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Sep 4 – 5, 2024
Tollestrup Auditorium
America/Chicago timezone

Overview: On September 4 and 5, 2024 the Organizing Committee of the Medical Device Sterilization Workshop will host a hybrid workshop for stakeholders exploring sterilization alternatives using accelerator-based radiation. 

The in-person workshop will take place at Tollestrop Auditorium on the Fermilab Campus in Batavia, Illinois.

Hybrid sessions will take place:

  • 8:00 am CDT to 12:30 pm (& possibly afternoon)- Wednesday, September 4
  • 8:30 am CDT to 12:00 pm - Thursday, September 5

Afternoon discussion sessions will be in-person only.

On Wednesday, September 4, there will be a no-host social event at Two-Brothers Roundhouse in Aurora (20 minutes away).

REGISTRATION DEADLINE: August 21, 2024 in-person, August 30, 2024 virtual

Virtual registration is free. Just ignore the registration and lunch fees.

Selecting lunch is highly recommended for in-person. There are no convenient off-site options. (registration and lunch are separate for administrative reasons.)

Important Registration Information:

  • Point of Contact – Thomas Kroc
  • Affiliation – Medical Device Sterilization Workshop 2024
  • Are you affiliated with an institution - say "Yes"
  • Home Institution Search -
    • other - then add your place of employment
  • Anyone traveling from outside of the US should ensure their passport or visa is marked as business travel.

Morning sessions will be streamed. This year, the FDA is ramping up its participation, going beyond last year’s mock-presub to discuss next steps. An international panel of regulators will look at differences in the regulatory processes in various countries and potential ways to harmonize them.

Invited Speakers

Keynote presentation – Jeffrey Shuren, FDA (invited)

  • Alternative Gasses
  • Alternative SAL
  • What does Max Dose Mean
  • Parametric Release
  • Dose Audits
  • Extensive conversations with FDA

Organizing Committee

  • Liz Claverie (Consultant, retired FDA head of Infection Control and Prevention)
  • Debbie Cotton (Retired)
  • Thomas Kroc (Fermilab, Emeritus)
  • Vu Le (Abbott)
  • Mark Pasmore (Baxter)
  • Mara Senescu (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
Starts
Ends
America/Chicago
Tollestrup Auditorium