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  4. Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide - 01/10/2024
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Town Hall | Virtual

Event Title
Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide
January 10, 2024

Date:
January 10, 2024
Time:
2:00 p.m. - 3:00 p.m. ET

On This Page: 

Summary

On January 10, 2024, the U.S. Food and Drug Administration (FDA) held a town hall to discuss the sterilization of medical devices, including ethylene oxide (EtO) and other sterilization modalities. During the town hall, the FDA:

  • Discussed medical device sterilization challenges and activities leading up to the FDA’s 2019 Advisory Committee meeting focused on EtO (General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee, November 6-7, 2019).
  • Reviewed major discussion points from the Advisory Committee and related FDA activities.
  • Described the medical device sterilization landscape and supply chain integrity.
  • Discussed the need for forward-looking and collaborative activities, and the role of FDA’s new series of sterilization town halls.

Background

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

Ethylene oxide (EtO) 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.

The FDA will share more about the current sterilization landscape in a regular series of town halls. The first town hall in this series will take place January 10, 2024.

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.”

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

Additional Town Halls on This Topic

Additional town halls focused on the sterilization of medical devices will be held on:

  • January 26, 2024
  • February 7, 2024
  • February 29, 2024
  • March 21, 2024

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

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