The FDA requires manufacturers of reusable medical devices to provide reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. Developing and validating these instructions can be a complex and highly specialized activity. Guidance on this process can be found in a document created by the FDA Center for Devices and Radiological Health entitled, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.” The guidance indicates, the labeling of a reusable medical device should clearly specify the appropriate material and equipment parameters to adequately reprocess the devices. Reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection. The validation of the cleaning and disinfection process may also be a necessary part of Premarket Notification – also called PMN or 510(k).Two documents referenced in the guidance are helpful in determining how to proceed are “AAMI TIR30:2011 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices,” and “AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers.”
Cleaning is the first step in reprocessing and should be described in the labeling as part of the overall reprocessing instructions. Instructions to the user should clearly communicate how to achieve thorough cleaning. Whichever reprocessing method is indicated, the ability of the method to successfully reprocess the device should be validated and then stated in the instructions for use. The validation should demonstrate that soil and contaminants have been effectively removed and the device is free of viable microorganisms. This may involve inoculation and/or intentional contamination of the device, variations on the cleaning and disinfection process and a determination of cleanliness and disinfection via bacteria counts and/or pathogen detection methods.