Validating IFUs for Reprocessed Medical Devices

Incidents of nosocomial or healthcare acquired infections (HAIs) and bacteria that have become resistant to antibiotics (“superbugs”) are a concern for U.S. FDA. These ongoing incidents have heightened FDA’s attention to manufacturers of reprocessed medical devices. Manufacturers need to design devices that can be reprocessed effectively after patient contact, validate that the devices can be reprocessed in the healthcare facility, and publish clear reprocessing procedures and instructions for use (IFU) that are easy for healthcare personnel to understand and follow.