Standards Development

Scope

This document provides requirements for sampling, analysis and culturing methods for the determination of endoscope contamination level in clinical use, including routine sampling used for monitoring the microbiological quality of patient ready endoscopes, validation, performance qualification and verification of the effectiveness of the endoscope processing. It also provides implementation guidance and information on actions recommended in case a contamination is detected.

This document does not apply to rigid endoscopes, and endocavity ultrasound probes. 

Purpose

The infectious risk associated to the use of contaminated endoscopes is well identified (1-3). To reduce the risk of patient infection, efforts have been made to improve medical device cleanability, develop more efficient processing procedures, publish guidelines and standards on manual or automatic reprocessing procedures (4-10). The implementation of periodic microbiologic surveillance has also been proposed by many authorities and professional associations to identify any lapses and / or deviations that may occur over time in the endoscope processing procedure (11-18).

According to the literature, the microbiologic non-compliance rate of patient-ready endoscopes varies
from 0.4% to 49% (19-21). However, the methods used to sample endoscopes, to analyse these
samples and to interpret the results vary widely from one study to the other and it is impossible to
identify the real contamination level of patient-ready endoscopes (22). The publication of an ISO
standard on endoscope sampling and culturing will provide to health authorities a standardized and
validated method to be referenced in all national guidelines recommending the implementation of
endoscope microbiological surveillance. The use of such a validated and standardized method will
ensure that samples taken by the end user are a true representation of the microbiological quality of
the endoscopes intended to be used on patients.

ISO 15883-4 (Washer-disinfectors — Part 4:Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes) (7) specifies the particular requirements, including
performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and
chemical disinfection of thermolabile endoscopes and the methods, required for testing. For type
testing and performance qualification, testing on real endoscopes are required for cleaning tests and
verification of the efficacy of the complete cycle. Unfortunately, no details regarding the method to be
used to sample these endoscopes are provided in this standard. For the same reasons as above, the
absence of a standardized method can lead to significant variations in the assessment of the
compliance of a washer-disinfector with the performance requirement of this standard. The publication
of an ISO standard on endoscope sampling and culturing will improve the reliability of the tests done
and will reduce the risk of validating a washer-disinfector whose efficiency has been overestimated and which could present a risk for patients.
1. Kola A, Piening B, Pape UF, Veltzke-Schlieker W, Kaase M, Geffers C et al. An outbreak of carbapenem-resistant OXA-48 -producing Klebsiella pneumonia associated to duodenoscopy.
Antimicrob Resist Infect Control 2015; 4:8. https://doi.org/10.1186/s13756-015-0049-4

2. Verfaillie CJ, Bruno MJ, Voor in ’t Holt AF, Buijs J G, Poley J-W, Loeve A J et al. Withdrawal of a
novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa.
Endoscopy 2015; 47:493–502. https://doi.org/10.1055/s-0034-1392080

3. Epstein L, Hunter JC, Arwady MA, Victoria Tsai V, Stein L, Marguerite Gribogiannis M et al. New Delhi metallo--lactamase-producing carbapenem-resistant Escherichia coli associated with exposure
to duodenoscopes. JAMA 2014; 312:1447–55. https://doi.org/10.1001/jama.2014.12720
4. Beilenhoff U, Biering H, Blum R, Brljak J, Cimbro M, Dumonceau J-M et al. ESGE-ESGENA
technical specification for process validation and routine testing of endoscope processing in washerdisinfectors according to EN ISO 15883, parts 1, 4, and ISO/TS 15883-5. Endoscopy. 2017 Dec;49
(12):1262-1275. https://doi.org/10.1055/s-0043-122073
5. Beilenhoff U, Biering H, Blum R, Brljak J, Cimbro M, Dumonceau J-M et al. Prevention of multidrugresistant infections from contaminated duodenoscopes: Position Statement of the European Society of
Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates
(ESGENA). Endoscopy. 2017 Nov;49(11):1098-1106. https://doi.org/10.1055/s-0043-120523
6. Beilenhoff U, Biering H, Blum R, Brljak J, Cimbro M, Dumonceau J-M et al. Reprocessing of flexible
endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the
European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology
Nurses and Associates (ESGENA) – Update 2018. Endoscopy. 2018 Dec;50(12):1205-1234. https:
//doi.org/10.1055/a-0759-1629
7. ISO 15883-4:2018. Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors
employing chemical disinfection for thermolabile endoscopes, https://www.iso.org/standard/63696.html;
2018 [accessed 11 October 2023].
8. FDA/CDC/ASM. Duodenoscope Surveillance Sampling and Culturing Protocols, https://www.fda.
gov/media/111081/download; 2018 [accessed 11 October 2023].
9. GESA - Gastroenterological Society of Australia. Infection control in endoscopy 2nd Edition, https:
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(Australia).pdf. 2003; [accessed 11 October 2023].
10. GESA- Gastroenterological Society of Australia. Infection Prevention and Control in Endoscopy
2021, https://www.gesa.org.au/public/13/files/Education%20%26%20Resources/Clinical%20Practice%
20Resources/Endoscopy%20Infection%20Control/IPCE%202021_Feb2022update.pdf; 2021
[accessed 11 October 2023].
11. Ministère des affaires sociales et de la sante. Instruction n° DGOS/PF2/DGS/VSS1/2016/220 du 4
juillet 2016 relative au traitement des endoscopes souples thermosensibles à canaux au sein des lieux
de soins, https://www.legifrance.gouv.fr/circulaire/id/41172; 2016 [accessed 11 October 2023].
12. CCLIN Sud-Ouest. Surveillance microbiologique de l’environnement dans les ES : Guide de
bonnes pratiques. https://www.cpias-nouvelle-aquitaine.fr/wpcontent/uploads/2015/08/Surv_microbio_environnement.pdf; 2016 [accessed 11 October 2023].
13. Beilenhoff U, Neumann C, Rey J-F, Biering H, Blum R, Schmidt V et al. ESGE-ESGENA Guideline
for quality assurance in reprocessing: microbiological surveillance testing in endoscopy. Endoscopy
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14. Ministère du travail de la santé et des solidarités. Conseil supérieur d’hygiène publique de France.
Eléments d’assurance qualité en hygiène relatifs au contrôle microbiologique des endoscopes et à la
traçabilité en endoscopie, https://solidarites-sante.gouv.fr/IMG/pdf/microbio_endoscopes-2.pdf; 2007
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15. Ministère des affaires sociales et de la sante. FAQ N°1. Traitement des endoscopes souples
thermosensibles à canaux. https://solidarites-sante.gouv.
fr/IMG/pdf/faq_instruction_traitement_des_endoscopes.pdf; 2016 [accessed 11 October 2023].
16. Ministère des affaires sociales et de la sante. FAQ N°2. Traitement des endoscopes souples
thermosensibles à canaux. https://solidarites-sante.gouv.
fr/IMG/pdf/dgos_faq_2_traitement_endoscopes_060819-2.pdf; 2019 [accessed 11 October 2023].
17. Ministère des affaires sociales et de la sante. DGOS/PF2/DGS/VVS1/PP3/2018/195 du 2 août
2018 relative à l’actualisation du traitement des endoscopes souples thermosensibles à canaux de type
duodénoscope au sein des structures de soins, https://www.legifrance.gouv.fr/download/pdf/circ?
id=43880; 2018 [accessed 11 October 2023].
18. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91 :2021:
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19. Bader L, Blumenstock G, Birkner B, Leiss O , Heesemann J , Riemann JF et al. HYGEA (Hygiene
in der Gastroenteroogie - Endoskop-Aufbereitung): Studie zur Qualität der Aufbereitung von flexiblen
Endoskopen in Klinik und Praxis* [HYGEA (Hygiene in gastroenterology--endoscope reprocessing):
Study on quality of reprocessing flexible endoscopes in hospitals and in the practice setting]. Z
Gastroenterol. 2002 Mar;40(3):157-70. https://doi.org/10.1055/s-2002-22326
20. Pineau L. Endoscope reprocessing: Retrospective analysis of 90,311 samples. Endosc Int Open
2023; 11: E247–E257 https://doi.org/10.1055/a-1991-1391
21. Gillespie E, Despina Kotsanas D, Stuart RL. Microbiological monitoring of endoscopes: 5-year
review. J Gastroenterol Hepatol 2008; 23:1069–1074 https://doi.org/10.1111/j.1440-1746.2007.05264.x
22. Alfa MJ, Singh H. Contaminated flexible endoscopes: Review of impact of channel sampling