Midwest Medical Device Sterilization Workshop

Gain practical information and insights on the latest advances in irradiation for medical devices sterilization and how to apply these technologies

Share experiences and gain greater understanding of the barriers to adoption of alternative technologies

Shape a dialog to pave the way to safer, more secure, more economic device sterilization options

 

Workshop overview: On September 18 – 19, the Illinois Accelerator Research Center (IARC) at Fermi National Accelerator Laboratory will host a regional workshop for stakeholders exploring accelerator-based sterilization alternatives. Fermilab has been tapped as a key partner to the federal government and industry in advancing the feasibility of particle accelerator-driven sterilization approaches. This work builds on our 50-year history of building and innovating these technologies for industry applications.

The workshop will focus on the current state of medical device sterilization, educate participants on the fundamental principles, address what information is needed to ease regulatory approval, and how scientists and industry can work together toward a new industry standard. The schedule will alternate between presentations and moderated panel discussions in order to give all participants an opportunity to be involved in the discussion.

 

Confirmed Speakers and Panelists

Keynote presentation – Byron Lambert (Abbott)
“Gamma to e-beam/x-ray: fundamentals to practice”

 

  • Peter Baker (Quantum EBX)
  • Jeremy Brison (IBA)
  • Tim Carlson (BD Medical)
  • John Conrad (iBIO)
  • Debbie Cotton (Baxter)
  • Emily Craven (Mevex)
  • Arved Deecke (Benebion)
  • Lance Garrison (NNSA)
  • Betty Howard (Steris)
  • Ken Kohler (Steris)
  • Thomas Kroc (Fermilab)
  • Byron Lambert (Abbott)
  • John Logar (J&J)
  • Christophe Malice (IBA)
  • Josef Mittendorfer (High Tech Consulting)
  • Mark Murphy (Pacific Northwest National Laboratory)
  • Clarence Murray (FDA)
  • Larry Nichols (Steri-Tek)
  • John Schlecht (Sterigenics)

 

Organizing Committee

  • Mark Pasmore (Baxter)
  • Debbie Cotton (Baxter)
  • Thomas Kroc (Fermilab)
  • Cherri Schmidt (Fermilab)
  • John Williams (Medtronic)

 

Who should attend: Recent events in the medical device sterilization community reinforce that sterility assurance is not specific to any particular company or vendor. All stakeholders need to work together to define and build the future of this industry. 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

 

Attendees should expect to:

  • Understand and contribute to conversation on the key drivers for choosing and implementing a sterilization approach:
    • The science of radiation sterilization technologies (X-ray, gamma, & E-beam)
    • The economics of sterilization technologies
    • The potential paths and obstacles to registration of a sterilization method for medical device sterilization
  • Network within the community supporting the sterilization of medical devices including industry, research, and regulatory organizations
  • Connect with Fermilab technology experts and tour Lab facilities
  • Influence discussion on the direction of medical device sterilization and potential collaboration opportunities and mechanisms to help realize that future

 

Event agenda and program: The two-day workshop will include speakers, panel discussions, tours, and active participation opportunities centered on four thematic areas:

  • You are Here! – Current paradigms and drivers in medical device sterilization
  • The Right Tool for the Right Job – Considerations for choosing your sterilization method
  • Flipping the Switch – Moving from planning to implementation
  • Accelerating the Path Forward – Prioritizing needs, opportunities, and points for collaboration

 

For further information, contact Thomas Kroc, Technology Application Physicist at IARC. Additional information on Fermilab’s medical device sterilization project work can be found here.