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Legal framework conditions for the reprocessing of medical devices

The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance wit...

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Detalles Bibliográficos
Autores principales: Großkopf, Volker, Jäkel, Christian
Formato: Texto
Lenguaje:English
Publicado: German Medical Science 2008
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831257/
https://www.ncbi.nlm.nih.gov/pubmed/20204096
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author Großkopf, Volker
Jäkel, Christian
author_facet Großkopf, Volker
Jäkel, Christian
author_sort Großkopf, Volker
collection PubMed
description The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM). For medical devices in the category “critical C”, the RKI/BfArM-recommendation provides that the processor’s quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007. On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate.
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spelling pubmed-28312572010-03-04 Legal framework conditions for the reprocessing of medical devices Großkopf, Volker Jäkel, Christian GMS Krankenhhyg Interdiszip Article The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM). For medical devices in the category “critical C”, the RKI/BfArM-recommendation provides that the processor’s quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007. On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate. German Medical Science 2008-09-03 /pmc/articles/PMC2831257/ /pubmed/20204096 Text en Copyright © 2008 Großkopf et al. http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free to copy, distribute and transmit the work, provided the original author and source are credited.
spellingShingle Article
Großkopf, Volker
Jäkel, Christian
Legal framework conditions for the reprocessing of medical devices
title Legal framework conditions for the reprocessing of medical devices
title_full Legal framework conditions for the reprocessing of medical devices
title_fullStr Legal framework conditions for the reprocessing of medical devices
title_full_unstemmed Legal framework conditions for the reprocessing of medical devices
title_short Legal framework conditions for the reprocessing of medical devices
title_sort legal framework conditions for the reprocessing of medical devices
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831257/
https://www.ncbi.nlm.nih.gov/pubmed/20204096
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