HTM COMPLIANCE

PROGRAMME

Compliance Timeline 1 July 1 July

HTM 01-01 2017 2018
HTM 01-06
HIGH RISK SURGICAL ALL ACUTE SURGICAL
PROCEDURES PROCEDURES
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1. Introduction
HTM 01-01 was published in 2016 to help health organisations to develop policies regarding the
management, use and decontamination of reusable medical devices at controlled costs, using risk
control which will allow them to comply with regulations 12 (2) (h) and 15 of the Health and Social Care
Act 2008 (Regulated Activities) regulations 2014.

2. Objective
To provide a rationale for steps taken to meet guidance in terms of checking protein residue levels and
the use of PCDs with the aim of validating and if necessary improving the washing process.
HTM 01-01 requires the daily use of a PCD in washer disinfectors along with other routine tests.

3. Practical steps
Washer PCD use
The HTM has made changes to the way in which washer-disinfectors are monitored; it indicates routine
use of Process Challenge Devices daily.

Daily tests – User

1. Check spray arm rotation for free movement
2. Check spray nozzles for blockage (paying particular attention to those fitted to carriages for
cannulated instruments)
3. Remove and clean strainers and filters etc
4. Ensure sufficient additives available and that dosing system is functioning
5. Process challenge device cleaning efficacy test
Weekly tests – User or CP(D)
1. Weekly safety checks
2. Carry out daily tests
3. Water hardness (all process stages)
4. Water conductivity (final rinse stage)
5. Automatic control test
Quarterly tests – CP(D)
1. Weekly safety checks
2. Automatic control test
3. Verification of calibration of WD instruments
4. Thermometric test for thermal disinfection
5. Cleaning efficacy test:
1
– reference load
general instruments
rigid endoscopic/MAT instruments
– test soil

Periodic monitoring by the User (see paragraph 2.271): Residual protein detection test (to
be carried out by nominated individual(s))

Main cleaning verification changes

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sts – CP(D) Yearly and revalidation tests – CP(D)

Yearly
Yearly and
and revalidation
revalidation tests tests – – CP(D)
CP(D)
1. Yearly safety checks
1. Yearly safety checks
1. Yearly safety checks
2. Automatic control test
2.
2. Automatic
Automatic control
control test
test
3. Verification of calibration of WD instruments
n of WD instruments
3.
3. Verification
Verification of of calibration
calibration of of WD
WD instruments
instruments
4. Water system:
4. Water
4.– Water system:
system:
chemical purity
–– chemical
chemical purity
purity
ins – bacterial endotoxins
–– bacterial
bacterial endotoxins
endotoxins
5. Drainage:
5.
5.– Drainage:
Drainage:
free draining
–– free
free draining
rge – efficacy of draining
discharge
– efficacy
– efficacy of
of discharge
discharge
ks: 6. Doors and door interlocks:
6. Doors and
6.– Cycle-start
Doors and door door interlocks:
interlocks:
ck interlock
–– Cycle-start
Cycle-start interlock
– In-cycle interlock interlock
–– In-cycle
In-cycle interlock
interlock
lock – Failed- cycle interlock
–– Failed-
Failed- cycle
cycle interlock
interlock
or failure 7. Fault indication on sensor failure
7.
7. Fault indication on sensor failure
Fault indication on sensor failure
test 8. Water vapour discharge test
8.
8. Water
Water vapour
vapour discharge
discharge test test
g tests: 9. Chemical additive dosing tests:
9.
9.– Chemical
Chemical additive
additive dosing tests:
dosing admitted
tests:
volume admitted reproducibility of volume
–– reproducibility
reproducibility of
of volume
volume admitted
admitted
n – low level detection
–– low
low level
level detection
detection
10. Load carriers
10.
10. Load
Load carriers
carriers
11. Air quality
11. Air quality
11. Air quality

4. Test
4. methods
4. Test
Test methods
methods
2.72 Test
and requirements aremethods, equipment
detailed in BS EN ISO and15883
requirements are 2.
parts 1 and detailed in BS EN ISO 15883 parts 1 and 2.
2.72
2.72 Test
Test methods,
methods, equipment
equipment andand requirements
requirements are
are detailed
detailed in
in BS
BS EN
EN ISO
ISO 15883
15883 parts
parts 1
1 and
and 2.
2.
The
es 2315 and 2316)The
Browne Browne
used
The STF STF
STF (product
(product
in combination
Browne is acodes
codes
(product 2315 2315
and
test which
codes 2315 and
and 2316)
2316) usedwith
complies
2316) used
in thein
in combination
combination
used is
is a
is a test
combination test
test which
awhich complies
complies
which with
with the
with the
complies the
requirements of EN ISO 15883.
requirements of ISO/TS 15883-5
requirements of ISO/TS 15883-5
The
ance on how to HTM offers
use such no further
devices, guidance
therefore theon how to is
following useproposed:
such devices, therefore the following is proposed:
The
The HTM
HTM offers
offers no
no further
further guidance
guidance onon how
how to
to use
use such
such devices,
devices, therefore
therefore thethe following
following is
is proposed:
proposed:

4.1 an
uation by placing Establish onthe
STFEstablish each current
rack situation
(5 racks by aplacing
for 15byDIN anwasher).
STF on The each rack (5 racks for a 15 DIN washer). The
4.1
4.1 the Establish the
the current
current situation
situation placing
bychamber.
placing an STF on each rack (5
(5 racks for a
a 15
15 DIN
DIN washer).
washer). The
products
ed such that they cover should
back, be placed
front and such
centre that
of thethey cover an theSTFback, onfront
eachand rackcentre racks forchamber.
of the The
products should be placed such that they cover the back,
products should be placed such that they cover the back, front and centre of the chamber. front and centre of the chamber.
4.2 anRun
rmal cycle with empty washer on a normal cycle with an empty chamber.
thechamber.
4.2
4.2 Run Run the the washer
washer on on a a normal
normal cyclecycle with
with an
an empty
empty chamber.
chamber.
4.3end Review
ch test at the of the the
full results of each test at the end of the full cycle.
cycle.
4.3
4.3 ReviewReview the the results
results of of each
each test
test at
at the
the end
end of of the
the full
full cycle.
cycle.
n the washer 4.4should
If any
be soil remains,
reviewed for then the
issues washer
such as should jets,
blocked be reviewed
spray for issues such as blocked jets, spray
4.4
4.4 If any
If any soil
soil remains,
remains, then the
then the whichwasher
washermay should
should be reviewed for
for issues
issues such
such asas blocked
blocked jets,
jets, spray
r parameter whicharm mayrotation
have or
caused any other
the parameter
failure. havebe reviewed
caused the failure. spray
arm rotation or any other parameter which may
arm rotation or any other parameter which may have caused the failure. have caused the failure.
4.5 then
ents to be made, If there
the are
cycleno should
amendments be changedto be tomade,
achievethenclean
the cycle
STF should be changed to achieve clean STF
4.5
4.5 dosingIf
If there
there are
are no amendments
nomean
amendments to
to be
be made,
made, then
then thetheorcycle
cycle should
should be be changed to to achieve
achieve clean
clean STF
indicators.
an increasing detergent This or may
lengthening increasing
the wash detergent
phase. dosing lengthening thechanged
wash phase. STF
indicators. This may mean increasing detergent dosing
indicators. This may mean increasing detergent dosing or lengthening the wash phase. or lengthening the wash phase.
4.6 Once
ieving a consistent cleanthe(Awashergood is achieving
guide would a consistent
be to run clean (A good guide would be to run 3 consecutive
3 consecutive
4.6
4.6 Once
Once the washer
the washer
washer can is
is achieving
achieving aa consistent
consistent clean
clean (A good guide would be to run 3 consecutive
can then be used cycles)
for normal thenuse.the then be used for normal use. (A good guide would be to run 3 consecutive
cycles)
cycles) then the washer can then be used for normal use.
then the washer can then be used for normal use.
4.7
he department can For routine
decide to monitoring,
use as many thedevices
department as it can decide
wishes and to
runuse as many devices as it wishes and run
4.7
4.7 with For routine monitoring, the
the department can decide to use as
as many
many devices
devices as as itit wishes
wishes and
and run
machines to comply them inFortheroutine
loadeddaily ortestmonitoring,
empty machines
requirement. department
to comply with canthe decide
dailyto use
test requirement. run
them in loaded or empty machines to comply with
them in loaded or empty machines to comply with the daily test requirement. the daily test requirement.
establish a 4.8 Thefor
protocol
4.8
department
these testsshould
The with an establish a protocol
action plan in the for
eventtheseof atests with an action plan in the event of a
The department
4.8 result.
failed department should should establish
establish a a protocol
protocol for for these
these tests tests with
with anan action
action plan
plan in in the
the event
event of
of a
a
failed result.
failed result.
SOP Guide to Compliance

Protein detection

‘One of the main purposes of cleaning surgical instruments is the removal of prion protein, particularly as
– when dried – it adheres very strongly to metal surfaces. Prion proteins are infectious by contact.
Protein tests should be able to detect residual proteins adhering strongly to surgical instruments. For this
reason, methods that detect proteins in situ are better detectors of risk than methods that attempt to
elute proteins that may be firmly attached to surfaces.’ (Section 2.271 HTM 01-01 part D)

This statement is misleading as there are many other purposes for cleaning medical instruments such as
lipids etc.

Data illustrated in Appendix 1 also brings into question the theory that ‘in situ methods are better detectors’.

ACDP indicates the upper limit of acceptable protein contamination after processing is 5 g BSA
equivalent per instrument side. A lower level is necessary for neurosurgical instruments.

It is necessary to use protein detection methods to check for the efficient removal of protein from surgical
instruments after processing. Protein levels are used as an indication of the amount of prion protein
contamination. Ninhydrin swab kits are commonly used for this purpose, but recent evidence shows that
ninhydrin is insensitive. Furthermore, proteins are poorly desorbed from instruments by swabbing. Other
commonly used methods have also been shown to be insensitive.

Firstly, it should be questioned that the level of 5μg per side of an instrument is considered a threshold
level. Simply considering the range of instruments and the range of sizes makes this statement virtually
meaningless and of no assistance in guidance.

While accepting that a 5μg measurement represents a level of risk it can then be assumed that a
process which is proven to be accurate and sensitive to a level of 1ug represents position from which an
assessment can be made with a safety margin.

Test kits are available which demonstrate a 1μg sensitivity to protein.

Additionally, evidence is available that swabbing methods are effective. The data used to denounce
swabbing came from a paper entitled Critical evaluation of ninhydrin for monitoring surgical instrument
decontamination N.K. Nayuni a, E. Cloutman-Green b, M. Hollis b, J. Hartley b, S. Martin c, D. Perrett a;
Journal of hospital infection 84 (2013) 97 –102
.
The paper points out correctly that ninhydrin is not sensitive to the 5μg level, however it then goes on to
associate swabbing with this lack of sensitivity – the evidence used is that a swab left a remaining 30%
of BSA, meaning that 70% was recovered. Subsequent studies have proven that ‘in situ’ techniques
have detected less than 50% of a known volume of protein. (Study by Health Facilities Scotland – 2016)

HTM Compliance Programme

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Hence it is concluded that a swab method with a sensitivity of 1μg provides adequate evidence of protein
residue and allows difficult to clean areas such as box joints and cannulated instruments to be sampled.

A study, illustrated in Appendix 1, demonstrates the effectiveness of swabbing – ‘Verification of detection

limit and swabbing technique for the detection of proteins from surfaces of stainless steel instruments’.

Swabbing techniques have been used and developed over 150 years:
– Quick, convenient and appropriate
– Used in variety of industry
– Law & Enforcement
– Forensics (e.g. Crime Scene Investigations)
– Airport Security
– Food Industry
– Pharmaceutical Industry
– Microbiology & Medicine
– Water Purification / Environmental Monitoring
– DNA Analysis (oral swabbing)
– Healthcare
– Proven technique across all industries, and still the first proven choice

Further studies have also proven the lack of accuracy and therefore sensitivity in scanning techniques.
One such study, illustrated in Appendix 2, was carried out by Health Facilities Scotland in which a
known (5μg) quantity of protein in the form of BSA, blood and brain was inoculated onto stainless steel
coupons under the scrutiny of DoH, HFS and an AE(D).This is similar to or less sensitive than the paper
referenced above which condemns swabbing as being ineffective.

Protein residue testing – What do I need to do and how many tests?

To reach compliance, the department should first establish a list of ‘high risk’ items from within the
normal operating process in the department. This should be based on the knowledge and skill of the
team and spread over several days, shifts and personnel. (Information on sample size follows later)

Example: establish the total number of high risk or difficult-to-clean instruments processed in a year. This
can then be used to calculate the average over a given period (a day, a shift) and can then be broken
down further to a washer. The outcome will be a figure from which the sample size can be calculated.

The sampling table below is taken from an International standard; it is suggested that the user makes
their own choice of sampling plan. ISO 11462 can provide guidance for trend analysis.
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Significant sampling

Batch Size Sample Size (Normal) Sample Size (reduced)

2-8 2 2
9 - 15 3 2
16 - 25 5 3
26 - 50 8 5
51 - 90 13 5
91 - 150 20 8
151 - 280 32 13
281 - 500 50 20
501 - 1,200 80 32
1,201 - 3,200 125 50
3,201 - 10,000 200 80
10,001 - 35,000 315 125
35,001 - 150,000 500 200
150,001 - 500,000 800 315
500,001 and over 1,250 500

For example, if the ‘lot’ is agreed to be 100 instruments in each period then the sample size will be 20
samples. A protocol can then be established which defines the process to be followed if a fail condition is
found – normally a root cause analysis and improvement process. Also, a record needs to be kept of
the results for review and trend analysis. The trend analysis needs to follow an agreed protocol which
again can be as simple as reviewing the results on a weekly/monthly basis. This can be as simple as
an excel spreadsheet which can produce a chart. This can be constantly monitored by visual display and
reviewed at a regular management review. Finally, the protocol can include an agreed reduction in tests
after an agreed continuous period of good results and a review as to the ongoing suitability of the agreed
test instruments reflecting the ongoing changes in the activities of the department.

What if I get a fail result?

Under normal SSD practice any dirty instrument is immediately acted on, investigated and returned,
along with the rest of the set for reprocessing. It is suggested that any fail result on protein testing is
treated in the same way. This will lead to establishing root cause and process improvement.

Trend analysis

This is a requirement of the HTM and is a means by which process improvement can be managed.
This can be done by reviewing the data on a regular basis.

Each FAIL result should be recorded and plotted on a simple chart with an indication of the root cause.
The information can then be reviewed on a regular basis and any trends such as day, shift, time,
operator, machine etc. logged on the chart such that any trends are clearly noticeable and a further
action plan put into place.

The data which is collected will in most instances be like that shown on the next page, with a very small
number of failures expected. This can be monitored using a simple excel spreadsheet. An example of the
expected results is on the next page.

HTM Compliance Programme

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Guide to Compliance SOP

Example of expected results

!"#$ % &"'' % is that
“The ambition (")*%all healthcare providers engaged in the
management and decontamination of surgical instruments used in
+,-,,-.+,/ % . %will be expected
acute care +% to have implemented this guidance by 1
+.-,,-.+,/ % July 2018.
,% However, providers
,% whose instruments are likely to come
into contact with higher risk tissues, for example neurological tissue,
+0-,,-.+,/ % . % to give this
are expected +%guidance higher priority and move to in situ
protein detection methodologies by 1 July 2017.”
+1-,,-.+,/ % .% +%
Professor Dame Sally Davies, Chief Medical Officer
+2-,,-.+,/ % .% +%
+/-,,-.+,/ % .% +%
+3-,,-.+,/ % .% +%
+4-,,-.+,/ % .% +%
+5-,,-.+,/ % .% +%
,+-,,-.+,/ % .% +%
,,-,,-.+,/ % .% +%
,.-,,-.+,/ % .% +%
,0-,,-.+,/ % .% +%
,1-,,-.+,/ % .% +%
,2-,,-.+,/ % .% +%

CE marking

The manufacturer will need to have CE-marked the product under the Medical Devices Regulations and
issue a declaration of conformity to demonstrate that the device has met all relevant essential
requirements for the medical device and that they have followed an appropriate conformity assessment
route.

Under current legislation the statement is impossible to comply with in relation to sterilization indicators
and therefore, by association, decontamination process indicators are not considered as either medical
devices or accessories to medical devices and therefore cannot be CE-marked.

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY

FRAMEWORK FOR MEDICAL DEVICES

Version 1.17 (09-2015)

Sterilization indicators monitor the performance of the sterilizer. They do not affect the sterilization
procedure and only provide additional information to the user.

Sterilization indicators do not fulfil either the definition of a medical device laid down in Article 1(2)a of
Directive 93/42/EEC or the definition of an accessory laid down in Article 1(2)b of Directive 93/42/EEC as
they are not intended specifically to be used together with a device to enable it to be used in accordance
with its stated use.

Guidance was sought from MHRA on 16th November 2016 with the following response:

“If the product is intended to be used specifically and routinely for protein detection after disinfection
processes have been carried out (i.e. systematically on every instrument) then the product would be
regarded as an accessory to the surgical instruments. If, however, the product is intended to be used for
the periodic inspection of surgical instruments to verify the efficacy of the washer-disinfector, then the
product would be an accessory to the washer-disinfector and as such would not be regarded as a
medical device because a washer-disinfector is already an accessory to the surgical instruments and it is
not possible to have an accessory to an accessory under the medical device regulations”.
SOP Guide to Compliance

Endoscope washer testing

HTM 01-06 requires that an AER (Automatic Endoscope Reprocessor) is tested on a weekly basis. Prior
to this, the test was carried out only as a quarterly requirement.

The test consisted of a soil which provided little in the way of a challenge to the AER and in practice
what fluid did remain in the tube was removed by the initial patency check or in the pre-rinse. The test is
difficult and inconsistent. This test is still included in the guidance (below) but is open to variation as it is
produced locally from variable sources. Practical users will know that the greater majority of the soil runs
out of the tube. The drying guidance is also variable as wide time and temperature conditions and no
humidity conditions are specified. Likewise, they will have experienced that the current soil is cleared
from the tube in the air or fluid patency check and if not then will usually be cleaned by the pre-wash.

Type tests

Using the test soil given in paragraph 16.5, this test can be used as an optional test to determine the water
distribution and cleaning efficiency of the chamber and load carriers to ensure a good water distribution.

16.3 Cleaning efficacy should be determined using the relevant test soil listed in ISO/TS 15883-5.
15883-5.
This soil isThis
usedsoil
toistest
used to test instruments
instruments after cycle.
after an EWD an EWD cycle.

16.4 The relevant test soil in ISO/TS 15883-5 or validated equivalent is applied to a reference load or surrogate
device of demonstrated relevance (see BS EN ISO 15883-4 Annex F or as specified in the relevant part of BS
EN ISO 15883-4).
15883-4). Effective from
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test soil can
water, 50 ml be made from: Page 8 of 10
•• water, 5030
glycerol, mL;ml
• glycerol, 30 mL;
16.6 •Mix horse
all theserum, 30 ml together andagitate in a stomacher to give a liquid of uniform consistency. Use
constituents
•• horse serum,
dehydrated hog30mucin,
mL;
immediately or store in an airtight5container
g at 2–5ºC for not more than one month or follow the manufacturer's
•• unbleached plain flour, 25 gg;
dehydrated
recommendation. hog mucin,
•• unbleached
aqueous plain flour,
safranine 2 g; 2 % mass fraction, 1 ml
solution,
• aqueous safranine solution, 2 % mass fraction, 1 mL.
Application and use

Preparation
16.7 If the soiland
hasstorage
been stored, allow it to equilibrate to room temperature before use.

16.8 The test should be carried out using water of a quality suitable for the system requirements using a
detergent recommended by the EWD manufacturer. The EWD manufacturer should provide guidance on the
minimum water quality suitable for the detergent recommended. All tests should be run in triplicate and for each
series of tests each of the three tests should meet or exceed the minimum acceptance criteria.

Method of application

16.9 Apply soil to the inner surface of the test pieces by injecting the soil into the tubes of the surrogate device
(approximately 5 mL into the 1 mm inner-diameter tube and 20 mL into each of the 2 mm inner-diameter tubes).
Lay the tubes on a horizontal surface and roll them to distribute the soil over the inner surface.

16.10 Hold them vertically to allow excess soil to drain away. Apply a small amount of air to each soiled tube
from a syringe full of air to blow out any residual soil. Then apply an even coat of soil to the outer surface using
the paintbrush. Allow excess soil to drain from the items and allow them to dry at room temperature (15–25°C)
for not less than 30 minutes and not more than two hours. To dry the inner surface of the tubes, connect each
tube to a small air pump and pass air down the tubes for the drying time.

Method of use

HTM Compliance
16.11Programme
Connect each surrogate tube to the EWD outlets with suitable connectors: one of the 2 mm inner-
diameter tubes connected to the biopsy lumen; and one of the 1 mm inner- diameter tubes connected to the
bridge lumen, if used. Run a routine EWD cycle. After completion of the wash cycle, the cycle should be
aborted, if possible. The test load should be removed and examined for the presence of residual soil. This test
16.7 If the soil has been stored, allow it to equilibrate to room temperature before use.
16.8 The test should be carried out using water of a quality suitable for the system requirements using a
detergent
16.8 The recommended
test should be by the EWD
carried manufacturer.
out using water of The EWD suitable
a quality manufacturer
for theshould provide
system guidanceusing
requirements on the
a
minimum
detergent water quality suitable
recommended by thefor the detergent
EWD recommended.
manufacturer. The EWD All tests shouldshould
manufacturer be runprovide
in triplicate and for
guidance oneach
the
series
minimumof tests
watereach of the
quality three for
suitable tests
theshould meetrecommended.
detergent or exceed the All
minimum acceptance
tests should be runcriteria.
in triplicate and for each
Guide to Compliance
series of tests each of the three tests should meet or exceed the minimum acceptance criteria. SOP

Method of application
Method of application
16.9 Apply soil to the inner surface of the test pieces by injecting the soil into the tubes of the surrogate device
(approximately
16.9 Apply soil 5tomL
theinto thesurface
inner 1 mm inner-diameter tube
of the test pieces byand 20 mLthe
injecting into each
soil intoofthe
thetubes
2 mmofinner-diameter tubes).
the surrogate device
(approximately
Lay the tubes on5a mL into the 1surface
horizontal mm inner-diameter
and roll themtube and 20 ml
to distribute theinto
soileach
over of
thethe 2 mm
inner inner -diameter tubes).
surface.
Lay the tubes on a horizontal surface and roll them to distribute the soil over the inner surface.

16.10 Hold them vertically to allow excess soil to drain away. Apply a small amount of air to each soiled tube
16.10a Hold
from them
syringe fullvertically to allow
of air to blow out excess soil tosoil.
any residual drain away.
Then Apply
apply a small
an even amount
coat of soil of
to air
thetoouter
eachsurface
soiled using
tube
frompaintbrush.
the a syringe full of air
Allow to blow
excess soilout
to any
drainresidual
from the soil. Then
items apply
and allowanthem
even tocoat
dryofatsoil
roomto the outer surface
temperature using
(15–25°C)
thenot
for paintbrush.
less thanAllow excessand
30 minutes soilnot
to drain
more from
than the
two items
hours.and allow
To dry thethem
innertosurface
dry at room
of thetemperature (15–25°C)
tubes, connect each
for not
tube to less thanair30pump
a small minutes
andand
pass not
airmore
downthanthe two
tubeshours. Todrying
for the dry thetime.
inner surface of the tubes, connect each
tube to a small air pump and pass air down the tubes for the drying time.

Method of use
Method of use
16.11 Connect each surrogate tube to the EWD outlets with suitable connectors: one of the 2 mm inner-
16.11 Connect
diameter each surrogate
tubes connected to thetube to the
biopsy EWD
lumen; andoutlets
one ofwith
the suitable connectors:
1 mm inner- diameterone of the
tubes 2 mm inner-
connected to the
diameter
bridge tubesifconnected
lumen, used. Runto athe biopsyEWD
routine lumen; and After
cycle. one of the 1 mmofinner-
completion diameter
the wash tubes
cycle, the connected
cycle shouldto the
be
bridge lumen,
aborted, if used.
if possible. TheRun
test aload
routine
shouldEWD cycle. After
be removed andcompletion
examined forof the presence
wash cycle, the cycle
of residual should
soil. be
This test
aborted,beif run
should possible. The test load should be removed and examined for the presence of residual soil. This test
in duplicate.
should be run in duplicate.
16.12 The manufacturer should establish worst- case conditions of temperature, detergent concentration,
16.12 Thedevice
surrogate manufacturer should
configuration, establish
based worst- case
on illustrations in BSconditions of temperature,
EN ISO 15883-4 Annex F, detergent
and water concentration,
pressure/flow
surrogate
rate for usedevice
duringconfiguration,
testing. based on illustrations in BS EN ISO 15883-4 Annex F, and water pressure/flow
rate for use during testing.
16.13 By analysing the fraction of soil removed during the cleaning process when operated for various time
16.13 Byshorter
periods analysing
thanthe fraction
those of soil
that will removed
normally be during
used, athe cleaning process
quantitative whenofoperated
comparison cleaning for various
efficacy cantime
be
periods shorter than those that will normally be used, a quantitative comparison of cleaning efficacy can be
made.
made.
16.14 The recommended minimum operating conditions given by the manufacturer should be based on these
16.14which
data, The recommended
should be made minimum
availableoperating conditions
to the User as part given
of the by the manufacturer
type-test data sheets.should be based on these
data, which should be made available to the User as part of the type-test data sheets.

Operational tests
Operational tests
16.15 During operational tests of cleaning efficacy with test soils, the disinfection stage and drying stage should
16.15
be Duringunless
disabled, operational
it can tests of cleaning efficacy
be demonstrated with test
that inclusion soils,
make thedifference
little disinfection stage
to the and drying stage should
results.
be disabled, unless it can be demonstrated that inclusion make little difference to the results.

Test soils
Test soils
16.16 The choice of test soil to be used should be that specified in the type tests or that described in paragraph
16.16which
16.2, The choice of testa soil
represents more to realistic
be usedtissue
shouldresidue.
be that specified in the type tests or that described in paragraph
16.2, which represents a more realistic tissue residue.
16.17 Drying the deposited test soil is important, as it has an influence on the difficulty of cleaning. At least two
16.17 Drying
hours plus or the deposited
minus test soil
15 minutes’ is important,
drying as it has including
time is required, an influence on the
lumens. difficulty
The of cleaning.
soil should At least
be spread two
on such
hours plus or minus 15 minutes’ drying time is required, including lumens. The soil should
that it appears dry within the specified drying time. After soiling lumen may be dried, by passing down low be spread on such
that it appears
pressure dry air dry within
for the the specified
required time. drying time. After soiling lumen may be dried, by passing down low
pressure dry air for the required time.
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Page 9 of 10

Browne Hexalumen

The Browne Hexalumen (HX 600 and HX 601) allows the test to be easily completed and furthermore
provides a consistent test. The test strips mimic the endoscope soil if it is dried properly and hence in
some cases the Hexalumen will provide a more difficult test to pass than the previous test soil. The
indicators are manufactured in an ISO 13485 quality system environment with close controls over
manufacturing parameters. Hence the Hexalumen may well present a more stringent challenge than the
previous method. This is a clear opportunity to improve the washing efficacy of the AER and maintain
that higher standard in the future.

The following steps are proposed for the introduction of the Hexalumen into weekly use.
1. Following the manufacturer’s instructions, place the indicators in the Hexalumen capsules.
2. Connect the device to the AER using the Luer lock connectors provided (other connectors are
available).
3. Run the machine on a normal cycle.
4. Inspect the indicators.
5. If all have washed off fully the machine has passed and can continue in use.
6. If there is any red remaining on the indicators, the cycle has failed and the AER should be reviewed.
Each channel is numbered to assist in fault diagnosis.
7. The cycle may need to be changed to achieve a clean result. Only when that is the case should the
AER be placed back into normal use.
8. The department should decide on a routine for weekly testing. This could be one machine per day on
a rotation basis – the guidance is not specific so a routine which best suits the efficient running of the
department can be implemented.
9. The machine number/cycle number/result and any comment or action taken should be recorded and
reviewed on a regular basis. Any fail result will lead to an investigation.

HTM Compliance Programme

Effective from
XXX Rev 1 Guide to Compliance SOP
SOP
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Guide to Compliance xxxxxxxxx
Page 10 of 10

References

Secker TJ, Hervé R, Keevil CW. Adsorption of prion and tissue proteins to surgical stainless steel
surfaces and the efficacy of decontamination following dry and wet storage conditions; J Hosp
Infect. 2011 Aug;78(4):251-5.

Secker TJ, Hervé R, Keevil CW. Current risk of iatrogenic Creutzfeld–Jakob disease in the UK: efficacy
of available cleaning chemistries and reusability of neurosurgical instruments; J Hosp Inf. 2010 Aug;
75(4), 309-13.

Critical evaluation of ninhydrin for monitoring surgical instrument decontamination N.K. Nayuni a, E.
Cloutman-Green b, M. Hollis b, J. Hartley b, S. Martin c, D. Perrett a; Journal of hospital infection
84 (2013) 97–102.

Appendices

1. Verification of detection limit and swabbing technique using RESI-TEST™ Protein Detection Kit
for the detection of proteins from surfaces of stainless steel instruments.

2. Health Facilities Scotland study. 2016: Report

Comparative Preliminary Study of Sensitivity of Residual Protein Detection Methods and Washer
Disinfector Process Challenge Devices (RES 184)
Appendix 1

Verification of detection limit and swabbing technique using RESI-TEST™ for

the detection of proteins from surfaces of stainless steel surgical instruments

1. Aim of study
To verify that the sensitivity and swab method of RESI-TEST™ are an acceptable and effective technique to detect
†
residual proteins from surgical instrument and meet the requirements of UK ACDP .
†
UK Advisory Committee on Dangerous Pathogens - Transmissible Spongiform Encephalopathy subgroup on prevention of CJD and vCJD; Annex C; General Principles of Decontamination and Waste Disposal, Protein Detection (§ C21 & C22).

2. Equipment
Fig. 1
2.1. Stainless steel surgical instruments (Fig. 1) comprised of:

a) 3 x Forceps (large)
b) 4 x Forceps (medium)
c) 3 x Scissors (curved blade)
d) 2 x Clamps
e) 2 x Beyer Rongeur (medium)
f) 2 x Blumenthal Rongeur (small)
g) 1 x Bone pliers
h) 1 x Bone cutters
Fig. 2
2.2. Simulated control surfaces (Fig. 2) comprised of :
2
a) 4 x Stainless steel coupons (5 cm )
2
b) 2 x Stainless steel coupons (25 cm )
c) 3 x Microscopic glass slides (7.5 cm x 2.5 cm)

3. Method
3.1. Pre-cleaning: Fig. 3

3.1.1. All instruments made protein free by cleaning in Decon® 90 detergent and
rinsing with copious amount of purified water.
3.1.2. All instruments shown to be protein free before inoculation using
RESI-TEST™ protein detection kit.

3.2. Inoculation:
Fig. 4
3.2.1. Each equipment pipetted with 50 µL of Bovine Serum Albumin (BSA) at
0.10 µg/µL concentration (giving 5 µg of protein).
3.2.2. Dried as a discrete spot (Fig. 3 & 4) or spread over equipment surface on one
side only. Discrete spots dried were visible, whereas spread samples were not.
3.2.3. Inoculated instruments dried for both 3 hours and 24 hours.

3.3. Testing:
Fig. 5
3.3.1. Testing was performed in accordance to RESI-TEST™ Instructions for Use (IFU).
3.3.2. Individual instruments were swabbed with a single RESI-TEST™ foam swab
moistened with sterile purified water over the entire inoculated side.
3.3.3. Swab immediately placed in RESI-TEST™ solution vial for 5 seconds.
3.3.4. Solution visually examined for colour change after 10 seconds.
A B
3.3.5. Tested samples compared against negative control (Fig. 5).
3.3.6. The reverse side of the instrument (non-inoculated side) was also tested as an
additional comparator for each test.

2 2
Figures 3 and 4: Dried protein residue on steel surface (with area of 1.5 cm to 1.2 cm respectively).
Figure 5: Unused RESI-TEST™ solution (A) and Negative Control Test (B) – Showing no protein residues.
1

HTM Compliance Programme

Appendix 1

3.4. Instrument Surface Area:

Each protein inoculated instrument surface area was digitally photographed

and the swabbing area calculated using ImageJ software.

3.5.1. Each instrument swabbing area and perimeter accurately measured

using calibrated software, Figure 6.
3.5.2. Surface area for each instrument measured 3 times and the
2
average rounded up to the nearest 0.25 cm .
Fig. 6 3.5.3. Accurately measured the area of the protein residue against the
surface, Figure 7.
3.5.4. Accurately measured the amount of protein residue over a given
Fig. 7 2
surface as µg/cm .

This allows measuring the efficiency and calculates the sensitivity of the
swabbing technique.

2
Figure 6: ImageJ calculated surface area of forceps as 13.0 cm .
2
Figure 7: ImageJ calculated dried protein residue area of 1.17 cm .

4. Results & Discussion

Table in Appendix, lists all the instruments and simulated surfaces used in the study. Fig. 8

Surgical instruments and simulated control test pieces of varying surface areas
2 2
between 5.0 cm and 41.25 cm tested, showed positive results for protein residues
(Fig. 8 & 9) in all cases with RESI-TEST™ at the 10 second read out time.

4.1. RESI-TEST™ solution changed colour from light-brown to light grey or blue; this
signifies a positive test for protein.
4.2. Detection of protein using the swabbing technique is confirmed as an effective
Not Forceps #6, #5 & #7
method of collecting protein and subsequent release into the test solution. Used
Neg.
Pos. Pos. Pos.
4.3. Instruments with localised dried protein (discrete spots) gave a light blue colour
Fig. 9
(§3.2.2).
4.4. Instruments with distributed dried protein gave a light grey to blue-grey colour
(§3.2.2).
4.5. Drying time of 3 hours and 24 hours made no difference to test results.
2
4.6. Tests with microscope glass slides (18.75 cm ) also tested positive for residual
proteins.

Neg. = Negative Not SS Coupon #1, #2

Neg.
Pos. = Positive Used Pos. Pos.

5. Conclusion
5.1. This study demonstrates that RESI-TEST™ performs consistently at detecting protein residues of 5 µg per instrument
side as specified by ACDP.
5.2. The study has verified that swabbing via the provided foam swabs is an effective method for detecting localised and
distributed residual proteins from surfaces of stainless
. steel surgical equipment.
2
5.3. Results show that RESI-TEST™ sensitivity of better than or equal to 1 µg/cm of protein is achieved per instrument
side.
5.4. Swabbing test pieces after 3 and 24 hours drying made no difference in the results obtained.

2
Appendix 1

Appendix
2 2
Table 1 – Effectiveness of swabbing on surfaces from 5cm to 41.25cm

RESI-TEST™
Inoculated RESI-TEST™
Inoculation Analysis Protein per
Instrument Type Surface Analysis
Type (non-inoculated unit area
Area After drying
side)
cm2 At 10 second read time (µg/cm2)
SS Metal coupon #1 localised 5.0 Positive Negative 1.00
SS Metal coupon #2 Spread out 5.0 Positive Negative 1.00
SS Metal coupon #3 localised 5.0* Positive Negative 1.00
SS Metal coupon #4 Spread out 5.0* Positive Negative 1.00
Forceps #1 - medium localised 12.0 Positive Negative 0.42
Forceps #2 - medium Spread out 12.0 Positive Negative 0.42
Forceps #3 - medium (brass handle) localised 13.0 Positive Negative 0.38
Forceps #4 - medium (brass handle) Spread out 13.0 Positive Negative 0.38
Scissors - Curved #1 localised 13.5 Positive Negative 0.37
Scissors - Curved #2 localised 13.5 Positive Negative 0.37
Scissors - Curved #3 Spread out 13.5 Positive Negative 0.37
Blumenthal Rongeur #1 localised 16.75 Positive Negative 0.30
Blumenthal Rongeur #2 Spread out 16.5 Positive Negative 0.30
Glass slide #1 localised 18.75 Positive Negative 0.27
Glass slide #2 Spread out 18.75 Positive Negative 0.27
Glass slide #3 Spread out 18.75 Positive Negative 0.27
SS Metal coupon #5 localised 25.0 Positive Negative 0.20
SS Metal coupon #6 Spread out 25.0 Positive Negative 0.20
Beyer Rongeur #1 localised 29.25 Positive Negative 0.17
Forceps #5 - large localised 30.0 Positive Negative 0.17
Forceps #6 - large Spread out 31.5 Positive Negative 0.16
Forceps #7 - large Spread out 31.5 Positive Negative 0.16
Clamps # 1 (brass handle) Spread out 35.0 Positive Negative 0.14
Clamps # 2 (brass handle) localised 36.5 Positive Negative 0.14
Beyer Rongeur #2 Spread out 37.75 Positive Negative 0.13
SS Bone Cutters localised 39.0 Positive Negative 0.13
SS Bone Pliers Spread out 41.25 Positive Negative 0.12

SS = Stainless Steel, *Tested at 24 hr

Positive = Presence/detection of residual proteins. RESI-TEST™ solution showed a colour change ranging from light grey to blue and different from
both the negative control test and unused RESI-TEST™ solution at the 10 second read-out time.
Negative = RESI-TEST™ solution showed no colour change and/or similar to negative control test and unused RESI-TEST™ solution at the 10 second
read-out time.

3
HTM Compliance Programme
Appendix 2

Comparative Study of Sensitivity of Residual Protein Detection Methods and

Washer Disinfector Process Challenge Devices

Sulisti Holmes, Head of Decontamination Services Health Facilities Scotland.

Extract from a presentation delivered to the Central Sterilising Club.

Objectives
1. To evaluate the ability of protein detection test kits to 3. To report the outcomes of the use of WD process
detect 5μg protein on 3 types of test coupons. challenge devices (PCD) and protein detection test kits
2. To determine the effect of samples locations in during cleaning efficacy test.
washer-disinfector (WD) on cleaning efficacy. 4. To monitor residual protein on instruments (previously used
on patients) after being processed in a WD and identify
potential problem.
Scope
In Scope: Out Of Scope:

l Surgical instruments or coupons made of stainless steel l Internal lumen

l Residual detection kits for surgical instruments provided l Other difficult access areas which
by manufacturers require dismantling using tools
l Process Challenge Devices (PCD) for instrument washer l Non-stainless steel instruments.
disinfector (WD)
l Use of BSA, heparinised horse blood, lamb brain
homogenate and Edinburgh Test Soil.

Methodology
Experiment 1 - Sensitivity of Protein Detection Kits

l 3 types of stainless steel test coupons (BSA, Heparinsed

horse blood and lamb brain homogenate)
l 22 samples, each containing 5µg protein equal to BSA
l One protein detection scanning technique
l Five protein swab test kits.

Results for Test 1 (Sensitivity of Protein Detection Kits)

Product BSA Brain Blood

A (Swab) All Positive All Positive All Positive

Product BSA Brain Blood

B (Swab) 3.95µg * 8.64µg * 4µg *
C (Swab) 1.86µg * 0.94µg * 1.0µg *
D (Scan) 2.34µg 3.06µg 3.52µg
E (Swab) 1.86µg * 1.45µg * 1.32µg *
F (Swab) 1.0µg Not included in Not included in
this test this test
*=(average)
Negative control : no colour change
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