Join us and your peers to continue the dialog on medical device sterilization science and take a deeper dive to understand how to utilize new radiation modalities.
Overview: On September 22, 23, and 24, 2021 the Organizing Committee of the Medical Device Sterilization Workshop will host a virtual workshop for stakeholders exploring sterilization alternatives using accelerator-based radiation.
Over three half-days, the workshop will build on the work presented in the past two years (summaries in links below) and work towards fostering collaboration and partnership under the common goal of patient safety:
- Updates on previous topics such as the performance of polymers tested in all three radiation modalities.
- How modeling and simulation can help you better utilize radiation on your products.
- Interactions with the FDA to help you overcome the Regulatory Apprehension that many experience in contemplating unfamiliar technologies.
- There will be multiple Q&A opportunities and breakout sessions to provide interaction and to allow you to present your experiences and confront your uncertainties.
Keynote presentation – Joyce Hansen (J&J)
- RayXpert representative
- PNNL/Team Nablo
- Kevin O’Hara, Sterigenics
- Ileana Pazos, NIST
- Steris AST
- Larry Nichols, Steri-Tek
- Peter Laurence, Nutek Bravo
- Jodi Lieberman, Sandia
- Emily Craven, Boston Scientific
- Suzanne Schwartz, FDA
- Angela Krueger, FDA
- Clarence Murray III, FDA
- John Williams, Medtronic
- Debbie Cotton (Baxter)
- Thomas Kroc (Fermilab)
- Vu Le (Abbott)
- Mark Pasmore (Baxter)
- John Williams (Medtronic)
Who should attend: Recent events in the medical device sterilization community reinforce that patient safety, in particular sterility assurance, is not specific to any particular company, vendor, or institution. This forum seeks to bring together voices from across these various organizations to define and build the future of this industry, for the benefit of the patients we serve. Participants from technical, business, and regulatory functions from the following organization types will benefit from workshop participation:
- Medical device manufacturers
- Accelerator manufacturers
- Contract sterilization vendors
- Medical device regulators
- Medical device regulatory
- Medical device and sterilization laboratories
Attendees should expect to:
- Examine the current science of radiation sterilization techniques (X-ray, gamma, and E-beam)
- Maintain connection with developments in the use of alternative technologies for medical device sterilization
- Influence discussion on the direction of medical device sterilization and potential collaboration opportunities and mechanisms to help realize that future
- Interact with staff of the FDA to better understand how to work with the FDA for approvals for new and existing products
Event agenda and materials:
- Current event agenda for September 22, 23 and 24
- Summary report from the 2019 Midwest Medical Device Sterilization Workshop
- Summary report from the 2020 Medical Device Sterilization Workshop
- Report: Accelerator-driven Medical Sterilization to Replace Co-60 Sources
For further information, contact Thomas Kroc, Technology Application Physicist at IARC. Additional information on Fermilab’s medical device sterilization project work can be found here.
Official Workshop Site
Access to the official site for the virtual workshop