The Food and Drug Administration issued draft documents today that address reprocessed reusable medical devices and their labeling instructions.
Draft guidance issued on reprocessed devices
The FDA said in a news release that it had identified design features of devices that reduce the likelihood of infection. These features include “smooth inner surfaces of devices with long, narrow interior channels, clear identification of components that must be discarded after patient use, and designs that take into account how fluid moves through reusable medical devices.”
The findings stem from the FDA's access to premarket and post-market data for reprocessed medical devices, it said. The agency also noted in the release the risks of acquiring an infection from reprocessed medical devices are “relatively low.”
The FDA plans to hold a public workshop in June to discuss device design and “scientific advances in reprocessing.”
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