Title :
Ethical issues in biomedical engineering: the Bjork-Shiley heart valve
Author :
Fielder, John H.
Author_Institution :
Dept. of Philos., Villanova Univ., PA, USA
fDate :
3/1/1991 12:00:00 AM
Abstract :
The ethical issues surrounding the failure of one type of Bjork-Shiley heart valve (due to fracture of the outflow strut), and Shiley Inc.´s handling of the problem are examined. withholding of information on the part of Shiley is discussed. The consequences of this behavior (as many as 765 fractures and 480 deaths have been estimated) are described. Regulatory changes that could prevent future problems of this nature are outlined.<>
Keywords :
cardiology; prosthetics; Bjork-Shiley heart valve; biomedical engineering; deaths; ethical issues; heart valve failure; information withholding; outflow strut fracture; regulatory changes; Acoustical engineering; Biomedical engineering; Clinical trials; Engineering profession; Ethics; Health and safety; Heart valves; Manufacturing; Product safety; Protection; Biomedical Research; Biomedical Technology; Disclosure; Equipment and Supplies; Ethics, Professional; Federal Government; Government; Government Regulation; Heart; Heart Valve Prosthesis; Humans; Industry; Information Dissemination; Information Services; Mortality; Organizational Policy; Patients; Prosthesis Failure; Research; Research Personnel; Risk; Risk Assessment; Scientific Misconduct; Social Control, Formal; Social Responsibility; Surgery; United States; United States Food and Drug Administration;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
