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U.S. Department of Health and Human Services

Safety

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Single Use Medical Devices (SUDs)

Audience: Hospital Administrators and Hospital Risk Managers

The FDA Center for Devices and Radiological Health has sent a letter to all U.S. hospitals reminding them about its intention to enforce certain requirements regarding the reprocessing of single-use medical devices (SUDs) for later use on patients. The letter provides a timetable and specifies actions that may be taken against hospitals that do not comply.

[April 25, 2001 - Letter - FDA]
[April 25, 2001 - CDRH Reuse Home Page - FDA]