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Validation in Hong Kong, are we ready?
Hong Kong Sterile Service Management Association Limited Seminar
4 July 2016
Mr. Samuel Law -Vice Chairman, Hong Kong Sterile Service Management Association Limited(HKSSMA) -Cluster Operations Manager, Central Sterile Supplies Department, NTWC
-Email : [email protected]
-Tel : 24685315
1. What is validation?
2. Purpose of validation
3. Validation of decontamination equipment
4. Who is responsible for validation?
5. What else we need to validate?
6. Summary
2
Content
3
1. What is validation? • Validation is a process.
• It uses objective evidence to confirm that the requirements which define an intended use or application have been met. Whenever all requirements have been met, a validated status is achieved.
• ISO 9000 Quality Management Definitions 4
Validation is independent procedure that is used for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.
Source: https://en.wikipedia.org/wiki/Verification_and_validation
1. What is validation?
Installation qualification(IQ)
Process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification.
(ISO/TS 11139:2006, definition 2.22)
1. What is validation?
Operational qualification(OQ)
Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures
(ISO/TS 11139:2006, definition 2.27)
1. What is validation?
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Performance qualification(PQ)
Process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting specifications
(ISO/TS 11139:2006, definition 2.30)
1. What is validation?
1. What is validation?
2. Purpose of validation
3. Validation of decontamination equipment
4. Who is responsible for validation?
5. What else we need to validate?
6. Summary
8
Content
9
2. Purpose of Validation
Why do we need validated procedure? Example: In Germany: • Required by law Medical Device Directive • Robert Koch Institute Guideline Hygienic
processing of medical devices European Union: Medical Device Directive 93/42 EEC, Amended by Directive 2007/47 EC
Why do we need validated procedure?
High safety in reprocessing of medical devices
(cleaning , disinfection , packaging , sterilization )
To protect the patients health and safety
To protect the staff
All steps of reprocessing must be carried out properly and documented 10
2. Purpose of Validation
11
Importance of validation
We can not assure sterility without proper validation
• What is sterility
• How to test sterility
• Non-sterile product affect patient safety
2. Purpose of Validation
How do we assure ‘Sterility’? What is sterility? Can we only base on the sterilizer printout to assure sterility?
12
2. Purpose of Validation
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How do we assure ‘Sterility’?
What is sterility?
Can we only trust the chemical indicator label?
13
2. Purpose of Validation
How do we assure ‘Sterility’? What is sterility?
Can we only trust the Biological Indicator ?
14
+ve
Result
(control)
-ve
Result
(test)
2. Purpose of Validation
How do we assure ‘Sterility’? What is sterility?
Is it a routine practice for laboratory test on sterility?
15
2. Purpose of Validation
• It is impossible to see sterility
• To ensure this target:
Routine
control Calibration Validation
of the reprocessing cycle are crucial 16
2. Purpose of Validation
1. What is validation?
2. Purpose of validation
3. Validation of decontamination equipment
4. Who is responsible for validation?
5. What else we need to validate?
6. Summary
17
Content 3. Validation of
decontamination equipment
Steam Sterilizer
Plasma Sterilizer
Washer Disinfector
Ultrasonic Cleaner
Endoscope Washer
Heat Seal Machine 18
How to validate? What are the standard?
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International Standard Adoption
19
3. Validation of decontamination equipment
A. Steam Sterilizer
ISO 17665
• Moist heat. Requirements for the development, validation and routine controls of a sterilization process for medical devices
International Standard Adoption
20
3. Validation of decontamination equipment
A. Steam Sterilizer
EN 285
• Requirements for large sterilizers (over 54 liter)
International Standard Adoption
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3. Validation of decontamination equipment
B. Plasma Sterilizer ISO 14937
General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
International Standard Adoption
22
3. Validation of decontamination equipment
C. Washer Disinfector
ISO 15883 Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
International Standard Adoption
23
3. Validation of decontamination equipment
D. Ultrasonic Cleaner
HTM 2030 Part III: Health Technical Memorandum 2030
International Standard Adoption
24
3. Validation of decontamination equipment
• E. Endoscope Washer
ISO 15883-1
ISO 15883-4
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If we are without International Standard for reference……
25
3. Validation of decontamination equipment ‘Manufacturer Standard’
26
3. Validation of decontamination equipment
F. Heat Seal Machine
Test the functionality of the Heal Seal Machine
27
3. Validation of decontamination equipment
Calibration of Heat Sealing Machine
• Sealing temperature is one of the critical parameters
• Insertion of Thermo Sensor to test the sealing temperature.
Type ‘T’ Thermosensor
Heating device for sealing
temperature
‘Manufacturer Standard’
28
3. Validation of decontamination equipment
Calibration of Heat Sealing Machine
溫度(°C) Temperature
壓力(N) Pressure
速度(m/min)
Speed
高溫 High-temp
175-185 100 10.0
低溫 Low-Temp
115-125 100 10.0
‘Manufacturer Standard’
29
• Seal test PASS
FAIL
3. Validation of decontamination equipment
‘Manufacturer Standard’
30
3. Validation of decontamination equipment
• Ink test
Take the photo after 20 seconds. The blue ink should not penetrate the seal seam, otherwise the test is fail.
PASS
Use the plastic tube to put 2mL blue ink into the pouch evenly near the sealed seam
‘Manufacturer Standard’
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• Based on International Standard protocol schedule
31
3. Validation of decontamination equipment
32
3. Validation of decontamination equipment
Steam Sterilizer Seq. Test Description Daily Weekly Quarterly Annually Reference
from CFPP Part C
Reference from ISO
17665-2
EN 285 2006+
A1 2008
1 Safety Checks User User Engineer Engineer 13452 - 13453
2 Automatic Control Test User Engineer Engineer 13205 7.1.5
3 Leak Rate Test (Vacuum Leak Test)
User Engineer Engineer 13206 A.6 8.2.3; 18
4 Induced Leak Rate Test User Engineer Engineer
5 Air Detector Performance Test for Small Load
Engineer 13207 A.7 8.2.4.2; 19.2
6 Air Detector Performance Test for Full Load
Engineer 13207 A.7 8.2.4.3; 19.3
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3. Validation of decontamination equipment
Steam Sterilizer Seq. Test Description Daily Weekly Quarterly Annually Reference
from CFPP Part C
Reference from ISO
17665-2
EN 285 2006+
A1 2008
7 Thermometric Test (small load)
Engineer 13208 A4.1 8.2.1.2; 16.1
8 Thermometric Test (full load)
Engineer 13209 A4.2 8.2.1.3; 16.2
9 Air Detector Function Test
User Engineer Engineer 13766 A.7 8.2.4.4; 19.4
10 Bowie-Dick Test User Engineer Engineer 13212 A.5 8.2.2; 17
11 Steam Non-condensable Gas Test
Engineer 13247 A.11 13.3.2; 22.1
34
3. Validation of decontamination equipment
Steam Sterilizer
Seq. Test Description Daily Weekly Quarterly Annually Reference from CFPP
Part C
Reference from
ISO 17665-2
EN 285 2006+
A1 2008
12 Steam Superheat Test Engineer 13248 A.11 13.3.4; 22.3
13 Steam Dryness Test Engineer 13249 A.11 13.3.3; 22.2
14 Steam Chemical Test Engineer 13742 – 13743
A.11 13.3.5
15 Hollow Load Test
User User
13213 A.2 8.2.5; 15
16 Microbiological Test User User User 13202 B.3
35
Reference Extracted from EN 285:2006+A1:2008
3. Validation of decontamination equipment
Steam Sterilizer Example: Thermometric Test
Reference Extracted from EN 285:2006+A1:2008
3. Validation of decontamination equipment
Steam Sterilizer Example: Thermometric Test
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37
3. Validation of decontamination equipment
Washer Disinfector Seq. Test Description Daily Weekly Quarterly Annually Reference from HTM
2030 Reference from
ISO 15883
1 Safety Check User Engineer Engineer HTM 2030 7.8 - 7.9
2 Automatic Control Test User User Engineer Engineer HTM 2030 12.4 - 12.8 ISO 15883-1 6.13
3 Doors and Door Interlocks - Cycle Start
Engineer Engineer ISO 15883-1 6.3.1
4 Doors and Door Interloacks - Loading / Unloading
Engineer Engineer ISO 15883-1 6.3.4
5 Drainage - Free Draining Engineer HTM 2030 9.38 - 9.39 ISO 15883-1 6.5.4
6 Thermometric Test - Thermal Disinfection
Engineer Engineer HTM 2030 11.4 - 11.11 ISO 15883-1 6.8.2
7 Water Quality Test Engineer HTM 2030 9.140 - 9.152 ISO 15883-1 6.4.2
8 Chemical Dosing - Accuracy and Repeatability
Engineer Engineer HTM 2030 9.279 - 9.284 ISO 15883-1 6.9.1
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3. Validation of decontamination equipment
Washer Disinfector Seq. Test Description Daily Weekly Quarterly Annually Reference from Reference from
ISO 15883
9 Chemical Dosing - Low Level Indication
Engineer Engineer HTM 2030 9.285 - 9.289 ISO 15883-1 6.9.2
10 Remove clean strainers and filters
User HTM 2030
11 Check spray arm rotation for free movement
User HTM 2030
12 Check Spray Nozzles for Blockage
User HTM 2030
13 Cleaning Efficacy - Soil Test of Reference Load
User User HTM 2030 10.7 -10.24; 14.8 - 14.18
ISO 15883-1 6.10.2-6.10.3
14 Cleaning Efficacy - Residual Proteinaceous Contamination
User User HTM 2030 10.7 - 10.24; 10.37 - 10.51
ISO 15883-1 Annex C
15 Cleaning Efficacy - Load Check Indicator STF
User User User
16 Final Rinse Water Test (Total Viable Count) (Optional)
User HTM2030 9.213 - 9.226 ISO 15883-1 6.4.2.4
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ISO 15883-1 HTM2030
3. Validation of decontamination equipment
Washer Disinfector Example: Soil Test
• Reference from ISO 15883 -1
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3. Validation of decontamination equipment
Washer Disinfector Example: Soil Test
Seq. Test Description Daily Weekly Monthly Quarterly Annually Reference from HTM 2030
1 Water System - Overflow Test EMSD HTM 2030 9.237-9.244
2 Sound Pressure Measurement
EMSD HTM 2030 9.353-9.359
3 Chemical Additive Dosing Test - Reproducibility
EMSD HTM 2030 9.279-9.284
4 Automatic Control Test User User User HTM 2030 12.4-12.8
5 Remove and Clean Strainers and Filters
User HTM 2030
6 Cleaning Efficacy - Test Soil for Reference Load
User User HTM 2030 19.18-19.31
7 Ultrasonic Activity Test - Sono Check
User User User Test Indicator Supplier
8 Monthly Checks (Including: Aluminum Foil Test)
User User User Modified from AS 2773
3. Validation of decontamination equipment
Ultrasonic Cleaner Seq. Test Description Daily Weekly Quarterly Annually Reference from HTM 2030
Reference from ISO 15883
1 Safety Check User Engineer Engineer HTM 2030 7.8 - 7.9
2 Automatic Control Test User User Engineer Engineer HTM 2030 12.4 - 12.8 ISO 15883-1 6.13
3 Drainage - Free Draining Engineer HTM 2030 9.38 - 9.39 ISO 15883-1 6.5.4
4 Chemical Dosing - Accuracy and Repeatability
Engineer HTM 2030 9.279 - 9.284 ISO 15883-1 6.9.1
5 Channel Non-obstruction Test
Engineer Engineer HTM2030 17.19 - 17.22 ISO 15883-4 6.6
6 Channel Not Connected Test
Engineer Engineer ISO 15883-4 6.7
7 Thermometric Test - Thermal Disinfection Stage
Engineer HTM 2030 11.4 - 11.11, 9.323 - 9.329
ISO 15883-4 6.9
8 Water Quality Test
Engineer Engineer HTM 2030 9.100 - 9.200 ISO 15883-1 6.4.2
9 Final Rinse Water Test (1) (Total Viable Count)
User User HTM2030 9.213 - 9.226 ISO 15883-1 6.4.2.4
10 Final Rinse Water Test (2)
User
ISO 15883-4 6.12.5.2, Annex E
11 Leak Test Fail Alarm
User User ISO 15883-4 4.2.3
12 Cleaning Efficacy - Residual Proteinaceous Contamination
User HTM 2030 10.37 - 10.49
ISO 15883-1 Annex C
13 Cleaning Efficacy - Soil Test of Reference Load
User User HTM 2030 17.33 - 17.40 ISO 15883-4 6.11.3-6.11.6
ISO 15883-5 Annex E
3. Validation of decontamination equipment Endoscope Washer
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1. What is validation?
2. Purpose of validation
3. Validation of decontamination equipment
4. Who is responsible for validation?
5. What else we need to validate?
6. Summary
43
Content
•User
•Supplier or Engineer(EMSD)
44
4. Who is responsible for validation?
•Users
•Credential – Qualification of Staffs
•Knowledge
• Sufficient training
45
4. Who is responsible for validation?
4. Who is responsible for validation?
Users Credential – Qualification of Staffs
46
Steam Receivers Operator Course
Class III or Class VI
Certificate of Competency for Steam Sterilizer
47
4. Who is responsible for validation?
Users Credential & Training
48
4. Who is responsible for validation?
Users Sufficient training
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49
4. Who is responsible for validation?
Users
Training Record
( Validation)
How to assure our staff are competent after training?
Monitoring
Spot check
Surprise check
Audit
50
4. Who is responsible for validation? Users
Example of User Carried Out Routine Checks /Validation for Steam Sterilizer
Steam Sterilizer:
1. Safety Checks
2. Bowie Dick test
3. Batch monitoring system
4. Who is responsible for validation?
Example of User Carried Out Routine Checks for Steam Sterilizer(Daily tests )
1. Safety Checks Aim:
• To ensure the safe functioning of the sterilizer
Procedure:
• Check and examine the door seal cleanliness and integrity; Cleanliness of penal; available of printer cassette & paper
Reference from CFPP Part C 13452 - 13453
Check Door Seal
4. Who is responsible for validation?
Example of User Carried Out Routine Checks for Steam Sterilizer(Daily tests )
Checklist of Safety Check
4. Who is responsible for validation?
54
Bowie Dick test POSITION OF BOWIE-DICK TEST DEVICE
Example of User Carried Out Routine Checks for Steam Sterilizer(Daily tests )
2.Bowie Dick test & 3. Batch Monitoring System
Batch monitoring
system
4. Who is responsible for validation?
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•Supplier
• Existing Problem: Conflict of interest?
55
4. Who is responsible for validation?
•Engineer(EMSD)
•Existing Problem:
•How to assure they are competent?
56
4. Who is responsible for validation?
• Example of EMSD Carried Out Validation Test for Washer Disinfectors/ Steam Sterilizer
57
4. Who is responsible for validation?
• Washer Disinfectors-Test for ultrasonic activity – Aluminium Foil Test
58
4. Who is responsible for validation? Engineer(EMSD)
Aim:
• To demonstrate that at the levels at which the controls are set the required sterilizing conditions will be produced in a test load of specified maximum mass and of sufficient size to fill the usable space
Procedure:
• Connect the metering device to the sterilizer chamber
• Conduct the successful air leakage test
• Place standard test pack as part of full load inside the sterilizer chamber with 7 temperature sensors
• Carry out a sterilization cycle
Reference from EN 285 2006+A1 2008 8.2.1.3, 16.2
ISO 17665-2 A4.2
CFPP Part C 13209
59
• Steam Sterilizer-Thermometric Test (Full Load)
4. Who is responsible for validation? Engineer(EMSD)
• Steam Sterilizer-Thermometric Test (Full Load)
60
4. Who is responsible for validation? Engineer(EMSD)
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Example of UK
UK Framework on Validation
4. Who is responsible for validation?
General Structure of UK 4. Who is responsible for validation?-Example of UK
User
• The person responsible for the day-to-day management of the sterilizer and washer disinfector.
• In a hospital, the USER could be a sterile services department manager, laboratory manager or theatre manager; in primary care he or she could be a general practitioner, dentist, or other health professional. Where a sterilizer/washer disinfector is used to process medicinal products, the USER is normally the production manager in charge of the entire manufacturing process.
4. Who is responsible for validation?-Example of UK
User responsibility
• to certify that the decontamination equipment is fit for use;
• to hold all documentation relating to the decontamination equipment, including the names of other key personnel;
• to ensure that decontamination equipment is subject to periodic testing and maintenance;
• to appoint operators where required and ensure that they are adequately trained;
• to maintain production records;
• to establish procedures for product release in line with the quality management system;
• to ensure that procedures for production, quality control and safe working are documented and adhered to in the light of statutory requirements and accepted best practice.
4. Who is responsible for validation?-Example of UK
Authorized Person (Decontamination) AP(D)
• The person who provides independent auditing and advice on the decontamination of reusable medical devices involving sterilizers, washer-disinfectors etc. He/she can review and witness validation processes of these machines. He/she should have direct contact with the USER and other key personnel.
• Completed a training course of SSD manager / Supervisor which is accredited by City & Guild UK
4. Who is responsible for validation?-Example of UK Authorized Person(D)
Responsibilities • the engineering management of decontamination equipment;
• line management and/or appointment of the CP(D);
• the safe and effective systems of work for all installed decontamination equipment within his/her area of responsibility;
• the acceptance criteria for operational and performance testing of all installed decontamination equipment;
• liaison with the AE(D), Decontamination Lead and other interested professionals;
• authorizing the use of decontamination equipment after major repair or refurbishment and after quarterly or annual tests.
4. Who is responsible for validation?-Example of UK
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Authorized Engineer (Decontamination), AE(D)
• provides independent auditing and advice on WD’s, sterilizers and sterilization. Refer to the original document for details of qualification and responsibilities for AE(D).
• The Institute of Healthcare Engineering and Estate Management (IHEEM) supports and operates the decontamination technology platform which is made up of IHEEM-registered AE(D)s
4. Who is responsible for validation?-Example of UK
AE(D) Responsibilities
• to provide to Management and others, general and impartial advice on all matters concerned with decontamination;
• to advise Management and others on programs of validation and testing;
• to audit reports on validation, revalidation and yearly tests submitted by the AP(D);
• to advise Management and others on programs of periodic tests and periodic maintenance;
• to advise Management and others on operational procedures for routine production;
• to advise Management on the appointment of the AP(D);
• to provide technical advice on purchasing and selection of decontamination equipment for the users;
• to provide technical advice on the relevant guidance on decontamination equipment and procedures.
4. Who is responsible for validation?-Example of UK
Competent Person (Decontamination) [CP(D)]
• The CP(D) is defined as a person designated by Management to carry out maintenance, validation and periodic testing of washer-disinfectors and sterilizers.
• The CP(D) should report directly to an appropriate member of the estates department (for example AP(D)) or should be subcontracted by them.
• Should complete a training course which is accredited by City & Guild in UK
4. Who is responsible for validation?-Example of UK
Competent Person (Decontamination) [CP(D)]
1. To carry out maintenance tasks; 2. To carry out repair work; 3. To conduct validation tests as
given in CFPP 01-01 Parts B, C and D;
4. To conduct periodic tests as given in CFPP 01-01 Parts B, C and D.
4. Who is responsible for validation?-Example of UK
Regulatory Framework in UK
4. Who is responsible for validation?-Example of UK
Validation Test Schedule 4. Who is responsible for validation?-Example of UK
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1. What is validation?
2. Purpose of validation
3. Validation of decontamination equipment
4. Who is responsible for validation?
5. What else we need to validate?
6. Summary
73
Content
A. Environment
B. Sterilization process & set content
74
5. What else we need to validate?
Hospital Building Note 13 a. Infrastructure / Building Work » Design criteria » Workflow and traffic control » General requirements » Specific functional design
requirements b) Operational Management » Environmental control » Attire and behaviour
5. What else we need to validate? A. Environment
76
HBN 13 Chapter 3
5. What else we need to validate? A. Environment
77
HBN 13
P. 16 Chapter 3
5. What else we need to validate? A. Environment
b) Operational Management
»Environmental control
5. What else we need to validate? A. Environment
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Elements of Environmental Control
1. Air flow 2. Pressure difference between adjacent area 3. Air exchange rate 4. Particle count 5. Temperature 6. Relative Humidity 7. Lighting
5. What else we need to validate? A. Environment International Standard (ISO 14644)
Cleanrooms Standard
80
5. What else we need to validate? A. Environment
P.10 Table 1
• HA Guidelines on Disinfection & Sterilization of Reusable Medical Devices for OT
81
5. What else we need to validate? A. Environment 1. Air Flow of CSSD
82
Decontamination Area(-ve)
IAP Area
+++ Sterilization Area
++
5. What else we need to validate? A. Environment
Decon IAP
Sterilization Area Sterile Store
- ve
pressure
+++ ve
pressure
++ ve
pressure + ve
pressure
Minimum Pressure Difference :
10-20Pa
Direction of air flow
2. Pressure Difference between adjacent area
83
5. What else we need to validate? A. Environment
3. Air Exchange Rate
84
5. What else we need to validate? A. Environment
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4. Particle Count Control
What is not acceptable in sterile instruments? 1. Bioburden 2. Particles
5. What else we need to validate? A. Environment
• ISO 14644 Cleanrooms & associated controlled environments – Part 1: Classification of air cleanliness
• Class 8 Standard
ISO 14644 Part 1 P.10 Table 1
5. What else we need to validate? A. Environment
Floor plan of 15 packing locations (217m2)
E機尾 A機尾
1 2 3
4 5 6 喉房
爐位:門 7 8 9 潔具房
10 11 12
13 14 15 抽風櫃
0.3 0.5 1.0 3.0 5.0 10.0
Concentration (Particle count / m3 of air)
Particle Size (um)Sampled
volume
(L)
Average 504 101 24 4 2 1
Max 1196 296 63 6 4 1
Particle Count Monitoring of IAP room
87
Airborne Particle Counter
5. What else we need to validate? A. Environment 4. Particle Count Control
88
5. Temperature 6. Relative Humidity
5. What else we need to validate? A. Environment
Routine monitoring of temperature and relative humidity Function:
•Monitor temperature and humidity
•Alert operators by alarming
if the parameters are out of predetermined range.
Frequency:
•Once an hour, data logged 24-hour a day.
89
5. What else we need to validate? A. Environment
5. Temperature & 6. Relative Humidity
• Extra Lighting in IAP
90
ISO 14644 Class 8
clean room standard
Lighting with 700 lux
5. What else we need to validate? A. Environment 7. Lighting
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A. Environment
B. Sterilization process & set content
91
5. What else we need to validate?
BEST PRACTICE OF REPROCESSING FOLLOW MANUFACTURERS’ “INSTRUCTIONS FOR USE”
92
5. What else we need to validate?
Information to be provided by the Medical Device Manufacturer ISO 17664
• Reprocessing instructions
• Limitations and restrictions
• Preparation at the point of use
Cleansing
Disinfection
Drying
Packing, Sterilization, Storage
• Inspection, maintenance and testing
• Validation of the reprocessing information
• Risk analysis
ISO 17664:2004, P9-13,
Information to be provided by the medical device manufacturer
93
5. What else we need to validate? 5. What else we need to validate? B. Sterilization process & set content
Form for New OT Instrument Set
94
• Requisition Form for New OT Instrument Set Formation
Registration of Ward Specific Medical device
• Set Specialty
Anaes/CTS/Dental/ENT/EYE/
General/GYN/MED/NS/OBS/ORT/Paed/Plastic/SURG/URO/VAS
• Set Priority
• High/Medium/Low
• Total no. of Items 95
5. What else we need to validate? B. Sterilization process & set content
96
5. What else we need to validate? B. Sterilization process & set content
• Packaging method: Container/Wrapper/Pouch • Protective Guard • Washing Method: Thermal Disinfection/Alcohol Disinfection • Sterilization method: 134 Steam/Plasma Standard/DUO/Flex/Express Cycle • BI test Required • Implant
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• Weight of set
97
5. What else we need to validate? B. Sterilization process & set content
1. Measure the weight
2.>10kgseparate 2 containers
Standardization of Washing Practice
• Example: ABDOMINAL MAJOR SET
98
5. What else we need to validate? B. Sterilization process & set content
Swab Reaction –
Click & Shake
Measure
& Record
99
5. What else we need to validate? B. Sterilization process & set content
Cleaning Efficacy Test ATP SWAB TEST
Reference RLU scale on instrument cleanliness from supplier
• Acceptable range was far less than 150 RLU in
our CSSD. The average RLU was 37.
100
5. What else we need to validate? B. Sterilization process & set content
Cleaning Efficacy Test ATP SWAB TEST
Implantable Instruments
No. Description Decontamination description Visual
Cleanliness
RLU
Before After Before After
1. Box with lid for
holding washers
Manual wash
With manual
pre-cleanse and
water jet before
decontamination;
Mini washer
disinfector;
With pre-soak gel
sprayed;
Standard cycle,
without
sonication.
Yes 404 34
2. Guide wire Yes 3028 49
3. Measuring
device Yes 5341 34
4.
A.O. 40mm
cannulated
screw tray
Yes 634 20
5. 4mm screw Yes 102 22
6. LCP plate,
7-hole
Manual wash
With manual
pre-cleanse
before
decontamination
Automatic
washer
disinfector (B);
With pre-soak gel
sprayed;
Standard cycle,
without
sonication.
Yes 686 24
7. 8-hole T plate
(x41.151) Yes 632 44
8. 8-hole T plate
(x41.141) Yes 617 22
9. 3.5mm screw
(size 88) Yes 88 37
10. Screw tray inner
cover Yes 925 476
Cleaning Efficacy Monitoring by ATP
5. What else we need to validate? B. Sterilization process & set content
Cleaning Efficacy Test ATP SWAB TEST
102
5. What else we need to validate? B. Sterilization process & set content
Standardization of Packing Practice
• Example: ABDOMINAL MAJOR SET (OT Tracking Set)
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Standardization of Sterilization Practice
103
5. What else we need to validate? B. Sterilization process & set content
屯門醫院中央消毒物品及無菌物品供應部 文件號碼 TMCSSD-C-SA-034-V1
版本 1
滅菌區工作注意事項 6 生效日期 01 – APR – 2014 下次修定 01 – APR – 2016 頁數 1
D&C+STOP Set 必須置於爐車頂層進行滅菌,以減少濕包的機會。
Standardization of Sterilization Practice
5. What else we need to validate? B. Sterilization process & set content
105
5. What else we need to validate? B. Sterilization process & set content
Registration of ward specific reusable medical device
Voucher
106
5. What else we need to validate? B. Sterilization process & set content
Registration of ward specific reusable medical device
Standardization of Packing Practice
107
Low Temperature Item – Approval List
• Approval List - Information
• Cycle Compatibility • Packaging
• Remarks
• Approved by whom and date
Cycle Packaging Remarks
Express / Standard Wrapper / Box Check Rings
Approved by Alex Leung Date 01/02/2015
5. What else we need to validate? B. Sterilization process & set content
Low Temperature Sterilization – Registration System
108
5. What else we need to validate? B. Sterilization process & set content
Low Temperature Sterilization – Registration System
Approval List Rejected List
7/4/2016
19
6. Summary
Are we ready?
109 110
• What is the governance in this area?
• What is the regulatory framework in Hong Kong?
• Who is knowledgeable enough to be the Authorized Engineer, Authorized Person, Competent Person?
• Do we have decontamination lead in your CSSD?
• What is the role of cluster lead in HA?
• Are we in the right track?
6. Summary
By Samuel Tat Hong LAW Vice-Chairperson Hong Kong Sterile Services Management Association Ltd. Hong Kong http://hkssma.org/ Cluster Operations Manager Central Sterile Supplies Department Tuen Mun Hospital and Pok Oi Hospital New Territories West Cluster Tel: (852)-24685315 E-mail : [email protected]
End Thank you for your attention