Reprocessing of Reusable Medical Devices: Information for Manufacturers
Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients.
In March 2015, the Agency published Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. The FDA finalized the 2011 draft guidance after considering approximately 500 comments. The final guidance document:
- reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices, many of which have become highly complex in design and are more difficult to reprocess;
- outlines general considerations for the design and safety of all reusable medical devices as well as what’s important to include in the reprocessing instructions for users to follow. To ensure that users can understand the reprocessing instructions and correctly follow them, the final guidance lists six criteria that should be addressed in the instructions for use with ever reusable device; includes a subset of medical devices (Appendix E) that pose a greater likelihood of microbial transmission and high risk of infection if not adequately reprocessed. 510(k) submissions for these devices should include data to validate reprocessing methods and instructions. Data to validate reprocessing methods and instructions includes protocols and complete test reports that demonstrate reprocessing instructions work reliably and consistently and are able to be followed as intended.
Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among various stakeholders. This includes the FDA; manufacturers responsible for providing adequate reprocessing instructions that are user-friendly and proven to work; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; and other organizations. You can find additional information on the Reprocessing of Reusable Medical Devices website.
- Final Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (PDF - 805KB)
- Devices for which a 510(k) should contain validation data (Reprocessing Final Guidance Appendix E.)
- Gastroenterology-Urology Devices Panel (May 14-15, 2015)