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

Statements

1 Prerequisites. The clinical service provider should obtain confirmation from the endoscope washer-disinfector (EWD) manufacturer that all endoscopes intended to be used can be reprocessed in the EWD.

2 Installation qualification. This can be performed by different parties but national guidelines should define who has the responsibilities, taking into account legal requirements.

3 Operational qualification. This should include parametric tests to verify that the EWD is working according to its specifications.

4 Performance qualification. Testing of cleaning performance, microbiological testing of routinely used endoscopes, and the quality of the final rinse water should be considered in all local guidelines. The extent of these tests depends on local requirements. According to the results of type testing performed during EWD development, other parameters can be tested if local regulatory authorities accept this. Chemical residues on endoscope surfaces should be searched for, if acceptable test methods are available.

5 Routine inspections. National guidelines should consider both technical and performance criteria. Individual risk analyses performed in the validation and requalification processes are helpful for defining appropriate test frequencies for routine inspections.

• References

• 1 Beilenhoff U, Neumann CS, Biering H. ESGE Guidelines Committee. et al. ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5. Endoscopy 2007; 39: 85-94
• 2 International Organization for Standardization. ISO 15883-1:2006. Washer-disinfectors – Part 1: General requirements, terms and definitions and tests. Available from: 2017 https://www.iso.org/standard/41076.html Accessed: September 6 2017
• 3 International Organization for Standardization. ISO 15883-4:2008. Washer-disinfectors – Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes. Available from: 2017 https://www.iso.org/standard/42060.html Accessed: September 6 2017
• 4 International Organization for Standardization. ISO/TS 15883-5:2005. Washer-disinfectors – Part 5: Test soils and methods for demonstrating cleaning efficacy. Available from: 2017 https://www.iso.org/standard/41175.htm Accessed: September 6 2017
• 5 DGKH, AKI, DGEA, DGSV. Leitlinie zur Validierung maschineller Reinigungs- Desinfektionsprozesse zur Aufbereitung thermolabiler Endoskope, Zentralsterilisation Suppl. 3/2011. Available from: 2017 http://www.krankenhaushygiene.de/pdfdata/leitlinien/VamaReDeZuAuThEn_weiss.pdf Accessed: October 18 2017
• 6 Department of Health (England and Wales). Health Technical Memorandum [HTM] 01-06). Part D: Decontamination of flexible endoscopes: validation and verification (including storage/drying cabinets). 2016. Available from: 2017 https://www.gov.uk/government/publications/management-and-decontamination-of-flexible-endoscopes Accessed: September 6 2017
• 7 Österreichische Gesellschaft für Sterilgutversorgung (ÖEGSV) (Austrian Society for Supply of Sterile Goods). Leitlinie für die Prüfung, Validierung und Überwachung von maschinellen Reinigungs-/ Desinfektionsverfahren für flexible Endoskope 2013. Available from: 2017 http://www.oegsv.com/guidelines/guidelines2014.htm Accessed: October 18 2017
• 8 Steering Group for Flexible Endoscope Cleaning and Disinfection (SFERD). Professional standard handbook cleaning and disinfection flexible endoscopes. Version 4.1, September 2017. Available from: 2017 http://www.infectiepreventieopleidingen.nl/downloads/SFERDHandbook4_1.pdf Accessed: October 18 2017
• 9 Deutsche Gesellschaft für Sterilgutversorgung (DGSV). Qualification requirements for persons entrusted with validation. Zentralsterilisation 2005; 13: 375-376
• 10 ESGE-ESGENA Guideline . Cleaning and disinfection in gastrointestinal endoscopy. Endoscopy 2008; 40: 939-957
• 11 Kommission für Krankenhaushygiene und Infektionsprävention. Anforderungen der Hygiene an die baulich-funktionelle Gestaltung und apparative Ausstattung von Endoskopieeinheiten. Bundesgesundheitsblatt 2002; 45: 412-414
• 12 International Organization for Standardization. ISO 17664:2004. Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices. Available from: 2017 https://www.iso.org/standard/31456.html Accessed: September 6 2017
• 13 ESGE Newsletter. Definition of “endoscope families” as used in EN ISO 15883. Endoscopy 2013; 45: 156-157
• 14 ESGE-ESGENA guideline for quality assurance in reprocessing. Microbiological surveillance testing in endoscopy. Endoscopy 2007; 39: 175-181