiltration coefficients. Based on these
results it is recommended that to estimate ultrafiltration rates in the clinical setting, the in-vitro ultrafiltration coefficientbeused, transmembrane pressures being correctedforthe colloid osmoticpressure
of plasma proteins.
Toxicity of middle molecules: clinical evaluation using a selectivefiltration artificial kidney. Jorstad, S.,
Smeby, L.C. and Wideroe, T.E. Artif Organs, 4,
Suppl, pp. 98-103(1981). Patients were treated with
a dialyzer able to remove moleculesbetween 10,00040,000 daltons. Returning substances with mol wt
Quality Assurance Guidelinesfor Hemodiulysis Devices
Chapter 6
HemocEialyzers
200-10,000 back to the patients was compared with
the effect ofconventionalhemodialysis. The patients
treated with this system obtained a more stable
hemoglobin concentration without blood transfusions. They also increased mean nerve conduction
velocity and their plasma increased in quality as
culture medium on human mononuclear phagocytes
grown in-vitro.
Hemodialysishypoxemia: evaluationof mechanisms
utilizing sequential ultrafiltration-dialysis. Brautbar, N., Shinaberger, J.H., Miller, J.H. and Nachman, M. Nephron, 26 (2), pp. 96-9 (1980). The
authors studied the role ofblood-dialyzer-membrane
interactions in hemodialysis-inducedhypoxemia by
measuring Pa02 and white blood cell counts during
isolated ultrafiltration (UF)compared to hemodialysis (HD, utilizing the same dialyzer and membrane).
Patients in the UF period displayed no hypoxemia
and rather a slight increase in Pa02; on contrast,
these patientsdisplayed significanthypoxemiawhen
HD was imposed. The authors suggest that the
hypoxemia characteristic of HD initiation is not
solely dependent on blood-dialyzer-membraneinteractions, but also requires blood-dialysate interactions.
Evaluation of dialysisadequacy. Gotch, F.A Contrib
Nephrol, 69, pp. 101-8;discussion 162-7 (1989). Review (20 refs.).
Preliminary clinical results with sodium-volume
modelingofhemodialysistherapy. Gotch, F.A , Lam,
M.A, Prowitt, M. and Keen, M. P m Clin Dial
Transplant Forum, 10, pp. 12-7 (1980).
Mathematic modeling of dialysis therapy. Sargent,
J.A and Gotch, F.A Kidney Int, Suppl, Suppl10,pp.
S2-10 (Sep 1980).
American National Standard: First Use Hemodialyzers. (ANSVAAMIRD16-1984). Association for
Advancement of Medical Instrumentation; Arlington, VA (1984). This standard is intended to provide
minimum requirements to ensure safe and effective
performance ofhemodialyzer devicesthat are manufactured ready-to-use.
Is a Clean Dialyzer a Good Dialyzer? A Hypersensitivity Data Collection Proposal. Chenoweth, D.E.
and Henderson, L.W. Contemp Dial (Mar 1984).
Discussion of possible causes of First Use Syndrome,
or dialyzer hypersensitivity reactions. Includes a
proposal for further study of the phenomenon.
Appendix E (Cont.)
Recommendations to Dialysis Facilities Regarding
Dialyzer Hypersensitivity Reactions (letter). H&ner, M.E. Food and DrugAdministration(Novl983).
Recomrnendationsrnade:stridlyfo11owmanufacturer's
rinsing procedures; all staff should be informed of
those rinsing procedures; any reaction be fully and
promptly reported.
Dialysis of the future. Gotch, F.A Kidney Int, Suppl,
24, pp. S100-4 (Mar 1988). The followingpredictions,
scientifically based, are made for dialysis of the
1990's: (1)treatment time will approach two hours;
(2) a K W U d . 0 must be provided in two hours; (3)
this will require a dialyzer &A U 750-1250,QB 200500, and QD 500-750 for individual patients; (4) bicarbonate dialysate will be required; (5) delivery
systems with precise UF control will be required; (6)
sodium,urea, and possiblly potassium modelingwill
probably required; (7) high hydraulic permeability
membranes and high biocompatibility membranes
and pyrogen free dialysate may be required. The
article includes background on all of these issues.
A mechanistic analysis of the National Cooperative

Dialysis Study (NCDS). Gotch, F.A and Sargent,
J.A Kidney Int, 28 (3), pp. 526-34 (Sep 1985). The
purpose of the NCDS was to determine the probability of clinical failure (PF) as a function of the level of
dialysis and protein catabolic rate (pcr, gflrg/day).
The level of dialysis prescribed in the NCDS was
mechanistically defined as IWV (product of dialyzer
urea clearance and treatment time divided by body
urea volume), which exponentially determines decrease in BUN during dialysis and is also a mathematical analogue of pcr, BUN.
Chapter 6
Hemodialyzers
Calculation of combined diffusive and convective
mass transfer. Sigdell,J.E. Int J h i f Organs, 5 (61,
pp. 361-72 (Nov 1982). In this study, the permeabilities of the boundary layers on both sides are treated
as included in the (equivalent)membrane. In an a p
pendix, the stacking of membranes is studied, giving
a general law for the calculation of overall permeabilities of a stack of individual membranes, regarded
as one (equivalent) membrane (such as a physical
membrane with two boundary layers). Permeability
data for boundary layers are quoted from earlier
works. In other appendices, the variation of the local
ultrafiltration along the dialysis path is studied, as
well as its effect on the effective permeability of the
membrane.
Clinical Estimates of Treatment Adequacy. Teschan, P.E. Artif Organs, 10 (3), pp. 201-4 (1986).
Principles and biophysics ofDialysis. Sargent,J.and
Gotch, F. ReplacementofRenal Functwn by Dialysis,
[ed. Drukker], Marinus Nijhoff, pp. 53-93 (1983).
National Cooperative Dialysis Study. Lowrie, E.G.
and Laird, N.M. [eds.]. Kidney Int, S-13 (1983).
Effect of the Hemodialysis Prescription on Patient
Morbidity (Report from the National Cooperative
Dialysis Study). Lowrie, E.F., Laird, N.M., Parker,
T.F. and Sargent, J.A NEJM, 305: 20, pp. 1176-81
(1981).
Release of pyrogens during clinical hemodialysis.
Weingast, J.A, VanDeKerkhove, KM., Eiger, S.M.,
Kluger, M.J. and Port, F.K Trans Am Soc Artif
Intern Organs, 31, pp. 359-62 (1985).
Appendix E (Cont.)
m a t e d Biblwgntphy
Chapter 8
Anticoagulation
Outbreak of pyrogenic reactions at a dialysis center.

Association with infusion of heparinized saline solution. Kantor, R.J., Carson, L A , Graham, D.R, Petersen, N.J. and Favero, M.S. Am J Med, 74 (31, pp.
449-56 (Mar 1983). An epidemiologicand laboratory
investigation documented that reactions occurred
only in patients who had anticoagulation with a
dilute solution of heparin. Analyses of heparinized
saline solution used during the outbreak revealed a
bacterial count of 7.4 X 10(5)/ml and a bacterial
endotoxin level of 1,300 ng/ml. Acinetobacter calcoaceticus var. Iwoffi was isolated from the solution.
Dilutedheparin solution was prepared at the dialysis
centerbyaddingcommenziallysuppliedsodiumheparin
to 0.9 percent sodium chloride infusion fluid. Bacteria and endotoxin were not detected in vials of stock
heparin and bags of unopened 0.9 percent sodium
chloride infusion fluid. The authors conclude that
contaminationofthe solution occurred a t the dialysis
center. ARer changes in the preparation and use of
heparin were instituted on December 4, 1978, no
pyrogenicreactions occurredin more than 400 subsequent dialyses.
Regional citrate anticoagulation:areport ofl Omonths
experience. Boyd, L.M., Felton, S.E., Highfill, B.K
and Underhill, V.L. J Nephrol Nurs, 2 (4) pp. 162-4
(Jul-Aug1985).
Coagulation problems in artificial organs. Flamenbaum, W. ASAlO Trans (United States), 32 (2), pp.
656-61 (Oct-Dec 1986).
Comparativeclinicaltrial ofregional anticoagulation
for hemodialysis. Akizawa, T., Kitaoka, T., Sato, M.,
Koshikawa, S., Hirasawa, Y., Kazama, M., Mimura,
N. and Ota, K ASAIO Trans (United States), 34 (3),
pp. 176-8 ( Jul-Sep 1988). The regional anticoagulating effects of mPT-175 (protease inhibitor), and
regional or low dose heparinization (RH or LH) were
examined comparatively by randomized controlled
protocol on 157 hemodialysis (HD) patients with
hemorrhagic complications. Increases in bleeding
because of HD were milder in RPT as compared with
RH and LH, and the bleeding time after needle
removal was significantlyshorter in FUT than that

in heparin. During HD, the prolongation of celiteactivated coagulation time (CCT) of the intracorpored blood was significantly milder in FUT in
heparin than that of blood passing through the
dialyzer, increased in FUTcompared with LH. F'UT
showed no prolongation of CCT after HD.
Hemodialysis without anticoagulation. One-year
prospective trial in hospitalized patients at risk for
bleeding. Schwab, S.J., Onorato, J.J., Sharar, L.R
and Dennis, P A Am JMed, 83 (3), pp. 405-10 (Sep
1987). This prospective study evaluated a protocol
forhemodialysiswithout anticoagulationi n a d e
group of hospitalized patients in unstable condition
with relative contraindications to anticoagulation.
Of 262 attempts a t hemodialysis without anticoagulation in 49 patients, 239 hemodialysis treatments
(91 percent) were successfully completed. This study
concludes that hemodialysis without anticoagulation can be reliable and effectivein closelymonitored
situations.
Heparin free dialysis: comparative data and results
in high risk patients. Caruana, RJ., Raja, RM.,
Bush, J.V., Kramer, MS. and Goldstein, SJ. Kidney
I&, 31 (6),pp. 1351-5 (Jun 1987). Heparin-freehemodialysis was compared to systemic heparinization,
intermittent saline flushes and constant saline infusions in eight, stable chronic patients dialyzing on
hollow-fiber artificial kidneys (HFAK)a t blood flows
of 250 to 300 mllrnin. Since the data showed that
heparin-freehemodialysiswithoutsupplementalsaline
was feasible in this patient group of stable, chronic
patients, 29 judged to be a t increased risk of hemorrhage h m heparinization were then prospectively
studied. Although higher hematocrit values were
associated with greater degrees of dialyser clotting,
stepwise discriminatory analysis employing blood
flow, blood pressure, hematocrit and transfusion administration could not develop an accurate predictor
or combination of predictors of clotting. No patient
experienced de novo or increased bleeding and problems with inadequate dialysis were not observed.
Appendix E (Cont.)
Pharmacokinetic monitoring of heparin therapy for
regular hemodialysis. Khazine, F. and Simons, 0.
Artif Organs, 9 (1) pp. 59-61 ( Feb 1985). The paper
describes the use of a pharmacokinetic model for
heparin prescription during hemodialysis leads to a
with
precise monitoring of the coagulation time (CT)
25% less heparin required. Two different populations were distinguished: the first group maintained
stable sensitivity and elimination constant, pennitting stable prescription and giving stable CT values
for up to 2 years. The other group exhibited wide
variations of these parameters, necessitating daily
dose monitoring.
The effect of in-vitro use of heparin in blood transfusions during dialysis on dialyzer clotting. Lowrey,
S.J., Femea, P.L. AANNT J, 11 (2) pp. 26-9 ( Apr
1984).
Dialysis membranes and coagulation system. Notohamiprodjo, M., Andrassy, K, Bommer, J. and Ritz,
E. Blood Purif, 4 (1-3), pp. 13041 (1986). Artificial
membranes used for hemodialysis differ from endogenous membranes, i.e. endothelial cells, by their
variable thrombogenicity. The key step in activation
of the coagulation system by dialysis membranes is
thrombocyteactivationwhichisprecededbyformation
of a protein layer of critical thickness. C ~ c i aquesl
tions concerning the quality of this protein membrane as a determinant ofthrombocyteactivation are
not well understood.
Heparin and its biocompatibility. Stiekema, J.C.
Clin Nephml ,26, Suppl 1, pp. S3-8(1986). Recently
heparin fractions and a heparinoid of low molecular
weight (LMW) have been developed because of their
potential to diminishthe hazard ofhemorrhagewhile
retaining their antithrombotic properties. Preliminary reports from pilot studies have confirmed the
increased efficacyin preventing deep vein thrombosis (DVT) of some of the new LMW heparin(oid)s;
however, improved safety with regard to bleeding
stillneedstobe shown. Theuse ofLMWheparinsand
of a new I;MW heparinoid in acute and chronic
hemodialysis has also been shown to be effective.
Pmbyhandheparinduringhae-:a,effects. Carmici, M. and Evangelisti, L. Life Support

Syst, 4 (31, pp. 205-9 (Jul-Sep 1986). Haemodialysis
neutropenia was improved by prostacyclin. The
membrane sieving coefficient fador and ultrafiltration volume were not improved by prostacyclin alone
(dialysis ID. Prostacyclin, together with heparin
(dialysis III), showed, 60 minutes after the start, an
Chapter 8
Anticoagulation
unchanged sieving coefficient fador compared with
that of heparin alone, while the ultrafiltration volume significantly (P less than 0.001) improved. The
results of this study confirm those of earlier studies
and suggest that prostaglandin I2 together with lowdose heparin improve the biocompatibility and efficiency of dialysis treatment.
Regional anticoagulation: hemodialysis with hypertonic trisodium citrate. vonBrecht, J.H., Flanigan,
M.J., Freeman, RM. and Lim, V.S. Am JKidney Dis,
8 (3), pp. 196-201(Sep 1986). Describes a simplified
method for performing regional citrate anticoagulation during hemodialysis. This method of citrate
dialysis is safe and effective during continuous blood
flow (doubleneedle) hemodialysis, and is no more
difFicult to perform than conventionalheparin dialysis. Singleneedle (reciprocatingblood flow)hemodialysis was successllly performed by the additional
use of a calcium-free dialysate and separate calcium
chloride inhsion (10% calcium chloride), but risks
the production of unexpected hypercalcemia.
Heparin-free hemodialysis with Cuprophan hollow
fiber dialyzersby a frequent saline flush, high blood
flow technique. Agresti, J., Conroy, J.D., Olshan, A,
Conroy, J.F., Schwartz, A, Brodsky, I., Krevolin, L.
and Chinitz, J. Trans Am Soc Artif Intern Organs,
1985,31 pp. 590-4.
Clinicaluse of heparin fractions,fragments, and h e p
arinoids. Messmore, H.L.Jr. Semin Thromb Hemost,
11 (2), pp. 208-12 (Apr 1985). Document Type:
Review (37 refs.).
Hemodialysiswithoutanticoagulation.Sanders,P.W.,
Taylor, H. and Curtis, J.J.Am JKidney Dis, 5 (l),pp.
32-5 (Jan 1985). In patients a t high risk of bleeding,
however, use of heparin significantlyincreasestheir
morbidity and, presumably, mortality. Over one
year, the authors performed 156hemodialysis procedures successfully without heparin in the transplant
dialysis unit. No dialysis procedure produced or
aggravated bleeding. Conversely, a coagulopathy
was not induced or worsened by dialysis without
heparin. A significantcomplication, defined as complete clotting of the artificial kidney with or without
clottingin the lines occurred in eight dialyses(5.13%
of the total) and resulted in an average blood loss of
150 ml. Partial clotting of the dialyzer did not interrupt the procedure and occurred nine times (5.8% of
the total). These results comparefavorablywith previously documentedcomplicationsfrom low-dose and
regional heparin.
Appendix E (Cont.)
Hemodialysiswithout anticoagulants:efficiencyand
hemostatic aspects. Casati, S., Moia, M., Graziani,
G., Cantaluppi, A , Citterio, A , Mannucci, P.M., and
Ponticelli, C. Clin Nephrol, 21 (2), pp. 102-5 (Feb
1984). In 29 patients with high risk ofbleeding, 111
hemodialyses have been performed without heparin
(WHD) or other anticoagulants. The same patients
were switched to low dose heparin dialysis (LDHD)
as soon as the bleeding risk had ceased. The dialyzer
had to be changed in 11and the drip chamber in 20
WHDsbecauseof partial clotting. This phenomenon
did not occur during LDHD.
Regional citrate anticoagulation in chronic hemodialysispatients. Seaton, R.D., Duncan, K A , Pinnick,
RV., Diederich, D.A and Wiegmann,T.B. TransAm
Soc Artif Intern Organs, 29, pp. 414-8 (1983). The
pronounced leukopenia caused by cuprophane dialyzer membranes was significantlybluntedby citrate
regional anticoagulation.Cellulose acetate produced
less leukopenia than the cuprophane, regardless of
anticoagulant. The p02 response to the initiation of
hemodialysiswas not affectedby dialyzer membrane
or anticoagulant choice. The authors conclude that
citrate anticoagulationreduces dialyzer-inducedleukopenia. Citrate anticoagulation does not, however,
change the hypoxemia present with acetate dialysis.
The dissociation of leukopenia and hypoxemia with
citrate anticoagulation suggests that pulmonary
sequestration is not a major cause of hypoxemia
during hemodialysis.
Heparin binding and release properties of DEAE
cellulosemembranes. Schmitt,E.,Holtz,M,Klinkmann,
H., Esther, G. and Courtney,J.M. Biomaterials,4(4),
pp. 309-13 (Oct 1983). Heparin release was studied
by contacting heparinized membranes with saline,
glycinebaer,phosphate buffer and plasma Incubation with plasma brought about the release of ~ WofO
the attached heparin. Crosslinking of the heparinized membrane with glutaraldehyde reduced the
heparin release by one half. The release reaction is
more critical in the case of increased heparin uptake
and a more efficient immobilization of heparin a p
pears necessary.
Regional citrate anticoagulation for hemodialysis in
the patient at high risk for bleeding. Pinnick, R.V.,
Wiegmann, T.B. and Diederich, D A N EngWMed,
308 (51, pp. 258-61 (Feb 3,1983).
Effect of heparin on platelet count and platelet aggregation. Shojania, AM. and Turnbull, G. Am J
Quality AsAseurance
Guidelinesfor H e d i a l y s i s Devices
Chapter 8
Anticoagulation
Hematol, 26 (3),pp. 255-62 (Nov 1987). The authors
speculate that the majority of subjects exposed to
heparin develop an antibody or a proaggregator that
can aggregate or agglutinate platelets in the presence ofheparin andcause destructionofplatelets,but
only in a small percentage of subjects receiving
heparin isthis reaction severe enoughto causethrombocytopenia
Citrate regional anticoagulation in haemodialysis.
Hocken, AG. and Hurst, P.L. Nephron, 46 (11, pp. 710(1987). Using synchronous pre- and post-dialyser
blood samples, measurement of the whole blood clottingtimes demonstrated the restriction ofanticoagulation to the extracorporeal circulation. It is concluded that citrateanticoagulationissafe,acceptable
and simple for use in haemodialysis for patients at
risk from systemic anticoagulation.
Long-term comparisons of citrate and heparin as
anticoagulants for hemodialysis. Wiegmann, T.B.,
MacDougall,M.L. and Diederich,D A Am JKidney
Dis, 9 (5), pp. 430-5 (May 1987). Citrate was compared to heparin as an anticoagulant during chronic
hemodialysis. Use ofcitrate as the sole anticoagulant
for periods of two months was easily accomplished,
free of complications, and resulted in comparable
clearance of solutes. Major laboratory parameters
were similar with both anticoagulants.
Severe metabolic alkalosis complicating regional
citrate hemodialysis. Kelleher, S.P. and Schulman,
G. Am J Kidney Dis, 9 (3), pp. 235-6 (Mar 1987).
Regional citrate hemodialysis has been effectively
used as an alternative to heparin anticoagulation
during dialysisofpatients a t increasedrisk for bleeding. This paper reports the occurrence of severe
metabolic alkalosis in two patients requiring high
infusion rates of citrate during hemodialysis while
being mechanically ventilated. Careful monitoring
of acid-base status is mandatory in this setting, and
reduction of citrate dose may be advisable.
Reducing the hemorrhagic complications of hemodialysis: a controlled comparison of low-dose heparin
and citrate anticoagulation. I?lakigan,M.J., ~ o n B r e cht, J., Freeman, RM. and Lim, V.S. Am J Kidney
Dis, 9 (2), pp. 147-53(Feb 1987). Dialysis-associated
bleeding was more frequent following low-dose controlled heparin anticoagulation than during hypertonic citrate therapy. Dialysis effectiveness measured by postdialysis chemistriesand weightlosswas
equivalent in the two groups.
Appendix E (Cont.)
Regional citrate anticoagulation:areportoflomonth's
experience. Boyd, L.M., Felton, S.E., Highfill, B.K
and Underhill, V.L. J Nephrol Nurs, 2 (4), pp. 162-4
(Jul-Aug 1985).
Studiesof coagulation and platelet functionsinheparin-freehemodialysis.Ivanovich,P.,Xu,C.G.,Kwaan,
H.C.. and Hathiwala, S. Nephron, 33 (2), pp. 116-20
(1983). Usingacellulose acetate dialyzer,both hemodialyzer and blood tubing were periodically flushed
with physiologicsaline, but no heparin was used. No
signscant clottingof the hemodialyzerswas encountered in uneventful dialyses. These findings support
clinicalexperiencethatthisanticoagulation-hmethod
can be used safely and effectively to dialyze patients
at risk for bleeding.
Preventing hemorrhage in high-risk hemodialysis:
regional versus low-dose heparin. Swartz, RD. and
Port, F.K Kidney Int, 16 (4), pp. 513-8 (Oct 1979).
Hemodialysis in patients with increased risk for
hemorrhage can be accomplished with either a regional or a low total dose of heparin. The incidence
of hemorrhage correlated with the estimated degree
of bleeding risk both a t expected and a t occult bleeding sites, and was the same or higher with regional
heparin in all categories. Hemorrhage was not correlated with preexisting coagulation abnormalities,
concurrent anticoagulant drugs, level of azotemia, or
ability to successllly limit systemic heparinization
during dialysis. The incidence of partial clotting of
the dialyzer was 3% to 5% with both heparin protocols. The authors conclude that regional heparinization has no clinical or practical advantage over lowtotaldose heparin in preventing bleeding associated
with hemodialysis.
Low-doseheparin in routine hemodialysismonitored
by activated partial thromboplastin time. Shapiro,
W.B., Faubert, P.F., Porush, J.G. and Chou, S.Y.
Artif Organs, 3 (11,pp. 73-7 (Feb 1979). Use of the
activated partial thromboplastin time (APTT), as
measured by (Coag-A-Mate)semi-automaticunit, in
lowering the dosage of heparin in stable chronic
hemodi~sispatientsw8sanal~ed.
APIT,asmeasured
by the Coag-A-Mateunit, provides a simple means of
lowering heparin requirements in routine dialysis
patients.
The effects of three different heparin regimes on
heparin concentrations in plasma and fibrin formationindialyzers. Gunnarsson,B., Asaba,H., Dawidson,
S.,Wilhelmsson, S. and Bergstrom,J. Clin Nephrol,
15(3),pp.135-42(Mar1981). Anticoagulation effects
were studied during a 4-hourhemodialysisin six paQuality Assurance Guidelines for Hernodialysis Devices
Chapter 8
Anticoagulation
tientsusing3 differentheparin regimens: (1)intravenousloadingdose only;(2)primingofthe dialyzer and
continuousinfusion of heparin for two hours; and (3)
intravenous loading dose and continuous infusion of
heparin based on anticoagulationkinetics. The anticoagulation kinetic regimen offered no advantage
over the single loading dose regimen with regard to
the formation and deposition of fibrin in the dialyzers.
Measurement of fibrinopeptideAin the evaluationof
heparin activity and fibrin formationduringhemodialysis. Wilhelmsson, S., Asaba, H., Gunnarsson, B.,
Kudryk, B., Robinson, D. and Bergstrom, J . Clin
Nephrol, 15 (5), pp. 252-8 (May 1981). In order to
monitor heparin activity during hemodialysis, they
evaluatedthree commonlyused methods: whole blood
activated coagulation time (WBACT), whole blood
thrombin time (WBTT), and heparin concentration
in plasma, determined with a chromogenic substrate. They three different heparin regimens: a
single intravenous loading dose only, priming of the
dialyzer with heparin followedby a heparin infusion
and a pharmaco-kinetic model. Good correlations
were found between WBACT, WBTT and heparin
concentration. Heparin activity during a dialysis
may be monitored with any of these three methods
with equal reliability. However, from a practical
point of view, WBACT appears most attractive because of its simplicity. FPAgeneration, frequency of
visible clots in the dialyzer and hemorrhagic manifestations were essentially the same for each of the
heparin dose regimens. The simple administration of
a single loading dose was as safe as the more complicated infusion technique.
Hemodialysis using prostacyclin instead of heparin
as the sole antithrombotic agent. Zusman, RM.,
Rubin, R.H., Cato, AE., Cocchetto, D.M., Crow, J.W.
and Tolkoff-Rubin, N. N Engl J Med, 304 (16), pp.
934-9(Apr16,1981). Anticoagulationduringhemodialysis is necessary to prevent clottingof the blood on
contact with the dialysis membrane. Heparin is the
usual anticoagulant used, but systemic anticoagulation may persist for hours, and hemorrhage is common. The authors successfully used an infusion of
prostacyclin,whichhas an in-vitrohalf-lifeofthree to
five minutes, as the sole anticoagulant on long-term
hemodialysis. Prostacyclin caused no clinically
important changes in the intrinsic clotting system,
and there were no hemorrhages or clotting of the coil.
The authors conclude that prostacyclin can safely
replace heparin as the sole antithrombotic agent
duringhemodialysis and maybe more advantageous
if anticoagulation is contraindicated.
E-33
Appendix E (Cont.)
RegionalCitrateAntic0agulation:AViableAl
Boyd, L.M. and Felton, S.E. ANNA J, 13,5,p. 267
(Oct 1986). Regional citrate anticoagulation is a
positive alternative to conventional methods of anticoagulation during hemodialysis. For the patient a t
moderate to high risk of bleeding, as well as those
patients with active bleeding at the time of dialysis,
regional citrate anticoagulation can be a safe, effective approach, when performed properly. One of the
major disadvantages, excessive cost, can be reduced
to an acceptable level.
Chapter8
Anticoagulation
Appendix E (Cont.)
Chapter 9
Cannulation of arteriovenousfistulae. Stansfield,G.

Nurs Times, 83 (41, pp. 38-9 (Jan 28-Feb 3 1987).
Discussion of gaining and maintaining access to the
A-V fistula for hemodialysis in order to obain maximum effects while creating the minimum of trauma
to the fistula. The paper notes that there is a lack of
research on this subject, but that there is strong
evidence that good needling technique contributesto
fitula survival. Evidence suggests that constant site
insersion in an antegrade direction should be the
method of choice. Needles and tubing sets shouldbe
chosen carefully (sideholes are important, and internal diameter and length areimportantin minimizing
pressure drop).
The fluid mechanics of hemodialysis catheters.
Mahurkar, S.D. TransAm Soc ArtifIntern Organs,
31, pp. 124-30 (1985). Use oftwo individualcatheters
is the most efficient, but two procedures are required
for treatment. ComparingCo-axialduallumen catheters to two semi-circular dual lumen catheters, the
latter is preferable due to ease of insertion, better
efficiency, less trauma, and fewer complications.
Renal nursing. Vascular access techniques. Mackenzie, S. Nurs Mirror, 160 (151, pp. 27-9 (Apr 10,
1985). This article reviews the nursing techniques
involved with subclavian catheters, femoral cathe
ters, and the Scribner shunt. Requirements for care
and complications of each are listed. Excellent tables
listing the above in this article.
Evaluation tool for hemodialysis arterial-venous fistula needle. Parker, J. Nephrol Nurse, 5 (3), p. 9
(MayJun 1983). This is a one-page format for evaluation of A-V fistula needles. It gives some reliable
and consistentguidelinesforevaluation of the needle
most appropriate for the patient's needs.
Hemodialysis access site morbidity. Aman, L.C.,
Levin,N.W. and Smith, D.W. Pnx: Clin Dial %nsplant Forum, 10, pp. 277-84 (1980).
Developing a teaching unit on vascular access of a
hemodialysis client. Sell, D., Greenspan, B. and
Hess, M. AANNT J,9 (3), pp. 10-25,66 (Jwi 1982).
Renal replacement therapy. 2-1. Access for haemodialysis. Pavitt, L. Nurs Times, 78 (18),pp. 749-52
(May 5-11,1982). Very basic article on different varieties of vascular access devices and long-termmanagement ofthem. Short discussionon complications.
Includes shunts, A-V fistula, subclavian.
Non-invasive blood flow measurement in expanded
polytetrafluomthylenegrabforhemodialysisaccess.
Rittgers, S.E., Garcia-Valdez, C., McCormick, J.T.
and Posner, M.P.JVascSurg, 3 (4), pp. 63542 (Apr
1986). Volume flow rates were measured in 31 ex(6 mm) of 26
panded polytetrafluoroethylene gr&
patients undergoinghemodialysis. Flow was calculated from the known access graft diameter and by
measurement of the mean Doppler shift frequency
waveform. The study demonstrated a safe, repeatable noninvasive measure of access grafk hemodynamics, which maybe useful as a functionalmonitor
and a warning of impending failure.
Dialysis performance of single lumen subclavian
hemodialysis: a comparative study with single lumen fistula hemodialysis. Vanholder, 8,Hoenich,
N. and Ringoir, S. Artiforgum, 6 (41,pp. 429-32 (Nov
1982). Study ofhemodialysisperformance and recirculation ratios of subclaviancatheter hemodialysisis
reported. Data are compared to the results obtained
when a conventionalin~single-lumenhemodialysisneedleisusedundersimilarconditiom.However,
the differences were not significant, and overall extraction ratios, calculated for the entire dialysis period with both access methods in 43 patients, were
identical. Recirculation averaged l2.5%for the fistular approachand 20%for the subclavian approach. It
is concluded that, as a whole, dialysisperformance is
somewhatlower with the subclavianvascular access
method.
Percutaneous subclavian vein catheterization for
hemodialysis: a report of 57 insertions. Al-Mohaya,
S., Sadat-Ali, M., Al-Muhanna, F. and IbrahimSaeed, A Angiology, 40 (61, pp. 569-73 (Jun 1989).
The authors report an analysis of 57 subclavian vein
catheterizations for hemodialysis. A total of 51
E-35
Appendix E (Cont.)
patients (34 men, 17 women) kept the Cobe singleand double-lumen catheters for 1,726 days. Their
experience indicates that percutaneous subclavian
vein catheterization is safe and provides quick access
for hemodialysis with no morbidity and mortality if
done correctly, patiently, and meticulously. The
authors believe that this should be the first choice in
patients with reversible renal failure and in patients
with chronic renal failure, who are usually elderly
and medically compromised, until a permanent vascular access is ready for use.
Clinical experience of arteriovenous fistulae for dialysis during an eighteen year period. Sisto, T. and
Riekkinen, H. Ann Chir Gynaeool, 77 (3), pp. 108-10
(1988). 382 Brescia-Ciminotype arteriovenousfistulae were created for chronic haemodialysis. Success
rate at the first attempt was 73.6% of281 cases. The
most common method of anastomosiswas end to side
vein to artery type. Thrombosis was the most frequent complication, other miscellaneous complications were less common.
Complicationsfrom permanent hemodialysis vascular access. Zibari, G.B., Rohr, MS., Landreneau,
M.D., Bridges, R.M., DeVault, G A , Petty, F.H.,
Costley, KJ., Brown, S.T. and McDonald, J.C. Surgery, 104 (41, pp. 681-6 (Oct 1988). Use of PTFE to
construct permanent hemodialysis vascular access
has a signZcantly higher incidence of thrombosis,
infection, pseudoaneurysm formation, and limb loss
(p less than 0.01 for all complications) and a significantly lower mean length of patency (p less than
0.0001) when compared with autogenous fistulas.
Age, sex, hypertension, diabetes mellitus, and the
use of perioperative antibiotics were not found to be
related significantly to access complications.
An evaluation of expanded polytetrafluoroethylene

(PTFE)loop grafts in the thigh as vascular accessfor
haemodialysisinpatients with accessproblems. Slater,
N.D. and Raftery, AT. Ann R Coll SurgEngl, 70 (4),
pp. 243-5 (Jul 1988). A total of 21 patients with
vascular access problems received 22 PTFE loop
graftsin the thigh asvascular accessforhaemodialysis.
Eighteen of 22 grafts supported haemodialysis during the patient's lifetime. Actuarial patient survival
was 50% a t two years with a cumulative graft patency in the survivors of 80.5%.
Complications related to subclavian catheters for
hemodialysis. Report and review. Vanherweghem,
J.L., Cabolet, P., Dhaene, M., Goldman, M., Stolear,
J.C., Sabot, J.P., Waterlot, Y. and Marchal, M. Am J
Chapter 9

Nephml, 6 (5),pp. 339-45(1986). Personal experience
with subclavian vein cannulations for hemodialysis
are given, and the pertinent literature on the subject
is reviewed. Taking into account all the complications discussed, recommendations are made for the
use of subclavian dialysis catheters.
Subclavian vein thrombosis: a frequent complication
ofsubc]avianvein~annulationforhem~s.
Vanherweghem, J.L., Yassine, T., Goldman, M., Vandenbosch, G., Delcour, C., Struyven, J. and Kinnaert, P.
ClinNephrd, 26 (5),pp. 235-8 (Nov1986).Subclavian
vein cannulation was suggested as a temporary vascular access for hemodialysis since one of its advantages was considered to be no damage to blood vessels. As they observed six patients with symptomatic
subclavianveinthrombosisamongl48patientshaving
received subclavian vein cannulation for hemodialysis,theysystematicdyperformedsubclavianven~
in 42 asymptomatic patients selected on the basis of
a history of previous subclavian vein cannulation.
The authors conclude that the subclavian vein cannulation leads to significant damages of the vessels,
excluding a whole arm, for future vascular access in
some patients.
High incidence of subclavian dialysis catheter-related bacteremias. Pezzarossi, H.E., Ponce dehon,
S., Calva, J.J., Lazo, de la Vega, S.A and Ruiz-Palacios, G.M. Infect Control, 7 (12),pp. 596-9(Dec 1986).
Thisretrospectivecohort study reviews the incidence
ofbacteremia in 48 patients undergoinghemodialysis using subclavian vein dialysis catheters (SDC)as
temporary vascular access. They found that the use
ofresterilizedcatheters was not arisk factor. Specific
guidelines for SDC insertion and care were established and followed, after which the infection frequency was reduced to 7.5% (1 episode per 45.5
patient-weeks ofcatheter use) in this high-risk population.
Graft infection and baderemia with a tolerant G
form of Streptococcus sanguis in a patient receiving
hemodialysis. Chmel H. JClin Micmbwl, 24 (21, pp.
294-5(Aug1986). Reportofacase ofatolerant Gform
Streptococcus sanguis infection involving an artificial vascular access site. The organism was isolated
from a pet dog of the patient. The organism was also
felt to be tolerant to penicillin. The patient was successfully treated by removal ofthe artificialgraft and
intravenous erythromycin therapy. Microorganisms
acquired from nonhuman sources are potential pathogens in the immunocompromised patient.
Appendh E (Cont.)
Internal jugular vein cannulation using 2 silastic
catheters. Anew, simple and safelong-termvascular
access for extracorporeal treatment. Canaud, B.,
Beraud,J.J., Joyeux,H. and Mion C. Nephron, 43 (2),
pp. 133-8 (1986). Subclavian vein cannulation, although a major progress in temporary vascular access, was associatedwith a significantmorbidity and
mortality. For the last two years, the authors developed a new approach consisting in internal jugular
vein cannulation (IJVC) with two silicone rubber
catheters with a long-term proved biocompatibility.
Infections associated with subclavian dialysiscatheters: the key role of nurse training. Vanherweghem,
J.L., Dhaene, M., Goldman, M., Stolear, J.C., Sabot,
J.P., Waterlot, Y., Serruys, E. and Thayse, C. Nephmn, 42 (2), pp. 116-9 (1986). The incidence was
greaterinhospitalizedpatients(15bacteremiasduring
1,948catheter days) than in ambulatory patients (2
bacteremias during 850 catheters-days) as well as
during a period correspondingto a greater number of
untrainednursesenrolledinthe dialysisteam. During
this period, 6 sepsies occurred in 19 catheters (other
periods: 7 sepsiedl16 catheters, p less than 0.01). Six
of 28 nurses had less than three months of professional experience (other periods: 1of 25, p less than
0.01). These data underline the key role of nurse
training in the prevention of catheter-related infections.
Staphylococcus aureus bacteremia in patients on
chronic hemodialysis. Quarles, LD., Rutsky, E.A
and Rostand, S.G. Am JKidney Dis, 6 (6),pp. 412-9
(Dec 1985). Staphylococcus aureus bacteremia occurred 96 timesin 58of671patients on chronichemodialysis during a nine-year period. The authors
suggest that chronic hemodialysis patients with S
aureus bacteremia have a relatively low mortality
and a low risk of infective endocarditis. Antibiotic
treatment shouldbe given for at least 28 daysin order
to minimize the risk of relapse.
Vascular access for hemodialysis. Patency rates and
results of revision. Palder, S.B., Kirkman, RL.,
Whittemore, AD., Hakirn, R.M., Lazarus, J.M. and
Tilney, N.L. Ann Surg, 202 (2),pp. 235-9 (Aug1985).
Failures of Cimino fistulae usually occurred early in
the postoperative period, secondary to attempts to
use inadequate veins. Thrombosis caused the majority of PTFE graft failures and was generally the
result of venous stenosis. Correction of such venous
stenosis is mandatory to restore graft patency and
can result in prolonged graR survival.
Quality Assurance Guidelinesfor H e d i a l y s i s Devices
Vm*
Chapter 9
Access Devices
Incidenceofsubclavian~catheter-~)ated~ons.
Kozeny, G.A, Venezio, F.R, Bansal, V.K, Vertuno,
L.L. and Hano, J.E. Arch Intern Med, 144 (9), pp.
1787-9(Sep 1984). Report of more than 1,300 dialyses in 74 patients who have had subclavian dialysis
catheters (SDCs) in place for a total of 3,065 days.
Sixty-one of these patients (82%) have had their
SDCs in place for 7 to 21 days, including37 (5Wo)for
longer than 21 days.
Complications of subclavian catheter hemodialysis:
a 5-year prospective study in 257 consecutive patients. Vanholder, R, Larneire, N., Verbanck, J.,
vanRattinghe, R , Kunnen, M. and Ringoir, S. Int J
Artif Organs, 5 (51, pp. 297-303 (Sep 1982). The
complications related to the use of subclavian
catheters for hemodialysis were prospectively studied in 257 consecutiveacute and chronic renal failure
patients. Using 394 catheters, 3006 single needle
dialyseswereperformed Mosthazardouscomplications
were sepsis (9), malposition (6), hemothorax (3),
bleeding(2), vena cava thrombosis (2), and pneurnothorax (2).
Single-needlevenous dialysis: a comparison of three
systems. Weinstein, AM., Frederick, P.M. and Sullivan, J.F. UremiaInvest 85,8 (2), pp. 69-77 (1984).
A comparison of a pressurekime, a timdtime device,
and a pressurdpressure device. Recirculation was
highestwiththe pressurdtime system,but was easily
compensated for with higher blood flow of that system. Clearances actually measured were in good
agreement with those predicted from theoreticalconsiderationsofrecirculationand blood flowin acountercurrent dialysis system.
High-flux hemodiafiltration: under six hourslweek
treatment. vonAlbertini, B., Miller, J.H., Gardner,
P.W. and Shinaberger, J.H. Trmns Am Soc Artif
Intern Organs 1984,30pp. 227-31. Better utilization
of existing high blood flow in mature vascular accesses with the described new technique of simultaneous high diffusion and convection results in a
marked increase of treatment efficiency. Coupled
with the better tolerance to high solute and weight
removal rates, this approach permits drastic reduction of treatment time over conventional hemodialysis without sacrificing treatment adequacy.
Blood recirculation duringhemodialysiswith a coaxial counterflow single-needle blood access catheter.
Ogden, D.A and Cohen, I.M. Tr&ns Am Soc Artif
Intern Organs, 25, pp. 325-7 (1979). (1) The average
Appendix E ( C o d
and the range of blood recirculation during hemodialysis employing a coaxial counterflow single needle
blood access catheter are markedly reduced compared to those observed in the same patients using a
standard 'Y" type needle and external flow direction
control device. (2) In a large group ofpatients, the
average measured recirculation of blood of .8% at a
blood flow rate of 200 d r n i n is sufficiently small as
to have little or no effect on the efficiency of dialysis.
(3)Recirculation increases with increasing extracorpored blood flowrate but remains sufficientlylow to
not significantly affect increased dialysis efficiency
obtained a t higher blood flow rates. (4) The coaxial
counterflow single needle catheter permits single
fistula puncture, eliminates the need for a flowdirection control device, and is associated with negligible
blood recirculation.
In-vivo measurement of blood recirculation during
'Y" type single needle dialysis. Ogden, D A J Dial,
3 (2-3), pp. 265-76 (1979). A method has been described andvalidated for obtaining a sample ofblood,
without separate venapuncture, which has the same
urea and creatinine composition as systemic venous
blood during hemodialysis. Using this technique, recirculation in-vivo during "Y" type single needle
dialysis, measured in 20 bovine fistulas, ranged from
6.9% to 56.5% and averaged 19.4%. These results .
suggest that fistula puncture methods and devices
that eliminate recirculation in the ex-vivo blood
circuit shouldbe used to maximize dialysisefficiency.
Topical thrombin and control of bleeding from the
fistula puncture sites in dialyzed patients. Vaziri,
N.D. Nephmn, 24 (51, pp. 254-6 (1979). The length of
bleedingfrom the puncture sites ofinternal arteriovenous channels was markedly reduced with the use
of topical thrombin in 12patients treated with hemodialysis. This procedure can, therefore, save patient
and staff time, minimize recurrent blood loss with
each dialysis, and prolong the life of vascular access
by diminishing the length of potentially hazardous
compression needed for proper hemostasis.
A review of Hemodialysis Catheters and Access

Devices. Hiclunan, RO. and Watkin, S. Dial &
Transplant, p. 481 (Sep 1987). Abrief description of
the access devices, other than the A-V fistula, often
used in hemodialysis vascular access. Article includes a table that lists devices from 10 diferent
manuPacturers by product, catheter, material, size
maximum flows, priming volume, and other information.
Quality Assurance Guidelinesfor Hemodialysis Devices
Chapter 9
Vasculw Access Devices
Successlluseofdouble-lumen,siliconerubber catheters for permanent hemodialysis access. Shusterman, N.H., Kloss, K and Mullen,J.L. Kidney Int, 35
(3), pp. 887-90 (Mar 1989), ISSN 0085-2538.
Topical anaesthesia for fistula cannulation in haemodialysis patients. Watson, AR, Szymkiw, P. and
Morgan, AG. Nephrd Dial Transplant, 3 (6), pp.
800-2 (1988). A local anaesthetic cream (EMLA;
Astra)gave more pain relief and improved the ease of
venepuncture comparedto lignocaineinjections. Patients expressed a strong preference for the EMLA
cream,which has advantages that outweigh the cost
and convenience factors.
Subclavianstenosis:amajor complicationofsubclavian
dialysis catheters. Barrett, N., Spencer, S., McIvor,
J. and Brown, E A N e p h d Dial Transplant, 3 (4),
pp. 4235 (1988). Subclavian catheterisation is frequently used for acute vascular access for haemodialysis and is thought to rarely result in long-term
clinical problems. Venographyin 36 cases,however,
revealed subclavian stenosis in 18 (50%), of whom 5
developed clinical problems. The incidence of subclavian-vein stenosis was related to the duration of
catheterisation 8 less than 0.05). It may also be
morecommoninblackpatients. Subclaviancatheterisation is therefore not necessarily an ideal form of
acute vascular access.
Recirculation: review, techniquesfor measurement,
and abilityto predict hemoaccess stenosisbefore and
after angioplasty. Nardi, L and Bosch, J. B M
PuriL 6 (21, pp. 85-9(1988). The measurement of recirculation duringtwo-needlehemodialysisprovides
valuable information about hemoaccess integrity
and indicates potential problems with possible compromiseofdialysiseffectiveness(improperclearances).
Recirculation greater than 10% is an indication fbr
further study.
Morbidity and mortality of central venous catheter
hemodialysis: a review of 10years' experience. Vanholder, V., Hoenich, N. and Ringoir, S. Nephron, 47
(41, pp. 2749 (1987). The morbidity and mortality of
hemodialysisby internal central venous catheterization in the subclavian and internal jugular positions
are reviewed. The most frequent complicationswere
inadequateflow(7.6%),inadvertentwithdrawal(5.6%),
and bacteremia (5.1%). The overallcomplicationrate
was 27.2%. Kinking, bleeding, and bacteremia occurred more frequentlyin patients with chronicrenal
Appendix E (Cont.)
failure, compared to patients with acute renal failure. Baderemia occurred more frequently after
prolonged periods of catheterization (greater than 1 0
days). The mortality of catheter dialysis could be
estimated to be between 0 and 1.25/l ,000 catheterization~.
Adequacy studies of fistula single-needle dialysis.
Vanholder, R, Hoenich, N. and Ringoir, S. Am J
Kidney Dis, 10 (61, pp. 417-26 (Dec 1987). It is concluded that urea kinetic data (KTN averaged 0.98)
and other parameters of dialysis adequacy indicate
that the efficiency ofthe single-needletechnique is a t
least as good as that obtained in the more currently
used two-needle technique. Fistula survival was
higher, and hospitalization rate and mortality not
different from two-needle dialysis. Subsequently,
the current reluctancetowards single-needle dialysis
as a routine procedure in chronic renal failure, a p
pears to be unjustified.
Thromboticcomplicationsofindwellingcentralcatheters used for chronic hemodialysis. Caruana, R.J.,
Raja, RM., Zeit, R.M., Goldstein, S.J. and Kramer,
MS. Am JKidney Dis, 9 (6), pp. 497-501 (Jun 1987).
A new double-lumen silicone-rubber dialysis catheter, designed to be placed surgically in central veins,
is now available. A review of the literature suggests
that pericatheterthrombus formationwith or without
occlusion of major veins has been a complication of
chronic centralvenouscatheterizationwith avariety
ofcatheters, inboth dialysisand nondialysis settings.
Complications related to subclavian catheters for
hemodialysis. Report and review. Vanherweghem,
J.L., Cabolet, P., Dhaene, M., Goldman, M., Stolear,
J.C., Sabot,J.P., Waterlot, Y. and Marchal,M. Am J
N e p h d , 6 (5),pp. 33945 (1986). Complicationsinclude pneumothoraxes and hemothoraxes due to
subclavian artery puncture; bacteremia related to
subclavian catheter infections; clinical evidences of
subclavian vein thrombosis; pericardial tamponade
due to right atrium perforation; and mediastinal
hematoma and right hemothorax due to superior
vena cava perforation. Review of the literature indicates that pneumothoraxes andlorhemothoraxes
occurred in 1.7% of the catheter insertions and that
sepsis related to subclavian dialysis catheters occurred in 8.9% of the patients, as systematically
investigated subclavian vein thrombosis involved a t
least 50% of the patients. Taking into account all
these complications,recommendationsare made for
the use of subclavian dialysis catheters.
Chapter 9
Cannulation of arteriovenousfistulae. Stansfield,G.
Nurs Times, 83 (4), pp. 38-9 (Jan 28-Feb 3 1987).
When avascular access site complicates care. Alt, D.,
Balduf, R. and Thompson, E. RN,49 (lo), pp. 36-9
(Oct 1986). High incidence of subclavian dialysis
catheter-relatedbaderemias. Pezzarossi, H.E., Ponce
de Leon, S., Calva, J.J., Lazo, de la Vega, S.A and
Ruiz-Palacios, G.M. Infect Control Dec 1986,7 (12)
pp. 596-9. This retrospective cohort study reviews
the incidence of bacteremia in patients undergoing
hemodialysis using subclavian vein dialysis catheters (SDC) as temporary vascular access. The presence of possible risk factors for SDC-relatedbaderemia, includingdurationofcatheterizationandnumber
of hemodialysis procedures, were not statistically
differentwhen patients with and withoutbacteremia
were compared, with the exception of a significantly
lower incidence of bacteremia among those patients
receivingantibiotictherapy at the time ofcatheter insertion. The use of resterilized catheters was not a
risk factor. Specific guidelinesfor SDC insertion and
care were established and followed, after which the
infection frequency was significantly reduced.
Reassessment of fistula puncture site blood loss.
Vaziri, N.D., Miyada, D.S., Saiki, J.K and Robinson,
MA. JDial, 3 (4), pp. 361-6 (1979). Fistula puncture
site blood loss during and after hemodialysis was
measured in 12 patients with end-stage renal disease. The values obtained in this study are 5 to 10
folds less than those found in the original reports.
Recent advances in dialytic technology are probably
responsible for the observed improvement. The
results also suggest that Cimino A-V fistulas are
superior to the heterologous graft.
In flow time and recirculation in single-needle
hemodialysis. Blurnenthal, S.S., Ortiz, M.A, Meinman, J.G. and Piering, W.F. Am J Kidney Dis, 8 (31,
pp. 202-6 (Sep 1986). The recirculation of previously
dialyzed blood in the lumen of the single-needle
catheter reduces dialysisefficiency andis a drawback
of single-needle dialysis. Maximizing the inflow
volume is essential for minimizing recirculation in
single-needle hemodialysis. Clinically insignificant
recirculation ensues when inflow time is maintained
between three to five seconds and time-time singleneedle devices are used, even in patients dialyzed
with single-lumen subclavian catheters.
Appendix E (Cont.)
A prospective study of the mechanisms of infection
associated withhemodialysiscatheters. Cheesbrough,
J.S., Finch, RG., Burden, RP. J Infect Dis, 154 (4),
pp. 579-89 (Oct 1986). Comparison of isolates with
skin cultures from the insertion site suggested that
the origin of the colonizing organisms was the skin
(36% of total), intralumenal contamination (57%), or
both routes (7%). Comparison of cultures taken during catheter insertion with those a t removal rarely
suggested that organisms introduced a t insertion
caused subsequent colonization. This study has
demonstratedthatinfectiouscomplicationshmusing
subclavianhemodialysis catheters exceed reported
rates for all other modes of vascular access used for
hemodialysis, as well as other indicationsfor central
venous catheterization.
Subclavianhemodialysiscatheterinfections. Dahlberg,
P.J., Yutuc, W.R and Newcomer, KL. Am JKidney
Dis, 7 (5), pp. 421-7 (May 1986). Overall catheter
colonization rate was 21-6%and catheter-associated
bacteremia occurred in 9.4%. Catheters removed
from febrile patients had much higher colonization
(48.3%) and bacteremia (34.5%) rates. In a randomized study comparing infection rates in catheters
tunneled subcutaneouslyor not tunneled, there was
no significant difference in the incidence ofinfection.
Catheters inserted over a guidewire to replace clotted
or malfknctioningcatheters were not associatedwith
higher infection rates.
Chapter 9
the incidence was greater in hospitalized patients
than in ambulatory patients as well as during a
period correspondingtoagreakrnumberofuntrained
nurses enrolled in the dialysis team. These data
underlinethekeyroleofnursetrainingintheprevention
of catheter-related infections.
Complicationsof vascular access in a dialysispopulation. Porter, J A , Sharp, W.V. and Walsh, E.J.
Curr Surg, 42 (4), pp. 298-300 (Jul-Aug1985).
High incidence of infectious complications with the
Hemasite vascular access device. Barth, RH.,
Schwartz, S. and Lynn, RI. Trans Am Soc Artif
Intern Organs, 30, pp. 450-7 (1984).
Renal nursing. Vascular access techniques. Mackenzie, S. Nurs Mirror, 160 (15), pp. 27-9 (Apr 10,
1985).
A morphological study ofbacterial colonisation of intravenous cannulae. Cheesbrough, J.S., Elliott, T.S.
and Finch, RG. J Med Microbiol, 19 (2), pp. 14957(Apr 1985). Microbiological findings indicated
colonisation of the intravascular portion haemodialysis cannulae, largely with skin commensalorganisms. Surface defects on the cannulae were shown to
be associated with microbial colonisation which occurred either as isolated colonies or in association
with a cellular fibrinous matrix. These observations
are illustrated and discussed.
Prevention of thrombosis in arteriovenous fistulas.

Fatal hemothorax caused by a subclavian hemodiUldall, R. Blood Purif, 3 (1-31, pp. 89-93 (1985). To
alysis catheter. Thoughts on prevention. Tapson,
prevent thrombosis in arteriovenous fistulas it is
J.S., Uldall, P.R Arch Intern Med, 144( 8 , pp. 1685necessary to obtain the knowledgeable cooperation
7 (Aug1984). A19-year-old woman died when a subnot only of the whole health care team, but also ofthe
clavian catheter that had provided vascular access
patient. The first step is preservation of forearm
for plasmapheresis penetrated her right atrium,
veins by avoiding unnecessary venipunctures in
pericardium, and parietal pleural, causing a hemotpatients with chronicrenal failure. Avoidance of prehorax. Precautions are recommended to minimize
mature~cannulationandcofiectn~
the risk of this complication in patients in whom
help to prevent vein wall damage. Alertness to the
subclavian catheters are used as a vascular access
presence of high venous pressures on dialysis and
route for hemodialysis or plasmapheresis.
observation ofinefficientdialysis due to recirculation
should lead to detection ofnarrowed segmentswhich
Avoiding deaths from subclavian cannulation for
can be surgically corrected before thrombosis occurs.
hemodialysis. Tapson, J.S. and Uldall, R. Int JArtif
Organs Sep 1983,6 (5) pp. 227-30.
Infections associated with subclavian dialysiscatheters: the key role of nurse training. Vanherweghem,
Infections associated with subclavianUldal1catheters.
J.L., Dhaene, M., Goldman, M., Stolear, J.C., Sabot,
Sherertz, RJ., Falk, RJ., Huffman, KA, Thomann,
J.P., Waterlot, Y., Serruys, E. and Thayse, C. NephC A and Mattern, WD. Arch Intern Med, 143(11, pp.
ron, 42 (2), pp. 116-9 (1986). The incidence of sepsis
52-6 (Jan 1983). The incidence of UC site infection
was not significantly greater in diabetic patients, in
and bacteremia based was higher than the incidence
patients with corticotherapy or in patients presentof infection reported with any other type of vascular
ing an underlying systemic disease. On the contrary,
access for hemodialysis.
Quality Assurance Guidelines for HernodialysisDevices
Appendix E (Cont.)
Annotated Biblwgrmphy
Chapter 10
Hemodialyzer Reuse
Release of pyrogens during clinical hemodialysis.

Weingast, J.A, VanDeKerkhove, KM., Eiger, S.M.,
Kluger, M.J. and Port, F.K Trans Am Soc Artif
Intern Organs, 31, pp. 359-62 (1985).
Pathogenesisoffever duringhemodialysis. Dinarello,
C.A Contrib Nephml, 36, pp. 90-9 (1983).
Beta 2-microglobulinkineticsin maintenance hemodialysis: a comparison of conventional and high-flux
dialyzersand the effectsofdialyzerreuse.DiRaimondo,
C.R. and Pollak, V.E. Am J Kidney Dis, 13 (5), pp.
390-5 (May 1989). To define the kinetics of beta 2M
during hemodialysis and the effects of dialyzer reprocessing, serum beta 2M, plasma C3a, and neutrophi1counts were measured immediatelypredialysis,
15,90,and 180minutes after beginning dialysis, and
15 minutes postdialysis in ten chronic hemodialysis
patients. Complement activation and neutropenia
during dialysis were significantlymore marked with
cuprammonium,but were not affected by reprocessingofeither dialyzer. In-vitm adsorption ofl24I-beta
2M to polysulfone fibers was greater than to cuprammoniurn; adsorption was not influenced by dialyzer
reprocessing.
Prevalence of nontuberculousmycobacteriain water
suppliesofhemodialysiscenters. Carson,L.A, Bland,
L.A, Cusick, L.B., Favero, M.S., Bolan, G.A, Reingold, AL. and Good, R.C. ApplEnvimn Microbwl, 54
(12),pp. 3122-5(Dec1988).This study was conducted
to determine the prevalence ofN!l?Mand other bacteria in water samples collected over a 13-weekperiod
from 115 randomly selected dialysis centers in the
United States. The results of this study support recommendationstouse 4% HCHO or a chemical germicidal equivalent for disinfectingdialyzers that are to
be reused.
Reuse of hemodialyzers. Results of nationwide surveillance for adverse effects. Alter, M.J., Favero,
M.S., Miller, J.K, Coleman, P.J. and Bland, L.A
Hepatitis Branch, Centers for Disease Control, Atlanta, GA30333. JAMA, 26O(l4),pp. 2073-6 (Oct 14,
1988). In 1986, the Centers for Disease Control, in
collaboration with the Health Care Financing AdQuality Assurwce Guidelines for Hernodialysis Devices
ministration, surveyed 1350 chronic hemodialysis

centers in the United Statesto ascertain practices associated with the reuse of disposable hemodialyzers
and the frequencyofpyrogenicreactions and septicemia among patients. Reusing hemodialyzers more
than 20 times and, in some instances, also using
manual reprocessingsystems was significantlyassociated with clustering of pyrogenic reactions regardless of the type of germicide used. To detect membrane leaks developing after multiple reuses, airpressure-leak tests should be performed on all reprocessed hemodialyzers.
Effects of disinfectants in renal dialysis patients.
Klein, E. E n v h n Health Perspect, 69, pp. 45-7 (Nov
1986). Overview of the risks andhazards of avariety
of disinfectants used in hemodialysis.
Effect of multiple use of dialyzers on intradialytic
symptoms. Bok, D.V., Pascual, L., Herberger, C.,
Sawyer, R and Levin, N.W. Pmc Clin Dial Transplant Forum, 10, pp. 92-9 (1980). Patients were
dialyzed on new and reused dialyzers via a double
blind study. Incidents of many intradialytic syrnptomsincludingchest pain, back pain, andnausea and
vomiting were significantly reduced with reused
dialyzers as compared to new dialyzers.
Mass transport in reused dialyzers. Gotch, F.A Pnx:
Clin Dial Transplant Forum, 10, pp. 81-5 (1980).
Prevention of anti-N like antibodies development
with nonformaldehyde reuse procedure. Man,N.K,
Lebkiri, B., Polo, P., desainte-Lorette, E., Lemaire,
A and Funck-Brentano, J.L. Pm Clin Dial Trunsplant Forum, 10, pp. 18-21 (1980).
Bacterial endotoxin in new and reused hemodialyzers: a potential cause of endotoxemia Petersen, N.J.,
Carson, L A and Favero MS. Trans Am Soc Artif
Intern Organs, 27, pp. 155-60(1981). New dialyzers
may contain an LAL-reactive material, but it is not
pyrogenic. However, if reuse dialyzers are reprocessed and storedwith a disinfectantthat containsendotoxin, that pyrogenic material may stay in the
membrane even &r rinseout of the disinfectant.
E-41
Appendix E (Cont.)
Methods for avoiding introduction of this endotoxin
to the patient includes discarding the recirculating
solution to waste. Water used for dilution of germicide should be endotoxin-free.
. Effect of first and subsequent use of hemodialyzers

on patient well-being: the rise and fall of a syndrome
associated with new dialyzer use. Charoenpanich,
R , Pollak,V.E., Kant, KS., Robson,M.D. and Cathey,
M. Artif Organs, 11 (2), pp. 123-7 (Apr 1987). In a
single large dialysis unit in which dialyzers are
routinely subjected to multiple use, the incidence
rates of intradialytic symptoms during first use and
reuse were compared. The results of this investigation suggest that subjecting dialyzers to anautomated reuse processing system before first use can
markedly diminish the incidence of first-use syndrome.
Repeated use of dialyzers is safe: long-term observations on morbidity and mortality in patients with
end-stage renal disease. Pollak, V.E., Kant, KS.,
Parnell, S.L. and Levin, N.W. Nephron, 42 (31, pp.
217-23 (1986). Through the examination of morbidity and mortality figures the authors suggest that
there are no adverselong-termeffects ofmultipleuse
of dialyzers.
National Kidney Foundation revised standards for
reuse of hemodialyzers. Am JKidney Dis, 3 (61, pp.
466-8 (May 1984). The National Kidney Foundation,
Inc convened a group with expertise and experience
in dialysis, includingone or more physicians, nurses,
consumers(patients), industry representatives, and
microbiologiststo formulate the described standards,
which were subsequently approved by the Executive
Committee of the National Kidney Foundation at its
December 2,1983 meeting.
Dialyzerreusein alarge dialysisprogram. Luehrnann,
D., Hirsch, D., Carlson, G., Constantini, E. and
Keshaviah,P. TransAm SueArtifIntern Organs, 28,
pp. 76-80 (1982).
Morbidity ofnondiabetichomehemodialysispatients
with and without dialyzer reuse. Siemsen, A.W.,
Wong,E.G., Sugihara, J.G. andMusgrave,J.E. Tians
Some aspects of residual formaldehyde testing when
reusinghaemodialysers. Woffindin,C. and Hoenich,
N A Int JArtif Organs, 8 (6), pp. 313-8 (Nov 1985).
To assess the adequacy of quantifying residual formaldehyde concentrations when reusing, four semiquantitative methods of concentration estimation
Chapter 10
HemodialyzerReuse
(Clinitesttablets,SchifPsreagent, Formalert Formotest)
were compared. Two methods ( S c M s reagent and
Clinitest) were inadequate in detecting low concentrations of formaldehyde and were associated with
false positives from interference by chemicals contained in the dialysate. False positives were demonstrated with one (Formotest) while the other was
capable of detectingformaldehydeconcentrations as
low as4.5mgfl. Recommended to selectthe most sensitive of these semiquantitative techniques for routine use and to perform regular screeningfor anti-N
antibodies and to periodically check formaldehyde
levels by the use of the highly specific Hantzsch
reaction.
Hemodialysisneutropenia and dialyzerreuse: role of
the cleansing agent. Gagnon, RF. and Kaye, M.
Uremia Invest, 8 (I), pp. 17-23 (1984). As part of a
study to evaluate the safety and efficacy of dialyzer
reuse, a comparativestudy oftwomethods ofdialyzer
reprocessing,manual and automated,was conducted.
Five stable end-stage renal disease patients on center hemodialysis were evaluated as to hematological
and metabolic parameters throughout two series of
three consecutive dialyses using first new and then
reused dialyzersreprocessed according to each of the
two methods. It would be reasonable to conclude
from these results that amongthe various differences
betweenthetwo~mceSSingmethods,restoratim
of the original level of biocompatibility of the reused
dialyzer's membrane is related to the concentration
of the cleansing agent.
Nursing aspects of dialyzer reuse. Baldasseroni, A
JNephml Nurs, 1(I), pp. 17-9 (Jul-Aug 1984).
Leukopenia with different regenerated haemodialysis membranes. Ksiazek,A , Soko-Lowska,G., Marczewski, K and SolskiJ. Int Uml Nephrol, 16 (11, pp.
61-7 (1984). The white blood cell count CWBC) decreases during haemodialysis and was investigated
as a b c t i o n of different dialysis membranes. Each
of them was used four times, applyingdifferent sterilization methods. The results indicate differences in
biocompatibility between cuprophan and PAN
membranes, independent of the sterilizationmethod
employed.
Anaphylat0xinfarmationduringhemodiatysis:mparison
of new and reused dialyzers. Chenoweth, D.E.,
Cheung, A K , Ward, D.M. and Henderson, L.W.
Kidney Int, 24 (6)pp. 7704 (Dec1983). Hemodialysis
of 11 end stage renal failure patients with new
cuprophan hollow fiber dialyzers produced significant leukopenia as well as increased plasma levels of
E-42
Appendix E (Cont.)
Anndated Bibliography
both C3a and C5a antigens during the initial phases

of the procedure. These observations suggest that
C3b deposition on the cellulosic membrane surface
durinfirstuse markedly diminishesthecomplementr
activating potential of cuprophan dialyzers when
they are subsequently reused.
Formaldehyde kinetics in reused dialyzers. Gotch,
F A and Keen, M.L. Trans Am Soc Artif Znten
Organs, 29 pp. 396-401 (1983).
Kidneydialysis:ambientformaldehydelevels.Smith,
KA Jr, Williams, P.L.,Middendorf, P.J. andZakraysek, N. Am Znd Hyg Assoc J , 45 (I), pp. 48-50 (Jan
1984). Ambient levels offormaldehydein kidney dialysis units were discussed. Five kidney dialysis
clinics were surveyed and air sampling was performedin all major work areas. Formaldehydelevels
were found to be below theTLVof 1.O part per million
(ppm)in all samples and the mean ambient level was
below 0.5 ppm. Feasible engineering controls that
would further reduce or eliminate potential employee exposures were identified.
Microbiologic evaluation of a new glutaraldehydebased disinfectant for hemodialysis systems. Petersen, N.J., Carson, L.A, Doto, I.L., Aguero, S.M.
and Favero, M.S. Trans Am SocArtifZntern Organs,
28 pp. 287-90 (1982). Development of anti-N-like
antibodies during formaldehyde reuse in spite of
adequate predialysis rinsing. Vanholder,R., Noens,
L., DeSmet, R. and Ringoir, S. Am JKidney Dis Jun
1988,ll (6) pp. 477-80. Five of 50 patients (10%)
became positive for anti-N-like antibodies 6 to 14
months &r the start of formaldehyde reuse, indicating that even a careful control of effluent formaldehyde concentrationcannot prevent the occurrence
of this abnormality.
Cuprophan reuse and intradialytic changes of lung
diffusion capacity and blood gases. Vanholder, R.C.,
Pauwels,R.k, Vandenbogaerde, J.F., Lamont,H.H.,
Van der Straeten, M.E.and Ringoir,S.M. Kidney Znt,
32 (I), pp. 117-22 (Jul1987). Reuse of cuprophan
dialyzers significantly attenuated the fall in leukocyte counts and the rise in C3a des Arg seen during
first use dialysis. Drop in arterial pa02 normally
seen with Cuprophan dialysis was not seen when the
dialyzer was reused.
Dialyzer performance over prolonged reuse. Gagnon, R.F. and Kaye, M. Clin Nephrd, 24 (11, pp. 217 (Jul1985). Studies were performed in patients on
maintenance hemodialysis to evaluate the role of
prolonged dialyzer reuse in the management of endQuality Assurance Guidilines for HernodialysisDevices
Chapter 10
HemodiulyzerReuse
stage renal disease. The data obtained demonstrate
that membrane permeability to small solutes (urea,
creatinine, phosphate) is maintained up to thirty
dialyzer uses. In-vitro studies confirmed this observation and established that clearances of larger solutes (vitamin B12) are also maintained over similar
extensive dialyzer reuse. Thus, these results clearly
demonstrate that prolonged dialyzer reuse in endstage renal disease patients constitutes a stableform
of renal replacement therapy provided adequate dialyzer reprocessing is applied.
Biocompatibility of dialysis membranes: effects of
chronic complement activation. Hakim, R.M., Fearon, D.T., Lazarus, J.M. Kidney Znt, 26 (21, pp. 1 9 4
200 (Aug1984). Reuse decreases the capacity of the
cuprophane membrane to activate complement but
does not significantly alter the capacity of cellulose
acetate membranes. The extent of complement activation paralleled the ability of these membranes to
induce neutropenia Recurrent dialysiswith new cuprophane and cellulose acetate membranes leads to
a decrease in pre-dialysisand "rebound leukocytosisn
neutrophil count, as well as amore intense activation
of complement and an enhanced endogenous clearance ofproductsof complement activation. The clinical sequelae of recurrent complement activation are
discussed.
Formaldehyde-related antibodies in hemodialysis
patients. Sander, S.G., Sharon, R., Bush,M., Stroup,
M. and Sabo, B. Transfusion, 19 (6),pp. 682-7 (NovDec 1979). Sera from patients dialyzed with disposable membranes neither had anti-N-likeactivity nor
agglutinated formaldehyde-treated red blood cells.
These findings are consistent with the hypothesis
that anti-N-like reactions of hemodialysis patients'
sera represent cross reactions of formaldehyde related antibodies with N antigens of normal red blood
cells.
Haemolysis due to formaldehyde-induced anti-Nlike antibodies in haemodialysis patients. Fassbinder, W., Frei, U. and Koch, KM. Klin Wochenschr,57
(13), pp. 673-9 (Jul3,1979). During reuse of formaldehyde sterilizedKiil-dialysers, red cell survival was
significantly reduced in patients with anti-N-like
positive sera, when compared with 19antibody negative control patients. Replacement of formaldehyde
sterilized dialysers by ethylene-oxide sterilized disposable dialysers resulted in a significant increase in
hematomit. Thisimprovement took place, although
antibody titres declined only slowly. The data demonstrate that formaldehyde sterilisation of dialysers
may cause antibody-mediatedhaemolysis contributE-43
Appendix E (Cant.)
ing to the extent of renal anaemia This immunohaemolysismay be corrected, in spite of continuing
antibody persistance, when formaldehyde exposure
is totally avoided, or possibly when minimized.
h e d i n g s of the National Workshop on Reuse of

Consurnables in H e d i a l y s i s . Sadler, J.H. Cedl.
Kidney Disease Coalition:Washington,DC (300pp.).
Hemodialyzer Reuse: Issues & Solutwns (an AAMI
Analysis and Review). Association for the Advancement ofMedical Instrumentation;Arlington,VA,(76
pp.) (1985). A review of dialyzer reuse including
cleaning, disinfection, and associated chemical hazards, quality control, and practical considerations.
Occupational Exposure to Formaldehyde. 29 CFR
Parts 1910 and 1926. Federal Register (December 4,
1987).
HighlightsofASN SpecialWorkshop on Reuse. RiceCoplin, K and Vlchek, D. Dial& Transplant, p. 140
(Mar 1987). Discussion of several topical issues:
alcide degredationof dialyzer membranes, sinkingof
formaldehyde with subsequent rebound, absence of
evidence regarding formaldehyde's carcinogenicity,
effect of sodium hypochlorite on biocompatability
factor associated with reuse.
Chapter 10
Hemodialyzer Reuse
Multiple use of dialyzers: safety and efficacy. Kant,
KS., Pollak, V.E., Cathey, M., Goetz, D. and Berlin,
R. Kidney Int, 19 (5), pp. 728-38 (May 1981). The
practice of multiple use of dialyzers was examined
over a 15-month period on all 104 patients in a
chronic maintenance hemodialysis facility. The
incidence of complicationsduring dialysis, of complicationsthat might be related to infection,and the rate
ofhospitalization was not greater in the unit practicing multiple use as compared with the rates in the
unit practicingsingleuse. Events possibly associated
with infection did not occur more frequently during
dialysesin which the dialyzerhad been usedbetween
2 and 20 times than they did with the initial use ofthe
dialyzer. With successive dialyzer use, there was no
signzcant change in the ability to remove fluid or in
the dialysance of urea and creatinine. The neutropenia that characteristicallyoccurs early in dialysis was substantially less with reused dialyzersthan
with their initial use. Under the operatingconditions
described,theauthors concludethatmultiple dialyzer
use over a 15-month period is safe, efficacious, and is
not associated with an increased rate of infection, of
morbidity, or of mortality.
Formation of anti-N-like antibodies in dialysis patients: effect of different methods of dialyzer rinsing
to remove formaldehyde. Lewis,KJ., Dewar, P.J.,
Ward,
M.K and Kerr, D.N. Clin Nephrol, 5 (11, pp.
Effect of chemical germicides on the integrity of
(Jan
1981). Use of formalin to sterilize dialyz39-43
hemodialyzermembranes. Bland, L A , Favero,M.S.,
ers
is
known
to be responsible for the formation of
~rrow,G.S.,Aguero,S.M.,Searcy,B.P.andDanielanti-N-iikeantibodyinlong-termhemodialysispatients.
son, J.W. MAIO D a m , 34 (31, p. 172-5 (Jul-Sep
Patients dialyzed as in-patients using formalin were
1988). Epidemiologic investigations of bacteremia
found to be completely free of anti-N-like antibody,
in dialysis patients by the Centers for Disease Conwhile amongthose on home dialysis, there was ahigh
trol (CDC) identified an association with the use of
prevalence (31%) and incidence. The hospital padialyzers disinfected with a specific chemical germitients were found to be receiving concentrations of
cide. A collaborative study by the CDC and the Food
formaldehyde less than 1micrograndml while those
and Drug Administration (FDA) was conducted to
on home dialysis received 3-13microgramdml. This
determine the effect of dialyzer disinfectants on five
is
offered as an explanation for the absence of anti-Ntypes of dialyzer membranes: three cellulosic
antibody
in patients usingformalin-sterilizeddialyz(Cuprophan,celluloseacetate,cuprammoniumrayon);
ers.
and two synthetic (polysulfone, polyacrylonitrile).
The disinfectants tested were 4% formaldehyde;
Relationshipbetweenformaldehyde-related antibodRenalin; Cidex Dialyzer; Sporicidin HO; Warexin;
ies and cross-reacting anti-N-like antibodies in paand RenNew-D. Water was the control. These
tients
undergoingchronichaemodialysis. Sharon, R
results and those obtained from epidemiologic studJClin
Path01 ,34(1), pp. 41-3(Jan 1981). An attempt
ies suggest that membrane integrity testing (e.g. an
was
made
to determine the sequence of events leadair-leak test) shouldbe an integralpart of dialyzerreing
to
the
production of two distinct antibodies in
processing.
patients with chronic renal failure who regularly
undergo haemodialysis with formaldehyde reused
Effect of multiple use of dialyzers on intradialytic
dialyzers. The production of anti-formaldehydered
symptoms. Bok, D.V., Pascual, L., Herberger, C.,
cells
started about six months after the beginning of
Sawyer, R and Levin, N.W. P m Clin Dial Transhaemodialysis
treatment. Only when the titre of
plant Forum, 10, pp. 92-9 (1980).
E-44
Appendix E (Cant.)
these antibodies reached 64 or 128 another, apparently cross-reacting, antibody appeared which reacted like an anti-N antibody. A strong direct antiglobulin reaction was found to be positive for formalin-treated red cells after five minutes of contact
with specific antibody, indicating a high W t y of
the antibody of the formalin-altered red cell.
Effect of multiple use of dialyzers on hepatitis B
incidence in patients and staff. Favero, M.S., Deane,
N., Leger, RT. and Sosin, AE. JAMA, 245 (2), pp.
166-7(Jan 9,1981). Data pertaining to incidence of
hepatitis B fiom a 1976 Center for Disease Control
Study were matched with responses fiom a Renal
Physicians Association survey on dialyzer reuse in
the United States. Incidence of infection of staff
having a t least one HBsAg positive patient was 2.9%
incenterspracticingreusevs.3.6%in centerspracticing single use. Nearly all (95%) staff who became
HBsAgpositive were associated with centers having
Quality Assurance Guidelinesfor Hentodialysis Devices
Chapter 10
Hemodialyzer Reuse
at least one HBsAg-positivepatient. The practice of
reusing dialyzers does not appear to be associated
with increased risk of hepatitis B infection among
patients and staff.
Effect of dialyzer reprocessing methods on complement activation and hemodialyzer-related s y m p
toms. Durnler, F., Zasuwa, G. and Levin, N.W. Artif
Organs, 11(21, pp. 128-31 (Apr 1987). The effects of
different dialyzerprocessingmethodsand ofreuse on
complement activation and dialyzer-related symptoms were studied in 96 maintenance hemodialysis
patients. The percentage of patients without symptoms during dialysis was sigdicantly greater with
reused dialyzersthan with new dialyzers. The severity of total symptoms correlated significantly
(p=0.0004)with complement activation. The results
suggest that total symptoms during dialysis are
correlatedwith the degree of complementactivation.
However, trends in the data pertaining to chest pain
suggest that factors other than complement activation may be important in the pathogenesis of some
dialyzer-related symptoms.
FDA 87-4217
FDA 87-4218
FDA 87-4221
FDA 87-4222
FDA 87-4223
FDA 87-4224
FDA 88-4160
FDA 88-4225
FDA 88-4226
FDA 88-4227
FDA 88-4228
FDA 88-4229
FDA 89-4158
FDA 89-4159
FDA 89-4165
FDA 89-4203
FDA 89-4231
FDA 89-4232
FDA 89-4234
FDA 90-4219
FDA 90-4235
FDA 90-4237
FDA 90-4238
FDA 90-4239
FDA 90-4240
FDA 90-4241
Proceedings of the First International Conference of Medical Devices Regulatory

Authorities (ICMDRA) - J u n e 2-6,1986 (PB 88-123005/AS, $25.95).
Have a New Medical Device? (brochure).
Regulatory Requirements for Devices for t h e Handicapped (PB 88-123013/AS,
$12.95).
An Introduction to Medical Device Regulations (pamphlet).
Classifying Your Medical Devices (brochure).
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
(PB 88-121801/AS, $14.95).
Import and Export - Regulatory Requirements for Medical Devices (August
1988)(GPO 017-012-00336-2, $2.25) (PB 89-121859/AS, $13.95).
Review and Summary of Hemodialysis System Investigative Reports from
California, the District of Columbia, Massachusetts and Ohio (PB 88-121793/AS,
$19.95).
Medical Device Reporting Questions and Answers (February 1988) (PB 88192737/AS, $14.95).
Export of Medical Devices: A Workshop Manual (September 1988) (GPO 017-01200338-9, $10.00) (PB 89-119663/AS, $28.95).
Import of Medical Devices: A Workshop Manual (September 1988) (Supersedes FDA
83-4167) (GPO 017-012-00337-1, $8.50) (PB 89-119671/AS, $21.95).
Applications of DNA Probes for the Diagnosis of Human Infectious Diseases: An
Overview (September 1988) (PB 89-120497/AS, $15.95).
Premarket Notification: 510(k) - Regulatory Requirements for Medical Devices
(November 1988) (GPO 017-012-00342-7, $3.75) (PB 89-145312/AS, $15.95).
Investigational Device Exemptions - Regulatory Requirements for Medical Devices
(May 1989) (Supersedes FDA 83-4159) (GPO 017-012-00346-0, $5.00) (PB 90128927, $23.00).
Regulatory Requirements for Medical Devices - A Workshop Manual - Fourth
Edition (May 1989) (Supersedes FDA 85-4165) (GPO 017-012-00344-3, $18.00) (PB
89-215388/AS, $36.95).
Labeling - Regulatory Requirements for Medical Devices (May 1989) (Supersedes
FDA 86-4203) (GPO 017-012-00345-1, $2.75) (PB 90-131418/AS, $17.00).
Nursing and Technology: Moving Into the 21st Century - Conference Proceedings May 16-18,1988 - Annapolis, MD (April 1989) (GPO 017-015-00237-3, $6.00) (PB 90100710/AS, $21.95).
Yorick: The CDRH Bionic Skeleton (pamphlet).
A Manual on Water Treatment for Hemodialysis (July 1989) (PB 90-121211/AS,
$31.00).
Medical Devices Standards Activities Report (Supersedes FDA 87-4219) (PB 90180134/AS, $23.00).
Device Recalls: A Study of Quality problems (January 1990) (PB 90-181272/AS,
$15.00).
The Device Priority Model: Development and Applications (October 1989) (PB 90165937/AS, $17.00).
Replacement and Repair of the Visual System: I. Visual Prosthetics 11. Retinal
Transplants - A Review (October 1989) (PB 90-181298/AS, $17.00).
Condoms and Sexually Transmitted Diseases - Especially AIDS (booklet).
AIDS-Information for the Dialysis Patient (pamphlet).
AIDS-Information for the Dialysis Health Professional (pamphlet).
U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Center for Devices and Radiological Health
Rockville, Maryland 20857
OFFICIAL BUSINESS
PENALTY FOR PRIVATE USE, $300
SPECIAL FOURTH CLASS RATE

POSTAGE AND FEES PAID
PHSlFDA
PERMIT NO. G-285

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QUALITY

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CDRH PUBLICATIONS - MEDICAL DEVICES

Problem Definition Study: Rubella Antibody Testing (PB 86-131935/AS, $9.95,

(Continued on inside back cover)

HHS Publication FDA 91-4161

Quality Assurance Guidelines for

Douglas L. Vlchek, BA, CHT

U.S. DEPARTMENT OF HEALTH A N D H U M A N SERVICES

Barbara Bednar, RN, CNN

The opinions and statements contained in this report are those of

Chapter 5: Dialysate and Dialysate Concentrate ..................

Appendix D: List of Tables. Figures. and Forms

Appendix E: Annotated Bibliography ............................

A source of basic background information of the

As authors we wish to convey to the readerluser

A first step in assisting the facility to develop

Quality Assurance Guidelines for Hernodialysis Devices

A training manual for the technical aspects of

plied materials and reviewed drafts of individual

Quality Assurance Guidelines for Hernodialysis Devices

OVERVIEW OF RECENT ACTIVITIES AND

Association for the Advancement of Medical Instrumentation

Joint Commission on Accreditation of Healthcare

Food and Drug Administration

Centers for Disease Control

Health Care Financing Administration

Occupational Safety and Health Administration .............. 1-4

End Stage Renal Disease Facilities

OVERVIEW OF PROBLEMS AND INCIDENTS

Quality Assurance Guidelines for Hemodialysis Devices

In 1984, the FDA awarded four contracts to study

Qualityadministration comprises management

The Center for Devices and Radiological Health

chased, operated, calibrated, and maintained prop

L Water treatment equipment;

2 Equipment to monitor operation of the water

5. Extracorporeal blood components (including blood

7. Dialyzer reprocessing and testing equipment;

8. Any other equipment associated with the dialysis procedure.

2. Selecting and specifying measurement techniques

3. Determining appropriate intervals a t which to

2. The equipment is used in conjunction with other

Quality Assurance Guidelines for Hernodialysis Devices

Association for the Advancement of

Food and Drug Administration

Joint Commission on Accreditation

J C A H 0 - a non-governmental organization primarily involved with accreditation of hospitals--has also

Guidelines for Hemodialysis Devices

Educational Projects. Over the past several

Other FDA Activities: The FDA also gathers

Centers for Disease Control (CDC)

As a result of these surveillance efforts, the CDC

Health Care Financing

In the final rulemaking for the End Stage Renal