Overview

More than 20 billion medical devices sold in the U.S. every year are sterilized with ethylene oxide (EtO), a crucial method used for helping to prevent serious infections. The FDA is implementing programs and initiatives to reduce the use of EtOand supporting innovative methods of sterilization for devices. Concurrently, the Environmental Protection Agency (EPA) is proactively working to reduce the amount of EtO used. In late May, EPA put forth a proposed rule governing emissions from EtO, which is carcinogenic. Now that the comment period is closed, panelists will discuss concerns outlined in the comments, how EPA and FDA are working together on EtO sterilization, and potential impacts EtO limits could have on the supply of medical devices and patient access.

Speakers

Khatereh R. Calleja, Senior Vice President, Technology and Regulatory Affairs, Advance Medical Technology Association (AdvaMed)
Mark B. Leahey, President and CEO, Medical Device Manufacturers Association (MDMA)
Clarence W. Murray, III, Assistant Director for the Sterility Devices Team, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH)
Moderated by Keith A. Matthews, Of Counsel, Wiley LLP

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