Processing Reusable Medical Devices and End-of-Life Investigation.

Abstract

Reusable medical devices are intended to be subjected to multiple cycles of clinical processing throughout the life of the device in accordance with manufacturers' instructions for use (IFUs). IFUs should include practical information on the service life of the medical device. This laboratory-based study investigated an approach to support an indefinite lifetime for reusable devices, where the end of life depends on the visual inspection and functional verification provided in the IFU. To evaluate the design features over a broad range of surgical instruments, worst-case, representative devices were identified based on their cumulative features. The devices were subjected to repetitive cycles of processing (cleaning, disinfection, and sterilization). At different stages during the study, the devices were examined for visual effects over time. In addition, extracted levels of total organic carbon and cytotoxicity were assessed. Trend analysis over the study did not show noteworthy effects of device processing over time, including cytotoxic residuals. The results indicated that the effects of repeated cycles of processing on the device tested were negligible regarding physical damage and residual chemical levels. These findings support an indefinite device lifetime using end-of-life indications, based on the IFU and inspection requirements (for cleanliness, damage, and proper function).