Reviving Quality: The Role of Reprocessed Medical Devices
Regulations and Standards for ReprocessingThe medical device reprocessing industry operates under stringent federal regulations to ensure safety. The U.S. Food and Drug Administration (FDA) provides oversight of third-party reprocessors and outlines cleaning, disinfection, sterilization, testing, labeling and record-keeping standards. Devices must be cleared by the FDA for reprocessing and...
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