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

© Georg Thieme Verlag KG Stuttgart · New York

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
Further Information

Publication History

Publication Date:
25 January 2007 (online)

Also available at
   Permissions and Reprints

Contents

1. Scope of this guideline

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

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
    PubMedSearch in Google Scholar
  • 2 DGSV (Deutsche Gesellschaft für Sterilgutversorgung [German Society for Sterile Supply]) . Qualification requirements for persons entrusted with validation.  Zentralsterilisation. 2005;  13 375-376
    PubMedSearch in Google Scholar
  • 3 ESGE-ESGENA Guideline Committee . Guidelines on cleaning and disinfection in gastrointestinal endoscopy - update 1999.  Endoscopy. 2000;  32 77-83
    Thieme ConnectPubMedSearch in Google Scholar
  • 4 ESGE-ESGENA Working Group . ESGE-ESGENA checklist for purchase of washer disinfectors for flexible endoscopes.  Endoscopy. 2000;  32 914-919
    PubMedSearch in Google Scholar
  • 5 Rey J F, Kruse A. Cleaning and disinfection in Europe according to the Endoscopic Societies’ guidelines.  Endoscopy. 2003;  35 878-881
    Thieme ConnectPubMedSearch in Google Scholar
  • 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
    Thieme ConnectPubMedSearch in Google Scholar
  • 7 ESGE/ESGENA guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy.  Endoscopy. 2007;  in press
    PubMedSearch in Google Scholar