Excerpts and Summary of a National Conference on Medical Devices

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Preface Harry S. Lipscomb, MD, Editor,Journal of the Association for the Advancement of Medical Instrumentation: Exponential growth of knowledge in the physical sciences has enriched the biological sciences immeasurably. Solid state physics, polymer chemistry and engineering design have provided machines and devices which have found broad application in medicine. Pacemakers, heart valves, new polymers for orthopedic prostheses, and diverse monitors of physiological function have materially contributed to human well-being. Now, however, physicians are confronted with an estimated 5,000 types of devices, produced by more than 1,300 manufacturers, and rapture has given way to a more realistic appraisal of the difficulties associated with the use of such devices in humans. Problems of electrical and mechanical safety, tissue compatibility, and usefulness must be examined in a free, sometimes abrasive dialogue which has characterized our growth as a nation. What exactly are medical devices? How should they be classified? Who will regulate

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