Registration is now closed. Webinar connection information will be distributed 24 hours in advance of the event.
Overview: On September 17, 2020, the Organizing Committee of the Medical Device Sterilization Workshop will host a virtual meeting for stakeholders exploring accelerator-based sterilization alternatives.
The meeting will provide an update on developments in material characterization and guidance over the past year. We plan to offer three presentations:
- A reprise of the physics fundamentals of radiation sterilization. How to understand what is actually happening that results in sterilization.
- An update from Team Nablo*. They have been studying polymers, used in medical devices, in all three radiation modalities, gamma, e-beam, and x-ray.
- An update on various activities to provide the industry with additional guidance on how to meet the performance and regulatory requirements for using alternative modalities.
There will be multiple Q&A opportunities to provide as much interaction as possible.
- Debbie Cotton (Baxter)
- Thomas Kroc (Fermilab)
- 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
*This “Team Nablo” project, named in memory of Sam Nablo, known by many in the radiation processing industry, is operated by Pacific Northwest National Laboratories (PNNL). This industry collaboration involving PNNL and eight industry players. It explores material compatibility for radiation sterilization (gamma radiation, e-beam and X-ray).