“Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they are complying with all steps as directed by the device manufacturers, and have in place appropriate policies and procedures that are consistent with current standards and guidelines,” FDA representatives wrote.
The steps recommended by the FDA include detailed training protocol for all personnel who reprocess the devices, a regular auditing and feedback system to measure adherence and a general revisiting of facility infection control policies and procedures.
The warning can be found here.
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