The Food and Drug Administration said Monday it released draft guidance for manufacturers of reusable medical devices on how to develop user-friendly, scientifically accurate instructions to properly clean and disinfect their instruments.

The federal watchdog agency also said it would host a public workshop June 8-9 with providers, manufacturers and other stakeholders to share its findings on ways to better sterilize reusable equipment.

The risk of infections from reprocessed medical equipment is "relatively low," the agency said. But in a note posted on its website, the agency said such infections are often not reported to the agency so that the true number of such infections is "unknown."
In a study of endoscopes, used in 10 million medical procedures a year, the FDA found about 80 cases of inadequate reprocessing between Jan. 1, 2007 and May 11, 2010. Inadequate reprocessing was linked to 28 reported infections, the FDA said.

The FDA said a review of premarket and postmarket data of reusable devices, such as endoscopes, showed certain features increased the likelihood of removing biologic debris and sterilizing the instruments. These features include making hard-to-clean components disposable, clearly marking components that have to be discarded during reprocessing and, for long, narrow devices, having a smooth inner surface.

In its draft guidance, the agency outlined steps manufacturers could take to make sure instructions for disinfecting their products were clear and easy-to-follow. The agency also shared recommendations for how to clinically validate that these reprocessing instructions work -- necessary for companies submitting their reusable devices for FDA approval.

The FDA said making instructions more accurate and readable was key, as current labeling can sometimes be unclear or impractical to follow. The agency also said research done in collaboration with the University of Michigan found even if manufacturers' instructions were followed, sometimes potentially hazardous debris could still be retained in the device.

The agency said it is currently working with the Association for the Advancement of Medical Instrumentation and ASTM International to reach an agreement on best practices.

"The FDA, industry and health care facilities share the responsibility of making sure that reprocessing procedures work and are properly implemented," Dr. William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health, said in a statement.

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