CC BY-NC-ND 4.0 · Endosc Int Open 2023; 11(03): E247-E257
DOI: 10.1055/a-1991-1391
Original article

Endoscope reprocessing: Retrospective analysis of 90,311 samples

Lionel Pineau
1   Eurofins Biotech Germande, Medical Device Testing, Aix-en-Provence, France
› Author Affiliations

Abstract

Background and study aims The contamination level of ready-to-use endoscopes published in the literature varies from 0.4 % to 49.0 %. Unfortunately, the comparison and the interpretation of these results are quite impossible, given the limited number of samples and sites included and the differences observed between sampling, culturing methods, and interpretation criteria.

Methods The objective of this retrospective study was to analyze the results of 90,311 endoscope samples collected between 2004 and 2021 in 490 private or public hospitals in France.

Results Through the full test period, the mean ratio of endoscopes at the action level was 12.6 % (19.5 % including alert level). Of the endoscopy units, 23.0 % had a ratio of compliant endoscopes ≤ 70.0 %. The overall microbial quality of gastroscopes, duodenoscopes, and colonoscopes is improving year by year, whereas an opposite trend is observed for ultrasound endoscopes and bronchoscopes. In 2021, following French guidelines, 13.0 % of the endoscopes should have been quarantined and 8.1 % were at the alert level, meaning that the contamination level of 21.1 % of the endoscopes exceeded what was defined as a maximum acceptable value.

Conclusions This study demonstrates that additional efforts, including implementation of microbial surveillance strategies using a standardized sampling method and periodic observational audits, must be made to improve the overall microbiological quality of endoscopes and reduce the risk associated with their use.



Publication History

Received: 25 May 2022

Accepted after revision: 16 November 2022

Article published online:
17 March 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Beilenhoff U, Biering H, Blum R. et al. ESGE-ESGENA technical specification for process validation and routine testing of endoscope reprocessing in washer-disinfectors according to EN ISO 15883, parts 1, 4, and ISO/TS 15883-5. Endoscopy 2017; 49: 1262-1275
  • 2 Beilenhoff U, Biering H, Blum R. 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; 50: 1205-1234
  • 3 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
  • 4 Pineau L, Desbuquois C, Marchetti B. et al. Comparison of the fixative properties of five disinfectant solutions. J Hosp Infect 2008; 68: 171-177
  • 5 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
  • 6 Beilenhoff U, Neumann C, Rey J-F. et al. ESGE-ESGENA Guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy. Endoscopy 2007; 39: 175-181
  • 7 Centers for Disease Control and Prevention. Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. http://medbox.iiab.me/modules/en-cdc/www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html
  • 8 Chiu KW, Tsai MC, Wu KL. et al. Surveillance cultures of samples obtained from biopsy channels and automated endoscope reprocessors after high-level disinfection of gastrointestinal endoscopes. BMC Gastroenterol 2012; 12: 120
  • 9 Saviuc P, Picot-Guéraud R, Shum Cheong Sing J. et al. Evaluation of the quality of reprocessing of gastrointestinal endoscopes. Infect Control Hosp Epidemiol 2015; 36: 1017-1023
  • 10 Bader L, Blumenstock G, Birkner B. et al. HYGEA (Hygiene in der Gastroenterologie - 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; 40: 157-170
  • 11 Saliou P, Garlantézec R, Baron R. et al. Microbiological investigation of endoscopes at Brest Hospital over a period from 2007 to 2009. Pathol Biol 2011; 59: 88-93
  • 12 Okamoto N, Sczaniecka A, Hirano M. et al. A prospective, multicenter, clinical study of duodenoscope contamination after reprocessing. Infect Control Hosp Epidemiol 2022; 18: 1-9
  • 13 Gillespie E, Despina Kotsanas D, Stuart RL. Microbiological monitoring of endoscopes: 5-year review. J Gastroenterol Hepatol 2008; 23: 1069-1074
  • 14 Eléments d’assurance qualité en hygiène relatifs au contrôle microbiologique des endoscopes et à la traçabilité en endoscopie. Conseil supérieur d’hygiène publique de France. March 2007. https://solidarites-sante.gouv.fr/IMG/pdf/microbio_endoscopes-2.pdf
  • 15 Alfa MJ, Singh H. Contaminated flexible endoscopes: Review of impact of channel sampling methods on culture results and recommendations for root-cause analysis. Infect Control Hosp Epidemiol 2022; 43: 623-628
  • 16 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
  • 17 Buss A, Been M, Borgers R. et al. Endoscope disinfection and its pitfalls – requirement for retrograde surveillance cultures. Endoscopy 2008; 40: 327-332
  • 18 ISO 11737-1:2018. Stérilisation des produits de santé — Méthodes microbiologiques — Partie 1: Détermination d'une population de microorganismes sur des produits. https://www.iso.org/fr/standard/66451.html
  • 19 Mark JA, Underberg K, Kramer RE. Results of duodenoscope culture and quarantine after manufacturer-recommended cleaning process. Gastrointest Endosc 2020; 91: 1328-1333
  • 20 Rauwers AW, Voor In't Holt AF, Buijs JG. et al. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut 2018; 67: 1637-1645
  • 21 Larsen S, Russell RV, Ockert LK. et al. Rate and impact of duodenoscope contamination: A systematic review and meta-analysis. E Clin Med 2020; 25: 100451
  • 22 Cottarelli A, De Giusti M, Solimini AG. et al. Microbiological surveillance of endoscopes and implications for current reprocessing procedures adopted by an Italian teaching hospital. Ann Ig 2020; 32: 166-177
  • 23 Marchese V, Di Carlo D, Fazio G. et al. Microbiological surveillance of endoscopes in a southern Italian transplantation hospital: a retrospective study from 2016 to 2019. Int J Environ Res Public Health 2021; 18: 3057
  • 24 Bartles RL, Leggett JE, Hove S. et al. A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing. Gastrointest Endosc 2018; 88: 306-313
  • 25 Ma GK, Pegues DA, Kochman ML. et al. Implementation of a systematic culturing program to monitor the efficacy of endoscope reprocessing: outcomes and costs. Gastrointest Endosc 2018; 87: 104-109
  • 26 Chapman CG, Siddiqui UD, Manzano M. et al. Risk of infection transmission in curvilinear array echoendoscopes: results of a prospective reprocessing and culture registry. Gastrointest Endosc 2017; 85: 390-397
  • 27 Snyder GM, Wright SB, Smithey A. et al. Randomized comparison of 3 high-level disinfection and sterilization procedures for duodenoscopes. Gastroenterology 2017; 153: 1018-1025
  • 28 Paula H, Presterl E, Tribl B. et al. Microbiologic surveillance of duodenoscope reprocessing at the Vienna university hospital from November 2004 through March 2015. Infect Control Hosp Epidemiol 2015; 36: 1233-1235
  • 29 Ross AS, Baliga C, Verma P. et al. A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli. Gastrointest Endosc 2015; 82: 477-483
  • 30 Statement from Jeff Shuren, MD, Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk. US Food and Drug Administration website. Published April 12, 2019. https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm Accessed March 30, 2021
  • 31 Decristoforo P, Kaltseis J, Fritz A. et al. Tyrolean Endoscope Hygiene Surveillance Study Group. High-quality endoscope reprocessing decreases endoscope contamination. Clin Microbiol Infect 2018; 24: 1101.e1-1101
  • 32 Aumeran C, Thibert E, Chapelle FA. et al. Assessment on experimental bacterial biofilms and in clinical practice of the efficacy of sampling solutions for microbiological testing of endoscopes. J Clin Microbiol 2012; 3: 938-942
  • 33 Richard M, Luu DucD, Pineau L. Efficacy of recovery solutions for endoscopes sampling: a comparative study. SHEA 19th Annual Scientific Meeting, San Diego, March 21st 2009.
  • 34 Heuvelmans M, Wunderink HF, Van der Mei HC. et al. A narrative review on current duodenoscope reprocessing techniques and novel developments. Antimicrob Resist Infect Control 2021; 10: 171
  • 35 Kenters N, Huijskens EG, Meier C. et al. Infectious diseases linked to cross-contamination of flexible endoscopes. Endosc Int Open 2015; 3: E259-E265