A Welsh perspective on water testing.
Should we chuck HTM2030 out with the bathwater ?
Pete Phillips
SMTL
Oct 2007
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
1 / 24
About SMTL (1)
Welsh Assembly Government core funding since 1981.
Testing and technical services on medical devices to the NHS in
Wales, Industry, and the UK Health Service.
Pharmaceutical Quality Assurance to 4 Welsh Trusts
Device Testing;
Incident investigation (e.g., stained instruments);
Technical Information + R&D;
Test Method development;
Clean Room, Bioburden, Endotoxin & Water Testing;
COSHH monitoring.
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
2 / 24
About SMTL (2)
17 staff, including pharmacists, microbiologists, technicians,
R&D, IT, admin staff.
UKAS accredited for testing
BSI/CEN technical committees
Work closely with Welsh Health Supplies and Welsh Health
Estates
Support services to CSSD departments in Wales since 1997
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
3 / 24
The Problem
HTM 2030
Washer Disinfectors failing regularly
Notified Bodies don’t like to see FAIL on test reports
Elements of the rinse water requirements are based on WfI
So...
How relevant are the requirements of HTM 2030 ?
Is there sufficient evidence that we must meet all of its
requirements ?
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
4 / 24
HTM 2030
Quality Control and Assurance is vital in production systems,
therefore..
Standards and Limits are helpful, BUT
Final rinse water is not injected
What impact does the rinse water have on the final product ?
Does the quality of water at present put the patient, instrument
or machinery at risk ?
Do we need the same water quality for endoscopes and surgical
instruments ?
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
5 / 24
The Water Sub Committee
Mike Simmons’ Welsh Decontamination Committee
Asked SMTL and WHE to look at the HTM2030 issue.
Set up Water sub committee
Joanna Ford - R&D - Literature review and survey of users &
industry
Paul Hay, Pamela Ashman - Microbiology - review of results
Bruce Fisher - QA/Chemistry expertise and advice
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
6 / 24
Terms of Reference
1
2
3
4
5
6
To evaluate the test procedures and limits defined in HTM-2030;
To research the effects that water which falls outside the
HTM-2030 limits will have on surgical instruments, endoscopes,
washer disinfectors and patients;
To make recommendations on the appropriateness of these tests
and limits for the Welsh NHS;
To ensure that appropriate safeguards are in place for the
protection and safety of patients;
To liaise with the Welsh CSSD managers and Endoscopy groups;
To report back to the WAG Welsh Decontamination Group.
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
7 / 24
Why not just use RO ?
Expense of installation
Expense of maintenance
NHS is usually cash starved
RO doesn’t always solve the problems
Some concerns over the effect on instruments (anecdotal)
Biofilm formation in machines (RO water is not the cause of
this)
Apart from achieving compliance with HTM2030, does RO
provide any benefits ?
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
8 / 24
Water Results - Introduction
Provide results from across the UK from NHS and non-NHS
customers.
Illustrate the results we have found over the last few years
Compare them to the HTM2030 limits
Try to analyse the risk of non-compliance with HTM2030
18 different sites
Not discussing any named sites
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
9 / 24
Water Results - Hardness
HTM2030 < 210mg/L
Risk:
limescale formation may inactivate detergents and disinfectants
may cause scaling on load items.
Results:
SSD mains water 20-150mg/L
Endoscopy 20-180mg/L
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
10 / 24
Water Results - TDS
HTM2030 4mg/100ml for purified water (RO or DI).
Risk:
not specified in HTM2030
German Instrument Preparation Group:
discolouration of stainless steel
does not cause corrosion to devices
Results:
SSD mains water: 1.4-20mg/100ml
Endoscopy: 6.5-20mg/100ml
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
11 / 24
Water Results - Chloride
HTM2030 <10mg/L
Risk:
significant levels of chloride ions ... will cause pitting and
corrosion in metallic items in the load
Results:
SSD mains water:5.5-50mg/L
Endoscopy: 5.5-15mg/L
German Document:
risk of instrument damage is low if < 120mg/L
water droplets may drastically exceed the limit of 120 mg/l
recommend the use of water of boiler feed quality for
washer-disinfector as per EN 285
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
12 / 24
Water Results - pH
HTM2030 5.5-8
Risk:
HTM2030 - no explanation
Results:
SSD mains water: <8
Endoscopy: <8
General consensus between Instrument manufacturers and CSSD
managers
High pH is unwise
ph >10 should be avoided
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
13 / 24
Water Results - Endotoxin (1)
HTM2030 ≤0.25EU/ml
Risk:
HTM2030 - products that will be used invasively e.g., surgical
instruments
USP - specifies limits expressed per device e.g.,: ≤20EU/device
risk of chills, fever, and systemic cardiovascular effects when
infused into humans.
Results:
SSD mains water: 0.2-40. Most 10-20 EU/ml
Endoscopy: 0.7-30. Some filtered supplies pass.
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
14 / 24
Water Results - Endotoxin (2)
Synergy paper (2006) Steeves & Steeves
rinse water not helpful indicator of endotoxin on final device
rinse water with 26.5EU/ml =⇒ 0.150EU/instrument
contamination occurs after the WD stage
“Unnecessarily stringent”
JWG of Hosp Inf Soc (HIS) 2002
“does not believe that routine endotoxin testing is required” for
rinse water in endoscopy.
Unfortunately no evidence provided.
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
15 / 24
Water Results - TVC (1)
HTM2030 - 0cfu/100ml (post disinfection water), 100cfu/100ml
(other water)
Risk:
HTM2030 - post-disinfection rinse water “should be free from
microbial contamination which could compromise the intended
use of the load”
Results:
SSD mains:0- >1,000 cfu/100ml
Endoscopy: most < 17cfu/100ml from filtered water
Surgical Instruments
Very little data to support the necessity of this limit for surgical
instruments.
Final sterilisation, so the main risk may be residual endotoxin.
Bioburden testing of instruments: usually <100
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
16 / 24
Water Results - TVC (2)
Endoscopy
Dependent on type of scope.
Bronchoscopes
Reported cases of ”pseudo infections” due to contaminated rinse
water.
Documented outbreaks of multi-drug resistant Ps. aeruginosa
cross infections
Willis (HPA) 2005
proposed a series of action levels for endoscopy rinse water
0/100ml - Satisfactory
1-9 on a regular basis - Acceptable - ”reasonable level of control”
10-100 - Unsatisfactory - investigate and super-chlorinate
>100 - Unacceptable - remove from use until resolved
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
17 / 24
Water Results - TVC (3)
JWG HIS (2002)
Final rinse water should be sterile or bacteria free.
GI tract endoscopes need not be sterile
Question need for weekly monitoring.
After ”regular monitoring” for a year, quarterly monitoring may
be sufficient
Muscarella (2000 & 2002)
gram-negative organisms pose risk during bronchoscopy and
ERCP
presence of small number of bacteria/ml may be acceptable if
endoscope is dried using 70% alcohol followed by forced air
appropriate dry storage is essential
sampling of the endoscope channels may be appropriate
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
18 / 24
Water Results - TVC (4)
MacKay, Leonard & Williams (2002)
Drinking water may have up to 300cfu/ml in the absence of
coliforms and E. coli
Biofilms in machinery and pipework are a significant problem
Biofilms on stainless steel require 10-100 times recommended
concentration of biocide to be effective
I.e., the main issue may be biofilms in the WD and pipework, as
opposed to the water supply
“Perhaps we should be concentrating on the prevention of
cross-infection rather than attempting to perform the microbiological
equivalent of turning water into wine”
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
19 / 24
RO Water
TVC
0-18cfu/100ml
one unit - April, July, October, January - all > 1000cfu/100ml
Endotoxin
Usually < 0.2EU/ml
All other tests
Pass just about all the time.
Big question:
does RO water prevent biofilm formation in supply pipes and
the AER/WD themselves ?
what is the source of the micro-organisms ? water or the
devices ?
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
20 / 24
How sensitive are WDs ?
One possibility is that the provision of RO water may extend the
life of Washer Disinfectors.
Has anybody seen an economic case yet to justify this ?
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
21 / 24
Next Steps
SMTL to complete literature review and discussions with
manufacturers
Draft out recommendations
Send out for consultation with Trust staff, manufacturers and
relevant experts
Produce a set of guidelines and/or recommendations for
approval by the WAG Decontamination Committee
In my view we need Evidence Based Guidelines which:
are acceptable to NBs, Trusts, Patients, and probably Directors
of Finance
are tailored for CSSD, Endoscopy etc - one size doesn’t fit all
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
22 / 24
Conclusion
So should be chuck out HTM2030 ?
No. It turns out that it provides a good starting point for us.
There are genuine risks associated with TVC, endotoxin and
dissolved chemicals.
These risks depend on the type of device - e.g., bronchoscope cf
GI endoscope
We need better evidence for some of the test limits
Some HTM2030 levels can probably be adjusted without any
clinical, instrument or machine implications, which might
eliminate the requirement for RO water in some areas
It also means that it is more likely that RO plant can be installed
in areas where it is of clear benefit
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
23 / 24
Contacting SMTL
If you have water test data to help us determine limits, or if you
have anything to contribute, please contact me at:
Pete Phillips
The Surgical Materials Testing Laboratory (SMTL)
Princess of Wales Hospital
Coity Road
Bridgend
CF31 1RQ
Tel: 01656-752820
Email: pete@smtl.co.uk
Pete Phillips (SMTL)
A Welsh perspective on water testing.
Oct 2007
24 / 24