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Guidelines on Cleaning and Disinfection in GI Endoscopy

Foreword Introduction

Since 1994, the Guidelines Committee has worked mainly This document addresses a number of important aspects of
on cleaning and disinfection of endoscopes and accessories. safety in gastrointestinal endoscopy with special emphasis
This important topic has been the subject of numerous on avoiding infection that may result from inadequate re-
meetings including nurses, industrial representatives and processing of endoscopes or endoscopic accessories. It is
microbiologists. the direct responsibility of users to follow these guidelines.
These guidelines were prepared by consensus of microbiol-
Our goal has been to obtain a safely reprocessed endoscope ogists, endoscopists, nurses and representatives of the bio-
at reasonable cost. We have taken into account that the medical industry.
ESGE Guidelines are circulated in countries with varying
economic possibilities. The ESGE Guidelines are a strong At all times, it is important to follow the manufacturers in-
recommendation but, within each country, endoscopists, structions and to comply with national law.
nurses and hospital administrations have to comply with lo-
cal regulations. Patients undergoing digestive endoscopy should be exam-
ined and treated without risk of transmission of infection
For these new guidelines, we have added a detailed techni- or side effects that may result from inadequately repro-
cal protocol for the daily work of nurses and assistants, as cessed endoscopic equipment (e.g., harm from residual
we have been aware of multiple local variations in the use chemicals on inadequately rinsed accessories).
of general guidelines.
The aim of these European Society of Gastrointestinal En-
The close co-operation between the ESGE and ESGENA is doscopy (ESGE) Guidelines is to set standards for the re-
a guarantee of efficacy and safety in the search for our main processing of endoscopes and endoscopic devices prior to
goal: high quality digestive endoscopy. each individual procedure, whether performed in hospitals,
private clinics or doctors offices.
Aksel Kruse, MD
Treasurer: ESGE All reprocessing should be carried out by specially trained
Co-Chairman: Guidelines Committee staff in purpose-designed environment. It is the responsibil-
ity of the healthcare provider to ensure that adequate facil-
Jean-Francois Rey, MD ities for reprocessing are available. Regular quality control
Secretary General: ESGE and the institutions adherence to validated reprocessing
Co-Chairman: Guidelines Committee procedures is the responsibility of both endoscopic and
healthcare providers and should be monitored by the hospi-
tal based hygiene/cross-infection control department or an
external organisation.

Endoscopy-Related Infections

Microorganisms may be spread by inadequately reprocessed

equipment from one patient to another or from patients to
staff members. Bacterial infections have been acquired dur-
ing endoscopy, such as Salmonella and Pseudomonas. Viral
diseases such as hepatitis B and hepatitis C have also been
transmitted during endoscopy.

Patients with immune deficiency syndromes or severe neu-

tropenia and those undergoing immunosuppressive chemo-
therapy or who have artificial cardiac valves have an in-
creased risk of infection. Diagnostic endoscopic retrograde
cholangiopancreatography and all therapeutic procedures
carry a higher risk of infection. Patients harbouring clini-

Endoscopy 2000; 32 (1): 77 ± 83 Definitions:

 Georg Thieme Verlag Stuttgart New York
·
ESGE ± European Society of Gastrointestinal Endoscopy
ISSN 0013-726X ESGENA ± European Society of Gastroenterology and Endoscopy Nurses
and Associates
78 Endoscopy 2000; 32 E.S.G.E./E.S.G.E.N.A.

cally latent infections (hepatitis, HIV, TB, Salmonella, Heli- Single-use accessories: Also called ªdisposableº, these are
cobacter pylori) may not be aware of their carrier status, and provided in a sterile state ready for use. The opening of a
therefore, all patients should be considered a potential risk. sterile package implies immediate use, as is routine in sur-
gery. After a single-use device has been used, all materials
Creutzfeldt-Jakob disease and endoscopy: Creutzfeldt- should be properly disposed of. Under no circumstances
Jakob disease is a so-called prion disease. Little is known should a single-use device be reused.
about the infectivity of prions. Transmission has been docu-
mented in patients treated parenterally with extracts from Reusable accessories: Reusable accessories should be ster-
nervous tissue such as meninges and pituitary glands from ilised. The sterilisation is carried out after proper cleaning,
infected patients. Transmission by the oral route probably as detailed below. Manufacturers provide validated standard
occurs only after the ingestion of nervous tissue from in- reprocessing parameters (temperature and time) for clean-
fected animals. ing, disinfection and sterilisation.

Prions are difficult to detect and to eradicate. Attempts to Classification of Endoscopic Accessories for Reprocessing
do so using chemical or thermal methods would destroy
the endoscope. Accordingly, if an endoscopy is requested The risk of cross-infection may vary, depending on the pro-
in a patient with Creutzfeldt-Jakob disease, the procedure cedure. The European Society of Gastrointestinal Endos-
should be reconsidered. copy recommends the following procedures:

Hazards to Endoscopic Personnel 1. Gastrointestinal Procedures

Diseases may be transmitted from the patient to endoscopic Wherever possible, the device used should be sterile;
personnel, so protection from direct contact with the endo- whether it is a single-use device and provided in a sterile
scopes and accessories is essential. Gloves and aprons state by the manufacturer, or a reusable one that has been
should be worn and protective masks and eye protection sterilised (e.g. biopsy forceps, polypectomy snares). If it is
should be available to avoid exposure to blood or body not technically possible to achieve sterilisation (e.g. in the
fluids. case of balloons or bougie dilators), the device should be
subjected to disinfection.
Protection against chemicals used in cleaning and disinfec-
tion procedures is of utmost importance in order to avoid 2. Biliary and Pancreatic Procedures
toxic and allergic reactions. Separate purpose-designed
rooms for cleaning and disinfection must be well ventilated All accessories used should be sterile. Reusable devices
and disinfectants should be used within a closed system. should be sterilisable. Balloons cannot be sterilised for
technical reasons. The use of reprocessed (i.e. disinfected)
Staff known to be disease carriers should avoid duties that balloons carries a risk of serial contamination of the biliary
could transmit infection to patients. It is recommended that or pancreatic duct system, or both. The ESGE does not re-
all staff be offered vaccination against type B hepatitis. commend the reuse of single use devices.

Definitions 3. Injection Needles

Endoscopic accessories: All devices used in conjunction Injection needles should be used once only. The European
with an endoscope to perform diagnosis and therapy, ex- Society of Gastrointestinal Endoscopy recommends the use
cluding peripheral equipment. of disposable needles for several reasons: there is a danger
to endoscopic personnel in dismantling needles, their nar-
Cleaning: Removal of blood, secretions and debris from en- row lumen is difficult to clean, they are likely to be con-
doscopes and accessories. taminated with blood; and the type of patients in whom
they are used are often infectious.
Disinfection: Reduction of the number of viable microor-
ganisms on a device, to a level appropriate for safe use on 4. Prostheses
a patient where sterilisation of the device is not necessary.
Disinfection may also be undertaken as a preliminary step Prostheses should be used as recommended by the manu-
to sterilisation, if necessary. Disinfection should be carried facturer.
out immediately after cleaning and immediately prior to
use.

Sterilisation: Validated process used to render a device free

from all forms of viable microorganisms (ISO 11137).
Guidelines on Cleaning and Disinfection in GI Endoscopy Endoscopy 2000; 32 79

Reprocessing of Endoscopes B. Manual Disinfection

The ESGE recommends the use of fully automatic washer- B.1. Disinfection must be carried out in a separate room
disinfectors. with proper ventilation. Protective gloves, eye protection
and aprons must be used and splashing avoided. The instru-
Alternatively, a rigorous manual procedure must be em- ment should be fully immersed in 2 % glutaraldehyde or
ployed. Before commencing with the reprocessing of endo- other chemical disinfectant of equal potency. All channels
scopes and endoscopy accessories, protective clothing must must be filled with disinfectant and soaked for not less than
be put on (as appropriate: protective gloves, glasses/visor, 10 minutes.
face masks, aprons/examination coats) in order to avoid
contact with infectious material and disinfectants or deter- B.2. Rinsing of the instrument with water must be under-
gents. taken after disinfection, internally and externally, to remove
all traces of disinfectant. The water must have drinking
A. Manual Cleaning water quality. If necessary, filtered water may be used for
rinsing.
A.1. As soon as the endoscope is removed from the patient,
the air/water channel must be flushed for 10 ± 15 seconds to B.3. Dry the endoscope externally and flush each channel
eject refluxed blood or mucus. Detergent solution should be with air. Wipe the eye piece and light guide connector as
aspirated through the suction/biopsy channel to remove se- well as the plugs before connecting the endoscope to the
cretions and debris. light source. Fit the disinfected and rinsed valves and acti-
vate air/water channels as well the suction channel. The en-
A.2. The endoscope should be immersed in water and de- doscope is now ready for use again.
tergent and cleaned externally. The outside of the instru-
ment is washed with disposable sponges or swabs. The dis- Disinfection of the endoscopes should be performed
tal end is brushed with a soft toothbrush and special atten- before each session and between procedures.
tion is paid to the air/water outlet nozzle and the bridge/ele-
vator where fitted. All valves are removed and washed. The
biopsy channel opening and the suction part should be C. Washer-Disinfectors
cleaned with a cotton bud.
After a manual cleaning as described above, the endoscope
A.3. Brushing through the suction/instrument channel and may be disinfected automatically according to specifica-
all accessible channels must be performed using a cleaning tion, attention being paid to temperature, flushing of all
brush designed for that instrument. The brush must be channels of the endoscope followed by a cleaning and a
passed through the channel several times until clean, and drying procedure. The duration of these reprocessing pro-
the brush itself must be cleaned in detergent with a soft grammes is about 30 minutes.
toothbrush each time it emerges. First the instrument chan-
nel is cleaned by brushing at least three times, cleaning the Accessories (1)
brush between each brushing. Thereafter, pass the cleaning
brush through the suction port and down the insertion tube A. Cleaning
until it emerges from the distal end at least three times,
cleaning the brush each time as above. Then pass the clean- A.1. Wash in detergent immediately after use.
ing brush from the suction part through the umbilical cord A.2. Dismantle as far as possible.
of the endoscope until it emerges from the suction connec- A.3. Brush with cleaning brush or toothbrush.
tor at least three times, as above. A.4. Flush detergent through lumens of hollow
components.
A.4. Rinse all the channels by flushing with water followed A.5. Use an ultrasonic cleaner for all accessories.
by air to expel as much air as possible prior to disinfection. A.6. Rinse thoroughly in water of drinking quality.

A thorough cleaning of the endoscope is a prerequi-

site for proper disinfection ± manual or automatic.

(1) The ESGE and ESGENA Protocol follows as an Addendum

80 Endoscopy 2000; 32 E.S.G.E./E.S.G.E.N.A.

B. Sterilisation

Sterilisation can be achieved by steam autoclaving as per

the manufacturers recommendations. Failure to follow the
manufacturers recommendations may compromise sterility
or the integrity of the device. Sterilisation can also be
achieved with ethylene oxide, although this procedure is
time-consuming and not readily available.

C. Storage
Sterile devices should be stored in individual packing. All
non-sterilisable accessories should be disinfected immedi-
ately prior to use.

Care of Accessories and Instruments

Great care should be taken to avoid the use of defective or

damaged accessories (e.g. biopsy forceps with kinks on the
shaft) because such instruments may not operate properly
and may also damage the endoscopes instrument channel,
causing both hygienic and mechanical problems, with a
consequent risk of incomplete reprocessing and even of se-
rious damage to the endoscope itself.

Comment

Due to their nature, endoscopic accessory devices are not

designed for repair in the event of breakage. Their repair
is not recommended by the European Society of Gastroin-
testinal Endoscopy, since the original properties may be al-
tered with consequent risks to patients and danger of dam-
age to endoscopes.

These guidelines draw attention to the necessity of increas-

ing the number of endoscopic devices in each endoscopic
suite, in order to ensure adequate availability, taking into
account the reprocessing time required. The implementa-
tion of these guidelines does therefore have economic im-
plications, increasing the cost of endoscopic procedures,
but it is necessary in order to protect both patients and en-
doscopy personnel.

These guidelines have been revised by

Axon A, Jung M, Kruse A, Ponchon T, Rey JF (ESGE)

Beilenhoff U, Duforest-Rey D, Neumann C, Petersen C,
Popovic S (ESGENA)
Jurkowski P, Kircher-Felgenstreff I (FUJINON)
Klasen P, Stief M (PENTAX)
Dreyer M, Slowey B (WILSON COOK)
Schuster A, Spencer KB (OLYMPUS)
Papoz A, Wilson D (BOSTON SCIENTIFIC)
Pietsch M, Roth K, Struelens M (Microbiologists)
Guidelines on Cleaning and Disinfection in GI Endoscopy Endoscopy 2000; 32 81

Protocol for Reprocessing Endoscopic Accessories

Introduction In the light of these developments ESGE and ESGENA

have worked together to produce this update of the ESGE
Today endoscopic procedures have become an important Guidelines, which combines the three previous guidelines
tool in the diagnosis and treatment of gastrointestinal dis- on hygiene and infection control in endoscopy. Included in
eases. In recent years the risk of infection has increased the new guidelines is a detailed protocol for reprocessing of
due to the increasingly invasive nature of the procedures. endoscopic accessories. Nurses and doctors may use these
Moreover, more and more elderly people, patients with updated European Guidelines and the enclosed protocol as
multiple diseases and patients with immune system defi- a reference manual while developing national versions or
ciencies are being endoscoped than ever before. In order to department specific protocols concerning hygiene and in-
prevent cross infections endoscopic control of infection fection control. Furthermore, these guidelines should also
measures have become increasingly important for both pa- raise awareness in endoscopy staff and service providers of
tients and the endoscopy staff. Therefore safe equipment re- the need for staff protection measures, necessary structural
processing and careful maintenance of endoscopic equip- requirements and a standardised reprocessing protocol.
ment are the basis for an efficient prevention of infections
programme in endoscopy. But however up to date at the time of publication, guide-
lines by their nature only reflect the current knowledge,
During the last 10 years, the reprocessing of flexible endo- opinions and research findings of experts in the field.
scopes has become more and more standardised, facilitated Knowledge is not static and new evidence and research is
by the increasing number of protocols that have been estab- constantly affecting and changing our practice. Guidelines
lished for manual and automated cleaning and disinfection. do not abdicate the professional from being constantly vig-
Although there has been a more or less standardised disin- ilant, and it is everybodys responsibility to act in the light
fection protocol for endoscope reprocessing this has not of newly produced evidence. Future research findings and
been the case for endoscopic accessories, as different Euro- new techniques and procedures may require amendments
pean membership countries permit a variety of reprocessing to or further editions of the current guidelines. Both ESGE
methods. Moreover, endoscopic accessories penetrating tis- and ESGENA will strive to respond to any such changes
sue require more stringent standards for reprocessing than with appropriate recommendations.
endoscopes. Case reports about cross infections caused by
inadequately cleaned and disinfected endoscopic acces- Ulrike Beilenhoff
sories have highlighted the need for a standardised repro- President of ESGENA
cessing protocol for endoscopic accessories.

Standards for Manual Reprocessing of Reusable Step 1. Cleaning

Endoscopic Accessories
± Disconnect and dismantle accessories as far as possible.
Protective Measures ± Immerse accessories in enzymatic detergent solution
± Transfer contaminated devices immediately after use to immediately after use.
the processing area and commence the disinfection ± Clean the single components of the devices externally
process. by using a soft cloth, sponge and brushes.
± Transport contaminated devices in a closed container ± Perform brushing/cleaning under the water surface in
from the endoscopy room to the reprocessing room, order to avoid splashing of contaminated liquids.
paying attention to protective measures concerning ± Inject detergent solution into all accessible channels
staff and environment. and lumen to remove secretion and debris (at least
± Before starting the reprocessing, put on protective 10 ± 20 ml solution in each channel).
clothing as appropriate: ± Ensure that all lumen are flushed completely to avoid
± chemically resistant gloves air blockage.
± protective glasses/visor ± Remove the instruments from the detergent solution.
± protective face masks
± special examination gown or coat (long-sleeved,
moisture-resistant) or plastic aprons with arms.
82 Endoscopy 2000; 32 E.S.G.E./E.S.G.E.N.A.

Warning: Warning:
± Only specially trained personnel should carry out ± During ultrasonic cleaning the temperature can
the reprocessing of endoscopic equipment ± this range from 40 to 60 8C. When using enzymatic
applies both to routine as well as emergency detergents ensure that the temperature should
endoscopy. not be over 45 8C, compatible with detergent effi-
± Enzymatic-type detergent solutions are cacy.
recommended vor cleaning endoscopy accessories. ± The temperature in the ultrasonic cleaner should
± Enzymatic detergents require a specific contact be monitored.
time, according to the manufacturers instruc-
tions.
Step 3. Rinsing
± Aldehydes may not be used for cleaning steps be-
cause they denature and coagulate protein, fixing
± Transfer the cleaned accessories to a bowl or tray, con-
it and this may impair cleaning.
taining drinking quality water without contamination
± Cleaning must take place before disinfection.
and renew the water after each rinsing cycle.
± The water quality available in the endoscopy unit
± Flush all channels completely and thoroughly in the
should be specified.
water to remove detergent residuals. Flush the channels
with at least 20 ml water.
Step 2. Ultrasonic Cleaning ± Rinse external surfaces thoroughly using drinking qual-
ity water to remove chemical residues.
± Use a medical grade ultrasonic cleaner with a fre- ± Remove the devices from the water.
quency range over 30 kHz (38 to 47 kHz) and a max. ± Drain or aspirate all channels with air to express resid-
operation temperature of 45 8C, following manufac- ual rinse water.
turers instructions.
± Use the same solution for the ultrasonic cleaner as for Step 4. Drying
the cleaning step.
± Ensure that the detergent used is a non-foaming solu- ± Dry the external surfaces with a non-shedding cloth and
tion, suitable for manual cleaning as well as for ultra- compressed medical air.
sonic cleaning. ± Dry each channel completely with compressed air.
± Renew the cleaning solution at least daily or more fre- ± Dry all coiled accessories in a hanging position to sup-
quently if the solution is contaminated. port the drying procedure.
± Ensure that the tray is large and deep enough to allow ± Assemble the accessories and check the correct func-
for complete immersion of the devices. tioning.
± Load the basket/tray of the ultrasonic cleaner with the
dismantled and pre-cleaned accessories (maximum 10 Step 5. Sterilisation
devices per cycle and tray).
± Avoid any ultrasound ªshadowsº/dead spaces where ul- ± Put the instruments into sterile packaging for special
trasound waves cannot act ± therefore do not overload instruments.
the tray. ± Select the adequate sterilisation procedure for the ther-
± The instrument should be coiled with a diameter of not mal stabile and thermal labile instruments in accord-
less than 15 ± 20 cm, in accordance with manufacturers ance with the manufacturers instructions (recommen-
instructions. dation: steam autoclave, pre-vacuum, 134 8C, 5 minutes
± Flush again all channels and lumen completely with at or equivalent cycles) and national laws.
least 10 ml detergent solution, to avoid air blockage. ± After completion of the sterilisation cycle, ensure all
± Follow the instructions of both the ultrasonic cleaner cycle stages and parameters have been achieved.
manufacturer and the devices manufacturer. ± Check the sterile packaging for any damage and the
± Cover the ultrasonic cleaner with a lid. sterilisation indicators.
± Leave the accessories in the ultrasonic cleaner and
complete the recommended contact time for ultrasonic- Step 6. Storage
al cleaning, following the manufacturers instructions
for devices, the ultrasonic cleaner and detergents, (rec- ± Store sterilised instruments in the sterile packaging in a
ommended ultrasonic cleaning time: 30 min). Remove closed cupboard, protected from dust, humidity and
the accessories from the ultrasonic cleaner. temperature fluctuations.
± Flush all channels with air to displace excess fluid. ± Follow instructions concerning the durability of the re-
spective sterile packaging.
Guidelines on Cleaning and Disinfection in GI Endoscopy Endoscopy 2000; 32 83

Standards for Automated Reprocessing Further Information

of Endoscopic Accessories
ESGE Secretary General
As an additional step, an automated washer-disinfector may Dr. Jean-FrancËois Rey
be used. Before this is done, pre-cleaning, ultrasonic clean- Institut Arnault Tzanck
ing and rinsing have to be computed. Follow steps 1 to 3 of Avenue du Dr. Maurice Donat
the ªStandards for manual reprocessing of endoscopic ac- 06700 St. Laurent du Var
cessoriesº. France

Step 4. Loading of an Automated Washer-Disinfector Tel. + 33-4-92273887

Fax: + 33-4-9307-5158
E-mail: [email protected]
± After thorough cleaning as described above load the
basket, immersion trays or tank of the machine in ac-
cordance with manufacturers recommendations.
± Attach channel connectors to ensure complete and thor-
ough irrigation of all lumens.
± Ensure that all channels are connected, the specific de-
sign of the machine must be taken into account.
± Handles, coils, or wires must be fitted into a special
basket.
± Remove the gloves and close the machine.

Step 5. Automated Reprocessing

± Select and start the cycle.

± After completion of the automated cycle, ensure that all
cycle stages and parameters have been undertaken.
± Open the machine and remove the accessories.
± Dry the accessories if necessary, with a non-shedding
cloth.
± Dry each channel with compressed air.

To complete the cycle, follow steps 5 ± 6 of the ªStandards

for manual reprocessing of reusable endoscopic acces-
soriesº (see page 82).