FDA delays reprocessing requirements enforcement
December 1, 2001 less than 1 minute read
FDA delays reprocessing requirements enforcement
Hospitals that reprocess devices labeled for single use have a one-year extension from the Food and Drug Administration (FDA) on reprocessing requirements that cover medical device reporting, tracking, corrections and removal, quality systems, and labeling, according to the Chicago-based American Hospital Association (AHA). However, hospitals still are required to register with the FDA and list the single-use devices that they plan to reprocess, the AHA reports.
The FDA will begin inspecting hospitals shortly to assess compliance, according to the AHA. The agency has said it intends to use those inspections to educate hospitals rather than punish them. This education approach will be in effect until Aug. 14, 2002, the FDA says, "provided that the hospitals are taking steps to correct the violations noted in the inspection and that the violations do not pose a serious public health threat."
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