FDA Releases Final Guidance on Reusable Medical Devices

A final industry guidance is aimed at helping device manufacturers develop safer reusable devices

The FDA has announced a final guidance aimed at helping device manufacturers develop safer reusable devices, especially devices that pose a greater risk of infection, according to a news release.

The document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.

The guidance also recommends that manufacturers consider processing challenges early in device design. Manufacturers will be expected to conduct testing to show that their cleaning and disinfection instructions will consistently reduce contamination.

“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective.”

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