FDA Seeks Better Reprocessing Instructions for Reusable Medical Devices

The Food and Drug Administration is seeking to improve the design and instructions for reusable medical devices that pose particular reprocessing challenges, such as flexible endoscopes, with a new draft guidance document and a public workshop for industry stakeholders in June.

When final, the draft guidance, which is now open for public comment, will replace the April 1996 FDA document, "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities." The new draft recognizes the growth in understanding and complexity of reusable medical devices since the 1996 guidance was issued and seeks to provide updated recommendations "regarding reuse instructions in labeling for reusable medical devices and the validation of the recommended reprocessing process in the instructions."

In a press release announcing the effort, the FDA cites endoscopes as an example of reusable medical devices that, according to the agency's review of adverse event reports, pose particular challenges to reprocessing. The FDA notes that from Jan. 1, 2007, to May 11, 2010, it received 80 reports of inadequate reprocessing of endoscopes and 28 reports of infection that may have occurred from improperly reprocessed scopes.

While the infection risk posed by reprocessed devices is relatively low, "the FDA, industry and health care facilities share the responsibility of making sure that reprocessing procedures work and are properly implemented," says William Maisel, MD, MPH, deputy director for science at the FDA's Center for Devices and Radiological Health.

Device features that make it easier to properly reprocess medical devices, according to the FDA's analysis, include: