U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Devices News and Events
  4. Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - 10/09/2024
  1. Medical Devices News and Events

Webcast | Virtual

Event Title
Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
October 9, 2024

Date:
October 9, 2024
Time:
2:00 p.m. - 3:00 p.m. ET

Summary

On October 9, 2024, the U.S Food and Drug Administration (FDA) held the Medical Device Sterilization Town Hall: Short Topics and Open Q&A. During this town hall, FDA discussed Predetermined Change Control Plans and hosted an open question and answer session.

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. 

For a complete list of previous sterilization town halls and information on upcoming events, visit Medical Device Sterilization Town Hall Series.

Materials

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

Submit comments or questions related to this town hall or this series to MedicalDeviceSterilization@fda.hhs.gov.

If you have 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.

Back to Top