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ARTICLE |

Artificial Hearts, Fractured Valves, and Other Problems With Medical Devices

Nir KOSSOVSKY, MD; Ram Kossowsky, PhD; Manuel Dujovny, MD
JAMA. 1985;254(23):3307. doi:10.1001/jama.1985.03360230037006.
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To the Editor.—  Recently, two separate articles on the artificial heart program appeared simultaneously in The Journal.1,2 Both articles failed to mention important medical details on three biomedical device issues: medical device failures, thrombogenicity of silicone, and infections with percutaneous implants. With literally millions of medical devices in use, it is important for today's physician to understand the nature of the body's reaction to devices as well as the devices' reaction to long-term implantation in the body.First, the fracture of the weld of Barney Clark's Björk-Shiley heart valve on the 13th postoperative day is described as being a manifestation of Murphy's Law.2 This is incorrect. The Björk-Shiley 60° convexoconcave valves have a fundamental flaw in the weld and, as of Sept 25, 1984, 107 cases of valve failure due to strut fracture have been reported; two thirds of which were estimated by Shiley to be fatal.3

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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