Reusable medical devices have come under scrutiny recently after a number of deaths were linked to bacteria infections associated with duodenoscopes.
The FDA, among other things, is recommending manufacturers consider reprocessing challenges early in device design, as well as be ready to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination.
The recommendations are part of a final guidance the agency issued on the reprocessing of reusable medical devices to enhance the safety of them, and address the possible spread of infectious agents between uses. The guidance also lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.
The FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.
Reusable medical devices have come under scrutiny recently after a number of deaths were linked to bacteria infections associated with duodenoscopes.
"This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them," said William Maisel, M.D., M.P.H., Deputy Director for Science and Chief Scientist at the FDA’s Center for Devices and Radiological Health. "Doing so should provide greater assurance to patients that the devices used on them are safe and effective.”
