Content Validation in Hong Kong, 1. What is validation...

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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

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Content

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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


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)


Operational qualification(OQ)

Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures



http://praxiom.com/iso-definition.htm








https://en.wikipedia.org/wiki/Requirement

https://en.wikipedia.org/wiki/Specification_(technical_standard)

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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








6. Summary

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Content

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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


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Importance of validation

We can not assure sterility without proper validation

• What is sterility

• How to test sterility

• Non-sterile product affect patient safety


How do we assure ‘Sterility’? What is sterility? Can we only base on the sterilizer printout to assure sterility?

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How do we assure ‘Sterility’?

What is sterility?

Can we only trust the chemical indicator label?

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How do we assure ‘Sterility’? What is sterility?

Can we only trust the Biological Indicator ?

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+ve

Result

(control)

-ve

Result

(test)


How do we assure ‘Sterility’? What is sterility?

Is it a routine practice for laboratory test on sterility?

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• It is impossible to see sterility

• To ensure this target:

Routine

control Calibration Validation

of the reprocessing cycle are crucial 16







6. Summary

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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

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A. Steam Sterilizer

ISO 17665

• Moist heat. Requirements for the development, validation and routine controls of a sterilization process for medical devices


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A. Steam Sterilizer

EN 285

• Requirements for large sterilizers (over 54 liter)


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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


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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.


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D. Ultrasonic Cleaner

HTM 2030 Part III: Health Technical Memorandum 2030


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• E. Endoscope Washer

ISO 15883-1

ISO 15883-4

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If we are without International Standard for reference……

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3. Validation of decontamination equipment ‘Manufacturer Standard’

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F. Heat Seal Machine

Test the functionality of the Heal Seal Machine

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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’

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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


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• Seal test PASS

FAIL



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• 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


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• Based on International Standard protocol schedule

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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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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

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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

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Reference Extracted from EN 285:2006+A1:2008


Steam Sterilizer Example: Thermometric Test

Reference Extracted from EN 285:2006+A1:2008


Steam Sterilizer Example: Thermometric Test

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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


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Washer Disinfector Seq. Test Description Daily Weekly Quarterly Annually Reference from Reference from

ISO 15883

9 Chemical Dosing - Low Level Indication


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


Washer Disinfector Example: Soil Test

• Reference from ISO 15883 -1

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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


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


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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6. Summary

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Content

•User

•Supplier or Engineer(EMSD)

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•Users

•Credential – Qualification of Staffs

•Knowledge

• Sufficient training

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Users Credential – Qualification of Staffs

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Steam Receivers Operator Course

Class III or Class VI

Certificate of Competency for Steam Sterilizer

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Users Credential & Training

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Users Sufficient training

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Users

Training Record

( Validation)

How to assure our staff are competent after training?

Monitoring

Spot check

Surprise check

Audit

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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


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



Checklist of Safety Check


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Bowie Dick test POSITION OF BOWIE-DICK TEST DEVICE


2.Bowie Dick test & 3. Batch Monitoring System

Batch monitoring

system


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•Supplier

• Existing Problem: Conflict of interest?

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•Engineer(EMSD)

•Existing Problem:

•How to assure they are competent?

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• Example of EMSD Carried Out Validation Test for Washer Disinfectors/ Steam Sterilizer

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• Washer Disinfectors-Test for ultrasonic activity – Aluminium Foil Test

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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

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• Steam Sterilizer-Thermometric Test (Full Load)


• Steam Sterilizer-Thermometric Test (Full Load)

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Example of UK

UK Framework on 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.


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.


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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


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.


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


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.


Regulatory Framework in UK


Validation Test Schedule 4. Who is responsible for validation?-Example of UK

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6. Summary

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Content

A. Environment

B. Sterilization process & set content

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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

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HBN 13 Chapter 3


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HBN 13

P. 16 Chapter 3


b) Operational Management

»Environmental control


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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

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P.10 Table 1

• HA Guidelines on Disinfection & Sterilization of Reusable Medical Devices for OT

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5. What else we need to validate? A. Environment 1. Air Flow of CSSD

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Decontamination Area(-ve)

IAP Area

+++ Sterilization Area

++


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

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3. Air Exchange Rate

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4. Particle Count Control

What is not acceptable in sterile instruments? 1. Bioburden 2. Particles


• ISO 14644 Cleanrooms & associated controlled environments – Part 1: Classification of air cleanliness

• Class 8 Standard

ISO 14644 Part 1 P.10 Table 1


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

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Airborne Particle Counter

5. What else we need to validate? A. Environment 4. Particle Count Control

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5. Temperature 6. Relative Humidity


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.

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5. Temperature & 6. Relative Humidity

• Extra Lighting in IAP

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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

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BEST PRACTICE OF REPROCESSING FOLLOW MANUFACTURERS’ “INSTRUCTIONS FOR USE”

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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

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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

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• 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

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• 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


1. Measure the weight

2.>10kgseparate 2 containers

Standardization of Washing Practice

• Example: ABDOMINAL MAJOR SET

98


Swab Reaction –

Click & Shake

Measure

& Record

99


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



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



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Standardization of Packing Practice

• Example: ABDOMINAL MAJOR SET (OT Tracking Set)

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Standardization of Sterilization Practice

103


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


105


Registration of ward specific reusable medical device

Voucher

106


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


Low Temperature Sterilization – Registration System

108


Low Temperature Sterilization – Registration System

Approval List Rejected List

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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

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