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FDA UCM 253010 Reprocessing Medical Devices

General

SteriLogix Posted by: SteriLogix 4 years ago

FDA UCM 253010 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – The FDA notes that labels on reusable medical devices should either tell users the device’s limits of reuse or inform the user how to tell when the device has reached the end of its lifecycle.

Specific section(s) read…

5.L The labeling should either 1) inform the user how many times the device can be reused, based on testing; or 2) provide the user with a mechanism or method to ascertain whether the device has exceeded its use life.

Reuse Life – Reuse life may also be addressed by validating the number of times the product can be reprocessed and reused, and providing this specification in the labeling.