Safety Issues Involving Medical Devices Implications of Recent Implantable Cardioverter-Defibrillator Malfunctions

摘要

Ultimately, Congress enacted the Medical Device Amendments of 1976 to better enable the FDA to establish the safety and effectiveness of medical devices.3 The legislation was based on the concept that the degree of device regulation should correlate with device complexity and perceived risk.5 During the 1980s, however, manufacturers were criticized for inadequate reporting of adverse events to the FDA, and for failing to report or conduct recalls.5 As further evidence of inadequate postmarket surveillance, some cited the withdrawal of the mechanical Bjork-Shiley convexo-concave heart valve from the market due to premature strut failure that ultimately affected 633 patients and was fatal in two thirds of those cases.