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
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Introduction
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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
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CFPP 01-01 How Technical are the
changes?
Background
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Dept. of Health issued
HTM 01-01 Part – A in
2007
l This listed demise of
HTM 2010/2030/2031
l HTM 01 documents to
now follow International
/European standards(at
the core),Industry
Standards and Health
Specific Documents
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Background
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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
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HTM 01-01 Part A stated ‘Health
Technical Memorandum 01
supersedes Health Technical
Memoranda 2010, 2030 and 2031.’
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‘BUT NOBODY TOLD US!!’
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Background
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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
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Background
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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)
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CFPP 01-01 How Technical are the
changes?
Now
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CFPP 01-01 issued: May 2012
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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’
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CFPP 01-01
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Technical Changes
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CFPP 01-01 Part B – ‘Common
elements’
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Split into 3 main parts:
i)Test equipment and MaterialsTemperature,pressure,flow measurement etc.
Ii)Design and pre-purchase ConsiderationsSpecification,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.
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CFPP 01-01
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Technical Changes
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CFPP 01-01 Part B – ‘Common
elements’
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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)
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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
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Technical Changes
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CFPP 01-01 Part B – ‘Common
elements’
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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
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CFPP 01-01
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Technical Changes
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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
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CFPP 01-01
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Technical Changes
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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)
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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
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Sterilizers
Validation
Periodic Tests
Daily Tests Differences
USER
1) HTM 2010- Bowie Dick test
for steam penetration –
Indicator to EN 867 .
Fail > 2 Deg.C depression in
centre of test pack.
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.
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Sterilizers
Validation
Periodic Tests
Weekly Tests Differences
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
4)
Automatic control Test
5)
Bowie dick test for steam
penetration
5)
Bowie dick test for steam
penetration
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Sterilizers
Validation
Periodic Tests
Weekly Tests Differences
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CP(D)/ TEST PERSON
Clinical Sterilizers
HTM 2010:
CFPP 01-01:
1)
Weekly Safety Tests
1)
Weekly Safety Tests
2)
Vacuum Leak Test – 1.3 mbar/min
2)
Air Leakage Test – 1.3.mbar/min
3)
Air Detector Function Test
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
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
5)
Bowie dick test for steam
penetration
Sterilizers
Validation
Periodic Tests
Quarterly Tests –
Differences
CP(D)/TEST
PERSON
HTM 2010(Cont’d):
6)Thermometric test for a small load –
3 sensors- Drain, Centre of Pack and
Clinical Sterilizers
CFPP 01-01:
6)Thermometric test for a small load –
7 sensors
Freespace
Freespace ,5 deg. C for 1st. 60secs.
then < 2 deg. C.
Equilibrium time 15 secs.
Freespace ,5 deg. C for 1st. 60secs. then
< 2 deg. C.
Centre of Test pack and drain differ by
< 2 deg.C.
Equilibrium time 15 secs.
During holding time Ind./Rec./drain
temp. < 1 deg.C and press. <0.05 bar
All measured temps.< 2 deg.C
Any temperature within pack, drain and
saturated steam temperature measured
from chamber press. differ by < 2
18
deg.C.
Sterilizers
Validation
Periodic Tests
CP(D)/TEST
PERSON
Quarterly Tests –
Differences
Clinical Sterilizers
HTM 2010(Cont’d):
CFPP 01-01:
7)Vacuum leak test(sensors removed)
7)Air Leakage test(sensors removed)
8)Air detector function test
8)Air detector function test
9)Bowie dick test for steam penetration.
9)Bowie dick test for steam penetration.
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Sterilizers
Validation
Periodic Tests
Yearly Tests Differences
CP(D)/TEST
PERSON
Clinical Sterilizers
HTM 2010:
CFPP 01-01:
1)
Yearly Safety Tests
1)
Yearly Safety Tests
2)
Steam NCG , Superheat & Dryness
tests(3.5 %, 25 deg.C,0.95 Metal loads)
2)
Steam NCG , Superheat & Dryness
tests(3.5 %, 25 deg.C,0.95 Metal loads)
3)
Vacuum leak test
3)
Air Leakage Test
4)
Vacuum leak test (sensors connected)
4)
Air Leakage Test (sensors connected)
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Sterilizers
Validation
Periodic Tests
Yearly Tests Differences
5) HTM 2010: Steam Purity
CP(D)/TEST
PERSON
Clinical Sterilizers
5) CFPP 01-01: Steam Purity
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K Sterilizer Validation Advisory Services Ltd
Sterilizers
Validation
Periodic Tests
Yearly Tests Differences
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
CP(D)/TEST
PERSON
Clinical Sterilizers
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
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Sterilizers
Validation
Periodic Tests
Yearly TestsDifferences
CP(D)/TEST
PERSON
Clinical Sterilizers
HTM 2010:
CFPP 01-01:
12a) Load dryness test(Fabrics)
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
13) Test for performance requalification as
required by user
14) Vacuum leak test (sensors removed)
14) Vacuum leak test (sensors removed)
15) Air detector function test
15) Air detector function test
16) Bowie dick test for steam penetration
16) Bowie dick test for steam penetration
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Sterilizers
Validation
Periodic Tests
As defined by the
Manufacturer
CP(D)/TEST
PERSON
HTM 2010:
CFPP 01-01:
1) No test
1)
Clinical Sterilizers
Dynamic Pressure Test.*
(Check on max. rate of pressure change doesn’t
cause damage to packaging)
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CFPP 01-01
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Technical Changes
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CFPP 01-01 Part D – ‘Washer
Disinfectors’
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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
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Washer Disinfectors
Validation
Daily Tests Differences
Periodic Tests
USER
WDs Surgical Instruments
HTM 2030:
CFPP 01-01:
1)
Automatic Control Test
1)
Automatic Control Test
2)
Check Spray Arms for Free Movement
2)
Check Spray Arms for Free Movement
3)
Check Spray Nozzles for
Blockage(Particularly Cannulated
Instrument carriages)
4)
Remove and Clean Filters & Strainers
3)
Check Spray Nozzles for Blockage
4)
Remove and Clean Filters & Strainers
5) Ensure sufficient additives available
and dosing system is functioning *
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Washer Disinfectors
Validation
Periodic Tests
Weekly Tests Differences
USER or CP(D)/TEST
PERSON
WDs Surgical Instruments
HTM 2030:
CFPP 01-01:
1)
Weekly Safety Tests
1)
Weekly Safety Tests
2)
Carry Out Daily Tests
2)
Carry Out Daily Tests
3)
Water Hardness all Stages
3)
Water Hardness all Stages
4)
Water Conductivity Final Rinse
4)
Water Conductivity Final Rinse
5)
Cleaning Efficacy Test by
Residual Soil Detection(Test soil
–’Edinburgh’ or equivalent)
5)
Cleaning Efficacy Test by
Residual Soil Detection(Test soil
to BS EN ISO 15883-5)
6)
Automatic Control Test
6)
Automatic Control Test
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Washer Disinfectors
Validation
Periodic Tests
Quarterly Tests Differences
CP(D)/TEST
PERSON
WDs Surgical Instruments
HTM 2030:
CFPP 01-01:
1)
Weekly Safety Tests
1)
Weekly Safety Tests
2)
Automatic Control Tests
2)
Automatic Control Tests
3)
Verification of Calibration
3)
Verification of Calibration
4)
Thermometric Tests Disinfection
repeated three times
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
5)
Cleaning Efficacy Test by
residual soil detection
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Washer Disinfectors
Validation
Periodic Tests
Yearly Tests Differences
CP(D)/TEST
PERSON
WDs Surgical Instruments
HTM 2030:
CFPP 01-01:
1)
Yearly Safety Tests
1)
Yearly Safety Tests
2)
Automatic Control Test
2)
Automatic Control Test
3)
Verification of Calibration
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
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
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Washer Disinfectors
Validation
Periodic Tests
Yearly Tests Differences
CP(D)/TEST
PERSON
WDs Surgical Instruments
HTM 2030:
CFPP 01-01:
5)
Cleaning Efficacy Test
5)
Cleaning Efficacy Test
6)
Performance Qualification Tests
6)
Performance Qualification Tests
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Washer Disinfectors
Validation
Periodic Tests
Yearly Tests Differences
CP(D)/TEST
PERSON
WDs Surgical Instruments
HTM 2030:
CFPP 01-01:
7) Drainage tests
7) Drainage tests
8)Chemical Additive dosing tests
8)Chemical Additive dosing tests
9)Load carriers – Alignment etc.
9)Load carriers – Alignment etc.
10)Load dryness test
10)Load dryness test
11)Process residues – Chemical
additives
11)Process residues – Chemical
additives
12)Calibration , limits and Function of
IMS checked during Quarterly and
Annual Testing *
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CFPP 01-01
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Technical Changes
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CFPP 01-01 Part E ‘Alternatives to
steam for the sterilisation of re-usable
Medical Devices’– Covers:
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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
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CFPP 01-01
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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
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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
?
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