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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

U. Beilenhoff, H. Biering, R. Blum, J. Brljak, M. Cimbro, JM. Dumonceau, C. Hassan, M. Jung, C. Neumann, M. Pietsch, L. Pineau, T. Ponchon, S. Rejchrt, JF. Rey, V. Schmidt, J. Tillett, J. van Hooft,

. 2017 ; 49 (12) : 1262-1275. [pub] 20171116

Jazyk angličtina Země Německo

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc18033553

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.

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$a Dumonceau, Jean-Marc $u Gedyt Endoscopy Center, Buenos Aires, Argentina.
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$a Jung, Michael $u 2nd Department of Internal Medicine, Katholisches Klinikum, Mainz, Germany.
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$a Neumann, Christiane $u ESGENA Past President, Birmingham, UK.
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$a Pineau, Lionel $u Biotech Germande, Marseille, France.
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$a Ponchon, Thierry $u Digestive Diseases Department, Hôpital Edouard Herriot, Lyon, France.
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$a Rejchrt, Stanislav $u 2nd Department of Internal Medicine, Charles University Teaching Hospital, Hradec Králové, Czech Republic.
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$a Rey, Jean-François $u Institut Arnault Tzanck, St. Laurent du Var, France.
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$a Schmidt, Verona $u Microbiology and Hygiene Department, Chemische Fabrik Dr. Weigert, Hamburg, Germany.
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$a Tillett, Jayne $u St. Woolos Hospital, Newport, UK.
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