Facts behind IFU validation: Here’s the who, what, where, when, why and how (including how much)

The No. 1 responsibility of everyone involved in reusable medical device reprocessing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after reprocessing. Minimizing the risk starts by complying with the manufacturer’s instructions for use (IFUs). As too many recent headlines documenting patient harm and even death have shown, failure to comply with IFUs, or using IFUs that have not been validated, can result in a contaminated device being returned to use and injuring patients. To correctly use and comply with manufacturers’ IFUs, you 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 processing guide from the manufacturer that describes how to decontaminate, clean and sterilize a reusable medical device before the device is returned to surgery. The FDA mandates that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). These IFUs are supposed to provide CS/SPD reprocessing personnel with the necessary information and steps to safely and thoroughly reprocess reusable medical devices and surgical instruments. Included in every IFU are specific, step-by-step instructions on how to properly decontaminate and clean the device prior to terminal sterilization. Over the past 40 years, the FDA has taken an ever increasing interest in reusable device IFUs and their impact on patient safety. The FDA’s concern with the content and the validity of manufacturers’ IFUs was codified on March 17, 2015, when the FDA issued “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”1 Section VII of the FDA report is titled, “Validation of Reprocessing Methods in Accordance with the Quality System Regulation.” This is where the FDA spells out to manufacturers the requirement to “validate” their IFUs.  The report states: “For class II and class III devices and select class I devices, manufacturers must establish and maintain procedures for validating the design of their device, which shall ensure that the device conforms to defined user needs and intended uses. 21 CFR 820.30(g). Manufacturers must also establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, 21 CFR 820.75(b). FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended.” Section VII further states that: “Cleaning, disinfection and sterilization processes should be validated to provide a high degree of assurance that a device will consistently meet predetermined specifications, in accordance with 21 CFR 820.75.” 2 Section VIII of the FDA report is titled, “Validation of Cleaning Process.” This is where the FDA lists the specific validation requirements that manufacturers must meet in order to prove that their IFUs actually work to provide clean devices prior to sterilization. The steps required for an instrument manufacturer to validate their cleaning IFU in accordance with the FDA’s requirements can be summarized in just five simple steps. They are: 1. The manufacturer provides an independent testing laboratory with a minimum sample of three or more instruments of the same type to be contaminated with test soil along with an additional instrument to serve as the control. 2. Following FDA and AAMI testing guidelines, the instruments must be thoroughly inoculated by the laboratory technician with Artificial Test Soil (ATS) containing challenge markers prior to starting the cleaning process. 3. After contamination, the cleaning steps that are listed in the manufacturer’s written IFUs must be followed step--by--step to their conclusion by the laboratory technician. 4. After completing the cleaning steps listed in the manufacturer’s IFUs, the efficacy of the cleaning procedure is assessed based on the residual levels of the markers remaining on the instruments after cleaning. 5. The results of the validation testing are then listed in the manufacturer’s “Cleaning Validation Report.” It is vital for patients’ safety to remember that the FDA’s rigid requirements for “validation” of cleaning IFUs only applies to new products that have been approved in the last few years. The vast majority (more than 98%) of the reusable medical devices and instruments that are used on patients’ everyday have never had their cleaning IFUs validated. Accordingly, it is up CS/SPD and clinical personnel to request “validated” cleaning IFUs from all of their reusable device and instrument suppliers. If CS/SPD and clinical personnel are relying on manufacturer IFUs that have not been validated “to ensure that the device can be effectively reprocessed and safely reused,” then they cannot be sure that the devices are clean, sterile and moisture-free after every reprocessing cycle. The question that every CS/SPD personnel need answer is, “Do I know that the devices that I am sending back to be used with patients are really safe?” Reducing a patient’s risk of harm caused by a contaminated device starts by always following the manufacturer’s validated IFUs. Everyone involved with reprocessing devices has the power to reduce patient risk and improve patient outcomes with their adherence to the manufacturer’s validated IFUs. That is why CS/SPD and clinical personnel must insist on validated IFUs to protect their patients. 1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling 2 Ibid., FDA