Position Statement

Prevention of multidrug-resistant infections from

contaminated duodenoscopes: Position Statement of the
European Society of Gastrointestinal Endoscopy (ESGE)
and European Society of Gastroenterology Nurses and
Associates (ESGENA)

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Authors
Ulrike Beilenhoff 1, Holger Biering2, Reinhard Blum 3, Jadranka Brljak4, Monica Cimbro 5, Jean-Marc Dumonceau6,
Cesare Hassan 7, Michael Jung8, Christiane Neumann 9, Michael Pietsch10, Lionel Pineau11, Thierry Ponchon12,
Stanislav Rejchrt 13, Jean-François Rey14, Verona Schmidt 15, Jayne Tillett 16, Jeanin van Hooft 17

Institutions Corresponding author

1 ESGENA Scientific Secretary, Ulm, Germany Ulrike Beilenhoff, ESGENA Scientific Secretariat,
2 Grevenbroich, Germany Ferdinand-Sauerbruch-Weg 16, 89075 Ulm, Germany
3 Olympus Europa, Hamburg, Germany [email protected]
4 University Hospital KBC-Zagreb-Rebro, Zagreb, Croatia
5 Medical Devices Division, CBC Europe Srl, Nova Milanese RECOMME NDATI ONS
(MB), Italy Patients should be informed about the benefits and risks
6 Gedyt Endoscopy Center, Buenos Aires, Argentina of endoscopic retrograde cholangiopancreatography
7 Digestive Endoscopy Unit, Catholic University, Rome, (ERCP)
Italy
8 2nd Department of Internal Medicine, Katholisches Only specially trained and competent personnel should
Klinikum, Mainz, Germany carry out endoscope reprocessing.
9 ESGENA Past President, Birmingham, UK
Manufacturers of duodenoscopes should provide detailed
10 Department of Hygiene and Infection Prevention,
instructions on how to use and reprocess their equip-
Medical Center, University Hospital, Mainz, Germany
ment.
11 Biotech Germande, Marseille, France
12 Digestive Diseases Department, Hôpital Edouard In the case of modifications to their equipment, manufac-
Herriot, Lyon, France turers should provide updated instructions for use.
13 2nd Department of Internal Medicine, Charles Detailed reprocessing protocols based on the manufac-
University Teaching Hospital, Hradec Králové, Czech turer’s instructions for use should clearly lay out the dif-
Republic ferent reprocessing steps necessary for each endoscope
14 Institut Arnault Tzanck, St. Laurent du Var, France model.
15 Microbiology and Hygiene Department, Chemische
Appropriate cleaning equipment should be used for duo-
Fabrik Dr. Weigert, Hamburg, Germany
denoscopes in compliance with the manufacturer’s in-
16 St. Woolos Hospital, Newport, UK
structions for use.
17 Department of Gastroenterology and Hepatology,
Academic Medical Center, Amsterdam, The Only purpose-designed, endoscope type-specific, single-
Netherlands use cleaning brushes should be used, to ensure optimal
cleaning.
Bibliography As soon as the endoscope is withdrawn from the patient,
DOI https://doi.org/10.1055/s-0043-120523 | Published bedside cleaning should be performed, followed by leak
online: 16.10.2017 | Endoscopy 2017; 49: 1098–1106 testing, thorough manual cleaning steps, and automated
© Georg Thieme Verlag KG Stuttgart · New York reprocessing, in order to:
ISSN 0013-726X

1098 Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106
 ▪ Remove debris from external and internal surfaces; Microbiological surveillance of a proportion of the de-
▪ Prevent any drying of body fluids, blood, or debris; partment’s endoscopes should be performed every
▪ Prevent any formation of biofilms. 3 months, with the requirement that all endoscopes
used in the unit are tested at least once a year.
In addition to the leak test, visual inspection of the distal In the case of suspected endoscopy-related infection, the
end as well as regular maintenance of duodenoscopes relevant device (e. g., endoscope, EWD) should be taken
should be performed according to the manufacturer’s in- out of service until adequate corrective actions have
structions for use, in order to detect any damage at an been taken.
early stage.
Outbreaks should be managed by a multidisciplinary
The entire reprocessing procedure in endoscope washer- team, including endoscopy, hygiene, and microbiology
disinfectors (EWDs) should be validated according to the experts, manufacturers, and regulatory bodies, accord-
European and International Standard, EN ISO 15883. ing to national standards and/or laws.
Routine technical tests of EWDs should be performed ac- In the case of suspected multidrug-resistant organism

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
cording to the validation reports. (MDRO) outbreaks, close cooperation between the
endoscopy unit and the clinical health provider is essen-
tial (including infection control departments and hospital
hygienists).

the development of purpose-designed cleaning equipment

G LOSSA RY has been intensified, and manufacturers have provided
Adenosine triphosphate (ATP) A substance present in all more instructions on how to reprocess duodenoscopes
living cells that provides energy for many metabolic pro- appropriately and how to identify when servicing is neces-
cesses and is involved in making ribonucleic acid. sary. The Position Statement addresses the importance of
Clinical care provider An organization, person or group staff training, reprocessing and maintenance of duodeno-
of persons legally responsible for the provision of a clini- scopes, process validation, and microbiological surveil-
cal service. This could be an institution, hospital or de- lance, as well as outbreak management.
partment, or a doctor working on his/her own premises.
Performance qualification Final inspections and tests to
confirm that an endoscope washer-disinfector is effective
Introduction
for endoscope reprocessing in the environment at the re- Since its introduction more than 40 years ago, endoscopic
processing area. It is based on the European and Interna- retrograde cholangiopancreatography (ERCP) has fundamen-
tional Standard EN ISO 15883. tally changed the treatment of biliopancreatic diseases. The
procedure is considered standard for the treatment of common
bile duct stones and of tumors obstructing the biliary tract, and
may be applied for pancreatic duct stones or strictures. Since
A BB R E VI AT I ONS the late 1970 s there have been sporadic reports of nosocomial
ERCP endoscopic retrograde cholangio- infections linked to endoscopic procedures, the majority
pancreatography caused by inadequate reprocessing of endoscopes [1].
EWD endoscope washer-disinfector Infections due to multidrug-resistant organisms (MDROs)
FDA [US] Food and Drug Administration however have increasingly become a concern in health care, in-
GI gastrointestinal cluding in gastrointestinal (GI) endoscopy [2]. Since 2010, re-
MDRO multidrug-resistant organism ports of individual cases and serial outbreaks of MDRO infec-
SOP standard operating procedure tions associated with ERCP have been published in the United
States of America (USA), France, Germany and the Netherlands
[3 – 8]. In addition, there have been cases and series of out-
breaks that have only been reported to national regulatory
This Position Statement of the European Society of Gas- bodies in the respective countries [2, 9 – 12].
trointestinal Endoscopy (ESGE) and European Society of Screening and identifying patients who are carriers of infec-
Gastroenterology Nurses and Associates (ESGENA) addres- tive organisms is often problematic. MDROs can be transmitted
ses the recent outbreaks of infection with multidrug-resis- from one patient to another, or, as the human gut can be re-
tant organisms following endoscopic retrograde cholangio- garded as a bacterial reservoir, within patients themselves. The
pancreatography, and proposes measures to prevent or hospital environment (hands, doorhandles, furniture, toilets,
manage such outbreaks. As a consequence of the outbreaks, bathroom facilities, etc) also poses a potential infection risk if

Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106 1099
 Position Statement

not cleaned/disinfected appropriately. A key component in the ▪ One outbreak was promoted by insufficient cleaning and
chain of infection is often poor hand hygiene of clinical staff, drying of endoscopes [3], while other outbreaks occurred
visitors, and/or patients. in spite of apparently appropriate reprocessing protocols
Because of limited antibiotic therapeutic options, infections [2, 4 – 8, 13]. This raises a question about the efficacy of the
with MDROs may result in poor clinical outcomes. Carbape- reprocessing procedures for flexible endoscopes.
nem-resistant enterobacteria are MDROs that produce GI endoscopes, including duodenoscopes, may have a bac-
carbapenemases – enzymes that hydrolyze the beta-lactam terial burden of 108 – 10, or 8 – 10 log10 on a logarithmic
ring and inactivate beta-lactam antibiotics [2]. Several strains scale, before reprocessing. Manual cleaning plus machine
of carbapenemase-producing intestinal bacteria have been de- reprocessing leads to an 8 – 12 log 10 reduction of the micro-
tected after outbreaks related to ERCP [13]. Immunocompro- bial load. Consequently, the safety margin is narrow at 0 – 2
mised patients, especially those with cholangiocarcinoma and log10 [18], and not achieved if the reprocessing is not car-
biliary stents, are at increased risk of acquiring these infections, ried out in line with the decontamination protocols. There-
often with resulting poor outcomes [2, 13, 14]. Despite the risk, fore, even minor deviations from reprocessing protocols
these immunocompromised patients potentially may benefit can result in potentially infective materials remaining in

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
significantly from therapeutic ERCP. parts of the endoscope, which consequently increases the
As a result of the MDRO outbreaks associated with ERCP, the risk of cross-contamination.
European Society of Gastrointestinal Endoscopy (ESGE) and the ▪ In several outbreak series, epidemiological investigations
European Society of Gastroenterology Nurses and Associates identified the duodenoscopes as the potential source of the
(ESGENA) formulated this Position Statement to give advice re- outbreak, but the outbreak strains could not be cultivated
garding the reprocessing of duodenoscopes. from all the suspected endoscopes. This may support the
hypothesis that periodic rather than continual irregularities
in reprocessing caused these outbreaks [2, 7, 11 – 13, 18].
Method Endoscope reprocessing includes a number of manual
This ESGE-ESGENA Position Statement is based on a multidisci- cleaning steps. Human error and inaccurate handling can
plinary consensus from an expert working group consisting of leave residual debris on and in the instruments after manual
gastroenterologists, endoscopy nurses, chemists, microbiolo- cleaning, which increases the risk of inadequate decontami-
gists, and industry representatives, with experience in develop- nation.
ing national and international guidelines in hygiene and infec- ▪ In many outbreaks, small cracks at the distal end of the
tion control. duodenoscopes were identified when the suspected endo-
A literature search was carried out evaluating published re- scopes were sent for maintenance or repair [4 – 8]. Small
ports of ERCP-related outbreaks, reviews, and national guide- defects were identified behind glass lenses and around the
lines, during the period 2010 – 2016. elevator mechanisms, which could have been the entry
Based on the assessment of the literature reviews and advice points for bacteria and subsequent biofilm formation. This
from various official national bodies, this Position Statement re- raises the question of whether the leak test can accurately
flects expert opinion on what constitutes good clinical practice identify these micro defects or whether the leak tests were
[15, 16]. The quality of evidence and strength of recommenda- not carried out according to manufacturers’ recommenda-
tions were not formally graded [17] as they were generally low. tions soon after the procedures.
The authors met twice during 2016. A consensus document ▪ Because of the lateral position of the lens, duodenoscopes
was agreed in 2017. The manuscript was sent to all ESGE and are more likely to be exposed to mechanical stress than gas-
ESGENA member societies and their individual members and troscopes or colonoscopes, which may be one reason for the
to two ESGE Governing Board members for approval, resulting occurrence of the aforementioned defects. The elevator
in this final version, agreed by all authors. mechanism and the narrow lumen behind the fixed distal
caps of duodenoscopes are difficult to access with standard
cleaning brushes [3, 4, 8].
Literature review and questions ▪ In many reports the quality and appropriateness of the
cleaning brushes used and their ability to access all parts of
raised by the outbreaks the distal tips of the duodenoscopes were identified as cru-
Although most of the duodenoscopes involved were made by cial in preventing cross-contamination [2 – 8]. The cleaning
Olympus, it is important to emphasize that duodenoscopes brush size needs to be appropriate for the size of the instru-
from all major manufacturers (Olympus, Pentax, Fujifilm) were ment/suction channel and other components. The brushes
involved in the reported outbreaks. should have adequate bristles to ensure thorough cleaning
The reported outbreaks and the publications featured the in line with manufacturers’ recommendations.
following issues: ▪ Insufficient hand hygiene and cleaning/disinfection of the
▪ Multidrug-resistant Enterobacteriaceae (including Klebsiella patient environment were also identified as factors favoring
pneumoniae and Escherichia coli) and Pseudomonas aerugino- bacterial patient-to-patient transmission [7]. Carbapenem-
sa were found in duodenoscopes, especially at the distal end, resistant Enterobacteriaceae infections were transmitted
around the forceps elevator mechanism [2 – 13].

1100 Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106
 from one patient to another whether they had undergone regulatory bodies in the USA and in Europe recommend not to
ERCP or not. discontinue carrying out ERCPs, but to inform patients about
▪ Reviews and editorials discussed the outbreaks and their the potential risk of infections during these procedures [9, 10].
consequences without agreeing on a single identifiable
cause but rather pointing to multiple factors [2, 11 – 13, Training, awareness, and professional duty
18, 19].
▪ In one hospital, despite apparently appropriate reproces-
RECOMMENDATION
sing, 2% of duodenoscopes were found to be contaminated
Only specially trained and competent personnel should
with nonpathogenic and pathogenic germs [20]. As an ad-
carry out endoscope reprocessing.
ditional step, all reprocessed duodenoscopes were then
quarantined for 48 hours before the next use, until negative
microbiological cultures were obtained [20].
RECOMMENDATION
In the reported cases the outbreaks were stopped by the fol-

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Manufacturers of duodenoscopes should provide detailed
lowing measures: instructions on how to use and reprocess their equip-
▪ The reprocessing procedure was reviewed and improved [3]. ment.
▪ The suspected duodenoscopes were taken out of service and
necessary investigations were initiated [3 – 8].
▪ Contaminated duodenoscopes were sent for maintenance,
repair, and replacement of single components, even though RECOMMENDATION
micro defects had not been identified by endoscopy staff In the case of modifications to their equipment, manufac-
during leak testing [4, 7, 8]. turers should provide updated instructions for use.
▪ At one center, duodenoscopes were sterilized with ethylene
oxide after conventional cleaning and disinfection. This did
not lead to a satisfactory reduction in micro-organisms [4]. Reprocessing of medical devices requires specialized knowl-
edge and skills, as emphasized by European and national guide-
lines and national laws/standards. It is the responsibility of the
Reactions from regulatory bodies clinical service provider to ensure the training and competence
In the USA the reported outbreaks drew considerable media at- of staff involved in the reprocessing of equipment [21 – 26], and
tention. The Food and Drug Administration (FDA) published to provide adequate staffing levels in addition to space and re-
several statements to raise awareness among health care pro- processing equipment (structure quality) to enable reproces-
fessionals that the complex design of duodenoscopes might sing according to manufacturers’ instructions. Staff should be
impede effective reprocessing [9]. Official bodies and profes- aware of their responsibilities in reprocessing complex medical
sional societies in various European countries (e. g., France, devices.
Germany, The Netherlands) also informed their health care pro- Reprocessing staff need to be familiar with:
viders accordingly, initiated appropriate actions, and issued re- ▪ The specific design of each endoscope model used in a
commendations on how to: department, including endoscopes on loan;
▪ Prevent cross-contamination; ▪ Infection prevention policies, including health and safety
▪ Improve/ensure effective reprocessing; issues and hand hygiene;
▪ Manage outbreaks. ▪ Endoscope decontamination processes, including all essen-
tial steps of cleaning, disinfection, drying, storage, docu-
mentation, and traceability.
Recommendations
In response to the reported outbreaks, ESGE and ESGENA make Officially recognized training courses and systems of ongoing
the following recommendations. competency assessment are available in many European coun-
tries. ESGENA has developed a European Curriculum that in-
Patient information and informed consent cludes the training and competencies required in reprocessing
of endoscopes [26].
RECO MMENDATION Reviews of outbreaks showed that the potential risk of infec-
Patients should be informed about the benefits and risks tions increases if national guidelines and local protocols are not
of ERCP. strictly followed [1, 2]. Therefore, periodic audits of the repro-
cessing procedures as well as periodic training sessions and
competency assessments are helpful tools to identify deficien-
It is undisputed that many biliopancreatic diseases, includ- cies, to implement improvements, and to ensure up-to-date
ing life-threatening conditions, can be successfully managed practices.
by ERCP. The risk of ERCP-related infections is relatively low
compared to the potential benefits. Consequently, national

Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106 1101
 Position Statement

If new endoscopes are introduced into an endoscopy unit, it Thorough cleaning is a prerequisite for effective disinfec-
is the manufacturerʼs legal responsibility to provide updated in- tion. Any deviation from guidelines and protocols may result in
formation on appropriate reprocessing protocols [27]. failure of the reprocessing procedure, as infection outbreaks
If health care professionals (physicians, nurses, reprocessing have demonstrated [1, 2]. Bedside cleaning and the manual
experts) have the impression that new or changed designs hin- cleaning steps with flushing and brushing of the entire channel
der or prevent safe reprocessing, it is their professional respon- systems are the most important steps for the removal of debris,
sibility to inform the service provider and/or the manufacturer blood, and body fluids. Remaining protein debris can become
about these difficulties. If the problem persists, regulatory fixed by drying or by using inappropriate chemicals. Biofilm for-
bodies must be informed. mation is possible if the cleaning and rinsing steps have not
been carried out correctly. As some Gram-negative bacteria
Reprocessing and maintenance of duodenoscopes can undergo cell division every 20 to 30 minutes, it is essential
to complete all reprocessing steps quickly, before bacterial
RECO MMENDATION growth and debris begin to dry on surfaces thereby promoting
the formation of biofilms [25, 28]. Micro-organisms embedded

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Detailed reprocessing protocols based on the manufac-
turer’s instructions for use should clearly lay out the dif- in biofilms are 10 to 100 times more resistant to process chemi-
ferent reprocessing steps necessary for each endoscope cals than planktonic (free-floating) micro-organisms [29], and
model. are frequently released from biofilms. Some national guidelines
recommend performance of all manual reprocessing steps
within 30 minutes after completion of the patient examination
[25, 30].
RECO MMENDATION In response to the recent outbreaks, endoscope manufactur-
Appropriate cleaning equipment should be used for duo- ers have reviewed and updated their reprocessing instructions
denoscopes in compliance with the manufacturer’s in- for duodenoscopes and have consequently alerted their custo-
structions for use. mers [9, 23].
Cleaning brushes are themselves difficult to clean and they
potentially carry over organic material, and damaged brushes
may damage the equipment channels. Therefore it is strongly
RECO MMENDATION recommended to use new single-use cleaning brushes for each
Only purpose-designed, endoscope type-specific, single- reprocessing cycle in order to prevent cross-contamination and
use cleaning brushes should be used, to ensure optimal damage to the endoscopes [21]. All guidelines emphasize the
cleaning. need for thorough brushing of all accessible channels [21 – 25,
31]. Studies have shown the positive effect of multiple clean-
ing/brushing procedures [32]. However it is difficult to calcu-
late the exact optimal number of brushing cycles, as the germ
RECO MMENDATION
load varies greatly from patient to patient.
As soon as the endoscope is withdrawn from the patient,
The currently available duodenoscopes differ in the design
bedside cleaning should be performed, followed by leak
of their distal tip and their elevator mechanism, depending on
testing, thorough manual cleaning steps, and automated
the manufacturer and the endoscope generation (see ▶ Ta-
reprocessing, in order to
ble 1). The differences between duodenoscopes, according to
▪ Remove debris from external and internal surfaces;
model and manufacturer, must be taken into account during
▪ Prevent any drying of body fluids, blood, or debris;
reprocessing, and the different types require different approa-
▪ Prevent any formation of biofilms.
ches for cleaning. The following general recommendations may
serve as a guide.
▪ Duodenoscopes with accessible elevator wire channels.
RECO MMENDATION If the elevator wire channel is accessible, it is essential to
In addition to the leak test, visual inspection of the distal flush the channel immediately by using dedicated cleaning
end as well as regular maintenance of duodenoscopes adapters upon withdrawal. It is necessary to connect it cor-
should be performed according to the manufacturer’s in- rectly in the endoscope washer-disinfector (EWD) as well as
structions for use, in order to detect any damage at an in the drying cabinets (if available). In addition the elevator
early stage. lever should be positioned according to EWD manufacturer
instructions (e. g. at a 45° angle).
▪ Duodenoscopes with removable distal caps. Removable dis-
Even if automated reprocessing is performed, a thorough tal caps and distal ends make cleaning easier as they enable
bedside cleaning followed by full manual cleaning according to free access for brushes to the elevator mechanism. Reusable
the manufacturer’s instructions for use is essential, paying spe- detachable caps also need a thorough manual cleaning be-
cial attention to appropriate brushing and detergent flushing of fore automated reprocessing.
all channels. The caps remain detached during automated reprocessing,

1102 Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106
 drying, and storage but the removable parts need careful Process validation and microbiological surveillance
reattachment before use.
If detachable components of the duodenoscope can be au-
RECOMMENDATION
toclaved, thorough manual cleaning prior to autoclaving is
The entire reprocessing procedure in endoscope washer-
also a prerequisite for successful sterilization.
disinfectors (EWDs) should be validated according to the
▪ Duodenoscopes with fixed distal caps. Fixed distal ends de-
European and International Standard, EN ISO 15883.
mand more attention during cleaning because the narrow
lumen behind the elevator is difficult to access with standard
cleaning brushes [2 – 7]. Special brushes are needed in order
to ensure thorough cleaning and to avoid any damage. Var- RECOMMENDATION
ious manufacturers have launched specially designed clean- Routine technical tests of EWDs should be performed ac-
ing brushes for duodenoscopes. Manufacturers (either of cording to the validation reports.
endoscopes or of cleaning accessories) should provide rele-
vant data about the compatibility of their cleaning devices

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
[2].
RECOMMENDATION
Microbiological surveillance of a proportion of each de-
▶ Table 1 Different designs of the distal tips of duodenoscopes.
partment’s endoscopes should be performed every 3
▪ Fixed distal end and a rinsable elevator wire channel months, with the requirement that all endoscopes used
▪ Fixed distal end and a sealed elevator wire channel in the unit are tested at least once a year.

▪ Removable distal cap and rinsable elevator wire channel

▪ Removable distal end that can be dismantled and autoclaved The validation of the entire reprocessing procedure is a pre-
having a brushable elevator wire channel
requisite for an effective and reproducible process [35, 36]. It is
important that the Performance qualification (see Glossary) is
done with all the different endoscope types used in each de-
In the recent ERCP-related outbreaks, small cracks, minor de- partment, in order to prove the efficacy of the reprocessing cy-
fects, and remaining debris with microbiological loads were de- cle with all endoscopes [35, 36].
tected at the distal end of some duodenoscopes during service Routine microbiological surveillance is important to identify
[4 – 8]. any deviations, technical errors, and failures of the reproces-
Audits following the outbreaks did not discover any lapses in sing cycle [35 – 37]. The ESGE-ESGENA Guideline recommends
reprocessing procedures, but the publications did not mention regular microbiological surveillance every 3 months and em-
whether a leak test was routinely performed manually and in phasizes the necessity of sampling all parts and available chan-
the EWD [4 – 8]. nels of an endoscope [37].
Case reports from gastroenterology, pneumatology, and After the recent outbreaks, the US Centers for Disease Con-
cardiology settings showed that damaged endoscopes caused trol have published interim recommendations on microbiologi-
a series of infections after transesophageal endoscopy and cal surveillance for duodenoscopes. However, these do not cov-
after bronchoscopy [1, 33, 34], which underlines the impor- er all parts and channels of duodenoscopes [38].
tance of the leak test. This raises the question of whether the The frequencies and test methods for microbiological sur-
leak test can detect micro defects or not. Therefore visual in- veillance are contentious and are the focus of controversial dis-
spection (using magnifying glasses) especially of the distal end cussions in various publications; these issues need further re-
of the duodenoscope for potential small defects and micro search [2, 11, 12, 23].
damage is recommended after completion of the entire repro- In the USA, additional tests for detecting residual tissue mar-
cessing cycle [22]. Manufacturers already recommend periodic kers (e. g., ATP, hemoglobin) have been introduced, with the
maintenance and routine replacement of certain components aim of validating the efficacy of manual cleaning before disin-
[9] to prevent harm resulting from micro damage. fection [2, 22,23] .
Thorough drying of all endoscope channels is necessary be-
fore storage, to prevent any growth of micro-organisms such as
waterborne bacteria that thrive in damp conditions.
In some countries drying cabinets are already recommended
(e. g., United Kingdom, France, The Netherlands). Other coun-
tries emphasize the quality of drying (e. g., Germany).

Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106 1103
 Position Statement

▶ Table 2 Quality criteria for the safe reprocessing of endoscopes.

Structure quality

Reprocessing room ▪ Separate, purpose-designed, reprocessing room

▪ Strict spatial and procedural separation between contaminated and clean working areas and workflow, with
a preference for two separate rooms

Staff number ▪ Adequate number of competent staff

Staff qualifications ▪ Only trained and competent staff perform endoscope reprocessing
▪ Structured training program, regular competency assessment, and updates
▪ Documentation of initial training, updates, and regular competency assessments

Process quality

Standard operating proce- ▪ Detailed reprocessing protocols according to manufacturer’s recommendations, including photos, for each
dure (SOP) for reprocessing different type of endoscope available in the department, with easily accessible copies also in the reprocessing

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
room
▪ Regular updates of SOPs, adopting new evidence and product changes
▪ Archiving of documented reprocessing cycle for each patient

Precleaning in endoscopy ▪ Rinsing/flushing of all accessible channels with detergents by using dedicated cleaning adapters
room ▪ Function checks of all channels
▪ Transport in closed containers

Manual cleaning of ▪ Manual leak testing, after each endoscopy procedure, after precleaning, and before starting the steps of the
endoscopes cleaning procedures
▪ Manual cleaning of all accessible channels and vital components using suitable brushes
▪ Single-use brushes only (size according to the channel diameter, approved for use with the specific gastro-
intestinal endoscope, new brush for each endoscope decontamination cycle)
▪ Special brushes for certain components (e. g., distal tip and elevator mechanism)
▪ Thorough cleaning of distal tip of duodenoscopes, including detachable components
▪ Flushing of all accessible channels with detergent, followed by rinsing with water, using dedicated adapters
▪ Visual assessment of cleanliness

Reprocessing in endoscope ▪ Correct positioning of endoscope in EWD including correct positioning of the elevator mechanism
washer-disinfector (EWD) ▪ Correct connection of all channels
▪ Checking at the end of disinfection to ensure that all connections are attached and have not come loose during
the cycle
▪ Visual assessment of cleanliness

Drying and storage ▪ Complete drying of all external and internal surfaces with medical compressed air
▪ Storage in closed, ventilated cabinets or drying/storage cabinets

Documentation ▪ Documentation of all manual and automated reprocessing steps, including technical parameters of the
reprocessing cycle, reprocessing staff, and patient in whom the endoscope was used
▪ Archiving of reprocessing details (according to national laws/standards)

Release of endoscope ▪ Verification of correct reprocessing by checking all process parameters

▪ Visual inspection of distal end components, using magnifying glass, for possible defects and damage
▪ Documentation of release for use

Outcome quality

Validation of reprocessing ▪ Validation according to EN ISO 15883 once a year

procedure ▪ Protocols for routine technical tests
▪ Documentation of validation

Microbiological surveillance ▪ Protocol for microbiological surveillance

▪ Documentation of microbiological surveillance

Maintenance ▪ Protocol for maintenance of all endoscopes, EWDs, and drying cabinets

Outbreak management ▪ Protocol in place for outbreak management

▪ Documentation of the evaluation of any outbreak management

1104 Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106
Outbreak management When there is suspicion of endoscopy-based transmission, in-
fections should be managed by a multidisciplinary team. Health
care professionals and manufacturers should be aware of their
RECO MMENDATION
legal responsibility to patients to ensure their safety.
In the case of suspected endoscopy-related infection, the
relevant device (e. g., endoscope, EWD) should be taken
out of service until adequate corrective actions have Disclaimer
been taken. ESGE/ESGENA position statements and guidelines represent a
consensus of best practice based on the available evidence at
the time of preparation. They may not apply in all situations
and should be interpreted in the light of specific clinical situa-
RECO MMENDATION
tions and resource availability. Further controlled clinical stud-
Outbreaks should be managed by a multidisciplinary
ies may be needed to clarify aspects of the statements, and re-
team, including endoscopy, hygiene, and microbiology
vision may be necessary as new data appear. Clinical considera-

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
experts, manufacturers, and regulatory bodies, accord-
tion may justify a course of action at variance to these recom-
ing to national standards and/or laws.
mendations. ESGE/ESGENA position statements and guidelines
are intended to be an educational device to provide information
that may assist endoscopists in providing care to patients. They
are not rules and should not be construed as establishing a legal
RECO MMENDATION
standard of care or as encouraging, advocating, requiring, or
In the case of suspected MDRO outbreaks, close coopera-
discouraging any particular treatment.
tion between the endoscopy unit and the clinical health
provider is essential (including infection control depart-
ments and hospital hygienists). Competing interests

If any contamination is found, or if a particular medical de- U. Beilenhoff has provided consultancy to Boston Scientific since July
vice is likely to be the cause of infection, it is the responsibility 2017. H. Biering has done customer presentations and trainings,
moderated workshops, and provided consultancy to Richard Wolf
of the clinical service provider to take the suspected equipment
GmbH, Olympus Europa, Dr. Weigert, and Ecolab. Reinhard Blum is
out of service (e. g., endoscopes, EWDs, accessories). Correc- employed by Olympus Europa, who hold patents on endoscopes in
tive actions should be taken such as maintenance, review and general; he is a member of the DIN/CEN/ISO TC/198/WG13 standards
improvement of the reprocessing cycle, and staff training. The group for safe reprocessing of endoscopes. M. Cimbro has been em-
outcome quality of the reprocessing cycle must be satisfactory ployed by CBC Europe since 2002; she has been a consultant since
2011 to ANOTE-ANIGEA (Italian Association of Gastroenterology and
before the suspected device can be used again [21, 37].
Endoscopy Nurses). M. Jung's hospital has received sponsorship from
The quality criteria for structure, process, and outcome Olympus Optical and other companies for an EUS/endoscopy course
quality of endoscope reprocessing are listed in ▶ Table 2. (22nd September 2017). M. Pietsch's department has received third-
party funding from Olympus for a research project, from 2015 to
2017. L. Pineau has provided training on hygiene and medical device
Summary evaluation for Pentax, Olympus, and Fujifilm, from 1999 to 2017.
T. Ponchon has served on an Advisory board for Fujifilm (January
Safe and effective endoscope reprocessing is crucial to patient 2015 to October 2017). J. Brljak, J.-M. Dumonceau, C. Hassan, C. Neu-
safety in endoscopy. Noncompliance with guidelines as well as mann, S. Rejchrt, J.-F. Rey, V. Schmidt, J. Tillett, and J. van Hooft have
deviations from standardized and validated reprocessing proto- no competing interests.
cols may lead to ineffective reprocessing, with the possibility of
patient-to-patient transmission. Recent MDRO outbreaks show
References
how narrow the margin of safety is, despite compliance with re-
processing protocols. Important tools in the prevention of in-
fections are: [1] Kovaleva J, Peters FTM, van der Mei HC et al. Transmission of infection
by flexible gastrointestinal endoscopy and bronchoscopy. Clin Micro-
▪ Staff training and regular competence assessment;
biol Rev 2013; 26: 231 – 254
▪ Staff adherence to guidelines and to manufacturers’ specifi-
[2] Muscarella LF. Risk of transmission of carbapenem-resistant Entero-
cations and instructions for use; bacteriaceae and related “superbugs” during gastrointestinal endos-
▪ Routine inspections of endoscopes, and regular/scheduled copy. World J Gastrointest Endosc 2014; 6: 457 – 474
maintenance; [3] Aumeran C, Poincloux L, Souweine B et al. Multidrug-resistant Kleb-
▪ Periodic quality assessment, with audits of staff compliance, siella pneumoniae outbreak after endoscopic retrograde cholangio-
microbiological surveillance, and validation of reprocessing pancreatography. Endoscopy 2010; 42: 895 – 899
cycles; [4] Epstein L, Hunter JC, Arwady MA et al. New Delhi metallo-β-lacta-
▪ Dedicated places and equipment for all reprocessing steps mase-producing carbapenem-resistant Escherichia coli associated
with exposure to duodenoscopes. JAMA 2014; 312: 1447 – 1455
(structure quality).

Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106 1105
 Position Statement

[5] Wendorf K, Kay M, Baliga C et al. Endoscopic retrograde cholangio- [24] Association of periOperative Registered Nurses (AORN). Guideline for
pancreatography-associated AmpC Escherichia coli outbreak. Infect processing flexible endoscopes. Guidelines for Perioperative Practice
Control Hosp Epidemiol 2015; 36: 634 – 642 2017: doi:10.6015/psrp.17.01.717
[6] Smith ZL, Yuong SO, Saeian K et al. Transmission of carbapenem-re- [25] Gastroenterological Society of Australia/Gastroenterological Nurses
sistant Enterobacteriaceae during ERCP: time to revisit the current College of Australia (GESA/GENCA). Draft document for discussion.
reprocessing guidelines. Gastrointest Endosc 2015; 81: 1041 – 1045 Infection control in endoscopy – Multidrug resistant outbreaks re-
[7] Kola A, Piening B, Pape UF et al. An outbreak of carbapenem-resistant sponse. Version: April 2016. Available from: http://www.genca.org/
OXA-48-producing Klebsiella pneumonia associated to duodenosco- public/5/files/Infection%20Control%20Guidelines%20Draft%20April%
py. Antimicrob Resist Infect Control 2015; 4: 8 [doi:10.1186/s13756- 202016.pdf [Accessed: April 20 2017]
015-0049-4] [26] ESGENA. European Curriculum for reprocessing flexible endoscopes
[8] Verfaillie CJ, Bruno MJ, Voor in ʼt holt AF et al. Withdrawal of a novel- and endoscopic accessories 2017. Forthcoming 3 Nov 2017, at
design duodenoscope ends outbreak of a VIM-2-producing Pseudo- http://www.esgena.org/statements-curricula.html
monas aeruginosa. Endoscopy 2015; 47: 493 – 502 [27] Council Directive 93/42/EEC of 14 June 1993 concerning medical
[9] US Food and Drug Administration (FDA). Safety Communication. devices (OJ L 169, 12.7.1993, p. 1). Available from:
Available from: http://www.fda.gov/MedicalDevices/Safety/Alert- http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CON-

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
sandNotices/default.htm [Accessed: April 20 2017] SLEG:1993L0042:20071011:en:PDF [Accessed: September 22 2017]

[10] Bundesinstitut für Arzneimittel und Medizinprodukte. Empfehlungen [28] Roberts CG. The role of biofilms in reprocessing medical devices. Am J
des BfArM. Hinweis des BfArM und des RKI zu komplex aufgebauten Infect Control 2013; 41: S77 – S80
Endoskopen (Duodenoskopen), deren Aufbereitung und damit ver- [29] Otter JA, Vickery K, Walker JT et al. Surface-attached cells, biofilms
bundenen Infektionsrisiken. German. Available from: https://www. and biocide susceptibility: implications for hospital cleaning and dis-
bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/DE/ infection. J Hosp Infect 2015; 89: 16 – 27
bfarm_rki_aufbereitung_endoskop.html [Accessed: April 20 2017] [30] Bertschinger P, Brenneisen M, Cathomas A et al. Schweizerische
[11] Humphries RM, McDonnell G. Superbugs on duodenoscopes: the Richtlinie zur Aufbereitung flexibler Endoskope. Gemeinsame Richtli-
challenge of cleaning and disinfection of reusable devices. J Clin Mi- nie der Schweizerischen Gesellschaft für Gastroenterologie (SGG),
crobiol 2015; 53: 3118 – 3125 Schweizerischen Gesellschaft für Pneumologie (SGP), Schweizeri-
[12] Petersen BT. Duodenoscope reprocessing: risk and options coming schen Gesellschaft für Spitalhygiene (SGSH), Schweizerischen Ver-
into view. Gastrointest Endosc 2015; 82: 484 – 486 einigung für Endoskopiepersonal (SVEP). German. Available from:
https://svep-aspe.ch/fileadmin/user_upload/pdf/Schweizerische_-
[13] Gastmeier P, Vonberg RP. Klebsiella spp. in endoscopy-associated in-
Hygienerichtlinie2013.pdf
fections: we may only be seeing the tip of the iceberg. Infection 2014;
42: 15 – 21 [31] Ministère de la santé, de la famille et des personnes handicapées,
DGS/DHOS, Comité Technique national des Infections Nosocomiales
[14] Kim S, Russell D, Mohamadnejad M et al. Risk factors associated with
(CTIN). Bonnes pratiques de désinfection des dispositifs médicaux.
the transmission of carbapenem-resistant Enterobacteriaceae via
Guide pour l’utilisation des laveurs-désinfecteurs d’endoscopes.
contaminated duodenoscopes. Gastrointest Endosc 2016; 83: 1121 –
French. November 2003. Available from: http://nosobase.chu-lyon.
1129
fr/recommandations/Ministere_Sante/2003_endoscopie_ministere.
[15] Guyatt GH, Schünemann HJ, Djulbegovic B et al. Guideline panels pdf [Accessed: September 22 2017]
should not GRADE good practice statements. J Clin Epidemiol 2015;
[32] Sethi S, Huang RJ, Barakat M et al. Adenosine triphosphate biolumi-
68: 597 – 600
nescence for bacteriologic surveillance and reprocessing strategies
[16] Guyatt GH, Alonso-Coello P, Schünemann HJ. Guideline panels should for minimizing risk of infection transmission by duodenoscopes. Gas-
seldom make good practice statements: guidance from the GRADE trointest Endosc 2017; 85: 1180 – 1187
Working Group. J Clin Epidemiol 2016; 80: 3 – 7
[33] Ramsey AH, Oemig TV, Davis JP et al. An outbreak of bronchoscopy-
[17] Dumonceau JM, Hassan C, Riphaus A et al. European Society of Gas- related Mycobacterium tuberculosis infections due to lack of
trointestinal Endoscopy (ESGE) Guideline Development Policy. bronchoscope leak testing. Chest 2002; 121: 976 – 981
Endoscopy 2012; 44: 626 – 629
[34] Seki M, Hashiguchi K, Tanaka A et al. Characteristics and disease se-
[18] Rutala WA, Weber DJ. Gastrointestinal endoscopes: a need to shift verity of healthcare-associated pneumonia among patients in a hos-
from disinfection to sterilization? JAMA 2014; 312: 1405 – 1406 pital in Kitakyushu, Japan. Infect Chemother 2011; 17: 363 – 369
[doi:10.1001/jama.2014.12559]
[35] Beilenhoff U, Neumann CS, Biering H et al. ESGE Guidelines Commit-
[19] Jung M, Beilenhoff U. Hygiene: The looming Achilles heel in endos- tee. ESGE/ESGENA guideline for process validation and routine testing
copy. Visc Med 2016; 32: 21 – 28 for reprocessing endoscopes in washer-disinfectors, according to the
[20] Ross AS, Baliga C, Verma P et al. A quarantine process for the resolu- European Standard prEN ISO 15883 parts 1, 4 and 5. Endoscopy 2007;
tion of duodenoscope-associated transmission of multidrug-resistant 39: 85 – 94
Escherichia coli. Gastrointest Endosc 2015; 82: 477 – 483 [36] Beilenhoff U, Biering H, Blum R et al. European Society of Gastroin-
[21] Beilenhoff U, Neumann CS, Rey JF et al. ESGE-ESGENA guideline: testinal Endoscopy (ESGE)-European Society of Gastroenterology and
cleaning and disinfection in gastrointestinal endoscopy. Endoscopy Endoscopy Nurses and Associates (ESGENA). Technical Specification
2008; 40: 939 – 957 for process validation and routine testing of endoscope reprocessing
in washer-disinfectors, according to EN ISO 15883, parts 1, 4, and
[22] Association for the Advancement of Medical Instrumentation. ANSI/
ISO/TS 15883-5. Forthcoming Nov/Dec 2017
AAMI ST91: 2015. Flexible and semi-rigid endoscope processing in
health care facilities. Available from: http://nascecme.com.br/2014/ [37] Beilenhoff U, Neumann CS, Rey JF et al. ESGE-ESGENA guideline for
wp-content/uploads/2015/09/ANSI-AAMI-ST91-Endoscopy-2015.pdf quality assurance in reprocessing: microbiological surveillance test-
[Accessed: April 20 2017] ing in endoscopy. Endoscopy 2007; 39: 175 – 181
[23] American Society for Gastrointestinal Endoscopy. Multisociety guide- [38] Centers for Disease Control and Prevention. Interim duodenoscope
line on reprocessing flexible GI endoscopes: 2016 update. Gastroin- surveillance protocol, updated April 3, 2015. Available from: http://
test Endosc 2017; 85: 282e – 294e www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-
protocol.html [Accessed: April 20 2017]

1106 Beilenhoff Ulrike et al. Prevention of multidrug-resistant … Endoscopy 2017; 49: 1098–1106