Updates on CFPP and Standards

Updates on CFPP and Standards CFPP 01-01 How Technical are the changes? R.Kingston Authorising Engineer (Decontamination) KSVAS Ltd. K Sterilizer Validation Advisory Services Ltd 1

Introduction R.Kingston,BSc.(Hons),C.ENG,MIMECHE,FIHEEM, MCIBSE,MInstE,FRSH Ksvas Ltd. Authorising Engineer(Decontamination) Provide Independent Auditing and Advice on Decontamination equipment,facilities and processes for the NHS,Private Healthcare providers and Pharmaceutical Companies. K Sterilizer Validation Advisory Services Ltd 2

CFPP 01-01 How Technical are the changes? Background Dept. of Health issued HTM 01-01 Part A in 2007 This listed demise of HTM 2010/2030/2031 HTM 01 documents to now follow International /European standards(at the core),industry Standards and Health Specific Documents K Sterilizer Validation Advisory Services Ltd 3

K Sterilizer Validation Advisory Services Ltd Background Archived documents: Health Technical Memorandum 2010 - Sterilization, Health Technical Memorandum 2030 Washer disinfectors, and Health Technical Memorandum 2031 Clean steam for sterilization To be consolidated into one guidance document: Health Technical Memorandum 01 HTM 01-01 Part A stated Health Technical Memorandum 01 supersedes Health Technical Memoranda 2010, 2030 and 2031. BUT NOBODY TOLD US!! 4

Background HTM 01-01 Part A Main Management changes were: AP(S) become AE(D) to align with MGS plus HV/LV Addition of Site based AP(D) Introduction of Permit to work system K Sterilizer Validation Advisory Services Ltd 5

Background HTM 01-01 Part A Management and Environment Proposed HTM 01-01 Part B Equipment covering test equipment,washer disinfectors and sterilizers.(subsequently B was to be sub divided and issued as: Part B General Part C Sterilisers Part D - Washer Disinfectors) K Sterilizer Validation Advisory Services Ltd 6

CFPP 01-01 How Technical are the changes? Now CFPP 01-01 issued: May 2012 CFPP 01-01 Part A The formulation of local Policy and choices manual CFPP 01-01 Part B Common elements CFPP 01-01 Part C Steam Sterilisation CFPP 01-01 Part D Washer Disinfectors CFPP 01-01 Part E Alternatives to steam for the sterilisation of re-usable Medical Devices Live documents for review up-date on regular(e.g 6 monthly) basis K Sterilizer Validation Advisory Services Ltd 7

CFPP 01-01 Technical Changes CFPP 01-01 Part B Common elements Split into 3 main parts: i)test equipment and Materials- Temperature,pressure,flow measurement etc. Ii)Design and pre-purchase Considerations- Specification,Tendering,Purchasing through NHS Supplychain etc. Iii)Validation and verification IQ,OQ,PQ etc. Pulls a lot of the common parts from HTM 2010 and 2030 into one section. K Sterilizer Validation Advisory Services Ltd 8

CFPP 01-01 Technical Changes CFPP 01-01 Part B Common elements Re-Introduces new role of site based Authorised Person (Decontamination) and Competent Person(Decontamination) roles(a requirement of HTM 01-01 Part A from 2007 but not adopted generally within the NHS) K Sterilizer Validation Advisory Services Ltd 9

CFPP 01-01 CFPP :-Key Personnel Executive Manager Ultimate Management Responsibility Decontamination Lead Decontamination Responsibility User - Responsible for Management of the Process Senior Operational Manager Responsible for Engineering aspects of Decontamination

CFPP 01-01 CFPP :-Key Personnel Authorising Engineer(Decontamination) Responsible for providing general and impartial advice on all matters concerned with Decontamination) Authorised Person(Decontamination) Responsible for providing day to day operational management for the safety of Decontamination Equipment Competent Person(Decontamination) Responsible for carrying out maintenance,validation and periodic testing of washer disinfectors and sterilizers.

CFPP 01-01 Technical Changes CFPP 01-01 Part B Common elements Introduces details of Permit to work system again a requirement of HTM 01-01 Part A but generally not adopted within the NHS. A Permit to Work system existed in HTM 2010 for a number of years for working on Laboratory Sterilisers but was not universally adopted within the Healthservice K Sterilizer Validation Advisory Services Ltd 12

CFPP 01-01 Technical Changes CFPP 01-01 Part B Common elements - Permit to work The User should sign the permit to allow the equipment to be taken out of use for routine testing, repair and maintenance by the CP(D). The CP(D) should sign the permit to allow the equipment back into use after routine maintenance and weekly testing. The User should also sign the permit to allow the equipment back into use. After repairs following a breakdown and after quarterly or annual testing, both the AP(D) and the User should sign the permit to allow the equipment back into use. The CP(D) carrying out the work should also sign the permit. In the event of work spanning a number of shifts or days, the signatures of all the CP(D)s involved should show continuity K Sterilizer Validation Advisory Services Ltd 13

CFPP 01-01 Technical Changes CFPP 01-01 Part C Steam Sterilisation - covers: Design and Pre- Purchase considerations Validation and verification Operational Management Steam plant(including steam quality and steam contamination) Only covers Clinical Sterilizers not Laboratory or small sterilizers(htm 2010 covered all types) Appendix A Particular Specification for Porous Load Sterilizers nb MES C14 etc. withdrawn by Department of Health K Sterilizer Validation Advisory Services Ltd 14

Sterilizers Validation Periodic Tests Daily Tests - Differences 1) HTM 2010- Bowie Dick test for steam penetration Indicator to EN 867. Fail > 2 Deg.C depression in centre of test pack. USER Clinical Sterilizers 1) CFPP 01-01 - Bowie Dick test for steam penetration Indicator to ISO 11140 3 Fail > 2 Deg.C depression in centre of test pack. K Sterilizer Validation Advisory Services Ltd 15

Sterilizers Weekly Tests - Differences Validation Periodic Tests CP(D)/ TEST PERSON Clinical Sterilizers HTM 2010: CFPP 01-01: 1) Weekly Safety Tests 1) Weekly Safety Tests 2) Vacuum Leak Test 2) Air Leakage Test 3) Air Detector Function Test 3) Air Detector Function Test 4) Automatic control Test 5) Bowie dick test for steam penetration 4) Automatic control Test 5) Bowie dick test for steam penetration 16 K Sterilizer Validation Advisory Services Ltd

Sterilizers Weekly Tests - Differences Validation Periodic Tests CP(D)/ TEST PERSON Clinical Sterilizers HTM 2010: CFPP 01-01: 17 1) Weekly Safety Tests 2) Vacuum Leak Test 1.3 mbar/min 3) Air Detector Function Test 4) Automatic control Test Indicated, recorded and load temps. all in Sterilisation Temp. Band.Diff. between Ind./Rec. < 2 deg.c. Diff between Ind./Rec. Press.< 0.1 Bar 5) Bowie dick test for steam penetration 1) Weekly Safety Tests 2) Air Leakage Test 1.3.mbar/min 3) Air Detector Function Test 4) Automatic control Test Indicated, recorded and load temps. all in Sterilisation Temp. Band. Diff. between Ind./Rec. < 2 deg.c. Diff between Ind./Rec. Press.< 0.1 Bar 5) Bowie dick test for steam penetration

Sterilizers Quarterly Tests Differences HTM 2010(Cont d): 6)Thermometric test for a small load 3 sensors- Drain, Centre of Pack and Freespace Validation Periodic Tests CP(D)/TEST PERSON CFPP 01-01: Clinical Sterilizers 6)Thermometric test for a small load 7 sensors Freespace,5 deg. C for 1 st. 60secs. then < 2 deg. C. Equilibrium time 15 secs. Centre of Test pack and drain differ by < 2 deg.c. During holding time Ind./Rec./drain temp. < 1 deg.c and press. <0.05 bar All measured temps.< 2 deg.c Freespace,5 deg. C for 1 st. 60secs. then < 2 deg. C. Equilibrium time 15 secs. Any temperature within pack, drain and saturated steam temperature measured from chamber press. differ by < 2 deg.c. 18

Sterilizers Quarterly Tests Differences Validation Periodic Tests CP(D)/TEST PERSON Clinical Sterilizers HTM 2010(Cont d): CFPP 01-01: 7)Vacuum leak test(sensors removed) 8)Air detector function test 9)Bowie dick test for steam penetration. 7)Air Leakage test(sensors removed) 8)Air detector function test 9)Bowie dick test for steam penetration. K Sterilizer Validation Advisory Services Ltd 19

Sterilizers Yearly Tests - Differences Validation Periodic Tests CP(D)/TEST PERSON Clinical Sterilizers HTM 2010: CFPP 01-01: 1) Yearly Safety Tests 2) Steam NCG, Superheat & Dryness tests(3.5 %, 25 deg.c,0.95 Metal loads) 3) Vacuum leak test 4) Vacuum leak test (sensors connected) 1) Yearly Safety Tests 2) Steam NCG, Superheat & Dryness tests(3.5 %, 25 deg.c,0.95 Metal loads) 3) Air Leakage Test 4) Air Leakage Test (sensors connected) 20 K Sterilizer Validation Advisory Services Ltd

Sterilizers Yearly Tests - Differences Validation Periodic Tests CP(D)/TEST PERSON 5) HTM 2010: Steam Purity 5) CFPP 01-01: Steam Purity Clinical Sterilizers 21 K Sterilizer Validation Advisory Services Ltd

Sterilizers Yearly Tests - Differences Validation Periodic Tests CP(D)/TEST PERSON Clinical Sterilizers HTM 2010: 6) Automatic Control test 7) Verification of calibration of sterilizer instruments 8) Air detector performance test for a small load(3 Sensors) 9) Air detector performance test for a full load(3 Sensors) 10) Thermometric test for a small load(3 Sensors) 11)Thermometric test for a full load(3 Sensors) Temp./press. Allowances as small load CFPP 01-01: 6) Automatic Control test 7) Verification of calibration of sterilizer instruments 8) Air detector performance test for a small load(7 Sensors) 9) Air detector performance test for a full load(7 Sensors) 10) Thermometric test for a small load(7 Sensors) 11)Thermometric test for a full load(7 Sensors) Temp./press. Allowances as small load 22

Sterilizers Validation Yearly Tests- Differences HTM 2010: 12a) Load dryness test(fabrics) Periodic Tests CP(D)/TEST PERSON CFPP 01-01: Clinical Sterilizers 12a) Load dryness test(fabrics) 12b) Load dryness test for a metal Load * 0.2% increase in weight of test box with bolts 12c) Hollow load test * - Steam Penetration into instruments with Lumens 13) Test for performance requalification as required by user 14) Vacuum leak test (sensors removed) 15) Air detector function test 16) Bowie dick test for steam penetration 23 13) Test for performance requalification as required by user 14) Vacuum leak test (sensors removed) 15) Air detector function test 16) Bowie dick test for steam penetration K Sterilizer Validation Advisory Services Ltd

24 K Sterilizer Validation Advisory Services Ltd Sterilizers Validation As defined by the Manufacturer Periodic Tests CP(D)/TEST PERSON Clinical Sterilizers HTM 2010: CFPP 01-01: 1) No test 1) Dynamic Pressure Test.* (Check on max. rate of pressure change doesn t cause damage to packaging)

CFPP 01-01 Technical Changes CFPP 01-01 Part D Washer Disinfectors Design and Pre-Purchase considerations Validation and Verification Water Supply Operational Management Appendix A Particular Specification for Washer Disinfectors used for Processing Surgical Instruments nb MES C30 etc. withdrawn by Department of Health Covers Instrument WD s plus Ultrasonics doesn t cover Washer Disinfectors for Human Waste Containers and AER s (Endoscope Washer Disinfectors) now covered by CFPP 01-06 HTM 2030 covered all Types K Sterilizer Validation Advisory Services Ltd 25

Washer Disinfectors Validation Daily Tests - Differences Periodic Tests USER WDs Surgical Instruments HTM 2030: CFPP 01-01: 1) Automatic Control Test 2) Check Spray Arms for Free Movement 3) Check Spray Nozzles for Blockage 4) Remove and Clean Filters & Strainers 1) Automatic Control Test 2) Check Spray Arms for Free Movement 3) Check Spray Nozzles for Blockage(Particularly Cannulated Instrument carriages) 4) Remove and Clean Filters & Strainers 5) Ensure sufficient additives available and dosing system is functioning * 26 K Sterilizer Validation Advisory Services Ltd

Washer Disinfectors Validation Weekly Tests - Differences Periodic Tests USER or CP(D)/TEST PERSON WDs Surgical Instruments HTM 2030: CFPP 01-01: 1) Weekly Safety Tests 2) Carry Out Daily Tests 3) Water Hardness all Stages 4) Water Conductivity Final Rinse 5) Cleaning Efficacy Test by Residual Soil Detection(Test soil Edinburgh or equivalent) 1) Weekly Safety Tests 2) Carry Out Daily Tests 3) Water Hardness all Stages 4) Water Conductivity Final Rinse 5) Cleaning Efficacy Test by Residual Soil Detection(Test soil to BS EN ISO 15883-5) 6) Automatic Control Test 6) Automatic Control Test 27 K Sterilizer Validation Advisory Services Ltd

Washer Disinfectors Validation Periodic Tests Quarterly Tests - Differences CP(D)/TEST PERSON WDs Surgical Instruments HTM 2030: CFPP 01-01: 1) Weekly Safety Tests 2) Automatic Control Tests 3) Verification of Calibration 4) Thermometric Tests Disinfection repeated three times 5) Cleaning Efficacy Test by residual soil detection 1) Weekly Safety Tests 2) Automatic Control Tests 3) Verification of Calibration 4) Thermometric Tests Disinfection repeated 3 times for PQ and commissioning ; 1 for periodic testing (A0 > 600) 5) Cleaning Efficacy Test by residual soil detection 28 K Sterilizer Validation Advisory Services Ltd

Washer Disinfectors Validation Yearly Tests - Differences Periodic Tests CP(D)/TEST PERSON WDs Surgical Instruments HTM 2030: CFPP 01-01: 1) Yearly Safety Tests 2) Automatic Control Test 3) Verification of Calibration 4) Thermometric Tests Disinfection repeated three times 7 Sensors Ind./Rec..2 deg.c from auto. control Sensor.On load each item < 4 deg.c from each other K Sterilizer Validation Advisory Services Ltd 1) Yearly Safety Tests 2) Automatic Control Test 3) Verification of Calibration 4) Thermometric Tests Disinfection repeated 3 times for PQ and commissioning ; 1 for periodic testing (A0 > 600) 7 Sensors Ind./Rec..2 deg.c from auto. control Sensor.On load each item < 4 deg.c from each other 29

Washer Disinfectors Validation Yearly Tests - Differences Periodic Tests CP(D)/TEST PERSON WDs Surgical Instruments HTM 2030: CFPP 01-01: 5) Cleaning Efficacy Test 6) Performance Qualification Tests 5) Cleaning Efficacy Test 6) Performance Qualification Tests 30 K Sterilizer Validation Advisory Services Ltd

Washer Disinfectors Validation HTM 2030: Yearly Tests - Differences 7) Drainage tests 8)Chemical Additive dosing tests 9)Load carriers Alignment etc. 10)Load dryness test 11)Process residues Chemical additives Periodic Tests CP(D)/TEST PERSON CFPP 01-01: WDs Surgical Instruments 7) Drainage tests 8)Chemical Additive dosing tests 9)Load carriers Alignment etc. 10)Load dryness test 11)Process residues Chemical additives 12)Calibration, limits and Function of IMS checked during Quarterly and Annual Testing * 31 K Sterilizer Validation Advisory Services Ltd

CFPP 01-01 Technical Changes CFPP 01-01 Part E Alternatives to steam for the sterilisation of re-usable Medical Devices Covers: Quality and Safety standards for Non- Steam sterilisation Guidance on Safety Risk assessment Surgical Instrument and other Device compatibility Based generally on EN 14937 and covers typically at present Ethylene Oxide(previously detailed in HTM 2010),Gaseous Hydrogen Peroxide and Ozone Not much detail more work required on document K Sterilizer Validation Advisory Services Ltd 32

CFPP 01-01 Summary of Technical Changes: As can be seen a lot are really part updates of HTM 2010,2030 and HTM 2031 but the core tests remain the same. This is not surprising as the HTM s,although archived,are still recognised worldwide as Good Practice Further work is still required to complete the level of detail of the testing given rather than keep on referring to European Standards K Sterilizer Validation Advisory Services Ltd 33

CFPP 01-01 The Future.

CFPP 01-01 Issue of new International/European/British Standards (such as ISO 17665 Part 3,development of new protein residue detection techniques /Alternative sterilisation processes etc.)will also require the documents to be reviewed and amended on an ongoing basis.

CFPP 01-01 The Missing Link(s): Laboratory Sterilizers Washers for Human Waste Containers

CFPP 01-01 Guidance needs to be expanded to cover Decontamination Equipment not covered at present e.g Laboratory Sterilisers,Human Waste containers etc.

CFPP 01-01 Going forward: The Devils in the Detail We need Common Interpretation/implementation

CFPP 01-01 To ensure CFPP s are updated to align with Current standards and best Decontamination Practice Professional Bodies such as IDSc.,IHEEM,IPS etc. need to adopt the guidance sections of the CFPP s together and review and update these on a regular(6 monthly?) basis. Hopefully by guidance being produced jointly by the Decontamination Professional Organisations variance in Interpretation and implementation will be minimised.

CFPP 01-01 How Technical are the Changes? Thank you Any Questions? K Sterilizer Validation Advisory Services Ltd 40