Ethical issues in biomedical engineering: the Bjork-Shiley heart valve

Author

Fielder, John H.

Author_Institution

Dept. of Philos., Villanova Univ., PA, USA

Volume

10

Issue

1

fYear

1991

fDate

3/1/1991 12:00:00 AM

Firstpage

76

Lastpage

78

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;

fLanguage

English

Journal_Title

Engineering in Medicine and Biology Magazine, IEEE

Publisher

ieee

ISSN

0739-5175

Type

jour

DOI

10.1109/51.70044

Filename

70044