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FDA releases approval guidelines for reusable medical devices
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The FDA today released enhanced recommendations on the production and disinfection of reusable medical devices, according to a press release.
Targeted at device manufacturers, the documentation includes guidelines on the labeling of these products and an explanation of six criteria taken into account by the FDA when approving new reusable medical devices. The agency advices industry members to consider these recommendations early in the development of new products.
The guidance follows outbreaks of carbapenem-resistant Enterobacteriaceae at the University of California, Los Angeles Health System and Cedars-Sinai Medical Center, both of which were linked to a duodenoscopic device used in endoscopic procedures. Both centers said the infection occurred despite correctly implementing cleaning procedures of the devices provided by the manufacturer (Olympus Corp.) and the FDA.
“Despite the recent concerns about multidrug-resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low,” William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the release. “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 health care community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective.”
For more information:
The industry guidance document is available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf.