Manufacturers of reusable medical devices and surgical instruments must receive clearance from the Food and Drug Administration before the product can be made available for purchase and use in the United States. Part of the labeling claim process requires that manufacturers produce validated instructions for use (IFU) for reprocessing of the reusable device. The medical device manufacturer’s (MDM) validated IFU for each device must be provided in writing to the health care facility purchasing or borrowing these devices. The instructions should describe, in detail, the validated steps for disassembly, lubrication, cleaning, disinfecting, packaging, and sterilization.

Written recommendations from MDMs for reprocessing surgical instruments and medical devices should be on file and consistently followed by health care facilities.