Reporting the Failure of Medical Devices

To the Editor: Clinical failures of medical devices are a serious problem. Pacemaker leads that lose their insulation, 1 heart-valve prostheses that jam, 2 aneurysm clips that fracture, 3 and dialysis pumps that overheat 4 create life-threatening situations. Early and rapid identification of failed...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 312; no. 7; p. 447
Main Authors Kossovsky, N, Dujovny, M, Kossowsky, R
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 14.02.1985
Subjects
Equipment Failure
Information Systems
United States
United States
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ISSN0028-4793
1533-4406
DOI10.1056/NEJM198502143120722

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Summary:To the Editor: Clinical failures of medical devices are a serious problem. Pacemaker leads that lose their insulation, 1 heart-valve prostheses that jam, 2 aneurysm clips that fracture, 3 and dialysis pumps that overheat 4 create life-threatening situations. Early and rapid identification of failed models, products, and production batches and dissemination of this knowledge are essential in order to protect the patient population at large. Two major information systems are available. Acting under the authority granted by the Medical Device Amendments of 1976, 5 the Food and Drug Administration, as of December 13, 1984, 6 requires manufacturers to report within five days the particulars of an . . . No extract is available for articles shorter than 400 words.
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJM198502143120722