Medical Device Sterilization: Continuing the Conversation

Thursday 17 Sep 2020, 09:25 → 13:00 US/Central

Debbie Cotton (Baxter), John Williams (Medtronic), Mark Pasmore (Baxter), Thomas Kroc (FNAL)

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.

 

Organizing Committee

• 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).

01 Introduction and Acknowledgements

01 VIDEO Introduction and Acknowledgements

02 Physics of Radiation Sterilization

02 VIDEO Physics of Radiation Sterilization

03 Industry-Wide Collaboration to Identify and Overcome Impediments to Transitioning to E-beam and X-ray for Medical Product Sterilization

03 VIDEO Industry-Wide Collaboration to Identify and Overcome Impediments to Transitioning to E-beam and X-ray for Medical Product Sterilization

04 Progress in Providing Guidance for the Industry - AAMI, ASTM, and Others

04 VIDEO Progress in Providing Guidance for the Industry - AAMI, ASTM, and Others

05 Industry Interest in Alternative Radiation Technologies in Light of Current Events – Discussion of the Pre-Conference Survey

05 VIDEO Industry Interest in Alternative Radiation Technologies in Light of Current Events – Discussion of the Pre-Conference Survey

2020 Workshop Report

09:40 → 09:45 Meeting Opens

09:45 → 10:00 Free-form Q&A

10:00 → 10:10 Introduction and Welcome

Mark Pasmore, Baxter International

10:10 → 10:40 Physics of Radiation Sterilization - the Basics That You Need to Know to Consider Your Sterilization Options

Thomas Kroc, Fermilab

10:40 → 10:50 Q&A Session

10:50 → 11:20 Update from Team Nablo - Measurements of Effects on Polymers for All Three Radiation Modalities

Mark Murphy, Pacific Northwest National Lab

11:20 → 11:30 Q&A Session

11:30 → 11:50 Progress in Providing Guidance for the Industry - AAMI, ASTM, and Others

John Williams, Medtronic

11:50 → 12:00 Q&A Session

12:00 → 12:30 Industry Interest in Alternative Radiation Technologies in Light of Current Events – Discussion of the Pre-Conference Survey

12:30 → 12:35 Acknowledgements and Next Steps

12:35 → 13:00 Free-form Q&A