FDA Targets Risks From Reused Medical Devices

The FDA has received reports of patients being exposed to microscopic amounts of blood, body fluids and tissue from reusable medical devices were inadequately reprocessed and is working with manufacturers and healthcare providers to improve the reprocessing of such devices, according to an FDA report.

The FDA said transmission of infection was extremely rare, but the potential for becoming infected prompted the new push.

"The risk of acquiring an infection from a reprocessed medical device is low," said William Maisel, MD, deputy director for science at the FDA's Center for Devices and Radiological Health, in the report. "The benefits of these procedures in diagnosing and treating medical conditions far outweigh any risk."

The FDA has created a new website and will work with healthcare providers and device manufacturers to make sure the reprocessing instructions are clear and scientifically validated, make sure healthcare facilities understand and follow the instructions and identify device designs that aid cleaning, disinfecting and sterilization.

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