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December 20, 1985

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

Author Affiliations

New York Hospital—Cornell Medical Center New York
Applied Research Laboratory Pennsylvania State University University Park
Henry Ford Hospital Detroit

JAMA. 1985;254(23):3307. doi:10.1001/jama.1985.03360230037006

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