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Sep 20 – 21, 2023
Tollestrup Auditorium
America/Chicago timezone

Overview: On September 20 and 21, 2023 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 - Wednesday, September 20
  • 8:00 am CDT to 12:15 pm - Thursday, September 21

Afternoon discussion sessions will be in-person only.

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

REGISTRATION DEADLINE: September 8, 2023 in-person, September 13, 2023 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 2023
  • 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 – Nicholas Butler (NNSA)

  • Ryan Ortega, FDA
  • Emily Craven, Boston Scientific
  • Samuel Dorey, Sartorious
  • Vu Lekate, Abbott
  • Kim Patton, MedAccred
  • Martell Winters, Nelson Labs
  • John Williams, Medtronic
  • Mark Pasmore, Baxter
  • Mara Senescu, Baxter

Organizing Committee

  • Debbie Cotton (Retired)
  • Thomas Kroc (Fermilab)
  • 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