Medical Device Sterilization: Understanding the Possibilities

22 Sep 2021, 09:00 → 24 Sep 2021, 16:00 US/Central

Thomas Kroc (FNAL)

Join us and your peers to continue the dialog on medical device sterilization science and take a deeper dive to understand how to utilize new radiation modalities.

Overview: On September 22, 23, and 24, 2021 the Organizing Committee of the Medical Device Sterilization Workshop will host a virtual workshop for stakeholders exploring sterilization alternatives using accelerator-based radiation. The workshops will run from 9:00 am CDT to 1:00 pm Wednesday and Thursday; 9:00 am CDT to noon on Friday.

REGISTRATION IS NOW CLOSED:  No late registrations will be accepted.

Over three half-days, the workshop will build on the work presented in the past two years (summaries in links below) and work towards fostering collaboration and partnership under the common goal of patient safety:

• Updates on previous topics such as the performance of polymers tested in all three radiation modalities.
• How modeling and simulation can help you better utilize radiation on your products.
• Interactions with the FDA to help you overcome the Regulatory Apprehension that many experience in contemplating unfamiliar technologies.
• There will be multiple Q&A opportunities and breakout sessions to provide interaction and to allow you to present your experiences and confront your uncertainties.

Connection information will be e-mailed to registrants 24 hours prior to the event.

Invited Speakers

Keynote presentation – Joyce Hansen (J&J)

• RayXpert representative
• PNNL/Team Nablo
• Kevin O’Hara, Sterigenics
• Ileana Pazos, NIST
• Betty Howard, Steris AST
• Peter Laurence, Nutek Bravo
• Emily Craven, Boston Scientific
• Aftin Ross, FDA
• Ryan Ortega, FDA
• Clarence Murray III, FDA
• John Williams, Medtronic

 

Organizing Committee

• Debbie Cotton (Baxter)
• Thomas Kroc (Fermilab)
• Vu Le (Abbott)
• 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
• Interact with staff of the FDA to better understand how to work with the FDA for approvals for new and existing products

 

The Summary Reports from previous workshops can be found at the bottom of the Announcement/Registration link below.

2017 2017 White Paper.pdf

2019 Midwest Medical Device Sterilization 2019 Workshop Summary Report.pdf

2020 Workshop

• 1 Workshop Introduction - Pasmore (1).mp4
• 2 Physics of Sterilization - Kroc (1).mp4
• 3 Material Performance - Murphy (1).mp4
• 4 Available Guidance - Williams (1).mp4
• 5 Panel on Industry Interest - Panel (1).mp4
• Midwest Medical Device Sterilization 2020 Workshop Summary Report.pdf

2021 Biographies

• Aaron Neighbour.pdf
• Aftin Ross.pdf
• Beau Rollins.pdf
• Betty Howard.pdf
• Byron Lambert.pdf
• Christiane Beerlage.pdf
• Clarence W. Murray III.pdf
• Emily Craven.pdf
• Gunther Burgstaller.pdf
• Ileana Pazos.pdf
• James Hathcock.pdf
• Joern Meissner.pdf
• John Williams.pdf
• Joyce Hansen.pdf
• Kevin O'Hara.pdf
• Ludovic Eychenne.pdf
• Mark Murphy.pdf
• Peter Baker.pdf
• Peter Laurence.pdf
• Randy Schwarz.pdf
• Ryan Ortega.pdf

2021 Presentations

• 210922Craven.mp4
• 210922EychenneGhilardi_rev211018_cmp.mp4
• 210922Ohara_rev211018_cmp.mp4
• 210922Pazos_rev211018_cmp.mp4
• 210922SchwarzMurphy_rev211018_cmp.mp4
• 210923Beerlage_cmp.mp4
• 210923Howard_rev211019_cmp.mp4
• 210923LaurenceNeighbour_cmp.mp4
• 210924Burgstaller_rev211018_cmp.mp4
• 210924Hansen_rev211019_cmp.mp4
• 210924MurrayOrtegaRoss_cmp (1).mp4

2021 Slide Decks

• BettyHoward Fermi Industrial Status of X-ray Final.pdf
• Christiane Beerlage_Zimmer Biomet.pdf
• EmilyCravenStandards.pdf
• EychenneGhilardiXray irradiation process simulation with RayXpert.pdf
• FDA__FermilabPresentation_Sept2021.pdf
• GuentherBurgstaller_Medical Device Sterilization Fermilab 2021.pdf
• IleanaPazos-MedicalDeviceSter_2021.pdf
• JamesHathcock Xray Discussion Capacity.pdf
• KevinOHara The Current State of the Mathematical Model (KOH) Final Sept 2021.pdf
• Nutek Bravo E-beam Seminar v1.1.pdf
• SchwarzMurphyPNNL.pdf

2021 Workshop

• 2021 Workshop Summary Report
• Final Agenda - Medical Device Sterilization Workshop 2021.pdf
• For Presenters - Video-audio-release-form-FRA.pdf

Wednesday, 22 September

09:00 → 09:15 Welcome

Opening Introductions

Conveners: Mark Pasmore (BAxter), Rick Verhaagen (Department of Energy), Timothy Meyer (Fermilab)

09:15 → 10:00 Keynote: Medical Device Sterilization of the Future

Convener: Joyce Hansen (J&J)

10:00 → 10:30 Modeling 1: User Friendly Fast Interface for Calculating Dose Distribution in Polymer Products

Application to estimate DUR, participation in panel discussion on modeling and simulation

Conveners: Mark Murphy ( PNNL), Randy Schwarz (PNNL)

10:30 → 11:00 Modeling 2: Introduction to RayXpert

X-ray radiation processing simulation with RayXpert

Conveners: Antoine Ghilardi (RayXpert), Ludovic Echyenne (RayXpert)

11:00 → 11:10 BREAK: 10 minutes

11:10 → 11:40 Modeling 3: The Current State of the Mathematical Model in Radiation Processing

Convener: Kevin O'Hara (Sterigenics)

11:40 → 12:10 NIST: Upgrades and Partnerships Enhancing High-Dose Radiation Calibration at NIST

Description of NIST services w.r.t. calibration and medical device sterilization, participation in panel discussion on modeling and simulation)

Convener: Ileana Pazos (NIST)

12:10 → 12:55 Panel Discussion: Needs

Who makes the equipment Industry modeling needs, expectations, inputs/outputs, qualifications.

Conveners: Antoine Ghilardi (RayXpert), Ileana Pazos (NIST), Kevin O'Hara (Sterigenics), Mark Murphy ( PNNL)

12:55 → 13:00 Day 1: Recap and Closing

Thursday, 23 September

09:00 → 09:10 Welcome: Recap Day 1/ Agenda Day 2

Recap Day 1 - Intro for Day 2

Convener: Mr John Williams (Medtronic)

09:10 → 09:40 Converting Modalities: Product Transfer to Alternative Sterilization Methods: Gamma to X-ray

Case Study on successful transition from gamma to x-ray.

Convener: Christiane Beerlage (Zimmer Biomet)

09:40 → 10:10 eBeam: A Global View to eBeam Sterilization

e-beam services w.r.t. capacity/expansion.

Conveners: Aaron Neighbour (Nutek Bravo), Peter Laurence (Nutek Bravo)

10:10 → 10:40 X-Ray: Future of X-ray Services

Future of Steris’ x-ray services w.r.t. capacity/expansion

Convener: Betty Howard (Steris)

10:40 → 10:55 BREAK: 15 minutes

20 minutes

10:55 → 11:10 Live: Survey

11:10 → 12:10 Break-out Sessions: 1. Modeling and Tools 2. Conversion and Capacity

1. Modeling and Tools
2. Conversion and Capacity

Conveners: Beau Rollins (Convatec), James Hathcock (Pall, BPSA), Joern Meissner, Mr John Williams (Medtronic), Mr Mark Pasmore (Baxter), Peter Baker, Thomas Kroc (FNAL), Vu Le (Abbott)

12:10 → 12:25 Panel Report Out

12:25 → 12:30 Recap and Closing

Friday, 24 September

09:00 → 09:05 Welcome: Recap Day 2/ Agenda Day 3

Convener: Ms Debbie Cotton (Baxter)

09:05 → 09:35 Standards Update: How standards are accelerating the adoption of machine source radiation sterilization

Update on standards and other guidance for the industry

Convener: Emily Craven (Boston Scientific)

09:35 → 10:05 Regulatory Aspects: Update on standards and other guidance for the industry

Update on standards and other guidance for the industry

Convener: Guenther Burgstaller (TUV)

10:05 → 10:35 Regulatory Aspects - Progressing Sterilization: Regulatory considerations and opportunities for collaboration in device sterilization

Conveners: Aftin Ross (FDA), Clarence Murray, III (FDA), Ryan Ortega (FDA)

10:35 → 10:50 BREAK: 15 minutes

10:50 → 12:05 Panel Discussion: Radiation - Collaboration: Where are we headed as an industry?

Conveners: Aftin Ross (FDA), Betty Howard (Steris), Byron Lambert (Abbott), Clarence Murray, III (FDA), Emily Craven (Boston Scientific), Guenther Burgstaller (TUV), James Hathcock (Pall, BPSA), Mr John Williams (Medtronic), Joyce Hansen (J&J), Ryan Ortega (FDA)

12:05 → 12:15 Closing

Convener: Dr Thomas Kroc (FNAL)