The U.S. Food and Drug Administration is telling patients that they should not cancel or delay procedures because of concerns about inadequate reprocessing of reusable medical devices, such as surgical forceps and stethoscopes.
FDA calls risks from reprocessed devices 'low'
A Dec. 28 consumer update reported that the FDA has received reports about inadequately reprocessed reusable devices, which exposed some patients to "microscopic amounts of blood, body fluids and tissue" from other patients.
The consumer update said that the FDA is working with manufacturers to provide clear reprocessing instructions and with hospital staff to ensure they understand and follow instructions, as well as to identify design features of devices that reduce risk of infection. The agency also is collaborating with standards organizations and government agencies.
Dr. William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said in the update that "the risk of acquiring an infection from a reprocessed medical device is low" and the "benefits of these procedures in diagnosing and treating medical conditions far outweigh any risk."
In April, the FDA issued draft guidance regarding reprocessed reusable medical devices and instructions for labeling them. The agency also said it had identified design features of devices that reduce the likelihood of infection. At that time, the FDA said that the risk of acquiring an infection were "relatively low."
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