FDA Guidelines For Reusing Medical Devices

In a recent announcement, the FDA has published the final guidelines for the reuse of medical devices. These new recommendations will help both dental professionals and manufactures to stop the possibility of infection from spreading across devices and practices.

The reuse of medical devices is common, which makes this news release pretty important. With the advancement of technology, reusable medical device designs are more difficult to reprocess to remove the contaminants that might remain. Manufacturers will have to develop safer products and provide clear directions for device use, as well as instructions for reprocessing correctly. There are six listed criteria that should be addressed in the manufacturer instructions:

  1. Labeling should reflect the intended use of the device.
  2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
  3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.
  4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
  5. Reprocessing instructions should be comprehensive.
  6. Reprocessing instructions should be understandable.

For more elaboration on their suggestions, please see the FDA reuse guidelines here.

Ultimately, these safety measures will help aid patients being treated and those using the devices feel more at ease with the technology they are using, purchasing, and reselling.


Please note, comments must be approved before they are published