Assessing the Impact of End-of-Life Processing on Reusable Medical Devices.

Abstract

End-of-life (EOL) testing requirements for reusable medical devices continue to cause confusion in the medical device industry. Regulatory expectations from U.S. and European Union authorities differ, particularly regarding whether manufacturers must conduct EOL testing or if a cautionary statement in the instructions for use is sufficient. ISO 10993-1:2021 mandates biological safety evaluations for the maximum validated number of processing cycles. Similarly, ISO 17664-1:2021, regulation (EU) 2