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Titolo:
Analysis of the French health ministry's national register of incidents involving medical devices in anaesthesia and intensive care
Autore:
Beydon, L; Conreux, F; Le Gall, R; Safran, D; Cazalaa, JB;
Indirizzi:
CHU Angers, Dept Anaesthesie, F-49033 Angers 01, France CHU Angers Angers France 01 Dept Anaesthesie, F-49033 Angers 01, France Hop Laennec, Dept Anaesthesie, F-75007 Paris, France Hop Laennec Paris France F-75007 Dept Anaesthesie, F-75007 Paris, France Hop Necker Enfants Malad, Dept Anaesthesie, F-75015 Paris, France Hop Necker Enfants Malad Paris France F-75015 sie, F-75015 Paris, France
Titolo Testata:
BRITISH JOURNAL OF ANAESTHESIA
fascicolo: 3, volume: 86, anno: 2001,
pagine: 382 - 387
SICI:
0007-0912(200103)86:3<382:AOTFHM>2.0.ZU;2-B
Fonte:
ISI
Lingua:
ENG
Soggetto:
CLOSED CLAIMS ANALYSIS; ANESTHESIA; PREVENTION; VIGILANCE; PIPELINE; MISHAPS; FAILURE; SAFETY;
Keywords:
equipment, anaesthesia machines; equipment, failure; monitoring, intensive care;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
27
Recensione:
Indirizzi per estratti:
Indirizzo: Beydon, L CHU Angers, Dept Anaesthesie, F-49033 Angers 01, France CHU Angers Angers France 01 sthesie, F-49033 Angers 01, France
Citazione:
L. Beydon et al., "Analysis of the French health ministry's national register of incidents involving medical devices in anaesthesia and intensive care", BR J ANAEST, 86(3), 2001, pp. 382-387

Abstract

This study details all incidents involving medical devices used in anaesthesia and intensive care reported to the relevant authorities in France in 1998. There were 1004 reports during that year. Incidents were classified asserious (harmful to patients) in 11% of cases; death resulted in 2% of cases. Equipment for ventilation and infusion, and monitors of all kinds, accounted for most of the reports, representing 37%, 30% and 12%, respectively,of all reports. The leading causes of failure varied according to the category of device. User errors, quality control problems during production of the device and design faults were the three main causes. The problems identified during the study period enabled the faulty medical devices to be improved in 12-44% of cases. We conclude that post-marketing vigilance is a useful way of improving the quality of medical devices.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 09/04/20 alle ore 00:20:19