REUSED MEDICAL DEVICES: Dangers Demand FDA Oversight
Noting the web of self-interests that plague progress in regulating hospitals' reuse of "single-use" medical devices, a Los Angeles Times editorial suggests the FDA oversee safety studies, while soliciting financial aid from both reprocessing companies and device manufacturers. While the dangers of re-using such devices remain nebulous due to a "woefully inadequate" safety evaluation system, medical device manufacturers "are sounding an alarm" concerning incidents of bacterial infection and surgical harm related to reprocessed devices. However, manufacturers' concern may be largely fueled by a greater concern over profits, which have been threatened by hospitals' use of reprocessing services. As the FDA "lacks the resources to oversee medical device reuse," the editorial recommends that it combine efforts with the Joint Commission for the Accreditation of Health Care Organizations "to require hospitals to abide by national protocols or contract out reprocessing work to the four private companies that successfully overhaul tens of millions of medical devices each year." While criticizing Congress' role in watering-down medical device oversight in 1992 and 1996, the editorial endorses a bill to require hospitals that report malfunctioning devices to note whether they were new or reused. The editorial concludes: "The United States leads the world in innovating medical devices but lags in regulating them. Government and industry need to begin working together to eliminate this conflict" (8/3).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.