The Food and Drug Administration (FDA) published a final agency guidance recently, entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff” (Guidance), which is intended to help device manufacturers enhance the safety of reusable medical devices, especially those reusable devices that pose a greater risk of infection.
The Guidance covers medical devices that are supplied either sterile/non-sterile and that require processing (e.g., clean, disinfect, sterilize) prior to initial use and/or reprocessing prior to subsequent patient use. Such repeat-use devices are commonplace in health care settings and are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in health care settings, the design of some devices makes it harder to remove some contaminants during reprocessing.
The FDA’s Guidance provides recommendations that medical device manufacturers should follow pre-market and post-market to help facilitate the safe and effective use of reprocessed devices. One important topic covered in the Guidance is reprocessing instructions, which the FDA views as critical to protect patients against the spread of infections. The Guidance notes that reprocessing instructions for reusable medical devices should comply with the following criteria to help ensure users understand and correctly follow such instructions:
- Labeling should reflect the intended use of the device;
- Reprocessing instructions should advise users to thoroughly clean the device;
- Reprocessing instructions should indicate the appropriate microbial process for the device;
- Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed; and
- Reprocessing instructions should be understandable and comprehensive (the following elements should be addressed when relevant: special accessories needed for reprocessing; point-of-use processing; disassembly and reassembly; method of cleaning; cleaning agents; rinsing; lubricating agents; visual inspection; method of disinfection/sterilization; reductions of sterilant residuals; drying; reuse life; patient/lay use; references; additional recommended instructions; and manufacturer contact information).
The Guidance also notes that device manufacturers must validate their device reprocessing steps in accordance with the FDA’s Quality System regulations. Further, marketing applications (510(k)s/PMAs) for devices intended to undergo reprocessing should include validated reprocessing instructions as part of the device labeling provided in the application. Thus, manufacturers of reusable medical devices that require reprocessing may want to update their device labeling to reflect the recommendations for reprocessing instructions noted in the Guidance. Manufacturers may also want to review the available information in their device files on reprocessing validation to confirm whether validation of reprocessing has been properly substantiated as discussed in the Guidance.