Definition of an IFU & Its Impact on Patient Safety

Complying with manufacturer’s instructions for use (IFUs) is an important patient safety issue. As too many recent headlines have shown, failure to comply with IFUs can result in a contaminated device being returned to the O.R. and causing a dangerous surgical infection. In order to comply with manufacturer’s IFUs, we first need to know and understand just what an IFU is and its role in patient safety. In its most basic form, an IFU is a step-by-step reprocessing guide to ensure that a reusable device is properly decontaminated, cleaned of all biomaterial, sterilized and voided of any residual moisture before the device is returned to surgery. The Food and Drug Administration (FDA) states that manufacturers of reusable medical devices “have the responsibility to support product label claims of reusability by providing complete and comprehensive written instructions for the handling, cleaning, disinfection, testing, packaging, sterilization, and, if applicable, aeration of their products.  Manufacturers also have the responsibility to conduct and document any testing necessary to validate the suitability of these instructions. Manufacturers have these obligations under U.S. Food and Drug Administration (FDA) labeling regulations (21 CFR 801).” In March of 2015 the FDA issued “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” (to view a copy of the report, click here. In the report, the FDA lists six criteria for reprocessing instructions (IFUs). FDA’s Six Criteria for Reprocessing Instructions

1. Labeling should reflect the intended use of the device.
2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.
4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
5. Reprocessing instructions should be comprehensive.
6. Reprocessing instructions should be understandable.

Thorough and safe reprocessing of a surgical instrument begins in the OR prior to transport to SPD. The first step in an instrument IFU is to place the soiled instrument in an instrument tray/container that contains sterile distilled water or an enzymatic cleaning solution to moisten the soil and prevent blood, mucus, and other debris from drying on the instrument. The second step in an instrument IFU is to thoroughly clean the instrument to remove blood, protein, and other potential contaminants from the surfaces, crevices, joints, and lumens of the instrument. The IFU must describe the cleaning process to be used (e.g., manual cleaning, ultrasonic cleaning or mechanical cleaning) to provide the best results. If all of the organic material is not removed, the instrument cannot be properly sterilized and it may cause a surgical infection if returned to surgery. The last step in an instrument IFU describes how to sterilize and package the instrument (sterilization method; cycle type, temperature, exposure time, aeration, etc.) before returning it to surgery. The IFU should also instruct you to always follow the sterilizer manufacturer’s written instructions for sterilization cycle parameters. Reducing a patient’s risk of a surgical infection caused by a contaminated instrument starts by always following the manufacturer’s IFUs. You have the power to improve patient outcomes with your adherence to manufacturer’s IFUs.