Medical Device Sterilization Town Hall: Short Topics, Q&A (original) (raw)
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 PM - 3:00 PM ET
Summary
Join the U.S Food and Drug Administration (FDA) on October 9, 2024, for the Medical Device Sterilization Town Hall: Short Topics and Open Q&A. During this town hall, we will discuss Predetermined Change Control Plans. We will also host an open question and answer session.
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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.
Details
Registration is not necessary. We encourage attendees to submit questions to MedicalDeviceSterilization@fda.hhs.gov at least one week in advance.
Date: October 9, 2024
Time: 2:00-3:00 p.m. EDT
Please dial in 15 minutes before the start of the call to allow time to connect.
Please click the link below to join the town hall: https://fda.zoomgov.com/j/1616274024?pwd=Qjh5OXdIWEFRM1hKZlREWlVtYVpFZz09
Passcode: qGmC$5
Please note: Participants who join the town hall using the Zoom link above should use computer audio (listen through computer speakers and speak through computer microphone/headset).
The dial-in information provided below is for participants who will be joining the town hall by phone only.
- U.S. Callers Dial: 1-833-568-8864 (Toll Free)
- For higher quality, dial a number based on your current location):
- +1 669 254 5252 US (San Jose)
- +1 646 828 7666 US (New York)
- +1 646 964 1167 US (US Spanish Line)
- +1 415 449 4000 US (US Spanish Line)
- +1 551 285 1373 US (New Jersey)
- +1 669 216 1590 US (San Jose)
- International Callers Dial: Please check the international numbers available
- Webinar ID: 161 627 4024
- Passcode: 632474
Materials
After the town hall, the presentation, printable slides and transcript will be 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.