On This Page:

• Summary
• Background
• Town Hall Materials
• Previous Medical Device Sterilization Town Halls
• Future Medical Device Sterilization Town Halls

Summary

On March 21, 2024, the FDA held the fifth medical device sterilization town hall and discussed:

• The value and use of consensus standards in premarket review
• The role of the CDRH Standards program in the development and recognition of consensus standards
• Recently recognized consensus documents for device sterility and their potential use in premarket review, and 
• The value of participating in the collaborative standards development process.

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).

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, including this regular series of town halls.

Learn more about sterilization of medical devices.

Town Hall Materials

• Printable Slides

Following this town hall, the presentation, printable slides and transcript will be 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.

Previous Medical Device Sterilization Town Halls

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

• Overview of Sterilization Landscape and Role of Ethylene Oxide (January 10, 2024)
• FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (January 26, 2024)
• Premarket Submission Expectations and Additional Considerations for Sterility Review (February 7, 2024)
• FDA’s Modifications Guidances and the Use of Device Master Files in Reviews (February 29, 2024)

Future Medical Device Sterilization Town Halls

• April 29, 2024, 1-2 pm ET. Tentative topics: Topics and Formats for the Continuing Sterilization Town Hall Series - A CDRH Panel and Stakeholder Discussion

• May 23, 2024, 1-2 pm ET. Tentative topics: Considerations for Selecting a Sterilization Modality 

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