Sterilization

Quality
Management
Group 2
Azanwati binti Hassan
Gracie anak Kadoi
Senorita anak Limping
Suhainiza binti Dahalan
 Learning Outcomes
1. State sterilizing processing facility
management.
2. Explain documentation for quality
management of sterilization.
3. Explain education and training for personnel
in quality management.
4. State performance management in quality
management.
5. Explain materials management in quality
management.
 Learning Outcomes
6. Explain monitoring sterilizing cycles
quality management.
7. Describe special performance tests for pre-
vacuum steam sterilizer.
8. Explain monitoring of the packaging
process.
9. Explain occupational health and safety for
personnel in quality management.
 Learning Outcomes
10. State environmental control in quality
management.
11. Evaluation, feedback and outcomes in
quality management
 Quality Management
What Is Quality Management?

Activities and functions involved in

determination of quality policy and its
implementation through means such as
quality planning and quality assurance
(including quality control).
(BD, 2019)
 Quality Management
Aims
quality management focuses on long-
term goals through the implementation of
short-term initiatives.
 1. Sterilizing
Person processing
in- charge of facility
the
management.
sterilizing processing facility
the authority Actively
to implement involved
specific the supervising
qualification requirement activities
of sterilizing
this,standard processing
Policies & procedure
2. Documentation for
• processing
qualityactivities
management of sterilization
• maintained record
• frequently reviewed
storage
• designated
• 7 years
• regulatory authorities
• facility policy
Documentation for quality management of
sterilization
Records to be includes:
I. Daily production statistics
II. All tests performed on equipment
III. Sterilizer cycling records
IV. Employee training records
V. staff work rosters
VI. Incident reports
VII.Quality & procedure/ operational manual
VIII.Maintenance records
 3. Education and training

On the job
Educational & Formal
practical
training orientation
training
 Education and training

Formal orientation
to provide a new employee with the
information he or she needs to function
comfortably and effectively in the
organization.

(Sonia 2018)
 Education and training
cont...
• Modes of transmission of infection
– eg: contact, airborne, droplet
• Infection control principle
– Standard precaution
• Cleaning & handling technique
– eg
 Education and training
cont...
• Packaging materials & wrapping techniques
– eg. envelops
• Sterilizer loading techniques
– Low heat-space in between & far from
chamber
 Education and training
• Principles of operation of sterilizer &
disinfecting equip.
 Education and training
cont...
• Sterilizing parameters
– 2 parameters
• Occupational health & safety issue
– PPE use
 Education and training

On the job training

A form of training provided at the

workplace.

(Wikipedia, 2020)
 Education and training
Cont...
Aim
• familiarized with the working environment
they will become part of
• a hands-on experience using equipment,
tools, materials,
• Aim= to dvelop career &the prosperous
growth of the organization.
 Education and training
On the job practical training curriculum
 Required Hours of study  Sterilizing methods
 Mental & physical health  Loading/unloading of
 Communication sterilizers
 Basic microbiology  Handling storage &
 Infection control distribution sterilized item
 Handling & cleaning of item  Negligence & accountability
 Pasteurisation & disinfection  Worker' compensation
 Inspection & assembly  Validation of cleaning,
of instrument disinfection, packaging &
 Wrapping techniques sterilizing processes,
& related equipment
4. Performance management in quality
management
Staff qualifications and staffing level shall be
sufficient
to ensure the continuous, safe and efficient
operation of the sterilizing processing facility

They shall be a written job description for

each category of staff
The facility manage by persons qualified to
the appropriate level by education, training
and experiences in sterilizing processes.

system - assessing staff performance after

orientation and at regular intervals in
accordance with the health care facility’s
policy
 5. Materials management in quality
management
• General • Deviation and fault
analysis
• Products identification • Product complaints
and traceability
• Recall protocol
• Batch control numbers
• Recall notice
• Sterilizing cycle records
• Recall report
a. General

 management of stock levels to support

reprocessing in the hospital facility

 sterile supply shall be handled & stored in

manner to maintain the integrity of
the pack
b. Products identification and traceability
c. Batch control numbers
 Each sterile product must labeled with batch
control identification
 Identification number or code of sterilizer
 Date of sterilization
 Cycle or load number
 Manufacture’s batch number of any
commercially prepared implantable
material
d. Sterilizing cycle records

 date of cycle
 sterilizer number or code
 cycle of load number
 exposure time and temperature
 name or identification of the loading
operator
 name or identification of the person
authorizing release of load contents from the
sterilizing processing facility

 the specific contents of the load

 readout result of physical, chemical or

biological indicator used

 record of mechanical testing, repairs and

preventive maintenance for each sterilizer
e. Deviation and faulty analysis.
 Shall be documented & established for
deviation reports review and other
indicators of quality problems.

f. Product complaints.
 Complain or defects relating to product
quality, safety or efficacy .
g. Recall protocol

 Develop policies and procedures for recall

of supplies from issued or stored loads.
 Documented and recorded
 Discretion of department head whenever
evidence of sterilization process failure.
h. Recall notice

 Identify the person / department

 State the sterilization batch information
and identify
 Require the recording in terms of product
name and quantity
 Specify the action to be taken
i. Recall report
 Written report shall be completed and filed
by designated person for overseeing the
activities of recall & shall :
i. Define circumstances that initiated the need
for a product recall
ii. List the total number and actual number
located
iii. To inform user department
iv. To ensure patient safety
 6. Monitoring sterilizing cycles
Physical Chemical Biological
Monitoring Indicator Indicator
• Time at • Selecting CI • General
temperature • Using CI • Selection
testing • External CI • Frequency of
• General • Internal CI use
• Frequency • Retrieval and • Quarantine of
• Quarantine of interpretation implantable
implantable • Non items
items responsive / • Incubating of
inconclusive BI
 7. Special Performance tests for pre-vacuum
steam sterilizers
 Used to determine the efficiency of the vacuum
system of a pre-vacuum sterilizer.

 They are not sterility assurance tests, reference

shall comply with International Standard (e.g
AS, EN, US ) or equivalent and shall meet user’s
requirement.
Leak Rate Testing

comply with International Standards (eg AS,

EN, US ) or equivalent
meet user’s requirement
performed daily before the Bowie Dick type
test.
 Bowie Dick Type Test
To be performed daily at 134ºc to 136ºc for 3
to 3½ min, after the leak rate test.
Aim
to detect air entrapment
to evaluate the ability of pre vacuum
sterilizer
to reduce residual air from the chamber
space to a level sufficient
to prevent air compaction by re-entrapment
into a load as steam is introduction after
evacuation.
Comply with International Standards (eg As,
EN, US ) or equivalent and shall meet user’s
requirement.

Commercially produced packs are available,

some of which mirror the performance of
the test pack, originally described by Dr. J.
Bowie and Mr J.Dick.
Bowie Dick Type Test
Air Detector Function

Performed monthly
Comply with International Standards (eg
AS, EN, US ) or equivalent
Meet user’s requirement.
Air Detector Performance Test

Performed every three month

following major maintenance
 repair to the sterilizer
comply with International Standards
(eg AS, EN , US ) or equivalent
meet user’s requirement.
Penetration Time Test

Performed at the of commissioning,

using the largest packs.
whenever packs contents,packaging
materials are altered.
8. Monitoring of the packaging process
include continuous checks for :
Integrity of the outer wrap
Integrity of seals
Correct labeling (including date of
manufacturer, batch number and
operator’s identification as appropriate)
Correct change of the internal indictor
( if used )
sterilized packs shall be selected at random
examined and on a weekly basis for :
Integrity of the outer wrap, integrity of seals
and correct labeling
Easy of opening
Correct packaging techniques.
Correct contents
Correct layout of contents
Condition of contents ( including a check of
cleanliness of instruments, alignment and
function as appropriate.
Correct change of the internal indicator (if used)
 9. Occupation Health and Safety
 Consideration should be given to staff health ,
uniform and hand washing.

i. Staff Health
 Staff should be good mental and physical health
and maintain a high standard of personal hygiene.

 Staff who are at risk of expose to blood fluids

should be offered the Hepatitis vaccine.

 Staff should be aware of management protocols

following exposure to blood and body fluids.
 Staff Health
Cont...
To be screened for their tuberculosis status

dermatitis , skin infections or infected lesions

staff
- examined by medical practitioner before
recommencing duties for their own
protection.
- to minimize or preclude potential cross
infection hazards.
 Staff Health
Cont...
-Superficial skin lesion -covered by an
occlusive dressing
Accidents shall be recorded and reported
according to health care facility’s policy and
staff seen by a medical practitioner ,if
necessary
 Staff Health
Cont...
ii. Staff Uniforms
To maintain a clean environment and
minimize risks of cross infection , staff -wear
a clean uniform for duration of each shift.

All hair shall be safely secured and covered

whilst preparing items for sterilization.
 Staff Uniforms
Cont...
Plastic aprons, fluids repellent masks, gloves
and eye protection shall be made available
and worn by staff when handling used or
soiled items.

Hand and wrist jewellery including plain

wedding bands, should not be worn as there
are likely to increase the presence of germ-
negative bacilli.
 Staff Health
Cont..
iii. Hand washing

 On commencement and completion of duty

 Before and after using the toilet

 After working in a “dirty” area.

 Before entering a “clean” area.

 Hand washing
Cont...
Before and after meal breaks.

Following any other action which may cause

contamination of their hands.

Hand washing technique and their importance

in reducing cross-infection shall be taught
during orientation programs and reiterated on
a regular basis
 10. ENVIRONMENTAL CONTROL IN QUALITY
MANAGEMENT
 Work practices and stock control
 separated from soiled items and areas in
which soiled items are handled and
cleaned.

 The working environment shall be

maintained in a hygiene state at all times.
ENVIRONMENTAL CONTROL IN QUALITY
MANAGEMENT

 Efficient ventilation shall

comply to International Standards
(e.g.AS,EN,US) or equivalent
 meet user’s requirement.
ENVIRONMENTAL CONTROL IN QUALITY
MANAGEMENT
 Minimizing lint production and use of
powder in the sterilizing processing facility
to prevent contamination of cleaned
instruments
to minimize risk to staff health and safety
11. Evaluation,Feedback & outcomes
• A program of evaluation of processes and
procedures shall exist within health care
facility.

• Regular audits shall provide the mechanism

for analysis of result,feedback,adjustment
and review of activities in order to ensure
quality outcomes.
 Conclusion…

Quality management in the sterilization

must remain a priority as to meet the standard
of institutional in order to provide a positive
and safety impact in the services for the patient
particularly.
Thank you for
your attention
 References
• Business Dictionary (2019) available at http://www.businessdictionary.com/definition/quality-
management.html
• ISO 13485 ( 2017) available at https://advisera.com/13485academy/blog/2017/06/28/how-to-
manage-the-medical-device-sterilization-process-according-to-iso-13485/
• Leah Robinson When To Review Healthcare Policies And Procedures-
available at https://www.policymedical.com/when-to-review-healthcare-
policies-and-procedures
• Charles A. Hughes 2003 ict The Sterilization Quality Assurance Process
https://www.infectioncontroltoday.com/environmental-hygiene/sterilization-quality-assurance-
process
• Julia kagan (2019) investopia, Workers' Compensation
https://www.investopedia.com/terms/w/workers-compensation.asp
• Sonia K (2019) Management study HQ
• MSSA (2011)