Medical Equipment Management Plan

EC.02.04.01 (2009)
EC.02.04.03 (2009)

I PURPOSE

The mission of MCG Health, Inc. (MCGHI) is to improve the health of the people of the State
of Georgia, Richmond County and the City of Augusta by providing cost-effective, quality
health and hospital services. Consistent with this mission, the Board of Directors, medical
staff, and administration have established and provided ongoing support for the Medical
Equipment Program described in this plan.

The purpose of the Medical Equipment Management Plan is to define the program to
manage medical equipment maintenance and safety for patients, visitors, and staff.

II SCOPE

The Biomedical Engineering Department operates between 8:00 am and 5:00 pm with
onsite coverage by staff. Biomedical Engineering staff is available on a 24/7 basis by using
a formal on call program. Services provided include, but were not limited to: Medical
Equipment inventory, Equipment Acquisition, Selection of new equipment, Incoming
Medical Equipment inspections, Planned Maintenance, Equipment repair, assistance with
Hazard Notifications and Recalls, Documenting user errors, and providing incidental
operator training.

III FUNDAMENTALS

A. Equipment Inventory

The purpose of this policy is to (1) outline components of the medical equipment
management program (MEMP) administered by the Biomedical Engineering
Department, and (2) to define criteria as well as a risk based assessment process to
be used in the development of strategy on how best to define, track and inspect
equipment to be included within the program. The risk based assessment is also used
to assign initial scheduled maintenance frequencies for a select grouping of devices
within the program. Initially proposed equipment inspection frequencies using the
criteria should be considered a baseline assessment in the initial development of
inspection schedules. These schedules are subject to change based upon the
following: equipment type; risk to patient should equipment fail; equipment utilization
factors; event history and scheduled maintenance procedures.

Medical equipment will be managed in accordance with the requirements of various

regulatory agencies such as The Joint Commission, the GA Department of Health and
OSHA.

Not all patient care devices listed within the Biomedical Engineering Department

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 equipment asset inventory will be included in the MEMP. Additionally, not all items
listed within the MEMP will be included in the scheduled inspection program.
Graphically, these relationships can be shown as follows:

Asset Inventory
Medical Equipment
Inventory
Scheduled Inspections
(MME)

Non-Life Support Equipment:

PM maintenance for this class of equipment falls into 3 categories:

1 PM activity is scheduled for every piece of equipment of this device type.

Ninety five percent (95%) of devices defined, as Non-Life Support, should
have current PM status. (Target: PM completed within 60 days of date
issued) *

2 PM history suggests that scheduled PM for every piece of equipment of

this device type is not necessary. These device types will be labeled as
No PM necessary (NPM), but a 10% sample (SAM) of this equipment will
be selected and tested, looking for problems hidden from the user, that
might otherwise be missed and could indicate a need to perform PM on
every piece of equipment of this device type.

3 NPM – No PM required. Items in this category have a very low risk to the
patient or staff when they fail, which are repaired only when reported as
defective.

Life Support Equipment:

Equipment that is typically (more than 50% of the time) used in life support will have a
life support priority group. Equipment in this priority group is included in the MEMP
and initially tested for safety and operational performance one or more times/year.
This equipment is given the highest priority for testing, calibration, and repair. One
Hundred percent (100%) of devices defined as Life Support should have current PM
status. (Target: PM completed within 90 days of date issued) *
Items currently risk ranked as Life Support equipment follow:

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 DEFIBRILLATOR (NON AED)
INCUBATOR, INFANT
MACHINE, ANESTHESIA
PACEMAKER, EXTERNAL
PUMP, BLOOD
SYSTEM, PERSUSION
VENTILATOR
VENTILATOR, ARABELLA
VENTILATOR, INFANT

* NOTE: Devices which are not located or made available for scheduled maintenance
within their scheduled inspection timeframes will be defined as overdue for testing, and
will remain overdue until documented efforts have been made to locate the specific
device, with maintenance performed as soon as the device can be made available. If
the device cannot be located within four months of the scheduled date, the inspection
work order will be closed out and defined as ‘could not locate.’ Devices not located or
validated to be in active use for a 12 month period will be removed from the active
inventory and no longer scheduled for inspection.

All of the included equipment is provided with a durable tag carrying a unique
Biomedical Equipment Control (BEC) number.

B. Non-Facility Owned Equipment

Rented equipment, loaned equipment, including that provided for demonstrations, and
staff-owned equipment, are all considered for inclusion in the program.

Facility use of patient-owned equipment is discouraged. Exceptions will be considered

on a case-by-case basis and only for those items deemed essential to the health and
well being of the patient, but not available through the facility or any preferred rental
vendors. The patient assumes all risk and liability for the use of personally owned
equipment, including timely performance of all required scheduled maintenance
activities.

C. Equipment Acquisition

The facility has a formal process for acquiring new capital equipment (defined as items
valued at $5,000 or more). This process requires that a formal requisition be
generated and that this requisition be evaluated and considered for approval by the
Capital Budget Committee which makes a judgment on the appropriateness of the
equipment with respect to the clinical services provided by the institution. The
Committee requests support from experts in certain specialized areas when it deems
this additional support necessary.

D. Selection of New Equipment

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 Once it is determined that a new piece of equipment is to be acquired, the facility
utilizes a routine selection procedure which involves a formal or informal analysis of
quotes or responses from alternate vendors to a written Request for Proposal (RFP)
before the purchase decision is made. This process requires assurance from the
vendors that the equipment meets appropriate minimum safety and performance
standards. Consideration is also given to the equipment’s ease of operation and to the
ready availability of assistance with on-going user training.

E. Incoming Inspections

All patient care equipment, whether owned, leased or rented is tested for compliance
with previously specified minimum safety and/or performance standards before being
used for the first time for patient care. The results of this testing are documented and
the records are filed on-site in the Biomedical Engineering Department. Similarly,
equipment that has been withdrawn from use and placed in storage is also tested to
these standards before being returned to service.

F. Planned Maintenance

All of the equipment listed in the facility’s Maintenance Monitored Equipment (MME)
Inventory is subjected to a carefully controlled regimen of performance assurance and
safety testing and scheduled maintenance. This mix of procedures is generally
referred to throughout this document as planned maintenance (PM).

PM = SM + PA + ST

The procedures and intervals for the scheduled maintenance (SM) are initially
determined using risk level or manufacturer’s specifications and modified based on
local experience. The procedures for the performance assurance (PA) and safety
testing (ST) have been developed by either the Director of Biomedical Engineering or,
in some cases, other service providers. They are based on both the manufacturer’s
published performance specifications and current, nationally recognized safety
standards.

Although the planned maintenance is usually completed on time (within 63 days of the
issue date of the computer generated work order), the computerized documentation
system includes an exception-reporting feature, which prompts the staff to investigate
any incomplete work orders. The primary documentation of the planned maintenance
consists of service reports that are kept in electronic form and/or in individual file
folders (old history) on-site (one folder for each piece of equipment) and for work
performed after July 2007 the primary documentation is electronic and held in our
Computerized Medical Maintenance System (CMMS). Computerized summaries of
the maintenance work are also available and are used to provide regular status reports
to the Department Managers and the Environment of Care/Safety Committee.

G. Equipment Repair Services

The individual making the service call fills out a red DNU “Do Not Use…” tag, if
available, noting the time that the service call was made on the tag, and attaches the

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 tag to the defective equipment item, otherwise less formal notes may be used with
contact information and problem description provided. Biomedical Engineering is
available in house from 8:00am to 5:00pm by calling 1-2228. Biomedical Engineering
is also available for emergency repair service 24 hours a day, 7 days a week by calling
1-8400, for the repair of equipment which is reasonably necessary in order for
customer to continue to effectively deliver a vital clinical service, and for which an
adequate temporary alternative is not available. When repair services are needed,
customer will promptly notify Biomedical Engineering staff and allow full access to
equipment.

Equipment Repair Services – (Imaging equipment under service contract)

The individual reporting a problem calls (1-3039) from 8:00am to 4:30pm and provides
the problem description and equipment identifier. A call will be placed with the vendor
for them. After hours staff may contact the vendor directly and request service, and
then leave a message at (1-3039) to allow for timely follow up of the service. Vendor
service reports are received and electronically attached to a computerized record
keeping system in both the Radiology department and in Biomedical Engineering for
tracking purposes.

Equipment Repair Services – (Non-Imaging medical equipment under service

contract)
The individual reporting a problem calls the vendor directly and informs Biomedical
Engineering (1-2228) of the service call and a Work Order is opened in a
computerized record keeping system. An electronic copy of the vendor service report
is used to close this tracking Work Order.

H. Hazard Notifications and Recalls

When a written hazard notification/recall involving a medical device, which is in use at

the facility, is received from the equipment manufacturer, all of the potential users of
the affected device will be notified of the potential problem through the facility’s internal
hazard notification process. When Biomedical Engineering receives equipment hazard
notices and alerts from the facility they will determine whether or not this equipment is
in use at the facility and notify the facility.

I. Education and Training of Maintenance Personnel

Biomedical Engineering service technicians are subjected to technical skill

assessments during their pre-employment interview, at 12 months after their hire
date, and annually thereafter. The education and training needs identified
through these assessments are addressed by internal technician cross training,
self study of service manuals, or supplemented by appropriate
manufacturer/service vendor training.

J. Documenting User Errors and Incidental User In-Services

In the case of repair requests that are handled by Biomedical Engineering personnel,
the service event is given a special coding if the call can be attributed to a user error,
rather than and equipment malfunction. If it can be confirmed that the user is

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 unfamiliar with how to operate the equipment properly, the service technician provides
the user(s) with an appropriate informal in-service, which is usually limited to
addressing the immediate problem. Probable user-related problems (when the service
technician can find no evidence of equipment malfunction and a reasonable theory of
the reason for the perceived problem is documented) are reported to the Environment
of Care/Safety Committee in the next Medical Equipment Safety Report.

K. Education and Training of Equipment Operators/Users

Responsibility for coordinating and implementing the education and training of the
equipment users is held jointly by the facility’s Education Department, the Medical
Director and the department managers. The most common sources of training on
specific equipment are the manufacturer’s initial in-services, the manufacturer’s
refresher in-services, the equipment user instruction manual or other audio-visual
equivalents, and other staff who have been trained on the proper use of the
equipment. Biomedical Engineering technical staff assists in this process whenever
they are competent to do so, and on an as-requested basis. Where a specific problem
is identified as a result of a service call, Biomedical Engineering staff provides an
incidental inservice, usually limited to correcting the user-related problem identified at
the time of the service call.

L. Incident Investigations and Medical Device Related Problem Reporting

Events within the facility in which someone is injured, or could have been injured, are
reported to the facility’s Risk Manager. In situations where an item of equipment is
directly involved, or is thought to have been directly involved, the facility has a policy
that the equipment be removed from service and impounded with as little disturbance
as possible to the settings and other evidence that might aid the investigation.
Biomedical Engineering staff act as a resource to the facility and, on request, assists
with investigating the circumstances of the incident, or in arranging for others to
investigate the incident. Determination of whether or not the incident is reportable
pursuant to the Safe Medical Devices Act of 1990 remains with the facility MCGHI
Legal or Risk Management Department.

M. Equipment-Related Emergencies

Examples of equipment related emergencies are illustrated in the

Attachment to this document.
Nursing departments are requested to provide a copy, to Biomedical Engineering, of
their plans outlining how they will manage a failure of what they consider critical
equipment.

IV. OBJECTIVES

A. Performance Improvement

In order to maintain an effective performance improvement process, there must be a

consistent way of measuring the effectiveness of the program, i.e. how well it is
accomplishing its mission.

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 The following questions are used as frameworks to assess program performance:

1) Is the program keeping up with the scheduled maintenance and

performance assurance/safety testing workload?
2) Have we kept the program services fully compliant with the basic
regulatory requirements?

These questions, and other applicable considerations, are addressed in the Annual
Program Effectiveness Assessment and Performance Improvement Report. At the
time when the Annual Assessment is prepared, areas of weakness that are
considered to need improvement are targeted as goals for the following year.
Progress with respect to these goals is reported in the quarterly Performance
Improvement Report to the facility’s quality management committee or quality council
Safety Committee.

Based on the last formal assessment, the facility has established the following
specific goals for FY 2010:

PI Goal #1: Reduce the average level of “unable to locate for PM” items to below 5%.

PI Goal #2: Increase the % of incidental inservices to above 50% for repairs
designated as use errors when specific users can be associated with the
equipment being evaluated.

PI Goal #3: Develop the tools to measure baseline response time to urgent or STAT
repair requests. In order to use the PDCA process to improve on our
response time to urgent or STAT repair requests.

PI Goal #4: Maintain a quarterly PM completion rate for life support equipment of
100%.

PI Goal #5: Maintain a quarterly PM completion rate for non-life support equipment of
95%.

B. Information Management

The heart of the program’s maintenance documentation system is the collection of

equipment maintenance history data kept in the Biomedical Engineering Department.

There is CMMS computer system that maintains records on all equipment on the
Biomedical Engineering inventory. This system has electronic records related to the
repair and maintenance of all equipment. A paper file exists which hold paper copies
of old history on older equipment. A Quarterly Report documenting the nature of any
user-related equipment problems or operator-error trends, equipment failures during
patient use, and status of planned maintenance (PM) completion rates, is provided to
the Safety Committee.

V. Process of the Medical Equipment Management Plan

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 a. EC.02.04.01 The organization manages medical equipment risks.
i. 1. The hospital solicits input from individuals who operate and service
equipment when it selects and acquires medical equipment. A
1. See hospital policy 11.02 Capital Equipment: Acquisition
2. The Director of Biomedical Engineering is a member of the Capital
Expenditure Committee
ii. 2. The hospital maintains either a written inventory of all medical
equipment or a written inventory of selected equipment categorized by
physical risk associated with use (including all life support equipment) and
equipment incident history. The hospital evaluates new types of
equipment before initial use to determine whether they should be included
in the inventory. (See also EC.02.04.03, EPs 1 and 3) C M D
1. The active (and inactive) inventory is kept in the Biomedical
Engineering CMMS computer system.
2. The Risk score is maintained within this CMMS as well.
3. Each new equipment type is evaluated for inclusion in the Medical
Equipment Management Program
iii. 3. The hospital identifies the activities, in writing, for maintaining,
inspecting, and testing for all medical equipment on the inventory. (See
also EC.02.04.03, EPs 2 and 3) C M D
1. Each device type that is included by risk in the scheduled
maintenance program has an assigned PM procedure in the
CMMS
iv. 4. The hospital identifies, in writing, frequencies for inspecting, testing,
and maintaining medical equipment on the inventory based on criteria
such as manufacturers’ recommendations, risk levels, or current hospital
experience. (See also EC.02.04.03, EPs 2 and 3) A D
1. The Biomedical Engineering CMMS contains the frequency of
scheduled maintenance based on the risk assessment of the
device type.
v. 5. The hospital monitors and reports all incidents in which medical
equipment is suspected in or attributed to the death, serious injury, or
serious illness of any individual, as required by the Safe Medical Devices
Act of 1990. A
1. See hospital policy 11.55 Product Recall & Reporting
2. See hospital policy 14.92 Safe Medical Devices
vi. 6. The hospital has written procedures to follow when medical equipment
fails, including using emergency clinical interventions and backup
equipment. A D 3
1. See Attachment 1
2. See Attachment 4
b. EC.02.04.03 The organization inspects, tests, and maintains medical
equipment.
i. 1. Before initial use of medical equipment on the medical equipment
inventory, the hospital performs safety, operational, and functional
checks. (See also EC.02.04.01, EP 2) C 3
1. Medical Equipment that is brought into the hospital or clinics is
either brought to Biomedical Engineering for inspection or
inspected on location (for larger equipment).
ii. 2. The hospital inspects, tests, and maintains all life support equipment.

2010 Medical Equipment Management Plan Page 8 of 51 Updated January 2010

 These activities are documented. (See also EC.02.04.01, EPs 3 and 4;
PC.02.01.11, EP 2) A D 3
1. Activity stored in Biomedical Engineering CMMS computer
software.
iii. 3. The hospital inspects, tests, and maintains non-life support equipment
identified on the medical equipment inventory. These activities are
documented. (See also EC.02.04.01, EPs 2-4 and PC.02.01.11, EP 2) C
D
1. Activity stored in Biomedical Engineering CMMS computer
software.
iv. 4. The hospital conducts performance testing of and maintains all
sterilizers. These activities are documented. (See also IC.02.02.01, EP 2)
AD3
1. Maintenance activity is stored in Biomedical Engineering CMMS
2. Performance testing is performed and documented by the
department using the sterilizers as a part of their quality
management efforts.
v. 5. The hospital performs equipment maintenance and chemical and
biological testing of water used in hemodialysis. These activities are
documented. A D 3
1. Maintenance records for equipment are documented in the
Biomedical Engineering CMMS.
2. Biological testing is documented in the Dialysis unit and copies
are entered into the Biomedical Engineering CMMS
c. A indicates scoring category A; C indicates scoring category C; 3 indicates direct
impact requirements apply; M indicates Measure of Success in needed; D
indicates that documentation is required

2010 Medical Equipment Management Plan Page 9 of 51 Updated January 2010

 Attachments follow:
Attachment 1 Example Equipment Failures & Basic Personnel Responses

Attachment 2 Maintenance Priority Level Determination

Attachment 3 After Hours or Emergency Service Call Procedure

Attachment 4 Table of Risk Assessment by Device Category with PM Frequency

2010 Medical Equipment Management Plan Page 10 of 51 Updated January 2010

 Attachment 1

Example Equipment Failures & Basic Personnel Responses

MCG Health
Medical Equipment Emergency Procedures

Department/Unit: ___Critical Care___ Cost Centers: ___SAMPLE_____________

Medical Procedures During Clinical Interventions Availability How to

Device Equipment During of Obtain Repair
Description Disruption/Failure Equipment Failure Backup Equipment Services
Ventilator Confirm that all connections are Manually bag patient until ventilator Replacement ventilator Respiratory Therapy will
secure function is restored or replaced. available from Respiratory exchange unit and send to
Therapy Dept. Biomedical Engineering for
Confirm that the Ventilator is repair
plugged into emergency power Rental of ventilator through
Respiratory Therapy Dept
Switch plug to an alternate electrical
outlet
Oxygen (Wall ) Request additional O2 cylinders from Connect O2 tank to ventilator or to Additional O2 tanks and Inform 1-WORK (1-9675)
Resp Therapy regulator for patient regulators are available from Facilities of the outage
Resp Therapy
Defibrillator Bring backup defibrillator to room Continue CPR during Code until Back up defibrillator located Biomedical Eng (1-2228) or
for use in code replacement defibrillator arrives near room xxxx Switchboard after hours
Bedside Physiologic Replace lead wires Provide critical care staff to visually Spare modules in clean supply Biomedical Eng (1-2228) or
Monitor or Modules monitor patient until some monitoring room Switchboard after hours
Replace patient cable is restored.

Exchange module with spare

Bring in transport monitor

Physiologic Monitor Go to each room and increase the Staff to circulate every xx minutes to Back up Central Station kept Biomedical Eng (1-2228) or
Central Station alarm volume to allow room alarms assess patients until central monitoring in Biomedical Eng, but must Switchboard after hours

2010 Medical Equipment Management Plan Page 11 of 51 Updated January 2010

 to be heard is restored be configured for specific unit
by Biomed before use

Large volume Infusion Obtain replacement pump Switch to manual drip until pump Clean supply room Biomedical Engineering (1-
Pump arrives if required 2228)

Intra-Aortic Balloon Request back up unit Utilize pharmacologic support to ?? Biomedical Eng (1-2228) or
Pump optimize patient’s preload, contractility Switchboard after hours
and after load

Reviewed/Approved by: _____________________________________ Date: _______________

2010 Medical Equipment Management Plan Page 12 of 51 Updated January 2010

 Attachment 2
Maintenance Priority Level Determination

All of the facility’s medical equipment is evaluated for Maintenance Priority

using the criteria described below.

A. Risk Criteria (RC)

The following four criteria are used to determine Maintenance Priority.

1) Equipment function (F);

2) Physical risks associated with the use of the device (A);
3) Manufacturer-specified maintenance requirement (M); and
4) Equipment incident history (H).

Equipment Function (F).

The numerical value assigned to the device’s Function (F) factor is determined by which of the following
three classes best describe the device’s usual function.

5 Medical devices that are used in direct patient care (therapeutic,

diagnostic and monitoring equipment).

3 Devices whose function is to support items that are used in direct patient
care in the clinical environment (e.g. battery chargers and printers).

1 Equipment which is not used for direct patient care (e.g. televisions).

Device Application (A).

The numerical value assigned to the device’s Application (A) factor is determined by which of the
following three classes’ best describe the physical risks associated with the device’s usual clinical
application.

10 Equipment that is typically (more than 50% of the time) used intended to
sustain life.

5 Potential for serious injury or patient death.

3 Potential for inappropriate therapy or misdiagnosis and consequent injury

/illness.

1 No significant risk of delay in therapy or diagnosis.

2010 Medical Equipment Management Plan Page 13 of 51 Updated January 2010

Maintenance Requirements (M).

The numerical value assigned to the device’s Maintenance Requirements (M) factor is determined by
which of the following three classes best describe the device’s generally known or manufacturer-specified
level of maintenance requirements.

5 Devices that requires frequent or extensive maintenance due to either

their design characteristics or specific application.

4. Devices that requires frequent light maintenance due to either their

design characteristics or specific application.

3 Devices that requires relatively infrequent or light maintenance due to

either their design characteristics or the specific application.

2. Devices that requires occasional light maintenance due to either their

design characteristics or the specific application.

1 Devices require little or no maintenance due to either their design

characteristics
or the specific application.

Equipment History (EH).

The numerical value assigned after analysis of the device’s Equipment History (EH).

-3 Less than 5% of PM work order noted a problem hidden from the user of the
device (e.g. device out of calibration)

0 Device has been tracked for problems hidden from the user for less than 1 year,
or between 5% and 10%

3 More than 10% of PM work order noted a problem hidden from the user of the
device (e.g. device out of calibration)

Risk Criteria (RC) Number.

The RC number = F+A+M+EH. It is used to quantify the priority level that should be given to the
maintenance monitoring of Medical Equipment in the program.

Equipment with a RC number >18 are classified as Priority Level 1. Level 1 items will be
considered life support equipment as defined by The Joint Commission.

2010 Medical Equipment Management Plan Page 14 of 51 Updated January 2010

 MCGHI – MEDICAL EQUIPMENT MANAGEMENT PROGRAM

Subject: After Hours or Emergency Service Call Procedure Page 1 of 1

File Name: MEMP After Hours or Emergency Prepared by: Michael Landis
Service Call Procedure 001.doc

Effective Date: 8-01-2007 Approved by: Richard Tobias

If the need arises for a piece of medical equipment to be repaired on an emergency basis after hours, on a weekend
or holiday, the clinical user shall call the hospital dispatch.

706 721 8400

Hospital dispatch will contact Biomedical Engineering Department on-call pager. On-call
Biomedical technician will respond within 30 mins. Escalation process will be initiated if
response exceeds 30 Min.

The individual making the service call fills out a red DNU “Do Not Use…” tag, noting
the time that the service call was made on the tag, and attaches the tag to the
defective equipment item (If no red DNU tag is available, a legible note will suffice).
Biomedical Engineering is available in house from 8:00am to 5:00pm (M-F)by calling
1-2228. Biomedical Engineering is also available for emergency repair service 24
hours a day, 7 days a week by calling 1-8400, asking for the switchboard operator to
page the Biomedical Engineering Technician On-Call, for the repair of equipment
which is reasonably necessary in order for customer to continue to effectively deliver a
vital clinical service, and for which an adequate temporary alternative is not available.
When repair services are needed, customer shall promptly notify Biomedical
Engineering staff and allow full access to equipment.

Equipment Repair Services – (Imaging equipment under service contract)

The individual reporting a problem calls (1-3039) from 8:00am to 5:00pm and provides
the problem description and equipment identifier. A call will be placed with the vendor
for them. After hours staff may contact the vendor directly and request service, and
then leave a message at (1-3039) to allow for timely follow up of the service. Vendor
service reports are received and electronically attached to a computerized record
keeping system.

Equipment Repair Services – (Non-Imaging medical equipment under service

contract)
The individual reporting a problem calls the vendor directly and informs Biomedical

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 Engineering (1-2228) of the service call and a Work Order is opened in an
computerized record keeping system. An electronic copy of the vendor service report
is used to close this tracking Work Order.

Approved ___________________________________________________________________________
Richard Tobias, VP Facilities Services Date
MCG Health, Inc.

2010 Medical Equipment Management Plan Page 16 of 51 Updated January 2010

Attachment 3 shows the current maintenance priority level for supported medical devices

2010 Medical Equipment Management Plan Page 17 of 51 Updated January 2010