Endoscopy 2017; 49(12): 1262-1275
DOI: 10.1055/s-0043-122073
Technical specification
© Georg Thieme Verlag KG Stuttgart · New York

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

Ulrike Beilenhoff
 1   ESGENA Scientific Secretary, Ulm, Germany
,
Holger Biering
 2   Grevenbroich, Germany
,
Reinhard Blum
 3   Olympus Europa, Hamburg, Germany
,
Jadranka Brljak
 4   University Hospital KBC-Zagreb-Rebro, Zagreb, Croatia
,
Monica Cimbro
 5   CBC (Europe), Nova Milanese, Italy
,
Jean-Marc Dumonceau
 6   Gedyt Endoscopy Center, Buenos Aires, Argentina
,
Cesare Hassan
 7   Digestive Endoscopy Unit, Catholic University, Rome, Italy
,
Michael Jung
 8   2nd Department of Internal Medicine, Katholisches Klinikum, Mainz, Germany
,
Christiane Neumann
 9   ESGENA Past President, Birmingham, UK
,
Michael Pietsch
10   Department of Hygiene and Infection Prevention, Medical Center, University Hospital, Mainz, Germany
,
Lionel Pineau
11   Biotech Germande, Marseille, France
,
Thierry Ponchon
12   Digestive Diseases Department, Hôpital Edouard Herriot, Lyon, France
,
Stanislav Rejchrt
13   2nd Department of Internal Medicine, Charles University Teaching Hospital, Hradec Králové, Czech Republic
,
Jean-François Rey
14   Institut Arnault Tzanck, St. Laurent du Var, France
,
Verona Schmidt
15   Microbiology and Hygiene Department, Chemische Fabrik Dr. Weigert, Hamburg, Germany
,
Jayne Tillett
16   St. Woolos Hospital, Newport, UK
,
Jeanin van Hooft
17   Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands
› Institutsangaben
Weitere Informationen

Publikationsverlauf

Publikationsdatum:
16. November 2017 (online)

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.