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Titolo:
Methodological contribution to material vigilance in blood transfusion
Autore:
Roussel, P; Pujol-Rey, A; Arzur, C;
Indirizzi:
Ecole Natl Sante Publ, F-35043 Rennes, France Ecole Natl Sante Publ Rennes France F-35043 Publ, F-35043 Rennes, France Estab Francais Sang Nord France, F-59012 Lille, France Estab Francais SangNord France Lille France F-59012 59012 Lille, France Estab Francais Sang Liede France, F-94623 Rungis, France Estab Francais Sang Liede France Rungis France F-94623 23 Rungis, France
Titolo Testata:
TRANSFUSION CLINIQUE ET BIOLOGIQUE
fascicolo: 4, volume: 8, anno: 2001,
pagine: 359 - 373
SICI:
1246-7820(200108)8:4<359:MCTMVI>2.0.ZU;2-F
Fonte:
ISI
Lingua:
FRE
Soggetto:
QUALITY;
Keywords:
blood transfusion; material vigilance; quality assurance; risk management;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
16
Recensione:
Indirizzi per estratti:
Indirizzo: Roussel, P Ecole Natl Sante Publ, Ave Pr Leon Bernard, F-35043 Rennes, France Ecole Natl Sante Publ Ave Pr Leon Bernard Rennes France F-35043
Citazione:
P. Roussel et al., "Methodological contribution to material vigilance in blood transfusion", TRANSF CL B, 8(4), 2001, pp. 359-373

Abstract

To reduce seriousness and frequency of iatriogenic risk implies preventionpolicies and efficient operational systems for vigilance. This risk management implies definition of precise organizations and procedures able to locate and to notify quickly undesirable events. This is the case about singleuse medical devices (SUMD) used in blood transfusion. This article is a contribution to the organisation of the implemented material vigilance in blood transfusion, collectively carried out with actors concerned (users, manufacturers, National Commission for Material Vigilance). It presents a lot of tools and methods to favour practices harmonization, as well as preventive a curative (specifications before purchase, main part of the quality contract between customer and supplier; internal control plan; index for medical device used in transfusion; illustrated glossaries for three main families of medical devices; index about symptomatic events; definitions of seriousness levels with their operational consequences; methods to manage a single use medical device judged as defective; tool for the review of incidents according to reference and batch). Then, the management of incidents about SUMD is presented within a material vigilance system integrated into the quality system of the institution, for user as for manufacturer. This is donein a chronological order with successively description of the incident, the assessment of the impact, the management of the associated risk, the periodical review of incidents and management of matters in dispute. (C) 2001 Editions scientifiques et medicales Elsevier SAS.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 31/03/20 alle ore 10:21:19