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

U. Beilenhoff; C. S. Neumann; H. Biering; R. Blum; V. Schmidt; J. F. Rey; null and the ESGE Guidelines Committee

doi:10.1055/s-2006-945191

Endoscopy, Table of Contents

Endoscopy 2007; 39(1): 85-94
DOI: 10.1055/s-2006-945191

Guidelines

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

U. Beilenhoff¹ , C. S. Neumann² , H. Biering³ , R. Blum⁴ , V. Schmidt⁵ , J. F. Rey⁶

¹ESGENA Treasurer, ESGE Guidelines Committee chairman, Ulm, Germany
²ESGENA President, Clinical Investigation Unit, City Hospital NHS Trust, Birmingham, UK
³R,D&E Health Care EMEA, Ecolab GmbH&Co OHG, Düsseldorf, Germany
⁴BU Endoscopy Reprocessing Systems, Olympus Medical Systems Europa Gmbh, Hamburg, Germany
⁵Leitung Fachgebiet Mikrobiologie und Hygiene, Chemische Fabrik Dr. Weigert GmbH & Co. KG, Hamburg, Germany
⁶ESGE Guidelines Commitee chairman, Institute A. Tzanck, Saint Laurent du Var, France

Abstract

2. Quality management: the roles of validation and routine testing
3. Responsibilities and qualifications
4. Validation
4.1. Prerequisites
4.2. Installation qualification (IQ)
4.3. Operational qualification (OQ)
4.4. Performance qualification (PQ)
5. Routine testing
6. Frequency
6.1. Frequency of validation and revalidation
6.2. Frequency of routine testing
7. References
8. Appendices
Appendix 1: Glossary
Appendix 2.: Example of a checklist of prerequisites for installation of a washer-disinfector
Appendix 3.: Example of a checklist for installation qualification
Appendix 4.: Example of a checklist for operational qualification
Appendix 5.: Example of a checklist for performance qualification
Appendix 6.: Routine testing: checklist

Full Text

References

7. References

1 DGVS . Leitlinie von DGKH, DGSV und AKI für die Validierung und Routineüberwachung machineller Reinigungs- und Desinfektionsprozesse für thermostabile Medizinprodukte und zu Grundsätzen der Geräteauswahl. Zentralsterilisation. 2005; 13 Suppl 1 1-33
2 DGSV (Deutsche Gesellschaft für Sterilgutversorgung [German Society for Sterile Supply]) . Qualification requirements for persons entrusted with validation. Zentralsterilisation. 2005; 13 375-376
3 ESGE-ESGENA Guideline Committee . Guidelines on cleaning and disinfection in gastrointestinal endoscopy - update 1999. Endoscopy. 2000; 32 77-83
4 ESGE-ESGENA Working Group . ESGE-ESGENA checklist for purchase of washer disinfectors for flexible endoscopes. Endoscopy. 2000; 32 914-919
5 Rey J F, Kruse A. Cleaning and disinfection in Europe according to the Endoscopic Societies’ guidelines. Endoscopy. 2003; 35 878-881
6 Leiss O, Beilenhoff U, Bader L. et al . Reprocessing of flexible endoscopes and endoscopic accessories - an international comparison of guidelines. Z Gastroenterol. 2002; 40 531-542
7 ESGE/ESGENA guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy. Endoscopy. 2007; in press