Medical Device Sterilization Workshop 2024

24 Sep 2024, 00:00 → 25 Sep 2024, 18:00 America/Chicago

Tollestrup Auditorium

Thomas Kroc (FNAL), William Pellico

Overview: On September 24 and 25, 2024 the Organizing Committee of the Medical Device Sterilization Workshop will host a hybrid workshop for stakeholders exploring sterilization alternatives using accelerator-based radiation. 

!! Please Note the change of dates !!

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 4:30 pm- Tuesday, September 24
• 8:30 am CDT to 2:30 pm - Wednesday, September 25

All presentation and discussion sessions will be hybrid.

On Tuesday, September 24, there will be a no-host social event at Two-Brothers Roundhouse in Aurora (20 minutes away).

REGISTRATION DEADLINE: September 10, 2024 in-person, September 17, 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 – 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

Tuesday, 24 September

.: Hybrid

Hybrid Session

.: Safety/Logistics

1 Welcome - FNAL

2 Fermilab 101

A short description of what Fermilab is, its history, and its accomplishments.

3 Keynote -

4 Update from the TUV-SUD Scientific Echange

10:00 Coffee Break - 20 minutes

5 TIR 17 Update

6 Alternative Gasses Panel

Chlorine Dioxide, Nitrogen Dioxide, Supercritical CO2, Vaporized Hydrogen Peroxide

7 UVC Techical Presentation

8 Morning Wrap-up & Close of Virtual Session

12:10 Lunch Break - 70 Minutes

.: Hybrid

Hybrid Session

9 Alternative SAL

10 What Does Max Dose Mean?

11 Parametric Release Panel

15:00 Coffee Break - 30 minutes

12 Tem Nablo Update

13 Dose Audits with Alternative Modalities

14 Close of Day 1

15 No-host Social - Two-Brothers Roundhouse

Wednesday, 25 September

.: Hybrid Session

16 Welcome - Day 1 recap

17 International Panel

18 FDA Agency Update

10:15 Coffee Break - 20 Minutes

19 Standards Development

20 UVC Regulatory Perspectives

21 Morning Wrap-up & Close of Virtual Session

12:05 Lunch Break - 60 Minutes

.: Hybrid Session

22 Regulatory Affairs Panel

23 Discussion - Collaborating w/ Kilmer/AAMI/PDA

24 Discussion - FDA - Panel

15:00 Coffee Break - 20 Minutes

25 Tours

26 Close of Workshop