FDA tightens requirements on reusable medical devices

By March 17, 2015Pharma Beat
FDA tightens requirements

The FDA has published strict new recommendations for preventing the transmission of antibiotic-resistant infections from reusable medical devices. These guidelines follow the recent outbreaks of drug-resistant “superbug” bacteria in patients undergoing endoscopic procedures using duodenoscopes in hospitals across the United States.

FDA’s guidance document, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”, provides requirements for new devices and recommendations for products currently on the market, applying to most medical devices intended for repeated use including duodenoscopes, bronchoscopes and endoscopes.

Canada seems to be following suit. Starting in September 2016, Health Canada will require all reprocessed single-use medical devices to follow Canadian Medical Device Regulations (CMDR). Although these new requirements will apply to all commercially reprocessed single use-devices, provincial and territorial hospital device reprocessing regulations will remain intact.

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