Register for The MedTech Conference to access important programming on the use of EtO in medical device sterilization.
EtO Sterilization of Medical Devices: The Impact of Evolving Regulatory Requirements
Tuesday, September 24
3:45 PM – 5:00 PM
Room 157 A
A panel of FDA and industry experts on sterilization processes, and environmental health and safety, will discuss the impact of emerging federal and state efforts to strengthen oversight of ethylene oxide (EtO) emissions that result from EtO use in medical device sterilization. Topics covered will include potential challenges MedTech companies could face in achieving and demonstrating compliance under evolving standards, and other potential impacts of changing EtO regulations on industry and public health.
MODERATOR: Ellen Kondracki, Vice President, Sustainability & EHS, BD
Dan Carestio, Chief Operating Officer, STERIS Corporation
Phil Cogdill, MBA, Sr. Director of Quality, Sterilization & Microbiology, Medtronic
Joyce Hansen, VP, J&J Sterility Assurance, Johnson & Johnson
Suzanne Schwartz, MD, MBA, Deputy Director (and Acting Director), Office of Strategic Partnerships & Technology Innovation, FDA
Realizing Organizational and Global Value with Sustainable Business Actions
Tuesday, September 24
10:10 AM – 10:50 AM
Stakeholder expectations and market demands are increasingly requiring businesses to address community health, climate change and sustainable operations. Strategically aligning environmental and business objectives is critical. Gain an understanding of how top-performing organizations are achieving impactful results for customers, employees, the communities in which they operate and the global environment. Hear from medtech companies who understand the business case for meeting local employee/community needs, environmentally conscious strategies and sustainable manufacturing processes.
MODERATOR: Greg Crist, Chief Advocacy Officer and Head of External Affairs, AdvaMed
Caroll H. Neubauer, Chairman and Chief Executive Officer, B. Braun Medical Inc.
Walt Rosebrough, President and CEO, STERIS Corporation
What is EtO Sterilization?
Ethylene Oxide (EtO) gas is one of the most common ways to sterilize medical devices, a process which is critical for preventing infections and ensuring patients have safe surgeries and medical treatments. EtO sterilization is a highly regulated process, and device manufacturers, hospitals and third-party sterilizers must follow rigorous controls established by FDA, EPA, OSHA and other government agencies to protect patients, workers and the environment.
Importance of EtO
For many medical devices, due to their size, shape, complexity or material composition, ethylene oxide is the only option for sterilization. For these products, alternatives such as steam, radiation or other sterilants do not achieve the needed levels of sterility assurance. In addition, for some medical devices, using non-EtO sterilization methods will result in material degradation, rendering the products potentially unsafe for patients.