Standards and the Flood of Medical Devices

Authors:
  • LRLeslie Rendell-Baker
    Leslie Rendell-Baker
  • DHDwight Emary Harken
    Dwight Emary Harken

Abstract
"One orders what one wants through specifications, maintains order through standardization, and determines what to live up to through standards."1 The hurricane of technology now striking medicine has brought with it a flood of medical instrumentation and devices that have greatly benefited patient care. The physician, however, has been carried far from the firm ground provided by his medical training into deep waters where his lack of expertise in evaluating sophisticated medical instrumentation is often evident. In the absence of recognized specifications, performance criteria, test methods, and other standards, the purchasing agent is left with little but the physician's personal . . .