The practice of reprocessing devices that are intended for single-use (SUD’s) began in hospitals in the late 1970’s. Since that time, the practice of reprocessing and reusing SUDs has become widespread. FDA has not regulated original equipment manufacturers (OEM’s), third parties, and hospitals that engage in reprocessing SUD’s in the same manner. In particular, to date, FDA has enforced existing premarket submission requirements only against OEM’s. FDA’s premarket review of an OEM’s device labeled for single-use does not ordinarily address whether reprocessing and reuse of such a device would present a risk to the public health.
The public health risk presented by a reprocessed SUD varies. Some devices, which are low risk when used only one time, may present an increased risk to the patient upon reprocessing. Other SUDs are low risk when used for the first time and remain low risk after reprocessing, provided that the reprocessor conducts cleaning and sterilization/disinfection of the SUD in an appropriate manner. Other SUDs, however, cannot be reprocessed safely and should not be reprocessed and reused under any circumstances. FDA is proposing to prioritize its enforcement of premarket requirements for reprocessed SUDs on the basis of the risk that is likely to be posed by the reuse of the device. This guidance document describes the factors the agency will consider to determine the level of risk associated with these devices and the way those factors will be applied to determine whether the risk is high, moderate, or low.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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Rockville, MD 20852
All comments should be identified with the title of the guidance.