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

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  • 7/4/2016

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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 : lawth@ha.org.hk

    -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

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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

    2. Purpose of Validation

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

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    2. Purpose of Validation

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    How do we assure Sterility?

    What is sterility?

    Can we only trust the chemical indicator label?

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    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?

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    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

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    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

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    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

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    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

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    3. Validation of decontamination equipment

    D. Ultrasonic Cleaner

    HTM 2030 Part III: Health Technical Memorandum 2030

    International Standard Adoption

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    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

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    3. Validation of decontamination equipment Manufacturer Standard

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    3. Validation of decontamination equipment

    F. Heat Seal Machine

    Test the functionality of the Heal Seal Machine

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    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

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    3. Validation of decontamination equipment

    Calibration of Heat Sealing Machine

    (C) Temperature

    (N) Pressure

    (m/min)

    Speed

    High-temp

    175-185 100 10.0

    Low-Temp

    115-125 100 10.0

    Manufacturer Standard

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    Seal test PASS

    FAIL

    3. Validation of decontamination equipment

    Manufacturer Standard

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    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

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    3. Validation of decontamination equipment

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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

    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

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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

    12 Steam Superheat Test Engineer 13248 A.11 13.3.