FDA Final Guidance on Reprocessing Reusable Medical Devices
The FDA published a final guidance on reprocessing reusable medical devices. This guidance is a step toward further reducing the risk of patient infection by providing manufacturers with recommendations to validate their reprocessing instructions to ensure devices remain safe and effective for reuse.
This final guidance includes:
- General considerations for reusable medical device design and reprocessing instructions in device labeling;
- Six specific criteria that manufacturers should address in reprocessing instructions;
- Recommended reprocessing validation methods designed to clean, disinfect and sterilize reusable medical devices; and
- A subset of medical devices for which 510(k) submissions should include protocols and complete test reports of the validation of the reprocessing instructions to demonstrate that reprocessing methods and instructions are adequate. The Reprocessing of Reusable Medical Devices website has been updated to highlight this device subset.