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  4. Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method - 07/10/2024
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Webcast | Virtual

Event Title
Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method
July 10, 2024

Date:
July 10, 2024
Time:
1:00 p.m. - 2:00 p.m. ET

Summary

During this town hall, we presented a mock pre-submission for a fictional medical device and explored regulatory, design and testing considerations when there is a change in sterilization method.

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 and future sterilization town hall event information, visit Medical Device Sterilization Town Hall Series.

Materials

The presentation, printable slides and transcript are also available on 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.

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