The Food and Drug Administration is seeking hospitals' comments on how they deal with a difficult but indeterminate problem: whether to use opened but unused single-use medical devices or pitch the products because their sterility may have been compromised. The FDA regulates the reuse of disposable devices but has not applied its policies to single-use devices that have been opened but not used; however, it hasn't ruled out doing so in the future. To that end, the FDA will publish a notice in tomorrow's Federal Register seeking information on hospitals' practices. That includes whether hospitals have written policies or procedures regarding open but unused devices, how they determine if such a device has been contaminated and what types of devices are being resterilized. The comment period will last 90 days. -- by Cinda Becker
FDA weighs problem of open but unused devices
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