| Medical device reprocessing: a regulatory model proposal for Brazilian hospitals. | |
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MedLine Citation:
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PMID: 22241207 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Medical device reprocessing is extremely important and complex, thus requiring both the operational skills for its implementation and the technical qualification of the professionals involved in the activity. The typical issues of medical device reprocessing involve technical, economical and regulatory aspects when involving either the so-called reusable articles or those considered as for a single use. The objective of the present study is to propose a new regulatory model for medical device reprocessing in Brazil that would, on the one hand, satisfy the requirements for quality and safety, as recommended in the literature and, on the other hand, prove to be operational under the conditions prevailing in Brazilian hospitals. The elaboration of the present normative proposal was based on the Consensus Conference technique among specialists in the area. Guided by the contribution of these specialists, a proposal is put forth of a regulatory model for reprocessing medical products, so as to address some previously identified gaps in the normative body currently used in Brazil. |
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Authors:
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Eliana Auxiliadora Magalhães Costa; Ediná Alves Costa; Kazuko Uchikawa Graziano; Maria Clara Padoveze |
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Publication Detail:
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Type: JOURNAL ARTICLE |
Journal Detail:
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Title: Revista da Escola de Enfermagem da U S P Volume: 45 ISSN: 0080-6234 ISO Abbreviation: - Publication Date: 2011 Dec |
Date Detail:
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Created Date: 2012-1-13 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0242726 Medline TA: Rev Esc Enferm USP Country: - |
Other Details:
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Languages: ENG; POR Pagination: 1459-1465 Citation Subset: - |
Affiliation:
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Universidade Estadual da Bahia, Salvador, BA, Brasil. |
Vernacular Title:
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Reprocessamento de produtos médicos: uma proposta de modelo regulatório para hospitais brasileiros. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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