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The Physician's Role in the Quality Control of Medical Devices

The Physician's Role in the Quality Control of Medical Devices There has been an exponential increase in medical devices employed in diagnosis and treatment, and government has become so concerned with their quality that a large new bureaucracy has come into being. Industry has become sufficiently concerned, and many new positions in their executive staffs now have responsibility for quality control. Only we physicians appear relatively unconcerned about the devices we employ for our patients. As individuals and as organization members we need to take the lead in the regulatory mechanism. The federal government and the courts have defined and classified devices as drugs and have assigned supervision and control to the Food and Drug Administration within the Department of Health, Education, and Welfare. By means of the Medical Device Amendments of 1976, a special Bureau of Medical Devices was created with the purpose of ensuring the safety and efficacy of diagnostic and therapeutic equipment and reagents. To comply with http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

The Physician's Role in the Quality Control of Medical Devices

Beck, William C.
JAMA , Volume 241 (1) – Jan 5, 1979
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Publisher
American Medical Association
Copyright
Copyright © 1979 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.1979.03290270046022
Publisher site
See Article on Publisher Site

Abstract

There has been an exponential increase in medical devices employed in diagnosis and treatment, and government has become so concerned with their quality that a large new bureaucracy has come into being. Industry has become sufficiently concerned, and many new positions in their executive staffs now have responsibility for quality control. Only we physicians appear relatively unconcerned about the devices we employ for our patients. As individuals and as organization members we need to take the lead in the regulatory mechanism. The federal government and the courts have defined and classified devices as drugs and have assigned supervision and control to the Food and Drug Administration within the Department of Health, Education, and Welfare. By means of the Medical Device Amendments of 1976, a special Bureau of Medical Devices was created with the purpose of ensuring the safety and efficacy of diagnostic and therapeutic equipment and reagents. To comply with

Journal

JAMA – American Medical Association

Published: Jan 5, 1979

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