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

 

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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

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• 2 DGSV (Deutsche Gesellschaft für Sterilgutversorgung [German Society for Sterile Supply]) . Qualification requirements for persons entrusted with validation.  Zentralsterilisation. 2005;  13 375-376
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• 4 ESGE-ESGENA Working Group . ESGE-ESGENA checklist for purchase of washer disinfectors for flexible endoscopes.  Endoscopy. 2000;  32 914-919
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• 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
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• 7 ESGE/ESGENA guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy.  Endoscopy. 2007;  in press
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