HUME REGION INFECTION

CONTROL
RESOURCE AND CONSULTING
SERVICE

ENDOSCOPE SURVEY

Completed April 2003

 Table of Contents
Page

1.0 Introduction 2
1.1 Emergence of a perceived issue/problem 2

2.0 Plan to address perceived 2

problem
2.1 Issue an alert notice 2
2.2 Review of current practices within the region 2
2.3 Identify problem 2
2.4 Formulation of recommendations
2.5 Identify key stakeholders and perceived 2
philosophical stance
2.6 Potential issues or concerns 2
2.7 Literature Review 2

3.0 Problem Statement 3

3.1 Clinical Significance 3

4.0 Key Stakeholders 4

4.1 Patients 4
4.2 Staff 4
4.3 Hospital Executives 4
4.4 Medical Officers 4
4.5 HRICRCS 5

5.0 Organisational Politics 5

6.0 Potential 6
Issues/Concerns
6.1 Expected or likely issues 6
6.2 Proposed management of concerns 7
6.3 Evidence 8

7.0 Literature Review 9

7.1 Conduction of Literature Review 10
7.2 Explanation of Acronyms 10
7.3 Current Recommendations and Guidelines 11
7.3.1 Australian 11
7.3.2 Overseas 11
7.4 What is the risk of transmission of disease? 12
7.5 Summary of Literature Review 13

8.0 Discussion of Survey 14

Results
8.1 Major issues arising form the results 14
8.2 Conclusion 15
8.3 Further discussion 15

9.0 Recommendations 16

10.0 Implementation 18

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 Table of Contents
Page

11.0 Addressing the problem 19

statement

12.0 References 20

Appendices
1. Alert Notice 22
2. Results of Endoscope Survey 23
3. HRICRCS recommendations for biological 39
monitoring of endoscopes and automated
endoscope reprocessors
4. Positive Test - action plan 40
5. Memorandum of Understanding proforma 42
6. Endoscope microbiological testing history 45
proforma
7. Endoscope processing history proforma 46
8. Questionnaire tool 47

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1.0 Introduction

A current clinical issue identified within our region is the provision of a ‘safe’
endoscopy service to customers. This involves cleaning, processing, storage, use
and monitoring activities of endoscopes and endoscope processing equipment. The
delivery of a safe endoscopy service is also reliant on nursing and medical
personnel being skilled to perform the procedures and activities associated with the
delivery of the procedure within a safe working environment. These activities are
required to meet current standards and guidelines with regard to use and
reprocessing of endoscopes in the clinical setting and provision of patient care.

1.1 Emergence of a ‘perceived’ problem.

HRICRCS are currently conducting site visits and audits of compliance of regional
hospitals’ Theatre/CSD units with AS 4187 and other relevant guidelines. This
included an overview of the endoscopy service, if provided. During these site visits
HRICRCS identified that processing and biological monitoring of owned and loan
endoscopes-especially flexible endoscopes was variable to the recommended
guidelines without explanation or justification for the variance. Monitoring activities
at some hospitals at best could be described ‘ad hoc’, or were non-existent or not
known. Some of the smaller hospitals within the region were delivering a service
with limited resources and equipment and compromised working environment.

2.0 Plan to address perceived problem

2.1 Issue an alert notice

! Send out an alert notice to all hospital regarding the need to follow
recommended guidelines (GENSA –1999) with regard to monitoring
and processing of endoscopes (Appendix One)
2.2 Review current practices within the region
! Identify current processing and biological monitoring activities
undertaken by hospitals within the region on endoscopes and
endoscopic processing equipment. Survey tool developed
2.3 Identify Problem
! Does a problem exist? Is the problem worth reviewing? Is the problem
clinically significant and to whom?
2.4 Formulation of recommendations
! Will recommendations need to be made to address issues arising form
the review?
2.5 Identify key Stakeholders and Philosophical Stance
! Who are the key stakeholders, how may these recommendations, if
made, affect them?
2.6 Potential issues or concerns
! Identify areas where conflict or resistance to any recommendations
made, may occur.
2.7 Literature Review
! Are current practices based on evidence, is the evidence valid and
well researched?

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3.0 Problem Statement

Endoscopes and the equipment used to process endoscopes within hospitals in the
region may not be undergoing appropriate processing and monitoring activities to
meet recommended guidelines. Are current recommended guidelines evidence
based and supported by scientific research, and can non-compliance affect patient
outcomes?

The following concerns will be addressed as part of the Problem Statement

1. What, if any, is the significance of the microbiology results and what do they
mean? What are the implications for patient outcomes?

2. Are current recommended guidelines evidence based? if not, are they still
relevant?

3. Will deleterious patient outcomes result when organisations do not comply

with the recommended guidelines and do not monitor endoscopes or
automated endoscope machines in accordance with them?

4. Do hospitals have enough resources (equipment, staff education and

knowledge) to deliver a ‘safe’ endoscopy service and post endoscope care?

3.1 Clinical Significance

1. This problem is of clinical significance because there is potential risk for

deleterious outcomes following inappropriate processing, monitoring and use
of endoscope with regard to;

a. Patient health
b. Staff health
c. Service provider liability
d. Endoscope provider liability
e. Endoscope life-span
f. Cost implications of all the above

by;

g. Organisations not meeting required standards with regard to

processing and monitoring of endoscopes and endoscopic processing
equipment
h. Organisations not having processes in place to ensure appropriate
monitoring of scopes and recording/reporting of results to the relevant
persons is occurring
i. Organisations not having the ability to identify an ‘at risk endoscope’ or
‘at risk endoscope processing method’ due to lack of monitoring or
recording of data.

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4.0 Key Stakeholders

Key Stakeholders have been identified and described below.

4.1 Patients-non-active participants-

Clinically relevant as outcomes of endoscope processing and monitoring may

impact on health outcomes.

AIM- To receive the best possible ‘care’. Most likely are not aware of, or witness
processing and monitoring activities and therefore have little comprehension of the
importance of these activities, and what is or should be occurring. Rely on
caregivers and hospital to ensure ‘safe environment is provided’ including provision
of cleaned reprocessed endoscopes.

4.2 Staff-active participants-

Staff health and workplace issues.

AIM- Are able to provide the best possible care using the best possible equipment
within a safe working environment. This may be hindered by lack of ability to have
the best equipment or resources to hand due to financial constraints or inadequate
risk assessment strategy.

4.3 Organisation Management-active participants-

Directors of Nursing are most likely to be the Executive Sponsor for the Infection
Control Program within their agencies. Other Hospital Administration Officers are
involved if ethico-legal, and/or risk minimisation implications arise.

AIM- Are able to provide the best possible care within a costed framework, that is
‘’the best affordable care’. Resource decisions are based upon availability and
prioritisation of limited resources and a risk assessment of need to/no need to
comply with all or part of recommendations as determined by potential outcomes.

4.4 Medical Officers -active participants

Provide endoscope and/or service on behalf of the hospital -

It is essential to liaise with medical officers (MO’s) to support any initiatives,

especially if changes to current processes are recommended, and personal cost
implications are incurred as owners of endoscopes.

AIM- Are able to provide the best possible medical care. The provision of medical
care is supported by the hospitals providing current and up to date equipment (AS
approved), and experienced educated staff working. Able to have input into
equipment purchases and changes to procedure that affect the way in which they
provide their service to the patient.

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4.5 HRICRCS-active participants-

Two consultants who work within a framework of assisting and supporting health
care facilities in the region to help prevent, minimise and control infection risks and
poor outcomes from non-compliance or breaches in infection control practices.
Responsible for conducting the review of endoscopic services, making
recommendations on the findings from this review and conducting the literature
search.

AIM- Organisations in the Hume Region provide a ‘safe environment’ for the delivery
of the endoscopy service to its customers. This includes all patients, staff and
providers of the service. In providing a safe environment the organisation engages
in risk assessment and resource management. Any adjustment within the
environment to comply with recommended standards and guidelines, will remain
compatible with the hospital philosophy and the philosophy of other key
stakeholders.

5.0 Organisational politics

Organisational politics are diverse and varied considering the service delivery
profiles of the 17 hospitals, which range from as low as 10 acute beds to over 150
acute beds. Each hospital has its own political agenda that is usually based upon,
the organisation strategic plan, community expectation, service delivery profile,
case- mix and management style.

The Department of Human Services is currently reviewing the use of glutaraldehyde

in hospitals. This has been in response to the Nurses Union within Victoria (ANF-
Vic Branch) voicing ongoing concerns regarding the use of ‘open glutaraldehyde’
systems still in use.

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6.0 Potential issues or concerns
6.1 Active Key Stakeholders may have the following concerns-

6.1.1 Resist involvement in the review process and acknowledgment of survey

outcomes, especially if current activities are seen to be satisfactory.

6.1.2 Accountability of key stakeholders for patient outcomes arising from use
of scope is identified, especially if processing cannot be demonstrated to
have met current guidelines

6.1.3 Adopting an external policy that impinges on their service delivery.

6.1.4 Have practices identified which may lead to urgent review or cessation of
their endoscope service or de-commissioning of equipment

6.1.4.1 In house political ramifications (staffing, MO’s)

6.1.4.2 Community ramifications (service ceases)
6.1.4.3 DHS case-mix funding (service delivery profile changes)

6.1.5 Change current activities undertaken within their own organisations with
regard to processing and monitoring of endoscopes

6.1.5.1 Cost implications and resources (equipment, education,

staffing)
6.1.5.2 In-house political ramifications (MO’s may only want their
equipment processed by a specific method).

6.1.6 Embracing current guidelines and recommendations if they are not

‘evidence based’ or supported by recognised and accepted studies or
scientific research.

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6.2 Proposed management of concerns

In managing issues it is important that HRICRCS recognise that active key

stakeholders may-

6.2.1 Fear that change will have a negative effect on current work dynamics.
This may hinder involvement in any initiatives resulting from the
investigation of endoscope processing. Key stakeholders may be
ambivalent towards being involved due to minimal knowledge of current
guidelines and the importance of meeting same.

To allay these fears, promote dissemination of information and evidence

to organisations to give ownership of knowledge to key stakeholders, this
will give impetus for self-change rather than external forced change.
Acknowledgement of the need for self-change will ensure better
compliance with recommended processes by key stakeholders

6.2.2 Not want to be identified as the accountable body, this raises liability
concerns, which may have remained unresolved or even unrecognised to
date. Organisations may not want to open a potential ‘can of worms’ even
if it is in the best interest of the organisation and the patient.

Identify that recognition of responsibility and accountability for testing will

be beneficial for all key stakeholders. Risk management strategies can
be developed by those deemed to be accountable. A memorandum of
understanding between parties will underpin current and new
arrangements for processing and monitoring.

6.2.3 Resist the adoption of external procedural activities, when key

stakeholders believe they are meeting current guidelines and do not need
to take further action.

Recommendations made will provide them with information to help their

organisation provide an endoscope service that meets minimum
standards and guidelines for infection control. Organisations and other
key stakeholders may choose not to acknowledge any external
recommendations. This is their prerogative and should be identified within
their risk assessment and management strategy.

6.2.4 Fear that review of current practices used by their organisation may
involve ceasing their endoscope service due to not meeting minimum
requirements

Assure key stakeholders that HRICRCS do not have the capacity to cease
their endoscopic services. HRICRCS will highly recommend changes and
upgrading to meet standards and guidelines, however the decision to
cease providing the endoscope service will ultimately remain with the
organisation and other key stakeholders providing the service.

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 6.2.5 Fear that review of current practices used by their organisation may
involve changing current practices to their endoscope service due to not
meeting minimum requirements

As above for both points 3 and 4, reassure that any changes made to
current practice is at the prerogative of key stakeholders.

Throughout the review and implementation process it will be important to;

encourage key stakeholders to have ownership of the review process,
encourage ongoing communication and dialogue between other key
stakeholders and HRICRCS and maintain transparency of the process.

It is important that no ulterior motives are thought to underpin the process,

especially given HRICRCS is funded by the Department of Human
Services, which is the governing body for the health industry in Victoria.

6.2.6 May resist the recommendations made by HRICRCS as a result of the

review if they do not believe they are scientifically supported or lack
evidence to support the need to adopt any changes that may have been
recommended.

Acknowledge that it is at the discretion of each organisation that provides

an endoscopy service to adopt recommendations. This discretion
includes an organisational evaluation of current evidence supporting
recommendations.

6.3 Evidence

For the purpose of this review the evidence is described as;

1. Information and feedback using the survey tool that demonstrates that
most hospitals within the region are not following the recommended
GENSA-1999 guidelines.

2. A review of literature to determine if the GENSA –1999 guidelines are

valid, and is there research to support the requirements and
recommendations stated in these guidelines.

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7.0 Literature Review

HRICRCS acknowledges that much has been written on the subject of endoscopes
and endoscopes processing, especially with reference to the use and concentration
of chemical disinfectants and differences of opinion in the timeframe required for
soaking of instruments to achieve high level disinfection. Lewis (1999, 34)

The difficulties in cleaning and processing of endoscopes, due to the inability of

many endoscopes to be fully immersed or unable to withstand high heat sterilisation,
has been well documented. Channels for the introduction of forceps and snares are
almost impossible to clean or be visually inspected to validate cleaning process.
Many studies have shown that when pulled apart endoscopes have had high levels
of soil and contamination apparent within the scope despite having been ‘cleaned
and disinfected’ ready for reuse. (Muscarella 1996, Lewis 1999, Muscarella 2000,
Chu and Favero 2000)

There has also been numerous articles written on the importance of cleaning
endoscopes to minimise bioburden and soil prior to the actual disinfection process.
Alfa, Degagne and Olson (1999, 2). In addition, studies on bronchoscopes have
been undertaken to assess the potential risk of transmission of mycobacteria strains
between cases. These studies have looked at potential reasons why contamination
of bronchoscopes with mycobacteria and other isolates has occurred, issues such
as rinsing water, ineffective alcohol and/or pressured air drying have been
investigated as likely causes of contamination. Muscarella (1996)

More recently with the advent of AER’s studies have looked at the efficiency of
manual cleaning and processing vs. manual cleaning and automated processing. A
study by Fraser, Zuckerman, Clouse, O’Rourke, Jones, Klasner and Murray (1993,
383-9) investigated the contamination levels post processing using microbiological
cultures taken from the scopes. The study showed that prior to an alcoholic rinse,
27% of endoscopes processed through AER’s, and 37% of endoscopes processed
manually grew gram negative and non-tuberculous mycobacteria, these levels
dropped to 10% and 27% respectively when alcoholic rinse was used at the end of
processing. Although the study stated that the results were not statistically
significant, of importance was that despite both manual and automated cleaning,
persistent contamination was apparent.

However, there is a paucity of evidence based research that examines the need to
microbiologically monitor endoscopes and endoscopic processing equipment. Most
current recommendations are empirical and are focussed on the test results
indicating endoscope processing failure. This failure does not indicate however if
there is a resultant infection risk to patients. Studies have yet to be conducted that
demonstrate a relationship between non-compliance with biological monitoring and
deleterious patient outcomes. This will be further expanded in the review of
literature

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7.1 Conduction of Literature Review

The literature review was conducted in two parts-

1. Search for current recommendations and guidelines pertinent to

endoscopes and endoscope processing

2. Electronic search using Cochrane Library and Ovid-Journals, Medline,

Premedline, EMBASE, CINAHL

Search words
Endoscope/ and: microbiological monitoring, cleaning, processing,
disinfection, sterilisation, automated reprocessors, environmental sampling,
infection control, quality assurance.

The following main topics emerged from the search

a. Infection transmission via endoscopes

b. Infection risk associated with endoscopic processors
c. Biological monitoring of endoscopes and endoscope processing
equipment
d. Cleaning and processing of endoscopes

The search was not exhaustive, some articles found in the Cochrane Library
were not available in English text and only the abstract could be used as a
generalised reference.

7.2 Explanation of Acronyms

AER-Automated endoscopic reprocessor

AS/NZS 4187-2003-Australian/New Zealand Standard
NH&MRC-1996-National Health and Medical Research Council
GESA-1999-Gastroenterological Society of Australia (often incorporated into
GENSA)
GENSA- 1999 Gastroenterological Nurses Society of Australia
BSG-British Society of Gastroenterology
ESGE-European Society of Gastrointestinal Endoscopy
ESGENA- European Society of Gastrointestinal Endoscopy Nurses and Associates
ASGE-American Society Gastroenterological Endoscopy
APIC-Association for Professionals in Infection Control and Epidemiology
CDC-Centres for Disease Control-USA
OPA-o-PHTHYALALDEHYDE (type of aldehyde)

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7.3 Current Recommendations and Guidelines

7.3.1 Australian

The newly released standard (AS/ANZ 4187-2003,105) states that “Reprocessing

machines and flexible endoscopes shall be routinely monitored microbiologically.
An endoscope reprocessing machine that is contaminated shall not be used until
clean and proven to be microbiologically safe”. The standard however does not cite
timeframes or methods to obtain microbiological samples and no references are
given to why testing should be undertaken. There is also no definition of
‘microbiologically safe’.

GENSA (1999, 4) states that “Microbiological monitoring is fraught with controversy.

Nevertheless, we have continued to recommend such assessment, while
recognising that our protocols are empiric in nature. This however should be of little
import as long as it is recognised that such procedures are utilised as an indirect
marker of both adequacy of cleaning/disinfection process and of structural integrity
of the instrument”.

The NH&MRC (1996, 36) (new edition to be released) discusses quality

management routines and indicates that readers should reference (GESA/GENSA
Infection and Endoscopy) for current advice on cleaning, disinfection and
microbiological testing requirements.

7.3.2 Overseas

The ESGE and ESGNE (no year cited) protocols do not make reference to routine
microbiological testing. The BSG 1998 working party report and the ASGE-1996
Position Statement also make no reference to the need for microbiological testing.
In an APIC special communications article, Alvarado and Reichelderfer (1999, 149)
discuss quality control and purport that the CDC does not recommend routine
microbiologic sampling of inanimate hospital environment and patient care items.
However if an endoscopy related infection is observed focused testing would be
warranted.

The Asia pacific Congress of Digestive Endoscopy working party was convened in
Hong Kong in 2000 to form a mandate on disinfection of endoscopes and
accessories, the aim being to lay down ‘minimal standards’ for disinfection and
reprocessing of endoscopes and accessories. The working party report by Tandon
(2000, 71) highlights quality control measures including periodic bacteriologic
monitoring of the endoscope and accessories. HRICRCS again notes that no time
frames are identified for such monitoring.

A German study on quality of reprocessing of endoscopes by Bader, Blumenstock,

Birkner, Lei, Heesemann. Riemann, and Selbmann (2002, 157-170), suggests that
the microbiological testing of endoscopes will aid in the detection of insufficient
reprocessing and as such should be performed for reasons of quality assurance.

A comparison of international guidelines for cleaning and reprocessing endoscopes

was undertaken by Lei, Beilenhoff, Bader, Jung and Exner (2002, 531-542). They

11
examined the differences between guidelines and reprocessing recommendations
with respect to cleaning, quality assurance and evidence base for these
recommendations. In an overview of the study they stress the need for
‘experimental investigations’ of the cleaning and disinfection process, however
experimental investigations was not able to be determined to mean microbiological
testing, although HRICRCS believe it was inferred.

In an article written by Muscarella (2002, 285-9), a well known and respected doyen
of all things endoscope, he acknowledges that routine sampling is not generally
recommended by the CDC and other relevant bodies in the US, although sampling
of rinse water in some reprocessing settings is supported. Muscarella argues that
rinse water used in endoscopy processing should also be routinely sampled due to
reported outbreaks of gram negative bacteria nosocomial infection outbreaks in
endoscopy patients.

All guidelines and most of the articles cited emphasised the need for stringent
manual cleaning of endoscopes as the best possible way to minimise the
transmission of infection between endoscopy patients.

7.4 What is the risk of transmission of disease?

Some sources say that the risk of transmission of infection is minimal, Leung (2000,
74) reports that the incidence of transmission of infection was one in 1.8 million (28
reported cases) as estimated by ASGE. The infections were thought to have
resulted from breaches in recommended cleaning and disinfection procedures and
contaminated AER’s.

However in contrast to these figures, Spach, Silverstein and Stamm (1993, 117-
128), in their review of 265 articles on transmission of infection by endoscopy,
identified that 281 and 96 cases of infection transmission via gastrointestinal scopes
and bronchoscopes had occurred respectively. (Spach et al 1993, 117) state
“Salmonella species and Pseudomonas aeruginosa were repeatedly identified as
the causative agents of infections transmitted by gastrointestinal endoscopy, and
Mycobacterium tuberculosis, atypical mycobacteria were the most common causes
of infections transmitted by bronchoscopy. One case of hepatitis B virus
transmission via endoscopy was documented”. Of the 84 cases of Salmonella
identified 1 patient died.

Gardner and Peel (1998, 247) cite that a study by Birnie et al, implicated
endoscopes with the transmission of Hepatitis B virus and studies by Wheeler et al,
Classen et al and Spach et al identified that endoscopes were responsible for
transmitting opportunistic pathogens from one patient to another patient. The
outcomes from these infections have ranged from colonisation to serious infection
and death. A report by Michele, Cronin, Graham, Dwyer Pope, Harrington,
Chaisson and Bishai (1997, 1093-5) demonstrated via DNA fingerprinting that
Mycobacterium tuberculosis was transmitted via a fiberoptic bronchoscope in a
health care facility in USA from one patient to another patient. A further report by
Bronowicki, Venard, Botte, Monhoven, Gastin, Chone, Hudziak, Rhin, Delanoe

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LeFaou, Bigard and Gaucher (1997,237) reported two cases of Hepatitis C virus
were transmitted via a colonoscope used on a Hepatitis C positive patient.

A recent newspaper article “Unsterile Devices Prompt Warnings” in the Los Angeles
Times (Glionna 2003) was written in response to The California Department of
Health Services issuing warnings after two hospitals in the Sacramento area
advised 3,250 patients they would need to take blood tests as they were possibly
exposed to an infectious disease via an unsanitised chamber in an instrument called
a colonoscope. The article goes on to describe a history of incidents where
transmission or potential transmission of infection has occurred via an endoscope.
The article also highlights that manufactures have long been aware of problems with
cleaning and processing of endoscopes and have stated that “satisfactory cleaning
cannot be achieved” when filing for patent.

7.5 Summary of Literature Review

# There is conflicting advice from leading bodies and working parties as to the
need to microbiologically monitor endoscopes and endoscope reprocessors,
including rinsing water. There is no definite scientific evidence that
demonstrates microbiological monitoring prevents transmission of infection by
an endoscope.

# Thorough pre cleaning of the endoscope prior to sterilisation/high disinfection

process is of the utmost importance

# Transmission of disease has occurred between patients following endoscopic

procedures.

# Other strategies and quality control measures should be implemented to

monitor effectiveness of and processing procedures, not withstanding
microbiological testing.

# Manufacturers of endoscopes should be accountable for working towards

better designed equipment that can withstand sterilisation processes

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8.0 Discussion of Survey Results

Survey Results (Refer Appendix Two).

The results of the review demonstrate that biological monitoring of loan and hospital
owned endoscopes and the equipment in which they are processed varies greatly
between hospitals.

The GENSA –1999 guidelines indicated that routine biological testing should be
carried out on all endoscopes, however the results show that some endoscopes,
especially loan scopes are not biologically monitored within the recommended
timeframes, or are not being monitored at all. Of particular concern is the fact that
most endoscopes being processed via AER’s are not being tested 4 weekly
(monthly) as recommended, especially loaned scopes which had the least
monitoring activities undertaken.

All organisations biologically monitored automated processing units. The GENSA

guidelines clearly stating that AER’s were required to be tested 4 weekly (monthly),
some organisations however tested less frequently and failed to meet this
requirement. Automated sterilisation processing units (Steris) require routine
biological monitoring, AS/NZS 4187-2003 recommends weekly monitoring; only two
organisations failed to meet this requirement. (possibly related to how often the
steris unit was utilised for endoscope lists).

The reasons why some organisations chose to not test any scopes or processing
equipment is not clear. Although the GENSA –1999 guideline is the most cited
reference by organisations for development of policy and procedure related to
cleaning and processing of scopes, many hospitals still failed to meet the
recommendations. Given that an alert notice was distributed 3 months prior to the
survey, hospitals cannot claim ignorance of these recommendations as an excuse
for non-compliance.

8.1 The major issues arising from the results are:

• Variation to recommended GENSA –1999 guidelines for biological monitoring

of endoscopes and endoscopic processing equipment.

• Inability to trace endoscope monitoring and processing history, especially

between different sites of use for loan endoscopes.

• Concerns regarding the inability by organisations to have implemented

monitoring protocols.

• Concerns regarding organisations providing an endoscope service with

outdated equipment and processing methods, which are of an OH&S
concern.

• Processing of rigid endoscopes by a high disinfection process was identified.

AS/NZ 4187-2003 states that rigid endoscopes should be sterilised, high

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 disinfection processes are not appropriate for rigid endoscopes. There are
no further recommendations for rigid endoscopes

Although rigid scopes are reported upon within the context of this
report, the aim of the review was to identify current biological
monitoring of flexible endoscopes, and endoscope processing in
accordance with GENSA –1999 and other relevant guidelines.

There is no definitive requirement or recommendation for biological

monitoring of rigid endoscopes. This is at the organisation’s
discretion.

8.2 Conclusion

Endoscope processing and monitoring activities throughout the region are not
standardised and do not reflect current recommended guidelines.

Of concern is the ongoing use of open glutaraldehyde systems still in use despite
significant Occupational Health and safety concerns (not addressed in this report)

Rotating loan scopes are more than likely undergoing different processes at different
sites. There is concern that this practice is deleterious to the scope and may affect
performance and integrity of same over time (not addressed in this report)

8.3 Further discussion required

Microbiological testing of rinsing water, recommendations for and timeliness (not

addressed in this report)

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9.0 Recommendations

The following recommendations are made by HRICRCS in response to the results of

the survey of endoscope practices within the region, findings within the literature
review and discussion with ‘experts’ in endoscopy service.

Recommendation One

All Hospitals have a system for tracking endoscopes and endoscope equipment
and processing method to patients.

Rationale

All hospitals should be able to trace endoscopes and endoscope equipment to a

particular patient in the event that identification of that patient on whom that
equipment is used is required.

Recommendation Two

All organisations to develop and implement a strategy for biological monitoring of

all endoscopes (owned and loaned) and endoscopic processing equipment. This
will help to rationalise and standardise current monitoring and processing
activities within the region.

Rationale

Evidence to attend to microbiological testing is scant and a difference of opinion

exists between Australian and overseas leading bodies of the need to do testing.
However, whilst the equipment remains difficult to clean, microbiological testing
provides some indication of the internal dynamics and integrity of the endoscope,
which currently cannot be assessed via external visual inspection. In light of this,
HRICRCS believes that the GENSA guidelines should be adopted.

Recommendation Three

Develop endoscope history records that stay with the endoscope. One record
details the endoscope’s processing history, the other record details the
endoscope’s biological monitoring history.

Rationale

Records are kept with every endoscope. This details processing history
(AER/Steris and results of biological tests on that equipment) and microbiological
test undertaken on the endoscope itself. This will help determine if problems are
occurring with a particular piece of equipment, and will aid in tracking any
positive results back to patient via tracing systems.

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Recommendation Four

Develop a memorandum of understanding pertinent to rotating loan scopes.

Memorandum to identify responsibility for biological monitoring of scopes and
outline any agreements between parties providing and utilising the endoscopes.

Rationale

Supports the standardised monitoring and processing activities and identifies

accountability and responsibility of active key stakeholders

Recommendation Five

Develop action plan for organisations in response to a positive test result to

biological monitoring.

Rationale

To enable organisations to respond to positive results in an appropriate and

organised way to minimise potentially poor outcomes.

Recommendation Six

Regular education and training sessions for existing staff and for orientation and
training for new staff reprocessing endoscopes

Rationale

Ensure knowledge is up to date and current with all aspects of endoscope

reprocessing and of recommended guidelines.

Recommendation Seven

Instigate other quality activities to monitor endoscope reprocessing adequacy.

Rationale

Implement other quality activities to monitor the effectiveness of cleaning and

reprocessing to compliment microbiological testing, i.e. Practice and process
reviews.

Recommendation Eight

Lobbying of the manufacturers of endoscopes by users to produce equipment

that is more readily cleaned and sterilised.

Rationale

Equipment that is difficult to clean and cannot be adequately sterilised will

always provide an increased infection risk to patients. The ability to lobby
manufacturers is limited at local levels, would need to be undertaken on as a

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 global initiative and as a response to definitive requirement by regulatory bodies
for all endoscopes to be sterilised.

Recommendation Nine

Rigid scopes undergo a sterilisation process

Rationale

Rigid scopes are required to be sterile as they enter sterile body tissue and
cavities and are described as ‘critical items’ (page 41, NH&MRC-1996)

10.0 Implementation
Following ratification by the Advisory Committee and referral to the Hume Region
Nurse Executives for comment, the endoscope report with the above
recommendations will be distributed to hospitals within the Region.

Implementation of the recommendations will be at the discretion of each

organisation.

Education sessions with relevant parties explaining the recommendations and the
documentation for recording will be available upon request.

18
11.0 Addressing the Problem Statement

1. What, if any, is the significance of the microbiology results and what do they
mean? What are the implications for patient outcomes?

• The significance of the results is in identifying possible technical/cleaning

breaches within the endoscope and the results may mean that ;

o Contamination is occurring from improperly cleaned and processed

endoscopes, or

o Contamination is occurring from within AERs or water used by the

AERs for processing or rinsing, or

o Poor integrity of the internal channels of the endoscope may be

harbouring soil and micro-organisms that are not visible.

o The implication for patient outcomes is that endoscope and processing

equipment is monitored for the quality of activities

2. Are current recommended guidelines evidence based? if not, are they still
relevant?

• As stated by GENSA-1999, their recommendations are empirical, they

conclude that biological monitoring is one method of quality assessment to
determine if appropriate cleaning and processing is occurring.

3. Will deleterious patient outcomes result from organisations that do not comply
with the recommended guidelines?

• Deleterious patient outcomes have arisen from endoscope use. There is

documented evidence that infections have been spread via used
endoscopes, which have not been adequately reprocessed, -either due to
poor practice or poor scope design which has resulted in poor patient
outcomes (death). There is no current evidence that directly ties patient
outcomes to the presence or absence of biological monitoring.

4. Do hospitals have enough resources (equipment, staff education and

knowledge) to deliver a ‘safe’ endoscopy service and post endoscope care?

• Difficult to answer this question as resources within organisations not directly

assessed. Noted that some organisations used open fume cabinets,
glutaraldehyde and older endoscopes, which increased staff and patient risk.
Questions relating to education and skill level of staff were not included in the
questionnaire, neither was an appraisal of post care abilities. Facilities are
encouraged to do a self-assessment of these areas.

19
12.0 References

Alfa, M. Degagne, P. Olson, N. Worst –case soiling levels for patient used flexible
endoscopes before and after cleaning. American Journal of Infection Control Vol 27
(5) October 1999 pp1-12

Alvarado, C. and Reichelderfer, M. APIC Guideline for infection prevention and

control in flexible endoscopy. American Journal Infection Control 28 (volume no.
unavailable) April 2000 138-155

American Society Gastroenterological Endoscopy (ASGE) Position Statement:

Reprocessing of Flexible Gastrointestinal Endoscopes. Gastrointestinal Endoscopy
Vol 43 (5) 1996 pp540546

AS/ANZ 4187-2003. Cleaning, disinfection and sterilizing reusable medical and

surgical instruments and equipment, and maintenance of associated environments
in health care facilities. Standards Australia/Standards New Zealand Publishers,
Australia 2003

Bader, L. Blumenstock, G. Birkner, B. Lei, O. Heesemann, J. Riemann, J. and

Selbmann, H. HYGEA-hygiene in gastroenterology-Endoscope processing; Study
on quality of reprocessing flexible endoscopes in hospitals and in the practice
setting. Zeitschrift fur Gastroenerologie Vol 40(3)(pp 157-170), 2002.

Bronowicki, J. Venard, V. Botte, C. Monhoven, N. Gastin, I. Chone, L. Hudziak, H.

Rhin, B. Delanoe, C. LeFaou, A. Bigard, M. and Gaucher, P. Patient to patient
transmission of Hepatitis C virus during colonoscopy. The New England Journal of
Medicine Vol 337 (4) July 1997 pp237-240

British Society of Gastroenterology (BSG). Cleaning and disinfection of equipment

for gastrointestinal endoscopy. Report of a working part of the British Society of
Gastroenterology Endoscopy Committee Gut (An International Journal of
Gastroenterology and Hepatology Volume 42 (4) April 1998 pp585-593

Chu, N. and Favero, M. The Microbiological Flora of the Gastroenterological Tract

and the Cleaning of Endoscopes. Gastrointestinal Clinics of North America Vol 10
(2) April 2000 pp233-244

European Society of Gastrointestinal Endoscopy (ESGE). European Society of

Gastrointestinal Endoscopy Nurses and Associates ESGENA. Protocol for
Reprocessing Endoscopy Accessories. No publication details available, downloaded
from following web site http://www.esge/com/g_repr99.html

Fraser, V. Zuckerman, G. Clouse, R. O’Rourke, S. Jones, M. Klasner, J. and

Murray, P. A prospective randomised trial comparing manual and automated
endoscope disinfection methods. Infection Control and Hospital Epidemiology
Vol 14 (7) July 1993 383-9

Gardner, J. and Peel, M. Sterilisation, Disinfection and Infection Control. 3rd Ed.
Churchill Livingstone Publishers, Malaysia,1998

20
Gastroenterological Society of Australia (GESA). Gastroenterological Nurses
Society of Australia (GENSA). Infection Control in Endoscopy. Cowen, A. Editor.
Gastroenterological Society of Australia Publishers Sydney, 1999

Glionna, J. Unsterile Devices Prompt Warnings. The Los Angeles Times. February
13, 2003

Lei, O. Beilenhoff, U. Bader, L. Jung M. and Exner, M. Reprocesssing of flexible

endoscopes and endoscopic accessories-An International Comparison of Guidelines
Zeitschrift fur Gastroenerologie Vol 40(7) 2002. pp 531-542

Leung, J. Working Party Report: Care of Endoscopes-Reprocessing of flexible

scopes. Journal of Gastroenterology and Hepatology 15, (volume no. unavailable)
2000 G73-G77

Lewis, D. A Sterilisation Standard for Endoscopes and Other Difficult to Clean

Medical Devices. Practical Gastroenterology (Volume and No. unavailable)
September 1999

Michele, T. Cronin, W. Graham, N. Dwyer, D. Pope, D. Harrington, S. Chaisson, R.

and Bishai, W. Transmission of Mycobacterium tuberculosis by a fiberoptic
Bronchoscope. Journal of American Medical Association Vol 278 (13) 1997 pp
10931095

Muscarella, L. Advantages and limitations of automated flexible endoscope

reprocessors. American Journal of Infection Control Vol 24 (4) August 1996 pp 304-
309

Muscarella, L. Automatic Flexible Endoscope Reprocessors. Gastrointestinal

Clinics of North America Vol 10 (2) April 2000 pp245-

National Health and Medical Research Council (NH&MRC) Infection Control in the
Health Care Setting. Australian Government Publishers, Canberra 1996

Spach, D. Silverstein, F. and Stamm, W. Transmission of Infection by

Gastrointestinal Endoscopy and Bronchoscopy. Annuls of Internal Medicine Vol 118
(2) January 1993 pp 117-128

Tandon, R. Working Party Report: Care of Endoscopes. Disinfection of

gastrointestinal endoscopes and accessories. Journal of Gastroenterology and
Hepatology 15 (volume no. unavailable) 2000 pp G69-72

21
 Appendix One

ALERT!
Microbiological testing of endoscopes (including bronchoscopes) and
automatic endoscope disinfectors
It has come to the attention of the Hume Region Infection Control Resource and
Consulting Services that some health care facilities in the region may not be aware
of the recommendations, relating to biological testing of scopes, contained in the
“Guidelines for Infection Control in Endoscopy” published by the Gastroenterological
Society of Australia –1999 (This document is commonly referred to as the GENSA-
guidelines).

The GENSA 1999 guidelines-page 66 recommends that;

1. Disinfecting machines and endoscopes processed in this way (automatic

endoscope processors i.e. medivator and soluscope) should be monitored
(biologically) every 4 weeks.

2. Duodenoscopes and bronchoscopes should be monitored (biologically) every

2-4 weeks.

3. All other gastrointestinal scopes should be routinely monitored (biologically)

every four months

4. If major changes are made in the Endoscopy Unit personnel responsible for
cleaning, or if there is a clinical suspicion of cross-infection related to
endoscopy, then further microbiological screening should be undertaken in
conjunction with a Clinical Microbiologist.

If you are processing endoscopes using automatic processors you may wish to
review your current procedures to determine if this recommendation is being
implemented in your facility.

Endoscope Questionnaire

The Hume Region Infection Control Resource and Consulting Service will be
forwarding a short questionnaire to all health care facilities in the region in the near
future to ascertain compliance with this recommendation with regard to facility
owned and loaned endoscopes.

The purpose of the questionnaire is to determine the current status within the region
in regard to processing and biological testing of scopes and will help identify and
determine, if any, regional strategies that may need to be implemented.

22
 Appendix Two

Results of Endoscope Survey

Demographics of endoscope use

Of the 17 acute public health organisations in the Hume Region, 15 provide an
endoscopy service.

Of the 15 organisations that provide an endoscopy service, 11 (73%) use owned,

and 11 (73%) use loaned endoscopes, with 6 (40%) using a combination of owned
loaned endoscopes.

Of the 11 organisations using loan endoscopes, 5 (33%) used permanent loan

endoscopes and 8 (53%) used a rotating loan, i.e. the endoscopes are brought to
the organisation with the endoscope service provider. Two organisations used a
combination of both permanent and rotating loan endoscopes.

In the event of current endoscopes being unavailable for use, only 5 (33%) of
organisations indicated that they would use interim loan endoscopes, yet 13 (87%)
had a strategy for interim loan as part of the contingency plan. Of the two hospitals
that did not state use of interim loan endoscopes, 1 (7%) indicated that they would
suspend the list, whilst the 1 (7%) remaining organisation did not have a
contingency plan.

The total number of gastroscopes in use in hospitals in the region is 38. Of these, 24
are owned by 10 hospitals, and 14 are loaned by 7 hospitals. Of the 7 hospitals
using the 14 loaned gastroscopes, there are 7 permanent and 7 on rotating loan.
Three of the 7 hospitals (43%) use permanent loan scopes and four (57%) use
rotating loan. This equates to four hospitals within the region using up to 7 loaned
gastroscopes. The number of actual rotating loan scopes is difficult to specify as the
same loan scope may be used by different hospitals, but each hospital has recorded
the scope.

There are currently 39 colonoscopes in use in hospitals throughout the region. Nine
hospitals own 21 of these scopes, whilst 18 are loaned by 8 hospitals. Of the 18
loan scopes, 9 are permanent loan and 9 are on rotating loan. Four of the 8
hospitals use rotating loan scopes. This equates to 4 hospitals within the region
using 9 rotating colonoscopes

The three hospitals providing a bronchoscopy service use 5 bronchoscopes, the two
hospitals providing the laryngoscopy service use 2 laryngoscopes and one hospital
providing the duodenoscopy service uses 3 duodenoscopes. All use and process
their own scopes.

Four hospitals provide a cystoscopy service using a total of 10 cystoscopes. Of

these hospitals, three own 9 scopes and one hospital has 1 scope on permanent
loan.

Of the remaining loan scopes in use, one hospital uses a 1 rotating loan
laparoscope, and one hospital uses 1 rotating loan arthroscope.

23
The most cited reference by organisations for development of policy and procedure
related to cleaning and processing of scopes is GENSA-1999 with 11, followed by
automated endoscope processor manufacturers instructions 10 (two types of
processors). Next came AS 418-1998 with 8, endoscope manufacturers instructions
with 5, and ACORN which was cited 4 times. The NH&MRC-1996 and Hospital
Procedure Manual were cited only once each.

Biological Monitoring of Endoscopes

Of the 11 organisations using own scopes, 8 (73%) identified that they had a
documented procedure in place for biological monitoring of the scopes, 1 (9%)
organisation was in the progress of writing a procedure and 2 (18%) organisations
have no documented procedure.

Of the 11 organisations using loan scopes only 2 (18%) had a documented

procedure for biological monitoring, which meant that 9 organisations (82%) had no
formal procedure in place. The responsibility for monitoring of loan scopes was
undertaken by 3 hospitals (27%), whilst 8 hospitals (73%) did not undertake
responsibility for testing. Of the 8 hospitals using rotating loan scopes, only 3 (37%)
identified the service provider as responsible for monitoring of the scopes, whilst 5
(63%) service providers did not take responsibility for the monitoring of scopes they
brought with them. No hospitals recorded that they had a formalised agreement for
the scope provider to take responsibility for monitoring of rotating loan scopes, but 2
(29%) are in the process of formalising the agreement.

Processing Method for Endoscopes

Unless otherwise specified, there is no differentiation between permanent and

rotating loan

Gastroscopes

One hospital is using a vented fume cabinet with glutaraldehyde for processing of
own scopes, and one hospital is using the same method for loan scopes. Two
hospitals are using vented fume cabinet with OPA for processing of loan scopes
Six hospitals are using automated endoscope reprocessors (AER’s), of these five
are using Soluscope with glutaraldehyde for owned and loan scopes, and one is
using a Medivator with OPA for own scopes. Seven hospitals are using a Steris
unit, six are processing own scopes and one is processing loan scopes.

Colonoscopes

Two hospitals are using vented fume cabinets for processing of loan colonoscopes,
one is using glutaraldehyde, and the other hospital is using OPA. Six hospitals are
using AER’s, of these, five hospitals are using Soluscope with glutaraldehyde for
processing of own and loaned scopes. The Medivator with OPA is used by one
hospital for processing own scopes. Please note that one hospital uses both
Soluscope and Steris for processing of loan colonoscopes

24
Bronchoscopes

The three hospitals providing bronchoscopy service, all process their own
bronchoscopes through a Steris unit.

Other scopes

The one hospital utilising the duodenoscopes, processes owned scopes in the Steris
unit. Cystoscopes are processed by four hospitals in the Steris unit, three hospitals
process their own scopes, whilst the other hospital processes a permanent loan
scope. Flexible laryngoscopes are processed in the Steris by the two hospitals who
own these scopes. The single laparoscope and arthroscope reported are rotating
loan scopes and are processed in the same hospital in an AER using OPA.

Timeframes for Biological Monitoring of Processing Units

The timeframes for biological monitoring of units varied between organisations and
between processing methods utilised by each organisation. The 5 hospitals using
the Soluscope System for high disinfection all biologically monitored their units, of
these, 3 tested monthly, 1 bi-monthly and 1 quarterly. The only hospital using the
Medivator tested monthly. Hospitals using the Steris system for sterilisation of
endoscopes all biologically monitored their units, 1- fortnightly, 4- weekly and 2-
monthly. The organisations using the vented fume cabinets did not biologically
monitor the units.

Timeframes for Biological Monitoring of Endoscopes

Again timeframes for biological monitoring of scopes varied between organisations,

especially gastroscopes and colonoscopes. There was also a big variation between
testing of own scopes compared to loan scopes.

Gastroscopes

Owned
Monitoring ranged from fortnightly to not tested at all, with one hospital giving no
answer. Of the three hospitals using the AER’s, two tested monthly, one gave no
answer. Of the six hospitals using the Steris System, one tested fortnightly, three
quarterly, one every 4 months and one hospital not tested the scope at all. The
remaining hospital using vented fume cabinet for processing, tested the scope
quarterly.

25
Loaned
Monitoring ranged from 3 monthly to not tested at all, with two organisations giving
no answer. Of the three hospitals using AER’s one tested quarterly, one did not
test, and one did not answer. The single hospital using the Steris system tested the
scope on arrival to the hospital. Of the three hospitals using vented fume cabinets,
one did not test, one didn’t know if they tested, and the other hospital gave no
answer.

Colonoscopes

Owned
Monitoring ranged from monthly to not tested at all, with one hospital giving no
answer. Of the three hospitals using the AER’s, one tested monthly, one hospital did
not test and the other one gave no answer. Of the six hospitals using the Steris
System, four tested quarterly, one every 4 months and one hospital did not test the
scope at all. No hospitals processed own scopes in vented fume cabinets

Loaned
Monitoring ranged from on arrival to not tested at all, with two organisations giving
no answer. Of the four hospitals using AER’s two did not test, and one did not
answer. Of the three hospitals using the Steris system, one tested the scope on
arrival to the hospital, two did not test scopes at all. Of the two hospitals using
vented fume cabinets, one did not test and the other hospital gave no answer.

Other endoscopes

Owned

The three hospitals using bronchoscopes all processed them in the Steris System
one tested 4 weekly, two tested monthly (please note that questionnaire format may
have affected this result with 4 weekly not given as a selection, the 4 weekly
response was added in other). The hospital using the duodenoscopes processed
the scope in the Steris unit and tested 4 weekly. Of the three hospitals using
cystoscopes, one tested monthly and two tested quarterly. The two hospitals using
laryngoscopes tested quarterly and processed the scopes in a Steris unit.

Loaned

The hospital using both loan laparoscope and arthroscope tested monthly and
processed the scopes in a Medivator unit. The only hospital using loan cystoscope
tested 4 monthly and the scope was processed in the Steris System.

26
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

Adjunct to Appendix Two

N = Number of respondents that answered to this question. Percentage = Number of

respondents who answered to this question as a percentage of total respondents.

N Percentage

Hospital does provide endoscope service 15 88%

Hospital does not provide endoscope service 2 12%

N=15

Hospital uses own endoscopes 11 73%

Hospital uses loaned endoscopes 11 73%

(refer below)

Uses a combination of hospital owned and 6 40%

loan scopes

If you use loan scopes, are they?

Permanent loan 5* 33%

Rotating loan 8* 53%

Interim loan 5 33%

*Two hospitals used both permanent and rotating loan scopes

In the event of the need for interim loan of scopes (as part of your contingency plan)
are they/or would they be provided by?

Endoscopy list is suspended 1 7%

Endoscopy Service Provider 5 33%
Other hospital/organisation 1 7%
Endoscope Manufacturer 7 47%
No arrangements in place 1 7%

27
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

Hospital Owned Scopes

No. of scopes in use No. of organisations in brackets

in hospitals

Gastroscopes 24 (10)

Colonoscopes 21 (9)

Bronchoscopes 5 (3)

Duodenosocopes 3 (1)

Cystoscopes 9 (3)

Laryngoscopes 4 (2)

Loaned Scopes P R P R

Gastroscopes 14 7 7* (7) (3) (4)

Colonoscopes 18 9 9* (8) (4) (4)

Bronchoscopes (0)

Laparoscope 1 1 (1) (1)

Arthroscope 1 1 (1) (1)

Cystoscopes 1 1 (1) (1)

Sigmoidoscope** 1 (1)
P=Permanent loan R=Rotating loan
*Total number of reported scopes by each organisation, however same scope may have been
reported more than once, if rotating between hospitals.
**Sigmoidoscope was listed as loaned scope by one hospital but details of processing and monitoring
was not identified in returned questionnaire, therefore not further reference is made to this endoscope

What guidelines and standards do you use to formulate your hospital’s policy and
procedure documents regarding the cleaning and processing of owned and loan
endoscopes?
Name of Standard or Guideline Number of hospitals using this guideline

GENSA/GENCA 1998 11
NH&MRC 1
AS4187 8
ACORN 4
Scope Manufactures Instructions 5
Hospital Procedure manual 1
Gallay Scientific 1
Device Technology 9

28
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

No. of organisations Percentage

Does your hospital have a documented procedure in place that identifies how often
biological monitoring of your own scopes is to occur?

N= 15
Denominator 11 (organisations using own scopes)

Yes 8 73%

No 2 18%

In progress 1 9%

No Answer /Not Applicable 4** not included

*Note that one respondent who answered no to use of own scopes, answered yes to this
question, but endoscopes are permanent loan and respondent represented in no
answer/not applicable
**Reponses not included in % as respondents use only loaned endoscopes

Does your hospital have a documented procedure in place that identifies how often
biological monitoring of loaned endoscopes is to occur?

N= 15
Denominator 11 (organisations using loan scopes)

Yes 2* 18%

No 9 82%

No Answer/Not Applicable 4 not included

*Two of the organisations who responded yes to this question who do not routinely use
loaned scopes indicated that they would;
1. test loan scopes on arrival to organisation and as per own scope routine for the
period of the loan
2. test scopes on arrival to the organisation
Respondents represented in no answer/not applicable

29
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

No. of organisations Percentage

Does the hospital undertake responsibility for biological monitoring of loan scopes?

N=15
Denominator 11 (organisations using loan scopes)

Yes 3* 27%

No 8 73%

No Answer/Not Applicable 4 not included

*Two of the organisations who responded yes to this question who do not routinely use
loaned scopes indicated that they would;
3. test loan scopes on arrival to organisation and as per own scope routine for the
period of the loan
4. test scopes on arrival to the organisation
Respondents represented in no answer/not applicable

Does the provider of endoscopic service (brings own scopes) take responsibility for
biological monitoring of endoscopes?

N=15
Denominator 8 (organisations using rotating loan scopes)

Yes 3 37%

No 5 63%

Unknown 3 not included

No Answer /Not Applicable 4 not included

If so, is this agreement formalised?

N=8
Denominator 8 (organisations answering yes to above)

Yes 1* 13%

No 7** 87%

No Answer /Not Applicable 7 not included

*The respondent answering yes to this question, answered no to the above. The intent of
the question was to identify formalised agreements affirming service provider responsibility,
not formalising an agreement for service provider not to have responsibility

**One respondent answered no to this question when response should have been no
answer or not applicable

30
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

No. of organisations Percentage

If agreement is not yet formalised, are you in the process of formalising the
agreement?

N=7
Denominator 8 (organisations answering no to above)

Yes 2 29%

No 5 71%

No Answer /Not Applicable 7 not included

Answered yes to this question and 1* not included

Answered yes to above question

*Same respondent who indicated that formalised agreement was for service provider not to
have responsibility for biological monitoring-Respondent not included in the data

31
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

HOSPITAL OWNED SCOPES

Table 1 Gastroscopes and frequency of biological monitoring (10 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using 1 1
Glutaraldehyde
Medivator using 1
OPA
Steris using 1 3 1 1
Paracetic acid
VFC using 1
Glutaraldehyde
VFC using
OPA

Table 2 Colonoscopes and frequency of biological monitoring (9 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using 1 1
Glutaraldehyde
Medivator using 1
OPA
Steris using 4 1 1
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

32
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

HOSPITAL OWNED SCOPES

Table 3 Bronchoscopes and frequency of biological monitoring (3 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using
Glutaraldehyde
Medivator using
OPA
Steris using 1 2
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

Table 4 Duodenoscope and frequency of biological monitoring 1 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using
Glutaraldehyde
Medivator using
OPA
Steris using 1
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

33
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

HOSPITAL OWNED SCOPES

Table 5 Cystoscopes and frequency of biological monitoring (3 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using
Glutaraldehyde
Medivator using
OPA
Steris using 1 2
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

Table 6 Laryngoscopes and frequency of biological monitoring (2 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using
Glutaraldehyde
Medivator using
OPA
Steris using 2
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

34
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

LOANED SCOPES

Table 7 Gastroscopes and frequency of biological monitoring (7 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using 1 1 1
Glutaraldehyde
Medivator using
OPA
Steris using 1
Paracetic acid
VFC using 1*
Glutaraldehyde
VFC using 1 1
OPA
*Not tested by the organisation-owner responsibility

Table 8 Colonoscopes and frequency of biological monitoring (8 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using 2,1a 1
Glutaraldehyde
Medivator using
OPA
Steris using 1, 1,1b
Paracetic acid
VFC using 1*
Glutaraldehyde
VFC using 1
OPA
*Not tested by the organisation-owner responsibility
a,b denotes same organisation, but may use different processes for colonoscopes

35
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

LOANED SCOPES

Table 9 Laparoscope and frequency of biological monitoring (1 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using
Glutaraldehyde
Medivator using 1
OPA
Steris using
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

Table 10 Cystoscope and frequency of biological monitoring (1 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using
Glutaraldehyde
Medivator using
OPA
Steris using 1
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

36
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

LOANED SCOPES

Table 11 Arthroscope and frequency of biological monitoring (1 organisations)

Processing Method Fortnightly 4 weekly Monthly 3 Monthly 4 Monthly 6 Monthly On Arrival Not tested Don’t Know No Answer
Soluscope using
Glutaraldehyde
Medivator using 1
OPA
Steris using
Paracetic acid
VFC using
Glutaraldehyde
VFC using
OPA

Note one organisation indicated that they would test all loaned scopes on arrival if in use as interim replacements

37
 Hume Region Infection Control
Resource and Consulting Service
Collated Endoscope Data

How often is the equipment used to process hospital owned and loaned scopes biologically monitored?

Table 12 Biological Monitoring of Processing Equipment

Processing Method Fortnightly Weekly Monthly 2 Monthly 3 Monthly 4 Monthly 6 Monthly Not tested No
Applicable
Soluscope 3 1 1
Medivator 1
Steris 1 4 2
VFC 3

Table 13 Utilisation of specific processing method for each type of scope per organisation

Processing Gastroscopes Colonoscopes Bronchoscopes Duodenoscopes Cystoscopes Laryngoscopes Laparoscopes Arthroscopes Total
Method
Own Loan Own Loan Own Loan Own Loan Own Loan Own Loan Own Loan Own Loan Own Loan
Soluscope 2 2 2 3 0 4 5
Medivator 1 0 1 0 0 1 1 2 2
Steris 6 2 6 3 3 1 4\3 1 2 22 7
VFC 1 3 0 2 0 3 5

TOTAL 10 7 9 8 3 1 3 1 2 1 1

38
 HRICRCS recommendations for
Biological monitoring of endoscopes and endoscopes
reprocessors (AER’s)

Recommended Biological Monitoring of Flexible Endoscopes which are sterilised or undergo

manual high disinfection processes.

Endoscope Type Frequency

Bronchoscope 2-4 weeks
Duodenoscopes 2-4 weeks
Gastroscopes 4 months
Colonoscopes 4 months
Other flexible gastrointestinal 4 months

Recommended Biological Monitoring of Flexible Endoscopes which undergo automated high

disinfection (AER’s) processes

Endoscope Type Frequency

Bronchoscope 2-4 weeks
Duodenoscopes 2-4 weeks
Gastroscopes 4 weeks/monthly
Colonoscopes 4 weeks/monthly
Other flexible gastrointestinal 4 weeks/monthly

*Recommendations derived form GENSA guidelines 1999. Research and review of the validity of
biological monitoring is occurring at present, and challenges to the validity of the GENSA
recommendations may become apparent in the future. However, until this research is established
and there is evidence to prove or disprove the validity of such testing, GENSA recommendations
should be followed. In Australia this body is recognised as having the leading experts in this field. It
is worth noting GENSA guidelines also only make reference to disinfection procedures and biological
monitoring, however HRICRCS recommends that flexible endoscopes processed via sterilisation are
monitored in the same way as disinfected endoscopes until further research proves that testing is not
required.

Recommended Biological Monitoring of Endoscope Reprocessors

Reprocessor Type Frequency

Steris Weekly
Soluscope Monthly
Medivator Monthly
GUS Organisation discretion
Fume Cabinet Organisation discretion

*Disinfection reprocessors as per GENSA guidelines, other units as per manufacturers instructions or
organisation discretion as units are not automated.

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 Positive Test Result
Action Plan
The person nominated to receive the test results (Refer Endoscopy Service- Memorandum of
Understanding) should contact the Director of Medical Services and or the Infection Control
Practitioner, and person in charge of Endoscopy Unit where the endoscope has been used to
formulate a working party and action plan.

There is currently no mandatory requirement to contact the Department of Human Services in

the event of a positive microbiological test result from either an endoscope or automated
endoscope reprocessor.

Positive test results should be identified as a ‘potential critical incident’ and although it is not
mandatory to report results as described above, the Department of Human Services suggests
that the Regional Office in your area be contacted in the event the issue progresses to a critical
incident, with the possibility of media exposure and community knowledge occurring. As such
the organisation should implement the critical incident management plan and identify the
contact /liaison person for the organisation.

Interpretation of the results to determine Clinical Significance

In the event of a positive test result identify the organism and level of growth. Consult
microbiologist to determine possible origin of the isolate (water borne, environmental, skin flora
etc) to eliminate contamination at time of sampling as source of positive result. Discuss the
significance of the result with microbiologist and potential outcomes for patients exposed to;
the endoscope with a positive test result, or endoscopes processed in an automated machine
with positive test result. Re-test to determine if isolate
is still insitu.

Actions

Contact other organisations (if any) that have used the same endoscope following the positive
test result.
Contact the owner of the endoscope (if not another organisation). Discuss clinical significance
and actions your organisation is taking in response to positive test result.

Dependent on the clinical significance of the results the organisation must decide upon actions
that reflect the risk management strategy and critical incident action plan. This may or may not
include contact tracing of patients exposed to or potentially exposed to an endoscope with a
positive result, or endoscopes processed through automated reprocessor with positive result.

The identified endoscope/automated endoscope reprocessor history must be checked to

determine if a positive result has occurred before, if so, when, and what isolate was identified.
Review all cleaning, processing, physical condition and maintenance records of
endoscopes/automated endoscope reprocessor. Check water supply and filtering systems to
automated processors, also check that chemical agents used in the processing are not
contaminated, diluted or being used at the wrong strength.

40
If required, withdraw the endoscope/endoscope processor from use until tests prove the unit to
be biologically safe for use as determined by your working party. Review the need to import
temporary equipment, or postpone endoscopy lists until issue is resolved.

Write up report of the incident, actions taken and any outcomes. Keep Regional Office of
DHS, other organisations and parties involved in this issue informed of progress and outcomes.

41
 (Insert Name of Organisation) Endoscopy Service
MEMORANDUM OF UNDERSTANDING
This memorandum of understanding outlines the responsibilities of the nominated parties
for the cleaning, processing and biological monitoring of the rotating loan endoscopes
used within this organization.

Responsibilities

Endoscope Owner

The endoscope owner will ensure that the endoscope is cleaned, processed,
dried, handled, stored and biologically monitored in accordance with
recommended standards and guidelines. The owner will ensure that
automated units, if used to process the endoscope, are biologically,
chemically and physically monitored in accordance with manufacturers
instructions and with recommended standards and guidelines.

Payment for microbiological analysis of the samples taken from the

endoscope/s is the responsibility of the owner of the endoscope/s unless
otherwise negotiated with the organization/s in which the endoscope is
used.

Endoscopy Service Provider

The party responsible for the transport of the endoscope between

organizations will ensure that the endoscope is packaged and transported to
minimize contamination prior to arrival to this organization.

Endoscope User

The organization using the endoscopes ensure that the endoscope is cleaned,
processed, dried and handled in accordance with recommended standards
and guidelines. The automated units, if used to process the endoscopes, are
biologically, chemically and physically monitored in accordance with
manufacturers instructions and with recommended standards and guidelines.

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Biological Monitoring

The nominated party as identified in the ‘agreement’ will ensure that

biological monitoring of the endoscope described below is in accordance
with recommended standards and guidelines.

The nominated party ‘agrees’ to undertake biological monitoring of the

endoscope specified below, which includes;

• Taking the biological sample and sending the sample for

microbiological analysis

• Recording of test results on endoscope monitoring history sheet,

• Reporting test results to relevant organisations to whom the scope

is also on loan, and to the owner of the endoscope.

Endoscope Brand and Type

…………………………………………………….
Endoscope ID Number
…………………………………………………….
Endoscope Owner
…………………………………………………….
Endoscope Users (other organisations)

……………………………………………………………………………

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 MEMORANDUM OF UNDERSTANDING
Agreement

I, …………………………………………………………………………………
(Owner of endoscope e.g. surgeon, or representative of organization if endoscope
owned by that organization e.g. NUM theatre)

On behalf of,
…………………………………………………………………………………
(myself, organization)

agrees to
…………………………………………………………………………………
(myself, organization)
being the nominated party responsible for undertaking the biological monitoring
of the endoscope as outlined on page 2.

The nominated party delegates responsibility to the following persons

………………………………………………. will be responsible for taking biological

sample and sending it to be analysed

……………………………………………… will be responsible for recording of test

results

……………………………………………… will be responsible for reporting of test

results

……………………………………………… will be responsible for payment of the

biological monitoring

Signed………………………………………………………………………………..

Name and Title (please print)…………………………………………………………

On behalf of the Organisation using the Endoscope - (please print)

………………………………………………………………………………………

Date………./……../………..

Signed………………………………………………………………………………..

Name and Title (please print)…………………………………………………………

On behalf of the Endoscope Owner- (please print)

………………………………………………………………………………………

Date………./……../………..

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 ENDOSCOPE RECORD
MICROBIOLOGICAL TESTING HISTORY
To be kept with endoscope

EXAMPLE ONLY
ENDOSCOPE ID NUMBER 657854321-Gastroscope-pentax
AND TYPE

ENDOSCOPE OWNER Dr. G Bell

ROUTINE MICROBIOLOGICAL MONITORING MONTHLY-if endoscope is processed at any site in an Automated Endoscope Reprocessor
4 MONTHLY-if processed by sterilisation or manual disinfection process

Name of party responsible Date this sample Sample taken by Testing Agent Pathology Endoscope Signed Additional
for testing of endoscope taken Used Department biological comments
(as identified on MoU) processing sample test result
and date
sample
taken

St Margarets 25/10/01 Jim Beam Ringers solution Northwest Pass xxxxxxxx

Pathology 25/10/01
St Margarets 23/2/02 Jim Beam Ringers solution Northwest Pass zzzzzzzzz
Pathology 23/2/02

45
 ENDOSCOPE RECORD
PROCESSING HISTORY
To be kept with endoscope

EXAMPLE ONLY
ENDOSCOPE ID NUMBER 657854321- Gastroscope-pentax
AND TYPE

ENDOSCOPE OWNER Dr. G Bell

INFORMATION TO BE ENTERED AT EACH SITE THAT ENDOSCOPE IS USED

Name of Hospital or Date Endoscope Type of Chemical Agent Processing Unit’s last Signed Additional comments
Endoscopy Unit used Processing Unit Used known biological test
and ID Number result and date test
taken

St. Elsewhere’s 20/7/02 Soluscope Glutaraldehyde Pass xxxxxxxx Processed 5 times

2345 26/6/02
Prince Charles 23/7/02 Steris Paracetic acid Pass zzzzzzzzz Processed 6 times
6789 7/7/02

46
 Hume Region Infection Control
Resource and Consulting Service
Endoscope Questionnaire
Please print clearly your responses

Name of Organisation

………………………………………………………………………………

Name of person in charge of endoscope processing

……………………………………………………………………………….

Name of person/s and their position/s completing questionnaire

……………………………………………………………………………….

……………………………………………………………………………….

Endoscopes
(please circle correct answer)

Does your hospital use endoscopes owned by the hospital? Yes No

Does your hospital use loaned endoscopes? Yes No

(refer below)

If you use loan scopes, are they?

Permanent loan
(scopes remain on the hospital premises) Yes No

Rotating loan
(scopes arrive and leave with endoscopy service Yes No
provider at each visit)

Interim loan
(short term - if own scopes are unavailable for period Yes No
of time i.e. for repair)

In the event of the need for interim loan of scopes (as part of your
contingency plan) are they/or would they be provided by?
(please tick)

Endoscopy Service Provider

Other hospital/organisation
Endoscope Manufacturer

47
 Hume Region Infection Control
Resource and Consulting Service
Endoscope Questionnaire

Hospital Owned Scopes

Please record the number of own scopes used

Gastroscopes ………………

Colonoscopes ………………

Bronchoscopes ………………

Other (specify) ………………………………………………………………………

Loaned Scopes

Please record the number of loan scopes used

Gastroscopes ………………

Colonoscopes ………………

Bronchoscopes ………………

Other (specify) …………………………………………………………………….

What guidelines and standards do you use to formulate your hospital’s policy and
procedure documents regarding the cleaning and processing of owned and loan
endoscopes?

Please list below

Name of Standard or Guideline Published by and year

48
 Hume Region Infection Control
Resource and Consulting Service
Endoscope Questionnaire
Processing-Hospital Owned Scopes
How do you currently process own endoscopes?
(use the information listed below to complete the Table 1)

Processing Unit
Medivator 1
Soluscope 2
Steris 3
Vented fume cabinet 4
Other unit (specify) 5 …………………………………………………..,

Disinfectant/sterilant
Glutaraldehyde A
OPA B
Paracetic acid C
Other (specify) D ……………………………………………………

Biological Monitoring-Own Scopes

Monthly 1
3 monthly 2
4 monthly 3
6 monthly 4
Other (specify) 5 …………………………………………………….

(*example only)
Scope type Processing Unit Disinfectant/sterilant Biological
Monitoring
Gastroscopes 2 A 1

*This indicates that the gastroscopes are processed using soluscope with glutaraldehyde
and the scopes are tested monthly

Please list appropriate letter and number beside each listed scope type (refer example given above)
Table 1
Scope type Processing Unit Disinfectant/sterilant Biological
Monitoring
Gastroscopes
Colonoscopes
Bronchoscopes
Other (specify)

Does your hospital have a documented procedure in place that identifies how often
biological monitoring of your own scopes is to occur?

Yes No

49
 Hume Region Infection Control
Resource and Consulting Service
Endoscope Questionnaire
Processing-Loan Scopes

How do you currently process loaned endoscopes?

(please complete Table 2 using same information as for Table 1)

Table 2
Scope type Processing Unit Disinfectant/sterilant Biological
Monitoring
Gastroscopes
Colonoscopes
Bronchoscopes
Other (specify)

Does your hospital have a documented procedure in place that identifies how often
biological monitoring of loaned endoscopes is to occur?

Yes No

Does the hospital undertake responsibility for biological monitoring of loan scopes?

Yes No

Does the provider of endoscopic service (brings own scopes) take responsibility for
biological monitoring of endoscopes?

Yes No

If so, is this agreement formalised?

Yes No

If agreement is not yet formalised, are you in the process of formalising the
agreement?

Yes No

50
 Hume Region Infection Control
Resource and Consulting Service
Endoscope Questionnaire

How often is the equipment used to process both own and loaned
scopes biologically monitored?

Biological Monitoring-Processing Equipment

Monthly 1
2 monthly 2
3 monthly 3
6 monthly 4
Other (specify) 5
……………………………..

Please list appropriate number as indicated beside each listed equipment

Processing Equipment Biological monitoring

Medivator
Soluscope
Steris
Other (specify) ………………………………….

Any further comments

………………………………………………………………………………………………

………………………………………………………………………………………………

………………………………………………………………………………………………

………………………………………………………………………………………………

………………………………………………………………………………………………

………………………………………………………………………………………………

………………………………………………………………………………………………

Please return this questionnaire in the envelope provided, or by email to

regional.ic@hume.org.au by the 9th September 2002-08-14

Thankyou for your time and participation.

51