USFDA issues its final guidance on medical devices reprocessing: “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”

USFDA has finally issued its final guidance on reprocessing of medical devices on March 12, 2015. The draft guidance was released in 2011. Reusable medical devices are devices that healthcare providers can reuse to diagnose and treat multiple patients. The guidance was proposed to reduce the risk of exposure to improperly reprocessed medical devices. Reusable devices should have adequate labeling with clear instructions for reprocessing devices and their accessories. The focus of this document is to provide guidance to medical device manufacturers in the complex activities involved in crafting and validating reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. The guidance provides six criteria for labeling to help users understand and follow the reprocessing instructions:

  • Labeling should reflect the devices intended use.

  • Reprocessing instructions should advise users to thoroughly clean the device.

  • Instructions should indicate the appropriate microbicidal process for the device.

  • Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.

  • Reprocessing instructions should be comprehensive.

  • Reprocessing instructions should be understandable.

The document also describes the type of documentation manufacturers will need to include in their premarket submissions for the validation of the reprocessing process.

You can View the full final guidance here.