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FDA to Increase Regulation of Hospitals and Reprocessing Companies
Because of the increased practice of reusing medical devices, the Food and Drug Administration is taking steps to more rigorously regulate the practice. A recent report by the General Accounting Office estimated that 20% to 30% of U.S. hospitals reuse devices such as surgical saw blades, drills, catheters, and forceps in order to cut the cost of the devices. While the devices are cleaned, sterilized and repackaged, there have been a number of reports of patients being harmed by such devices. Under the new guidelines, hospitals that reuse devices and the independent companies that sterilize and repackage them will be regulated in the same manner as the device makers. This will mean that hospitals and reprocessing companies will now have to submit information to the FDA indicating the safety and effectiveness of a device used more than once. Additional rules also call for the registration of businesses that reuse or reprocess medical devices as well as the submission of "adverse event reports." While the new guidelines only apply to hospitals, the FDA said that they might later be applied to all healthcare facilities. For more information and the latest updates, visit the Food and Drug Administration web site at www.fda.gov.