SEDL / STP / STP898-EB / STP33296S

Vascular Prostheses: The Need for Standards—Historical and Surgical Perspectives

Wesolow, A
Clinical professor of surgerychief, S.U.N.Y. Downstate Medical CenterThoracic Surgical Section, V.A. Medical Center, BrooklynTogus, NYME

Pages: 25    Published: Jan 1986

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Abstract

The historical and surgical perspectives with respect to standards for vascular prostheses are summarized under three headings: (1) device legislation tracing the activities of the Food and Drug Administration (FDA), ASTM, and International Organization for Standardization (ISO) from 1964 culminating in the present Medical Device Legislation as signed in 1976; (2) scientific community involvement via the media of ASTM, American Society for Artificial Internal Organs (ASAIO), Association for the Advancement of Medical Instrumentation (AAMI), and ISO; and (3) research observations focusing upon the causes of failure of vascular prostheses. Failures fall into six classes containing multiple specific causes. The conclusion is that the time is ripe for the establishment of performance standards and specifications for vascular prostheses from the aspects of political and governmental climate, scientific community awareness, willingness and expertise, and technical knowledge for the development of methods of testing and evaluation to minimize the risk of failure of vascular prosthetic devices and of the patients bearing these same implants.