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  4. Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) - 01/26/2024
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Town Hall | Virtual

Event Title
Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO)
January 26, 2024

Date:
January 26, 2024
Time:
12:00 p.m. - 1:00 p.m. ET

On This Page: 

Summary 

On January 26, 2024, the FDA held the second in a series of medical device sterilization town halls to:

  • Describe the FDA’s early actions to help assure sterilization capacity in the U.S. and recent activities to reduce overall EtO reliance while maintaining a resilient supply of sterilized medical devices
  • Discuss the FDA’s understanding of opportunities and challenges to using alternative sterilization methods
  • Describe creation of a dedicated EtO Tiger Team to advance innovations in medical device sterilization.

Background

Sterilization is a critical step in the manufacturing process for certain medical devices. Sterilization of medical devices helps prevent serious infections. Inadequate sterilization can lead to life-threatening infections. 

Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).

Ethylene oxide is the most commonly used method to sterilize medical devices in the United States, and it is widely used by medical device manufacturers and contract sterilizers worldwide. Other existing sterilization modalities cannot currently replace the use of EtO for many devices. While some novel technologies hold promise, innovative alternative sterilization methods are still in early phases of research and development.

The FDA is committed to reducing reliance on EtO sterilization use while ensuring the integrity of the supply chain so that patients and providers have continued access to the sterile devices they need. To meet this goal, FDA continues to take a multipronged approach, including regulatory flexibilities, supply chain analysis and mitigation, collaboration, innovation, and communication, including this regular series of town halls.

Learn more about sterilization of medical devices. 

Town Hall Materials

The presentation, printable slides, and transcript are available on CDRH Learn under "Specialty Technical Topics," sub-section "Sterility.” 

For comments or questions related to this town hall or this series, please email us at MedicalDeviceSterilization@fda.hhs.gov. 

If you have general questions about this town hall or this series, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Future Medical Device Sterilization Town Halls

  • February 7, 2024
  • February 29, 2024
  • March 21, 2024

Previous Medical Device Sterilization Town Halls

Watch previous town halls and access related materials on CDRH Learn under "Specialty Technical Topics," sub-section "Sterility.” 

For a complete list of previous and future sterilization town hall event information, visit Medical Device Sterilization Town Hall Series.

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