Principles of Effective Decontamination

Protocols
1. INTRODUCTION

THE MOST IMPORTANT STEP IN THE PROCESS OF ENDOSCOPE

DECONTAMINATION IS SCRUPULOUS MANUAL CLEANING PRIOR TO
DISINFECTION

DEFINITION

"Manual cleaning" refers to the physical task,

performed by hand, of removing secretions and
contaminants from the endoscope with
appropriate brushes, cloths, detergents and water.
It should NOT be confused with "mechanised
cleaning” (where a cleaning process is performed
by a machine) or "mechanised disinfection" (when
a clean endoscope is placed in a machine which
disinfects and rinses the instrument).

Mechanised cleaning is not appropriate for endoscopes

In order for manual cleaning to be effective it must:

1. Be performed by a person conversant with the structure of the endoscope and

trained in cleaning techniques;

2. Be undertaken immediately after the endoscope is used so that secretions do

not dry and harden;

3. Follow a protocol which, using appropriate detergents and cleaning equipment,

allows all surfaces of the endoscope, internal and external, to be cleaned;

4. Be followed by thorough rinsing to ensure that all debris and detergents are
removed prior to disinfection.

26.
2. EFFECTIVENESS OF RECOMMENDED PROTOCOLS
Hanson et al48,49 has shown that recommended protocols removed all microbiological
contamination from endoscopes used to examine patients with HIV and HBV infection.
They have also confirmed that endoscopes artificially contaminated with serum
containing high titres of these viruses have all microbiological activity removed by
appropriate reprocessing. These results have been confirmed by a number of other
studies. One of the most important is that of Deva et al189. This excellent study made
three critical findings:

1. When followed meticulously, recommended reprocessing protocols removed

microbiological contamination.

2. That bacterial contamination was an accurate index of viral contamination.

3. That even minor deviations from cleaning protocols resulted in persistent

microbiological contamination after disinfection.

Chu et al190 has quantitated the dramatic reduction in bio burden levels following
effective cleaning of colonoscopes. They have also confirmed the contamination of
endoscopes during the cleaning process by water borne organisms including
pseudomonas and enterobacteriaceae.

Not all investigators have been able to confirm such satisfactory results in reprocessing.
Kovacs et al191 reported a strain of Pseudomonas aeruginosa responsible for three
separate clinical episodes of E.R.C.P. associated cholangitis over an 11 year period.
They concluded the organism developed adaptive chemical resistance to glutaraldehyde
because it could be recovered from the instrument after stringent recommended
reprocessing protocols. Kovacs et al192 found that endoscopes artificially contaminated
with Mycobacterium chelonei did not have all bacteria removed by recommended
reprocessing. The clinical implications of this study are less clear since clinical disease
is unlikely to occur from Mycobacterium chelonei. Cronmiller et al193 contaminated
colonoscopes with Enterococcus faecalis and found some remaining contamination after
ten minutes of glutaraldehyde immersion. Bordas et al194 found that “in use” tests
demonstrated not all bacterial contamination was removed by recommended protocols.
Van der Voort et al195 and other authors have found remaining HIV RNA on endoscopes
when using PCR techniques. However the significance of this was extremely doubtful,
particularly since the study of Deva et al50 using the duck hepatitis B model has shown
that duck hepatitis virus remaining on instruments detected by PCR was not infective
when injected into ducks and therefore is likely to represent remaining viral RNA rather
than intact infective particles.

The number of organisms detected in most of these studies has been extremely small
and of doubtful clinical significance. Nonetheless it does emphasise that our present
reprocessing techniques are less than ideal and have a lower margin of safety
than is desirable. It emphasises the need for all steps in reprocessing protocol to
be carried out meticulously.

3. ENDOSCOPE STRUCTURE
There are at least fifty different models of flexible endoscopes available in Australia. An
instruction book is supplied with each endoscope by the manufacturer.

IT IS ESSENTIAL THAT EVERY PERSON RESPONSIBLE FOR ENDOSCOPE

DECONTAMINATION READS THESE INSTRUCTION BOOKS AND IS FAMILIAR
WITH THE PARTICULAR CHARACTERISTICS OF EACH MODEL OF ENDOSCOPE
REQUIRED TO BE CLEANED.

27.
COMMON FEATURES

External

All flexible fibrescopes have a light guide plug, an umbilical cable (cord), a control head
and an insertion tube.

(a) The Light Guide Plug

The light guide plug fits into the light source. The air/water and suction channels have
ports in the light guide plug.

The light guide plug of a video endoscope is heavier than that of a fibrescope and needs
to be handled with care.

VIDEO ENDOSCOPES

The terminals in the light guide plug are

NOT IMMERSIBLE and must be covered by
the cap supplied with the instrument prior to
cleaning.

(b) The Umbilical Cable/Universal Cord

The umbilical cable connects the light guide plug to the body of the endoscope. The
external surface may be contaminated by splashes or hand contact during endoscopic
procedures.

(c) The Control Head

The control head contains the control handles, which allow the operator to flex the
instrument and to access the suction and air/water functions by use of valves. Fibreoptic
endoscopes have an eyepiece on the control head. Video endoscopes are similar in
construction to fibreoptic endoscopes, except that they do not have an eyepiece - the
image is seen on a video screen. The control head is contaminated during endoscopic
procedures by the operator's hands. The control handles have grooved surfaces, which
must be carefully brushed during cleaning. The hollow structure of some control handles
should be noted and care taken to ensure that the undersurface is thoroughly rinsed and
emptied of fluids. The seats, which house the suction and air/water valves (buttons),
must be thoroughly cleaned. The biopsy channel port is located at the base of the
control handle near its junction with the insertion tube. This port must be brushed
carefully during the cleaning process.

(d) The Insertion Tube

The insertion tube enters the patient's body and is grossly contaminated during the
procedure. The distal tip of the insertion tube houses the microchip (in video
endoscopes), the openings for the suction and air/water channels and the lens covering
the flexible fibreoptic light guides. The section of the insertion tube adjacent to the distal
tip is known as the bending section. It is made from soft flexible material and is
particularly vulnerable to damage especially if handled carelessly.

28.
Common Internal Features

The suction and air/water channels and the fibreoptic light guide extend from the light
guide plug to the distal tip. In non-video models an additional fibreoptic bundle, the
image guide, extends from the control head to the distal tip. The cables, which allow the
tip to be flexed, run through the insertion tube. Any damage to either the umbilical cable
or the insertion tube can potentially damage any of the internal structures. Care must be
taken during cleaning procedures to ensure that the umbilical cable and insertion tube do
not become kinked or acutely bent. KINKS IN BIOPSY CHANNELS TRAP DEBRIS
AND LEAD TO FAILURE OF THE CLEANING PROCESS. Suspected damage should
be referred to the supplier for assessment and repair. A negative leakage test does NOT
preclude damage to internal endoscope structures.

Special Internal Features

Most duodenoscopes have an additional channel - the forceps elevator (raiser) which is
extremely fine (capacity 1-2 mls) and requires scrupulous attention during the cleaning
process. Cleaning adaptors for this channel are provided with each duodenoscope AND
MUST BE USED.

Some colonoscopes have a carbon dioxide channel (C02) that is connected to the
air/water channel. Cleaning protocols should include individual flushing of this channel.

Flushing channels are found in some endoscopes. These are usually grossly
contaminated during procedures and must be independently flushed during cleaning
whether or not they have been used.

4. CLEANING EQUIPMENT
All endoscopes are supplied with appropriate cleaning adaptors. It is vital that persons
cleaning endoscopes are conversant with these adaptors and use them correctly.
Rubber "0" rings on the adaptors must be inspected regularly for defects or looseness
and should be replaced as required. Substitute cleaning equipment should not be used
unless approved by the supplier of the instrument, e.g. using a syringe to squirt fluid into
a port which requires a screw thread adaptor is not safe practice.

Cleaning brushes for both channels and valve ports are also supplied. These have a
limited life. They should be inspected regularly and replaced when worn or kinked.

Soft toothbrushes are useful to clean grooved control handles and to brush the distal tip
and biopsy ports. Cotton buds may be used to clean the suction valve port but should
not be used in the air/water port as threads can become caught and cause blocked
channels.

Adequate supplies of disposable cloths or swabs should be available.

5. CLEANING FLUIDS
Endoscope suppliers have reported a reduction in channel blockages since the
introduction of enzymatic detergents. These products promote protein lysis and enhance
the efficacy of brushing and flushing and are the preferred detergent. Where an enzyme
product is not immediately available, a neutral instrument detergent can be used.
Household detergent is NOT suitable. Chlorhexidine based detergents have been
reported to damage instruments when followed by glutaraldehyde disinfection and should
NOT be used.

29.
Manufacturers of enzymatic solutions report optimum efficacy when used in warm water.
However, enzymes will continue to be active in water that has cooled to room
temperature. The use of hot water will destroy the enzyme activity. Heavy
contamination may exceed the enzyme capacity.

6. RINSING WATER
It is increasingly recognised that hospital tap water may be contaminated with a variety
of micro-organisms149,196-204. Pseudomonas and related species149,197, atypical
198,200,201,204
mycobacteria and legionella198,199,202,203 are the most important frequently
detected contaminants. Whether or not the hospital water is contaminated will depend
on a wide variety of factors which include the quality of the water delivered to the
hospital, the age and particular structure of the hospital plumbing system and hot water
temperature. Where the plumbing is old or has been altered, particularly if there are
blind endings and where a high flow is not occurring frequently, the risk of contamination
is increased. Hot water systems which have the temperature regulated to prevent patient
scalding will also increase the likelihood of water contamination. A constant temperature
of at least 55°C at the point of use is necessary in order to prevent persistence of
organisms in warm water.

The principal risks of such contaminated water in endoscopy units are that endoscopes
and accessory equipment will become contaminated during the washing or rinsing
process and that the organisms will proliferate in damp areas of the endoscope during
storage. It is likely that this is one of the principal mechanisms for colonisation of
endoscopes and disinfecting machines.

Organisms contaminating the endoscope or accessory equipment during washing or

rinsing steps inbetween patient examinations may be introduced to the next patient on
the list. This risk is likely to be extremely small and probably only significant where an
invasive procedure, e.g. injection sclerotherapy or E.R.C.P. is undertaken or if the
patient has a severely compromised immune system, (e.g. leukaemia, HIV infection).
Contamination of biopsy or culture specimens may also cause confusion by falsely
suggesting that infection is present, (e.g. pseudo infection)24,205-207.

This risk has prompted a call for filtration of all water used to wash and rinse
endoscopes. Such a general usage is both difficult, expensive and may carry its own
significant problems. Filters which are not changed and/or regenerated (including
autoclaving) may in fact become a source of contamination themselves, increasing
208-211
rather than reducing the problem . In general, however, persisting vegetative
pathogens are unlikely to survive in a completely dry environment.

Bacteriological examination of tap water is not simple. The tap mouth should be flamed
to eliminate surface gram negatives and at least a litre (preferably more) of tap water
needs to be collected. Therefore, a practical alternative to monitoring water quality or
filtering water is meticulous air drying of all channels following an alcohol flush after each
case.

Recommendations

1. The quality of water delivered to the endoscopy unit be examined on a regular basis.
If significant contamination is found then filters should be installed.

2. FILTERED OR STERILE WATER MUST ALWAYS BE USED FOR FINAL AND

BETWEEN PATIENT RINSING OF DUODENOSCOPES AND BRONCHOSCOPES.

30.
3. Where filtered water is not used, it is absolutely essential to use alcohol flushing and
prolonged air drying at the end of lists for routine endoscopes and colonoscopes.
ALCOHOL AND AIR DRYING BETWEEN CASES FOR ROUTINE ENDOSCOPY
AND COLONOSCOPY WILL BE IMPRACTICAL BECAUSE OF TIME
CONSTRAINTS IN BUSY UNITS. ALCOHOL RINSING BETWEEN CASES FOR
DUODENOSCOPES AND BRONCHOSCOPES IS DANGEROUS BECAUSE OF
THE POTENTIALLY DISASTROUS RISKS OF INTRODUCING ALCOHOL INTO
THE PANCREATIC DUCT OR BRONCHI.

4. Where water guns are used, they must be able to be disassembled for cleaning and
disinfection.

5. In small units or isolated areas where neither filtration nor regular bacteriological
water testing is practical, then alcohol flushing and air drying between EACH case is
an acceptable alternative for routine endoscopy and colonoscopy.

7. RINSING
Rinsing should take place under running water so that all traces of detergent and
disinfectant are flushed away. Failure to adequately rinse glutaraldehyde from
endoscopes has been reported to cause severe post colonoscopy colitis212 and may be
responsible for some cases of post E.R.C.P. pancreatitis. Static rinsing, i.e. rinsing in
bowls of water is not recommended.

The amount of water required to thoroughly rinse an endoscope after disinfection will
vary according to the design and length of the instrument. It is unlikely that volumes of
less than 150mls of fresh water in each channel will be effective in removing chemical
residue.

8. DISINFECTANT
Disinfectants for endoscope reprocessing need to have wide bacterial properties together
with the ability to kill relevant viruses including HIV, HBV and HCV. Testing should have
been conducted under clinical operating conditions as well as under laboratory
conditions. Many disinfectants have either a restricted spectrum of activity or have not
been adequately tested.

At the time of writing, glutaraldehyde is the only acceptable chemical disinfectant

available in Australia for use in unsealed systems. 2% alkaline glutaraldehyde (e.g.
Cidex) or 2% neutral complex glutaraldehyde (e.g. Aidal plus) are recommended.

Soaking time

Effective manual cleaning of the item to be soaked is critical in determining the

effectiveness of chemical disinfection.

Endoscopes which are not adequately cleaned will not be adequately disinfected even
with prolonged soaking times.

The Gastroenterological Society of Australia and the

Gastroenterological Nurses Society of Australia
recommend at least 10 minutes soaking in 2%
glutaraldehyde at 20°C following the recommended
cleaning regimen.

31.
Chemical disinfection must take place in an area with adequate physical controls such as
forced air extraction. Soaking bowls must have close fitting occlusive lids. Forced air
extraction should extend to the rinsing sink. Post disinfection rinsing should be
performed in COLD running water (warm or hot water increases the amount of fumes
generated).

ENDOSCOPY SHOULD NOT BE PERFORMED IN CENTRES WHERE ADEQUATE

FACILITIES FOR CLEANING AND DISINFECTION ARE NOT AVAILABLE.

Staff required to chemically disinfect endoscopes must be provided with education in the
safe use of glutaraldehyde and with personal protective clothing which includes
impervious gowns (or gowns and plastic aprons), gloves which have been approved for
use with glutaraldehyde and face shields (see Occupational Health and Safety).

9. GENERAL MAINTENANCE
Leak testing of endoscopes should be performed after use as per manufacturers’
instructions. Failure to detect a leak prior to thorough cleaning and disinfection may
result in major damage to the instrument.

Examination of the instrument lens and outer sheath should be performed following each
session to detect any signs of cracking or damage. The function of angulation cables
should be checked.

Inspection of "0" rings on valves for sign of wear should be performed at the end of each
session. "0" rings should be changed when signs of wear are detected. Biopsy caps
should be checked for signs of wear and replaced as required.

10. LUBRICATION
Lubrication is used to ensure optimal functioning of both endoscopes and accessories.
The “O” rings on suction and air/water control buttons require lubrication to prevent the
buttons sticking in the depressed position. Traditionally silicone oil supplied with the
endoscope has been used. Silicone oils can be either petroleum based or in a water
soluble base. There is evidence that both preparations may impair reprocessing213.
Biological fluid can be entrapped within oil globules and protected from disinfectant
action. The choice is therefore to either take particular pains to ensure complete
removal of silicone based lubricants or to use surgical instrument lubricant.

Recommendation

(a) Accessory items processed in ultrasonic cleaners should be lubricated with an

instrument lubricant following completion of the ultrasonic cleaning. They should
then be wiped with a clean, lint-free cloth and allowed to air dry prior to packaging for
steam sterilisation.

(b) Where silicone oil lubricants are used for suction and air/water control buttons, they
should be applied immediately before use (after chemical disinfection). It is
essential to remove lubricant residue to allow germicide contact. Ultrasonic cleaning
will remove any small remaining amounts of lubricant.

32.
11. WORK AREAS
Work areas should be planned carefully. The areas should be well ventilated and the
cleaning area should include the following:

1. At least one sink designated for the cleaning of instruments, referred to as the “dirty”
sink. This should be made of materials which are impervious to solution, such as
stainless steel, porcelain or of a plastic bonded material. The sink must be of
sufficient dimensions to adequately hold a full length colonoscope without causing
the instrument injury, e.g. laundry tub size. The sink should be supplied with running
hot and cold water.

2. An area adjacent to this sink where the components of the instrument are removed
for cleaning. The “dirty” bench is then suitable for holding instruments awaiting
chemical disinfection.

3. An area for disinfection of instrument. In the case of automated disinfectors the

dimensions and requirements must be assessed by the make and model of the
machine to be installed. For manual disinfection, a container of solution of sufficient
dimensions to hold an instrument without injury to the instrument would need to be
available. It is preferable that this container be a fixed sink placed under an
appropriate fume extraction system. Otherwise a container especially designed for
glutaraldehyde disinfection of instruments is available. This must be placed in a
fume extraction cupboard.

4. Where an automated disinfector is used, rinsing is performed within the machine.

Where manual rinsing occurs, a sink designated for rinsing only clean instruments
must be available.

33.
Decontamination Regimens
Introduction

It is known that stored endoscopes may become colonised with vegetative bacteria
during storage, especially if the drying process is not adequate157. Unfortunately the
complex structure and fine channels of endoscopes preclude absolute certainty that
drying processes are always effective. Therefore endoscopes must have a full
disinfection process performed prior to use on the day and at the end of the list.

At the end of a list, using 70% isopropyl alcohol to enhance the drying process, the
endoscope must be thoroughly forced air dried prior to storage. Methylated spirits is
NOT suitable for this process.

1. MANUAL CLEANING
The following steps should be performed immediately following a procedure.

1.1 IMMEDIATELY after each procedure with the endoscope still attached to the
light source, grasp the control head. Using a disposable cloth soaked in
detergent solution, wipe the insertion tube from the control head to the distal tip.
Discard cloth.

1.2 Place distal tip in detergent solution. Aspirate through suction channel - depress
and release suction button rapidly to promote debris dislodgement.

1.3 Depress and release air/water button several times to flush water channel.
Occlude air button to force air through the air channel.

1.4 Some types of endoscope have air/water channel cleaning adaptors that should
be placed in the air/water valve seat at this point as per manufacturers
instructions to flush the air channel. If there is no such adaptor the water bottle
connector should be removed from the endoscope taking care not to
contaminate its end. The endoscope should be removed from the light source
and taken to the cleaning area. (If due to local circumstances there is a delay
prior to thorough cleaning place the endoscope in a bowl of enzyme solution and
soak. Ensure protective caps are applied before immersing in solutions.) IT IS
ESSENTIAL THAT THE ENDOSCOPE IS NOT ALLOWED TO DRY PRIOR TO
CLEANINGAS THIS WILL ALLOW ORGANIC MATERIAL TO DRY MAKING
REMOVAL FROM CHANNELS DIFFICULT OR IMPOSSIBLE.

1.5 In the case of video scopes the protective cap over the plug should be applied.
Leak test the instrument as per manufacturer’s instructions. WARNING: It is
essential that manufacturer’s instructions be followed.

1.6 Remove all valves and buttons. Brush and clean paying particular attention to
internal surfaces. Place buttons in an ultrasonic cleaner.

1.7 Place endoscope in enzymatic/detergent solution and using the brushes provided
by the manufacturer brush the suction/biopsy channel in all directions. If the
brush contains obvious debris it should be cleaned before being withdrawn.
Each channel should be brushed until all visible debris is removed. Wash all
outer surfaces.

1.8 Using a soft toothbrush, gently clean the distal tip of the endoscope.

34.
1.9 Brush control handles and biopsy port. Brush around valve seats.

1.10 Clean valve seats thoroughly - check that all visible debris has been removed.
Use special brushes if provided by manufacturer.

1.11 Fit cleaning adaptors. Thoroughly flush all channels with enzymatic solution.

1.12 Rinse outer surfaces. Flush all channels thoroughly with fresh water. It is
essential that all detergent be removed prior to disinfection.

1.13 Purge channels with air to remove rinsing water. Dry outer surface with soft
cloth.

1.14 Disinfect as per section 2.

2. MANUAL DISINFECTION

2.1 After manual cleaning immerse endoscope in disinfectant so that the entire
endoscope is submerged. Fill all channels with disinfectant so that all air bubbles are
expelled. All channel entrances must be under the surface of the disinfectant during this
procedure to ensure that no air enters the channel. Remove the buttons and valves from
the ultrasound, rinse, dry and then immerse in glutaraldehyde as per 2.2 or autoclave if
applicable. It is preferable to have extra supplies of buttons and valves to ensure that
adequate cleaning is performed prior to immersion in glutaraldehyde.

2.2 Endoscopes

SOAK FOR 10 MINUTES IN 2%

GLUTARALDEHYDE AT 20°C

Bronchoscopes

SOAK FOR 20 MINUTES IN 2%

GLUTARALDEHYDE AT 20°C

IF THE TEMPERATURE IS LOWER THAN

20°C THEN THESE SOAKING TIMES WILL
NEED TO BE PROLONGED (ACCORDING
TO PRODUCT SPECIFICATIONS)

A timer with an alarm is essential to ensure that accurate soak

times are achieved. (Digital timers are more accurate.) A fluid
thermometer with digital readout is recommended to constantly
monitor temperature of glutaraldehyde solution.

35.
2.3 Purge disinfectant from all channels with air and remove endoscope, valves and
buttons from disinfectant, taking care to avoid drips and splashes.

2.4 Rinse exterior of endoscope thoroughly and flush channels with fresh water to
remove traces of glutaraldehyde. Rinse all valves and buttons thoroughly.

2.5 Purge all rinsing water from channels.

2.6 If the instrument is being prepared for reuse, remove the cleaning adaptors. Dry
exterior surfaces with a soft cloth and reassemble endoscope.

If the instrument is to be stored do not remove cleaning adaptors and refer to point 3.1.

3. AT THE END OF THE LIST

3.1 Flush all channels with 70% Isopropyl alcohol (approximately 2mls for elevator
channels, approximately 20m1s for each other channel). If using a multichannel
cleaning adaptor the quantities of alcohol may need to be increased.

3.2 Force air dry all channels. Ensure that the air source has a flow regulator and
use lower pressure on fine channels. Use bayonet fittings rather than luer lock to
attach the air tubing to the cleaning adaptors and fit securely but not tightly - if
safe pressure is exceeded the bayonet fitting will give way. Use of excessive air
pressure may cause damage to the instrument.

3.3 Ensure that all outer surfaces are dry.

3.4 Check the instrument for any sheath or lens damage. Polish the lens with the
cleaner provided by the manufacturer. DO NOT REASSEMBLE ENDOSCOPE.

3.5 Store endoscope (disassembled) in a well ventilated storage cupboard, which

permits full length hanging on appropriate support structures.

Endoscopes should not be stored in transport

cases as these may themselves become
contaminated.

3.6 Lubricate all "0" rings on buttons, valves and cleaning adaptors and store
separately

4. ENDOSCOPIC ACCESSORY EQUIPMENT

The cleaning and disinfection of reusable endoscopic accessories is equally as important
as that of the endoscope.

Endoscopic accessories have been implicated in the transmission of infection.

(a) Cleaning

As with endoscopes, the cleaning of accessories as a prerequisite to sterilisation is

mandatory.

1. All equipment should be immersed in enzymatic detergent immediately following use

until cleaning can be performed.

36.
2. The equipment should be dismantled as far as possible and all visible soiling
removed.

3. Any spiral coil, hinged or complex structured accessories should be placed in an

ultrasonic cleaner and processed according to manufacturers’ recommendations. NB
Keep hands out and lid on. (Refer Aust. Std 2773)

4. Any fine bore cannulae or tubing accessory items will require thorough flushing with
enzymatic detergent. Other accessory items, depending on design, will require a
combination of flushing and brushing to clean surfaces.

5. Following cleaning by either of these methods, accessory items should be thoroughly

rinsed and dried prior to disinfection, autoclaving or ethylene oxide sterilisation.

(b) Disinfection

In general, accessory equipment used in gastroenterological procedures requires high

level disinfection. However, accessories that enter sterile tissue or the vascular system
must be sterile. This includes biopsy forceps, injection sclerotherapy needles and all
accessories used for E.R.C.P. Where an alternative exists, all non-autoclavable
reusable accessories should be phased out.

1. All autoclavable equipment must be cleaned thoroughly prior to sterilisation process.

2. All non-autoclavable equipment should be immersed in glutaraldehyde ensuring all

cavities are flushed with glutaraldehyde. The soaking time will depend on whether
the accessory item will be required to enter sterile tissue (see section on
Disinfection).

Some accessory items require specific comment.

Sclerotherapy needles are difficult to clean and reprocess to a sterile state. Therefore
it is recommended that only single use sclerotherapy needles be used.

Water bottles and connectors. These accessory items should be autoclaved at the
beginning and end of each session as they have been implicated in the transmission of
infection. All non-autoclavable bottles and connectors should be replaced with those that
are fully autoclavable.

Where an alternative exists all E.R.C.P. accessory items that are not autoclavable
should be phased out.

Dilators are likely to come in contact with tissue that has been abraded or otherwise
damaged by the dilation process. They should therefore have undergone high level
disinfection immediately before the session. Note the operative field will not be sterile as
the patient’s own microbiological flora will contaminate the area. Dilatation is also
frequently performed using an endoscope that has undergone high level disinfection.

37.
5. REPROCESSING FLEXIBLE BRONCHOSCOPES AND
ACCESSORIES
Refer to section on mycobacteria and Serratia marcescens. in the section “The Infecting
Organisms”:

1. The Center for Disease Control and Prevention recommends that bronchoscopy
should not be performed on patients with active tuberculosis unless absolutely
necessary.

2. No method will successfully achieve high level disinfection of bronchoscopes unless

adequate mechanical cleaning has been performed – Mycobacterium tuberculosis
survived ten complete disinfection cycles in 2% glutaraldehyde after inadequate
cleaning3.

3. Automatic disinfectors and bronchoscopes have frequently been colonised with

atypical mycobacteria214-217.

4. Flexible bronchoscopes that cannot withstand the process outlined below because of
age, design or damage should not be used.

IMMEDIATELY FOLLOWING USE

1. If specimen trap has been used, disconnect from suction line.

2. Aspirate enzymatic/detergent solution through the instrument (approximately

200mls) by depressing the suction button/valve.

3. Using a disposable cloth soaked in enzymatic/detergent solution wipe insertion tube

from control handle to distal tip to remove excess secretions and debris.

4. Disconnect the instrument from the suction and light source.

5. Take instrument to cleaning area.

6. NB If cleaning cannot be performed immediately ensure the instrument is leak

tested then leave soaking in enzymatic solution until full cleaning can be
performed.

CLEANING OF INSTRUMENT

1. Perform leakage test in freshly prepared water. Manipulate controls to check action
of distal tip and to detect any breaches of the outer skin of the scope when the A
rubber is stretched.

2. Disassemble the instrument by removing biopsy cap and suction valve/button.

3. Disassemble suction valve and clean with brushes, then place in ultrasonic cleaner.
If using reusable biopsy caps, brush cap and then rinse.

4. Immerse instrument in enzymatic/detergent solution. Using the cleaning brush,

brush the suction channel by inserting the brush in the suction port in a downward
fashion to the distal tip. Brush until all debris is removed (it may be necessary to
clean the brush inbetween accessing channel). Brush the biopsy channel downward
to the distal tip. NEVER BRUSH FROM THE DISTAL TIP UPWARDS. NOTE:
Some twin channel instruments will require brushes of differing sizes.

38.
5. Using a brush, clean both suction and biopsy ports.

6. Using a very soft toothbrush, brush distal tip. do not brush soft exterior sheath of
scope. Brush control handle and eyepiece with soft toothbrush.

7. Wipe outer sheath with soft cloth.

8. Attach cleaning adaptor.

9. Flush enzymatic/detergent solution through all channels (approximately 100mls).

10. Flush clean water through all channels (approximately 200mls).

11. Expel water from all channels using regulated air.

12. Place instrument in 2% glutaraldehyde ensuring all external surfaces are in contact
with the solution. Flush glutaraldehyde through all channels removing all air from
channels. Place suction valve/button and biopsy cap in glutaraldehyde.

13. SOAK FOR 20 MINUTES in a container with a firm fitting lid.

14. Use a timer for accurate measure of soaking times.

BETWEEN CASES

1. If the instrument is to be used again for another patient, remove instrument from
glutaraldehyde solution and into a sink of sterile/filtered water. Flush all channels
with sterile/filtered water to remove any traces of glutaraldehyde.

2. Rinse suction valve and biopsy cap in sterile water and then dry.

3. Attach air connectors to expel water from channels.

4. Pat instrument dry with clean cloth.

5. Reassemble the instrument.

AT THE COMPLETION OF THE SESSION

1. Remove instrument from glutaraldehyde and place in a sink of fresh water. Using
tap water flush the channels to remove all traces of glutaraldehyde.

2. Insert approximately 20mls of 70% alcohol into the cleaning adaptor.

3. Attach air supply and force air dry the scope.

4. Bronchoscopes should be stored on hangers designed for the purpose, NOT COILED
IN CASES. Do not reassemble. Remove all cleaning adaptors.

5. Dry all valves and caps.

39.
ACCESSORY EQUIPMENT

All equipment used for taking samples and specimens must be sterile. Cytology brushes
are single use, as are specimen traps. A variety of forceps are suitable for use via the
biopsy port. Take care to ensure the diameter of such equipment is suitable for insertion
in the small channel. NEVER FORCE FORCEPS OR BRUSHES IN THE CHANNEL AS
THE CHANNEL WILL BECOME DAMAGED.

All forceps must be sterile. The most important step in the sterilisation process is that
the equipment must first be clean. Forceps should be placed in an enzymatic solution
immediately after use BEFORE secretions can dry on the equipment.

1. The forceps, cups and wire coil must then be cleaned manually using a soft
toothbrush.

2. Place equipment in ultrasonic cleaner and process according to manufacturers’

instructions.

3. Rinse equipment.

4. Dry thoroughly.

5. Package and label equipment.

6. Forward to CSSD.

6. VARIATION IN CLEANING AND DISINFECTION REGIMENS

DEPENDING UPON THE SUPPOSED INFECTIVE STATUS OF THE
PATIENT
A number of surveys have shown that the practice of varying the cleaning and
disinfection regimen according to the supposed infective status of the patient is
widespread75,76,218-221. Reynolds et a176 reported that in up to half the endoscopy units
surveyed in Massachusetts, hospitals changed their reprocessing techniques after use in
patients with known HIV infection, tuberculosis or hepatitis. Common practices include
using ethylene oxide "sterilisation" or prolonging chemical immersion times for
endoscopes used in patients with these diagnoses. Such an approach is totally
unscientific and illogical. Many patients who have these disorders and do not know or
conceal such knowledge will be subjected to endoscopic procedures. It is therefore
totally unacceptable to have a cleaning and disinfection schedule that does not
effectively deal with such unrecognised cases. By logical extension, if the cleaning and
disinfection regimen is adequate to deal with unknown cases, then it is also adequate to
deal with known cases. Conversely, the use of special precautions in known infected
cases clearly implies that the regimen used under routine circumstances is thought to be
inadequate to prevent transmission of these diseases. There is clear, adequate
evidence to show that the cleaning and disinfection schedule recommended in this
review is adequate to prevent the transmission of infectious disorders including HIV
infection, hepatitis and tuberculosis. There is therefore NO JUSTIFICATION to alter the
cleaning and disinfection regimen if patients are known to have these disorders.

It must be noted these statements apply to common pathogens such as human immuno
deficiency virus, hepatitis viruses and bacteria. Special and unusual hazards do exist.
The problems associated with modified Prion Protein diseases (Creutzfeldt Jakob
Disease and other spongiform encephalopathies) are considered on pages 18 and 19.
These agents are highly resistant to conventional forms of microbiological destruction
and the containment measures outlined in the section should be followed.

40.
There is no evidence that Mycobacterium tuberculosis can develop adaptive chemical
resistance. A special problem with Mycobacterium tuberculosis, however, exists in
relation to staff and patient cross infection from contaminated aerosols. As noted in the
section on Mycobacterium tuberculosis, the Centre for Disease Control strongly
recommends that bronchoscopy is not undertaken in patients with known active
tuberculosis. Where open cavitating tuberculosis exists the risk of aerosol spread is
extremely high. Persistent and explosive coughing is frequent during and following
bronchoscopy and the risk of mycobacteria containing aerosols is significant even with
closed tuberculosis. Appropriate precautions in the examination room will include
negative air pressure ventilation with operating theatre levels of air exchange together
with appropriate personal protective measures for the staff.

Adaptive chemical resistance to a wide range of disinfectants has been convincingly

shown for atypical mycobacteria and problems associated with the decontamination of
automatic disinfectors are considered on page 52.

7. REUSE OF MEDICAL DEVICES LABELLED ‘SINGLE USE ONLY’

The annual cost to the United States health services alone of devices labelled ‘Single
Use Only’ is estimated to exceed three billion dollars. It is therefore hardly surprising
that in a climate of progressive fiscal restraint, health care facilities will attempt to
restrain costs by reusing devices labelled ‘Single Use Only’. The safety, ethical and legal
issues involved in such reuse have proved to be complex and divisive, various
stakeholders viewing the problem from one perspective only222-237.

Major physical issues in reprocessing ‘Single Use Devices’ are clearly stated in the
compliance policy guide of the F.D.A.:

1. That the device can be adequately cleaned and sterilised.

2. That the physical characteristics or quality of the device will not be adversely
affected; and

3. That the device will remain safe and effective for its intended use.

Less clear are the ethical and legal issues raised in reprocessing. The underlying issues
revolve around the opposing arguments of utilitarianism and contractarianism. Does the
maximisation of benefit to society as a whole from the more efficient use of medical
financial resources outweigh a small but essentially unquantifiable increase in risk to the
individual patient in whom a ‘single use only’ device is reused?

Not surprisingly where the underlying ethical issues are complex and inconclusive, the
legal position is even more clouded. The exact legal position will vary from country to
country and even from jurisdiction to jurisdiction within a country.

The overall legal position is likely to be that most actions for redress in the event of injury
related to reuse of a ‘single use only’ device will be in negligence. Clearly the
contravention of specific laws within a particular country will also be relevant.

In general, arguments of negligence will turn on the questions of Duty of Care and
Informed Consent. Under the Duty of Care concept a practitioner is obliged to provide a
standard of care not substantially less than provided by a prudent body of his peers. The
High Court of Australia has recently extended the Duty of Care concept such that the
Court may determine what is an appropriate standard of care. It is necessary for an
institutional practitioner using a ‘single use only’ device to be able to demonstrate
product efficacy and safety. This may be by either using a reprocessing technique that is
identical to a process validated in existing medical literature or to have carried out a
rigorous development testing and validated reprocessing protocol.
41.
Surprisingly there is relatively little literature describing acceptable validated
reprocessing protocols for the majority of ‘single use’ devices. After an extremely
exhaustive review, E.C.R.I.222 (an independent non-profit health service research agency
with the W.H.O. status of a collaborating centre) could only conclude “E.C.R.I’s. review
and analysis of published clinical studies concludes there is no clear evidence that reuse
of ‘single use’ medical devices is either safe or unsafe for patients.”!

Institutions proposing to reuse ‘single use only’ items will face the necessity of
developing and validating protocols which can ensure the safety and efficacy of
reprocessed items.

Endoscopists have until recent years dealt with these problems with the convenient but
highly unsatisfactory device of simply ignoring them. Major problems remain in the
reprocessing of endoscopes themselves, let alone accessory devices. Fortunately recent
advances in design and manufacture of accessories have resulted in significant
improvement. Biopsy forceps can now be autoclaved and there can be no justification
for failing to use either disposable or sterilised reusable biopsy forceps232-237. Relatively
low cost disposable items are now available for a number of other accessories where
clinical usage/design mitigate against effective reprocessing (e.g. endoscopic injecting
needles). The main area of debate in the reuse of ‘single use only’ items in endoscopic
practice centers around the relatively expensive E.R.C.P. accessories, particularly
catheters, sphincterotomes, guidewires and balloons. Fortunately for the majority of
these items, device failure during operation is unlikely to have major clinical
consequences. Major debate therefore centers around the efficacy of cleaning and
sterilisation202.

The available literature provides no clear evidence that reprocessing can be achieved
safely or that there is significant cost benefit. The prudent course appears to be either
not to reuse items that are labelled ‘single use only’ or to do so under the strictly
controlled conditions outlined above.

The above comments refer to equipment where there is at least a reasonable basis for
labelling ‘single use only’. Unfortunately there are a number of items labelled in this way
for which there appears to be no real justification. An example would be polyp traps.
These devices can, in fact, be satisfactorily cleaned and disinfected or even cold
sterilised by prolonged immersion in chemicals. However, it is difficult to see why high
level disinfection or sterilisation would be necessary since the polyp trap is usually only in
the suction line for a relatively brief period with a positive suction flow away from the
endoscope at all times. A number of other examples of abuse of this labelling are
apparent.

Given the enormous financial implications, discussions about reprocessing of ‘single use
only’ devices should not simply be abandoned. Manufacturers should be encouraged to
develop reusable products, but since the cost of research and development is
substantial, incentives such as preferred purchasing options are necessary. Device
manufacturers should be encouraged to become involved in reprocessing of their own
products. They are usually in the best position to estimate the reprocessing
requirements and limitations of the product. Governments are unlikely to become active
participants in third party commercial reprocessing of ‘single use’ devices since in many
countries this is likely to expose them to the full legal requirements imposed on
manufacturers. Government support for research and development for third party
reprocessors may be necessary if manufacturers are not prepared to become involved in
reprocessing their own devices.

42.
Endoscopic Disinfecting Machines
Machines designed to disinfect and rinse endoscopes have been available for more than
15 years but have been slow to gain universal acceptance as a variety of serious and
even fatal infections have been traced to various defects in automatic
disinfectors17,22,155,207,214-217,238. A survey of practices in the United States reported in
199270,218,238 showed that mechanised disinfection was used in almost half of the
endoscopy centres surveyed. The same report documented a widespread lack of
knowledge of the potential problems of contamination associated with automatic
processors. This is despite extensive literature documentation of these problems239,240.
Recently developed machines have corrected many previous design faults. However,
many of the claims are not supported by controlled studies in peer reviewed journals.
Rather they rely on in-house data or reports from commercial testing laboratories241-246.
The perceived advantages of disinfecting machines include:

§ Standardisation of endoscope reprocessing.

§ Reduced exposure of staff to chemicals (particularly glutaraldehyde).
§ Reduction in staff time spent on disinfection.

NONE OF THE CURRENTLY AVAILABLE MACHINES NEGATE THE NEED FOR

THOROUGH MANUAL CLEANING. THIS IS AN ESSENTIAL PREREQUISITE TO
DISINFECTION. CLAIMS BY MANUFACTURERS OF SOME MODELS OF
AUTOMATIC ENDOSCOPE DISINFECTORS THAT MANUAL PRE-CLEANING IS
UNNECESSARY ARE NOT SUPPORTED BY PUBLISHED LITERATURE IN
RESPECTED PEER REVIEWED JOURNALS.

MACHINE DESIGN AND PRINCIPLES

The number of automatic disinfecting machines available is increasing rapidly.
Numerous machines are being promoted, often with relatively scant evidence of long
term safety and efficacy. The following are ideal principles and design features that
should underlie the design and use of automatic disinfectors:

1. The machines will rarely show contamination when new. Unfortunately this is when
most machines are tested. Problems with bacterial contamination rarely become
apparent in machines before six months and become progressively more likely as
the machine ages. “Automatic disinfectors have a sorry history with many past
models having clear and obvious defects which should have led to the confident
prediction of serious contamination. Modern processors are more sophisticated and
testing of newer models rarely reveals contamination. However, the ability of
bacteria to outwit should not be underestimated. Increasing wear and age reveals
unsuspected defects. Biofilm, valve failure, surface irregularities, fissuring, filter
failures and chemical familiarity all offer colonisation opportunities for ever vigilant
bacteria.”247.

2. Water Supply: Machines should be plumbed into the water supply rather than use
manual filling. It may be necessary to install pre-filters, i.e. filters in the water supply
prior to its entry into the automatic disinfector. Fresh water should be used for each
cycle to avoid disinfectant contamination of rinse water. Water quality should be
monitored and filters instituted if necessary. If duodenoscopes or bronchoscopes are
processed in the machine, membrane cartridge filtration of 0.2micron or equivalent
alternative water treatment is mandatory. Once filter systems are installed they in
turn must be regularly serviced and monitored. It is all too easy for filters
208-211,217,248
themselves to become a source of contamination .

43.
3. Fume Containment: Provision should be made for the extraction of disinfectant
fumes from within the machine or the machine should be contained within a fume
extraction hood.

4. Disinfectant Supply: Machines which use a concentrated solution and in-use dilution
for a single cycle (e.g. STERIS system) avoid the problem of dilution of the
disinfectant with rinsing water. Machines which contain a tank of disinfectant for re-
use should be monitored for disinfectant concentration to determine appropriate
disinfectant change schedules. Machines which require filling of a disinfectant
reservoir must incorporate a pump mechanism to obviate the need for pouring
of solutions into the machine.

5. Cycle Counter: Visual display and a permanent record of the cycle number should
be available to indicate the appropriate time for disinfectant change. Automatic
recording of disinfection activity is desirable.

6. Self-disinfection: All machines should have a cycle for auto-disinfection.

Unfortunately this term is used loosely and in many machines the so called “auto-
disinfection cycle” does not extend to all parts of the machine which may allow
significant contamination to develop. It is preferable that the auto-disinfection cycle
should use or certainly be capable of using a disinfectant alternative to that which is
routinely used in the reprocessing cycle. A number of organisms including atypical
mycobacteria (particularly Mycobacterium chelonae) can become extremely resistant
to glutaraldehyde22,217. Elimination of such colonising organisms may require
purging of the whole system with alternative agents including chlorine-releasing
disinfectants, peroxide compounds or absolute alcohol.

7. Drying: A drying cycle using filtered air should be complemented by a facility that
irrigates the channels of the endoscope with alcohol.

8. Leak Testing: Machines should perform leak testing of the endoscope at least once
during the reprocessing cycle.

9. Warning Systems: Audible warning alert should be incorporated for the detection of
channel blockage preventing adequate channel perfusion of disinfectant solutions,
water filter blockage, leakage detection.

10. Proof of Process: A printout of cycle parameters should be incorporated.

11. A heating facility allows for lower in-use concentration of disinfectant and shorter
contact time. The temperature should be monitored if heated disinfectant is used in
the machine.

12. Individual Channel Perfusion: Machines which are to be used for reprocessing
duodenoscopes must allow for the differential pressures required to use the widely
differing sized channels. The forceps elevator channel in duodenoscopes is a
particular problem because of the extremely fine bore.

13. Maintenance: A maintenance schedule which ensures tanks, pipes, strainers and
filters of both the machine and water treatment system are kept free of biofilms and
other deposits should be instituted.

14. Strict bacterial monitoring of disinfecting machines and endoscopes is essential

wherever endoscope reprocessing machines are used. Machines which are shown
to be contaminated should not be used until cleaned and proven to be
microbiologically safe (see Microbiological Testing of Endoscopes).

44.
Proof of Process
Quality control measures are accepted critical processes in the provision of high quality
goods and services in all business areas.

In the health field, quality control is fundamental to the delivery of safe and effective
clinical services. Endoscopy is hindered by the inability to use sterilisation techniques
with clearly defined end points (e.g. steam sterilisation) in the reprocessing of
endoscopes.

Several instances of multiple transmission of serious viral infections as a result of

medical procedures have caused public, legal and governmental concern. This has
provided an added stimulus to develop quality control processes in the reprocessing of
endoscopes and accessories249,250.

Experience in industry shows that processes that have clearly defined progress points
can successfully develop automated systems. Where defined progress points do not
exist then education is a more successful option. In numerous parts of this manual it is
stressed that cleaning is the critical part of any successful endoscope and accessory
reprocessing protocol. Unfortunately it is difficult to automatically record progress points
in the cleaning system. For this reason, GENSA and GESA are introducing a formal
training and certification process for those involved in endoscope and accessory
reprocessing. In contrast, many aspects of the disinfection process can easily be
subjected to automatic recording of important parameters.

The purposes of quality control processes outlined below are:

1. To ensure that those reprocessing endoscopes and accessories have a clear

understanding of the important principals of reprocessing and to fully understand
each of the numerous steps necessary in reprocessing.

2. To record measurable parameters such as disinfection immersion times, disinfection

concentration etc.

3. To ensure that a record exists so that appropriate retrospective linkage analysis can
be undertaken. Some examples of the importance of these records include:

(a) Investigation of possible transmission of viral diseases by endoscopy. It is

critical to be able to identify the endoscope used in the infected patient; to be
able to identify the patients endoscoped with that instrument before the index
case and after the index case; to be able to demonstrate that the instrument was
cleaned by a qualified person and subject to a disinfection cycle where adequate
parameters such as time, concentration and temperature were used (see section
on investigation of possible endoscopic transmission of viral diseases).

(b) The interpretation of cultures from endoscopes. Various examples are given in
the section on bacteriological surveillance of endoscopes. A further example
might be where low levels of vegetative bacteria seem to be randomly recovered
from a variety of endoscopes. Linkage analysis may show that endoscopes with
positive cultures are only occurring when a particular person cleans the
endoscope. Clearly this would be cause for retraining of that person.

45.
The type of information required is not limited to but includes the following:

1. Date of procedure.

2. Name of patient (including relevant identification such as date of birth, UR

number or address). This information could be formatted on a facility label.

3. Instrument and serial number/code linked, i.e. this means that the particular
endoscope used to examine a patient is specifically recorded.

4. Order of patients examined on the list.

5. Signature of the person who manually cleaned the instrument.

6. Signature of the person who rinsed the instrument.

7. Signature of the person who disinfected the instrument.

8. Signature of the person who rinsed the instrument.

9. Signature of the person who tested the strength of the chemical disinfectant.

10. Signature of the person who tested the temperature of the chemical disinfectant.

11. Signature of the person who timed the soaking of the instrument in a chemical
disinfectant.

In addition to the above, a register of the batch number of the chemical disinfectant and
the date it was decanted into the tank, changed or topped up should be maintained.

Many units will have some or all of the above information recorded in a variety of
locations ranging from patient chart to daily register. It is important that a unit based
record is kept regardless of whether the information is in the patient’s chart. Such a
register should be maintained in the unit according to each unit’s policy.

In view of the possible litigation involved, it is essential that the person/s responsible for
reprocessing of endoscopes sign their name following completion of each task. The use
of automated machines still requires the instrument to have been manually cleaned prior
to the disinfection cycle. It is important that the person who commences each phase of
the process completes that particular phase. In situations where more than one person
would perform part or parts of a phase in the manual cleaning process, then the person
who deems the instrument to be fully cleaned must sign the register. It is therefore
recommended that the full manual cleaning of an instrument be performed by one
person only or that if a change in personnel occurs that the process be recommenced to
completion. The person responsible for soaking the instrument or connecting correctly to
an automated machine would then be deemed to have checked the strength of the
solution, the temperature and that all channels and external surfaces are in contact with
the chemical disinfectant.

Rinsing the endoscopes free of chemical disinfectants to a biologically inert level is

another critical phase of the cleaning and disinfection process251-254. The person
responsible for rinsing the instrument free of chemical disinfectant will need to sign the
register.

46.
Accessories

Should accessories be traceable? The following principles should be followed:

1. Accessories which breach sterile surfaces and are difficult to reprocess, such that
sterility cannot be regularly achieved, should be single use only, e.g. sclerotherapy
needles.

2. Accessories which breach sterile surfaces, are not labelled ‘single use only’ and have
documented validated reprocessing systems need only standard indicators, i.e.
cleaning by an appropriately certified nurse and indicator evidence of sterilisation,
e.g. biopsy forceps. They need not be individually traceable.

3. Accessories which breach sterile surfaces and ARE labelled ‘single use only’ require
an institutionally validated reprocessing protocol (see ‘single use only’ section) and
should be individually traceable.

Each unit/facility is encouraged to develop a register suitable to their particular needs.

The sample register as used at P.A.H. Brisbane is provided as an example which may be
used in whole or in part, provided that all the principles and information are readily
accessible and traceable. Computer printouts from automated machines will require
either modification or be used within the register.

47.
 Department of Gastroenterology & Hepatology

Daily Validation Register

A Date: Time:

GlutaraldehydeConcentrationSignature_______________
B ___

Sink 1 Sink 2 Sink 3 Sink

4

Glutaraldehyde
C
Sink 1 Sink 2 Sink 3 Sink 4
Batch No.__________ Batch No. _________ Batch No. __________ Batch No. __________

Plus __________ Plus __________ Plus __________ Plus __________

Expiry date ________ Expiry date ________ Expiry date _________ Expiry date _________

st st st
st
Date of 1 use______ Date of 1 use _____ Date of 1 use ______ Date of 1 use ______

Signature _____________________

Ultrasonic Validation after 10 minutes

D
Pass signature ______________ Fail signature
__________________

Terminal Disinfection
E Air Guns and Tubing Signature __________________

H2O Guns and Tubing Signature __________________

48.
 Daily “Proof of Process” of Scope
and Accessories
Scope Cleaned Rinsed Glutaraldehyde Final Accessor Confirmed Cleaned Ultra- Rinsed
Name number by by Time Temp Rinse by y as sterile by sonic by
Sink Sig. Number “S” or Dis- for 10
infected min
“D”

49.
 Department of Gastroenterology & Hepatology

Register of Staff involved in

Endoscope and Accessory Reprocessing
NAME SPECIMEN SIGNATURE

50.
Investigation of Possible Viral Transmission
by Endoscopy
The clear evidence of Hepatitis C transmission by endoscopy in France (see Hepatitic C
section) together with a series of medically acquired serious viral infections has raised
public concern. Increasingly patients will raise the possibility of whether serious viral
diseases had been acquired as a result of endoscopic procedures. A number of such
claims have already been made in Australia and elsewhere. The aim of this section is to
provide general advice for endoscopy units when patients raise the possibility that an
endoscopic procedure undergone in that facility has been the source of an acquired viral
disease. The most likely viruses involved are Hepatitis C, Hepatitis B and HIV. In some
cases these claims will be opportunistic seeking financial gain or seeking to divert
attention from the real source of infection. However, it is important to realise that in some
patients the source of infection will be genuinely unknown and these patients may
sincerely believe that endoscopy is the most likely cause of their disease. If your unit
has followed the recommendations laid down in this manual then it is extraordinarily
unlikely, indeed it will be unique, if your unit has transmitted a serious viral disease by
endoscopy. We would therefore recommend:

1. It will be in the best interests of the patient, public health in general, the endoscopy
community and your own unit if a prompt, thorough, competent and decisive
investigation is undertaken without delay.

2. It is NOT your role to attempt to determine other possible sources of a patient’s

infection!

3. Do NOT conduct the investigation yourself. You are likely to be involved in emotive
disputes regarding the source of infection and your investigation will lack the
credibility of an independent body.

4. Recognize that a possible conflict of interest exists if the patient is under your
continuing care and you have a financial or controlling interest in the centre.

5. In most cases the best independent authority will be the public health unit of your
State Health Department who will be able to provide appropriate proforma. You may
or may not wish to suggest to the public health unit that they take advice from an
independent microbiologist nominated by you.

6. In practice an appropriate protocol will require:

(a) The endoscope used on the patient in question should be easily and reliably
identified.

(b) The endoscope should be inspected by the manufacturer for defects.

(c) Patients on whom this instrument has been used following the index case should
be tested for the viral disease in question.

(d) Patients endoscoped before the index case should also be tested. This will
usually involve the three patients examined prior to the index case.

(e) Staff should be tested for the appropriate virus infection.

(f) An independent assessor will observe the endoscope reprocessing protocols.

(g) The anaesthetic technique will be assessed.

51.
 (h) Accessories which penetrate sterile tissue (e.g. biopsy forceps, polypectomy
snares, sphincterotomes) should be sterile.

There is always the possibility of a Scottish verdict – not proven either way. In general
the speed and thoroughness with which you respond to any complaint increases the
likelihood that a definitive result will be obtained. If you have followed the recommended
protocols then this will almost certainly be negative and will be of benefit to the facility,
yourself, endoscopy in general and presumably the patient.

The importance of prompt and thorough investigation is demonstrated by the response to

a statement in the Royal Australasian College of Surgeons’ policy document “Infection
Control in Surgery”256 stating, “There is a report from Gosford, New South Wales of a
patient probably acquiring Hepatitis C from colonoscopy.” This statement has been
widely reported in the public and medical press and has simply raised public and
professional anxiety without any definite foundation. We would again stress that the best
interests of all involved are best served by a prompt, thorough investigation that comes
to a definite conclusion.

52.
 Microbiological Testing of Endoscopes
(Including Bronchoscopes) and
Automatic Endoscope Disinfectors
1. INTRODUCTION
Appropriate bacteriological surveillance of endoscopes and automatic processors has
proved one of the most difficult and controversial areas of infection control in endoscopy.
It is therefore appropriate to state the principles involved together with the details of
sample acquisition, processing and interpretation.

Microbiological contamination of endoscopes may occur if:

1. Reprocessing has been inadequate or otherwise deficient.

2. The endoscope is damaged.

Reprocessing deficiencies may occur during:

1. Manual cleaning. This will include all aspects of proper cleaning, from allowing
biological material to dry on or in the endoscope through failure to carry out each of
the numerous cleaning steps properly. Deva et al50 has shown that failure to brush
even the short segment of the biopsy channel between the suction button and the
biopsy forceps port resulted in persistent viral and bacteriological endoscope
contamination even after an otherwise adequate manual reprocessing and full
disinfection. The colonoscopic transmission of Hepatitis C in France may well have
resulted from failure to brush colonoscope channels adequately.

2. Disinfection failures may occur because of the use of inappropriate disinfectants,

inadequate immersion time or more frequently the use of contaminated automatic
processors.

Endoscope Damage:

It is not possible to adequately inspect the internal channels of endoscopes. Cracking,

splitting, fissuring, joint disruption, actual channel wall holes can all be the source of
bacterial contamination within the scope which can be difficult to impossible to detect by
routine inspection and testing. BACTERIOLOGICAL SURVEILLANCE OF
ENDOSCOPES IS FREQUENTLY THE ONLY MEANS OF DETECTING THESE
PROBLEMS AT THIS TIME.

2. TESTING SCHEDULES
Whether or not bacteriological screening of standard endoscopes and colonoscopes
needs to be performed and if so how frequently remains controversial. On the other
hand MICROBIOLOGICAL MONITORING OF DUODENOSCOPES IS ESSENTIAL.
The presence of potentially transmissible bacterial pathogens following inadequate
cleaning is usually accompanied by the inadequate removal of other enteric bacteria.
Thus microbiological monitoring of endoscopes should be viewed as an indirect
marker of adequacy and completeness of the cleaning and disinfection process, i.e. is
a marker of rigorous adherence to the recommended protocol and also as a measure
of structural integrity of the instrument. Assessment should focus on the acceptability
of the total number of organisms remaining.

53.
 Routine taxonomic identification is not indicated except where microbiological failure
persists after a rigorous review of compliance with both cleaning and disinfection
protocols, after review of the structural soundness of the endoscope or where clinically
recognised cross-infection is apparent. Numerous studies document the transmission
of infection by contaminated duodenoscopes during E.R.C.P. (see E.R.C.P section).
In many of these outbreaks the endoscopy units involved were unaware of the
instrument contamination and the serious clinical infections being caused. The
outbreaks were frequently overlooked for prolonged periods and only came to light as
a result of investigation of a series of infections with similar or unusual organisms.

WHAT TO LOOK FOR

Viruses

It is frequently asked why microbiological surveillance does not extend to viruses. The
principles involved here are:

1. Viruses can only proliferate within cells. Therefore proliferation in the internal
channels of endoscopes or in automatic disinfectors does not occur.

2. Deva et al50 have shown that bacterial contamination after reprocessing is an

accurate reflection of viral contamination. Where bacteria remained on or in an
endoscope after reprocessing there was also frequently remaining viral material.
Conversely however, in no case where all bacterial contamination had been
removed were remaining intact viruses demonstrated.

3. The detection of intact infective viruses is extraordinarily complex, prolonged and

expensive, indeed, prohibitively expensive for routine surveillance purposes. Many
viruses, e.g. HBV, cannot be cultured in vitro. The detection of viral nucleic acid by
PCR techniques (see Hepatitis C section) certainly does not necessarily reflect the
presence of intact infective viral particles.

Bacteria

Bacterial cultures should be directed to the detection of:

§ Endoscopes and Colonoscopes

Common pathogens, including pseudomonas, klebsiella, proteus, E coli and
salmonella.

§ Automatic Processors and Bronchoscopes

Pseudomonas, similar organisms and atypical mycobacteria.

Previous recommendations that other common tap water contaminants, including

legionella and cryptosporidia should be looked for do not appear to be clinically useful
and are difficult and expensive. We do not recommend routine cultures for these
organisms.

54.
3. RECOMMENDATIONS
Because of differential risks of infection transmission, recommendations vary with both
the proposed use of endoscopes and with the method of disinfection and cleaning:

1. Disinfecting machines and endoscopes processed in this way should be monitored

every four (4) weeks.

2. Duodenoscopes and bronchoscopes should be monitored every 2-4 weeks.

3. All other gastrointestinal scopes should be routinely monitored 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.

4. MICROBIOLOGICAL TESTING PROTOCOLS

These protocols are primarily instituted to detect an increased residue of enteric bacteria
following routine cleaning and disinfection which represents a surrogate marker of
inadequate cleaning or of structural damage to the channels of the endoscope.

Method of Sampling

1. 10mls of sterile water (or Ringer's solution) is withdrawn from a freshly opened bottle
using a sterile needle and syringe and put into a sterile universal container.

2. A second 10mls of sterile water (or Ringer’s solution) is flushed to fill the channel to
be sampled.

3. A sterile endoscope brush is passed down the biopsy channel, withdrawn and swirled
in the universal container containing the sterile water (or Ringer's solution). The
brush will need to be handled using sterile gloves. The endoscope brush should be
sterilised by autoclaving or gas sterilisation.

4. A further 10mls of sterile water (or Ringer's solution) is flushed through all of the
channels (air-water, suction) by using a sterile syringe. The rinse fluid (20 to 30 mls)
is collected in another sterile universal container.

5. Both containers are labelled and sent with a request form detailing the following:

a. Type of scope sampled and serial number.

b. Name of person to whom report should be sent.

c. Test request - Endoscope routine culture.

Note:
Organisms (especially pseudomonas) can multiply in fluids. Therefore it is essential that
the sample is promptly processed after collection. If there is likely to be any delay the
sample should be refrigerated. Any delay, such as samples being collected in the late
afternoon and not processed until the following day, may lead to erroneous results.

55.
Laboratory Procedure - Infection Control

1. The collected sample is centrifuged down to lml.

2. All specimens – blood agar and MacConkey agar under aerobic conditions only.

3. Semi quantitation of bacterial growth should be performed, e.g. no growth, 10 to 100

colonies, 100 to 10,000 colonised, > 104 colonies.

5. INTERPRETATION OF CULTURES
Each endoscopy unit in conjunction with a clinical microbiologist must set its own
threshold for the initiation of action if cultures are positive. Some examples are given
below:

1. Low numbers of environmental type organisms, e.g. Staph epidermis, may be

encountered not infrequently. These are most likely to represent collection process
contamination rather than a significant problem with the disinfection or cleaning
process. The most appropriate initial response is to review the sample processing
technique to reduce the chance of contamination.

2. A growth of Pseudomonas spp from a duodenoscope or an automatic processor that

processes duodenoscopes would be cause for serious and immediate concern. This
is a high risk clinical situation and the immediate responses would include removing
the automatic processor and duodenoscope from service, careful culturing of the
automatic processor to see if it is the source of contamination, careful inspection of
the duodenoscope for defects and repeated cultures after manual reprocessing to
see if infection persists and clinical follow up of patients recently undergoing
E.R.C.P. and related procedures with that duodenoscope.

3. Significant numbers of enteric organisms, e.g. E coli or Enterococcus faecalis being

recovered from one instrument only. This suggests that there is a mechanical defect
in the instrument and careful inspection with replacement of the insertion tube if no
other defect can be identified.

4. Significant or borderline numbers of enteric organisms such as E coli, Enterococcus

faecalis being recovered from a variety of instruments within the unit. This is strong
evidence of inadequate reprocessing. It is most likely to be due to defects in the
manual cleaning program. Much less likely is a problem in an automatic disinfector,
(e.g. worn valves, serious biofilm accumulation etc). Appropriate response here
would be a detailed review of all staff’s cleaning and disinfection techniques, if
necessary by an independent assessor.

5. Culture of Mycobacterium tuberculosis organisms from a flexible bronchoscope.

This is a potentially serious problem. Responses would include removal of the
bronchoscope from service, mechanical review of the instrument by the
manufacturer, review of any automatic disinfector used including detailed cultures
and clinical surveillance of patients recently bronchoscoped with that instrument.

6. Growth of Mycobacterium chelonae from a bronchoscope. It is almost certain that

this will prove to be due to a contaminated automatic disinfector that needs to be
taken out of service and decontaminated.

7. ANY isolation of salmonella or shigella should cause concern.

56.
6. MICROBIOLOGICAL SURVEILLANCE OF AUTOMATIC
DISINFECTORS
The method of sample collection for automatic disinfectors will vary depending upon the
design of the individual machine. It is therefore appropriate to seek advice from the
manufacturers or consult with your hospital clinical microbiologist. Commonsense would
suggest that the most appropriate point of the machine to sample is the attachment of
the machine to the endoscope. For machines with a single point of attachment (e.g.
Medivator) this is relatively simple. Where there are multiple endoscope connections the
problem becomes more complicated. Further, it is essential to know the design of the
machine to determine which is the optimum part of the cycle to collect the sample. In
most cases this will be in the rinsing cycle. Early detection of machine contamination is
best effected by a concentration process. For example, a technique which works well
with the Medivator is to connect a sterile sealed Millipore filter to the outlet of the
machine where it normally attaches to the endoscope and to cycle at least 200ml of fluid
through the filter in the rinse cycle mode. The disc can then be removed and plated
directly. Since the principal contaminants of automatic disinfectors are Pseudomonas
and related species and various forms of atypical mycobacteria, cultures should be
directed towards these organisms.

57.
Occupational Health and Safety in the
Endoscopy Workplace
1. INTRODUCTION

The relevance of a chapter on Occupational Health and Safety in the Endoscopy

Workplace in a manual on “Infection Control in Endoscopy” may be questioned. In
previous editions this chapter was inserted because of the demonstrated lack of
appropriate concern by administrators for such important topics as glutaraldehyde
sensitivity and immunisation against Hepatitis B. We have decided to retain the chapter
because this document is widely available in endoscopy units and the chapter provides
some simple guidance. It does not purport to be an extensive or comprehensive review
of occupational health and safety issues.

2. CHEMICAL AND HAZARDOUS SUBSTANCES EXPOSURE

A. Glutaraldehyde

(a) Structure
Glutaraldehyde is 1,5-pentanedial. It is an aliphatic dialdehyde that undergoes standard
aldehyde chemical reactions to form acetals, cyanohydrins, hydrazones and bisulphite
complexes. It reacts with proteins by forming cross-linkage reactions. Glutaraldehyde
concentrations in air may be determined by a number of methods. A readily available
commercial instrument is the hand held glutaraldehyde meter, which has a detection
range from 0.05-5ppm v/v. THE INSTRUMENT, HOWEVER, IS SUBJECT TO
INTERFERENCE FROM A VARIETY OF CHEMICAL COMPOUNDS INCLUDING
ALCOHOL AND OTHER ALDEHYDES (as well as colognes and perfumes), AND WHEN
USED IN THE PRESENCE OF THESE WILL GIVE FALSELY ELEVATED READINGS.

Caution is needed in the interpretation of readings. Estimation of isolated values is not

as important as cumulative exposure over the course of a working day.

(b) Occupational Health

A wide variety of animal and human studies are available. Many of these are
summarised in the full public report, Glutaraldehyde -Priority Existing Chemical No. 3 by
the National Industrial Chemicals Notification and Assessment Scheme. (Australian
Government Publishing Service, Canberra, 1994)

The national exposure standard for glutaraldehyde is 0.1ppm. v/v (Peak Limitation)257. It
should be noted that industrial health problems have been reported with exposure
258,259
concentrations below 0.2ppm . It is difficult to be certain whether peak values are
exceeded from time to time, but go undetected. Documented adverse human health
effects include respiratory, nasal and skin problems. Headache, nausea,
lightheadedness, palpitations and tachycardia have also been reported, although the
association with these remains less certain.

Eye Irritation
Accidental splashes with glutaraldehyde may cause severe irritation, pain and light
258
sensitivity. Conjunctival and corneal irritation from vapour exposure occur frequently .

58.
Staff members wearing contact lenses should consult with their ophthalmologists
regarding the suitability of their lenses in the endoscopy setting. Some lenses may
become discoloured or impregnated with glutaraldehyde and cause eye irritation.

Respiratory Irritation
Respiratory irritation, including irritation of the nose and throat have been commonly
reported. Chest tightness, coughing, asthma and apparent initiation of asthma have also
been reported258-265.

Skin Sensitisation
Contact dermatitis from skin sensitisation has been reported on numerous studies265-270.
It is important to note that this contact dermatitis may be associated with deep skin
fissuring and cracking, resulting in an increased susceptibility to blood contact infections
(e.g. HIV).

Epidemiological studies have not shown any correlation between miscarriage or foetal
deformity and glutaraldehyde exposure271,272.

Clearly, there is a wide variation in the susceptibility to the toxic effects of

glutaraldehyde. It is important to keep exposure to the minimum possible, since once
allergic response occurs, even exposure to minute vapour concentrations may
precipitate symptoms.

(c) Safety Measures

Glutaraldehyde has been a major cause of the occupational health problems outlined
above. In many instances this has been due to the failure to provide adequate fume
containment and ventilation systems. Features of an effective fume cupboard for
Glutaraldehyde use include296:

• Air directed from the front access of the cupboard, across the work area and
extracted through a baffle at the rear of the cupboard.

• A fan above the work area with air extracted via ducting to a safe location outside
the building.

• A face velocity of 0.5-1.0 m/sec at the front of the cupboard.

Details of appropriate engineering firms, plastic fabricators etc can be obtained in each
State from G.E.N.S.A. representatives.

It would be unfortunate if some States proceed with their proposed bans for endoscope
reprocessing using glutaraldehyde, even in well contained systems. There is presently
no alternative chemical disinfecting agent for manual reprocessing which is as effective
and has a better safety profile. The many problems associated with automatic
disinfectors are outlined in the appropriate section. In some units automatic disinfectors
will prove to be a safe and effective means of reprocessing. Small units or occasional
users may well find the expense and appropriate care and maintenance of the machines
present major problems.

(d) Personal Protective Equipment

Only gloves that have been approved for use with glutaraldehyde should be worn. In
view of the extensive range of gloves available on the market, it is suggested that the
manufacturers be asked to provide information regarding the gloves suitability for use
with glutaraldehyde.

59.
Protective eye wear should be used. Full face shields proved the greatest protection
against chemical and biological material splash.

Impervious aprons should also be used to prevent splashes coming in contact with
clothing or exposed skin.

(e) Monitoring

The occupational health hazards of glutaraldehyde have been well documented and it is
unacceptable that staff be expected to work in areas where adequate occupational health
and safety measures have not been instituted257,273. Where staff develop symptoms or
where there is any doubt as to the efficacy of control measures, Occupational Health and
Safety personnel should be contacted.

B. Other Chemicals
There are unfortunately no chemical disinfectants suitable for endoscopes that are totally
user friendly. It needs to be appreciated that while the Occupational Health and Safety
problems of glutaraldehyde have been widely publicised, many of the newer compound
agents appearing on the market have had little formal investigation of their irritant
properties. Many of the chemicals used in closed systems can be highly dangerous if
exposure occurs to a concentrated form. This includes peracetic acid and chlorine
releasing agents. Storage of any large quantities of alcohol poses a significant fire
hazard.

3. INFECTIOUS DISEASES

A. Infections, diseases transmitted by blood and other biological fluids

i. Human Immuno deficiency virus (HIV)

The greatest risk here is of needle stick injury. Staff with skin breaks (burns,
cuts, fissures, cracking, dermatoses, etc) should have the appropriate area
covered or be employed in areas where the possibility of blood or biological fluid
contaminating the open area is negligible. The rate of sero conversion after
exposure to HIV infected blood or other biological fluids ranges from 0.1% to
0.4%274-276. In general the greater the innoculum the greater the risk of disease
transmission.

ii. Hepatitis B Virus (HBV)

Again the greatest risk is from needle stick injury. The sero prevalence of HBV
is 2-4 fold higher in health care workers than in blood donors277,278. The risk of
transmission by needle stick injury varies according to the e antigen status of the
blood. Sero conversion occurs in 1-6% following e antigen negative blood
exposure but rises to 20-40% with E antigen positive blood278,279-281.

iii. Hepatitis C Virus (HCV)

Again the greatest risk is from needle stick injury. The sero prevalence of
Hepatitis C in health care workers does not appear to be increased over and
above the general population282-284. It is estimated that sero conversion occurs
following 1-10% of needle stick injuries284-286.

B. Management of Risk of Blood Borne Transmission

All endoscopy units should have an appropriate sharps disposal policy. Needle stick
injury poses a very real threat of disease and careless practices by medical or nursing
staff should not be tolerated.

60.
All endoscopy units should have a clearly defined policy for needle stick and sharps
injuries. In general this should follow the course laid out in A.N.C.A. Bulletin No.16, 1996
– Australian National Council on A.I.DS, “Needle stick and blood accidents –
management of exposure to blood/body fluids contaminated with blood including needle
stick/sharps injuries with a potential for HIV or other blood borne infections”.

It is essential that swift action is taken to institute anti-retro viral therapy where
appropriate287. This will include combined regimens for high risk exposure. It is again
stressed that prophylaxis should commence WITHIN HOURS of high risk exposure289.

C. Infections, Diseases Transmitted by Aerosols

Mycobacterium Tuberculosis
See sections on Mycobacterium tuberculosis and Reprocessing of Bronchoscopes. It is
again stressed that bronchoscopy should be avoided wherever possible in patients with
known or suspected tuberculosis. There is a significant risk of nursing and medical staff
contracting Mycobacterium tuberculosis when bronchoscopy is carried out on tubercular
patients without proper precautions. Masks are particularly important where airborne
infection may occur and a particulate mask capable of filtering 1 micron particle should
be worn by endoscopy room staff during bronchoscopies and by patients during recovery
phase if coughing.

D. Oral – Faecal Transmission Infection

Health care workers in endoscopy units frequently come into contact with patients with
diarrhoeal diseases and Hepatitis, including Hepatitis A. Occupationally acquired
disease amongst health care workers has been reported to include Salmonella, Hepatitis
A, Shigella, Cryptosporidia, Helicobacter pylori and E. coli290. However, there are no
reports that specifically document an increased risk to endoscopy unit staff. Hepatitis A
vaccination may be appropriate for health care workers in endoscopy units.

4. OTHER HEALTH AND SAFETY ISSUES

A. Immunisation
All endoscopy personnel should be immunised against Hepatitis B and antibody titres
checked on a regular basis.

The optimal management of needle stick injury with Hepatitis C positive blood is
unknown but the administration of immuno globulin is not recommended.

B. Protective Clothing and Equipment

The possibility of splashing by blood and bodily fluids is not necessarily predictable and
all personnel likely to encounter splashing (endoscopist and immediate assistant) should
wear water repellent gowns which should be changed between cases if soiled.

C. Eye Protection
Endoscopists and their primary assistants should wear eye protection either face shields
or glasses.

D. Gloves
Gloves should be worn wherever there is a risk of exposure to blood or body fluids. This
will include all endoscopy personnel having direct procedural patient contact. Gloves
used when reprocessing endoscopes must be impervious to glutaraldehyde and other
chemicals. Sterile latex gloves are recommended for endoscopists and assistants during
E.R.C.P.

61.
E. Masks
Masks are particularly important where air borne infection may occur and a particulate
mask capable of filtering one micron particles should be worn by endoscopy room staff
during bronchoscopy. Masks should also be worn if there is a significant likelihood of
splattering of blood or bodily substances. Special masks are required for use with high
energy Yag lasers.

F. Latex Allergy
The conversion of natural rubber latex into commercial products is a highly complicated
process involving the addition of a wide variety of chemicals. Leaching of natural and
additional chemicals during the manufacturing process varies widely. Not all apparent
“latex allergies” will in fact represent true reactions to latex but may be due to a wide
variety of other chemicals remaining in the finished product. Systemic allergic reactions
to latex are Type I immunological responses. Other reactions such as contact dermatitis
may be due to Type IV delayed hypersensitivity reactions. Symptoms in Type I
responses will include itching, rash, dermatitis, angio-oedema, urticaria, facial swelling,
wheezing and rarely fainting or shock. Type IV reaction in the form of contact dermatitis
is, however, the most common reaction291-293.

The apparent dramatic increase in latex allergy in recent years appears to be due both to
the increased use of latex containing products since the introduction of universal
precautions and to differences in manufacturing techniques. Health care workers with a
history of atopic disease (e.g. asthma, hay fever, eczema) are at increased risk of latex
sensitisation. It is rarely necessary for health care workers in endoscopy units to use
latex based gloves on a regular basis. Non-latex gloves including vinyl, polyethylene,
plastic, neoprene or nitrile based gloves are suitable alternatives. Where latex
containing gloves need to be worn fabric or other lining is usually available294-295.
Powder free gloves significantly reduce the amount of aerosolized latex particles,
thought to be a major route of sensitisation.

Where latex allergy is suspected referral to a Specialist with experience in latex allergy
testing is advised. It should be noted that some skin prick tests for latex allergy have
been associated with severe reactions. Where latex allergy is suspected it is important
to fully document the clinical situation. Where contact reaction is established then strict
avoidance of further latex exposure is important to prevent the development of systemic
manifestations. Where systemic manifestations have developed, total occupational
avoidance is critical and sufferers need to be warned of the risks of latex exposure
during medical or surgical procedures.

It is important to take patients’ statements that they are allergic to latex seriously.
Severe latex allergy reactions have occurred after simple rectal examinations done using
latex gloves. Apparently one incident has included cardiac arrest. It is therefore
important that staff do not use latex gloves in the examination of patients with known or
suspected latex allergy.

Consideration should also be given to appropriate selection of equipment when

performing oesophageal and haemorrhoid banding procedures. Latex free bands are
available.

62.
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Guideline Application Statement

These guidelines have been prepared by the Gastroenterological Nurses Society of

Australia and the Section of Endoscopy of the Gastroenterological Society of Australia
and every care has been taken in their compilation. The guidelines are intended to be
used as a guide only and not as an authoritative statement of every conceivable step
or circumstance which may or could relate to the performance of the procedures
outlined.
Practitioners should use these guidelines as an aid in relation to disinfection and not as
a complete or authoritative statement of such procedures.

The Gastroenterological Society of Australia, the Gastroenterological Nurses Society

of Australia and the compilers of these guidelines shall not be liable to users of these
guidelines nor to any other person, firm, company or other body for any loss, direct,
indirect or consequential, on whatsoever account for any omission or negligent mis-
statement contained herein, or by reason of, arising from or in relation to any such
user, by any other person, company or body relying or acting upon or purporting to rely
or act upon any matter contained therein or arising thereout.

81.