Medical Device Sterilization 2022: From Possibilities to Practice

21 Sep 2022, 08:30 → 23 Sep 2022, 11:45 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 21, 22, and 23, 2022 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:

• 8:30 am CDT to 12:00 pm - Wednesday, September 21st
• 8:30 am CDT to 12:00 pm - Thursday, September 22nd 
• 8:30 am CDT to 11:45 pm - Friday, September 23rd 

REGISTRATION DEADLINE: September 7, 2022

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

• A mock Pre-submission interaction with the FDA

• Emerging modeling and simulation tools to help you better utilize radiation on your products.

• A panel discussion with members from the bio-processing industry illustrating how industry cooperation can smooth the regulatory process

• There will be multiple Q&A opportunities 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 – Aftin Ross (FDA), confirmed

• Ryan Ortega, FDA – leading the Mock Pre-submission, confirmed
• PNNL/Team Nablo
• Vu Le, Abbott
• James McCoy, BD
• Daniel Badali, Triple Ring Technologies
• TRAD

Organizing Committee

• Debbie Cotton (Retired)
• 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

Announcements

• 1st Announcement 2022 v3.pdf
• 2022 attendee thank you.pdf
• 2022 presenter thank you.pdf
• 2nd announcement 2022 v1.pdf
• 3rd Announcement 2022 v1.pdf
• 4th Announcement 2022 v1.pdf
• 5th Announcement 2022 v1.pdf
• agenda final 220914.pdf
• Medical Device Sterilization Workshop 2022 Summary Report Final.pdf
• webinar & survey info attendees.pdf
• webinar & survey info presenters panelists.pdf

Slide Decks

• Badali - Design for Sterilization - Harnessing the power of virtual dose mapping tools.pdf
• Bogs Sterilization Conversions.pdf
• Crawley A Practical Approach.pdf
• Eychenne Dorey Trad_IBA_Aerial_SSB.pdf
• Fifield Schwarz TeamNabloLatest 220929.pdf
• Hathcock Biotech Xray OneVoice.pdf
• mccoy tir 104.pdf
• Ortega Mock PreSub slide deck (final).pdf
• ross increasing understanding.pdf

Videos

• 220921_Bogs.mp4
• 220921_Hathcock-Panel.mp4
• 220921_McCoy.mp4
• 220921_Ross.mp4
• 220921_Welcome.mp4
• 220922_Crawley.mp4
• 220922_Mock_Presub.mp4
• 220922_Post_Mock_Presub.mp4
• 220922_Welcome.mp4
• 220923_Badali.mp4
• 220923_Closing.mp4
• 220923_Nablo.mp4
• 220923_Panel.mp4
• 220923_TRAD.mp4
• 220923_Welcome.mp4

Wednesday, 21 September

08:30 → 08:45 Welcome: Introductions

Conveners: Mark Pasmore (Baxter), Roger Snyder (DOE)

08:45 → 09:30 Keynote: Effective Communications with the FDA on Alternative Technologies for Medical Device Sterilization

Convener: Aftin Ross (FDA)

09:30 → 10:00 Presentation: TIR-104: A Case Study

Convener: James McCoy (Becton Dickinson & Company)

10:00 → 10:15 Break

10:15 → 10:45 Presentation: Sterilization Conversions

Convener: Mark Bogs (ICU Medical)

10:45 → 11:45 Panel: Driving a “One Voice” Bioprocess Approach to Qualify X-ray as an Equivalent Alternative to Gamma

Conveners: James Hathcock (Pall Biotech), Ken Wong (SanoFi), Matt Hammond (Amgen), Ping Wang (Janssen Pharmaceutical), Thomas Kroc (FNAL), Timo Neuman (Merck-Millipore)

11:45 → 12:00 Closing: End of Day Questions and Closing

Convener: Mark Pasmore (Baxter)

Thursday, 22 September

08:30 → 08:40 Welcome: Recap Day 1 / Agenda Day 2

Convener: Debbie Cotton

08:40 → 09:10 Presentation: A Practical Approach to Establishing a 2x Process for E-Beam Sterilization of Medical Devices

Convener: Eric Crawley (Abbott)

09:10 → 09:30 Break

09:30 → 10:25 Panel: Mock Pre-Submission with FDA

Conveners: Christopher Dugard (FDA), Clarence Murray (FDA), Kristen Bozzelli (Baxter), Mark Pasmore (Baxter), Patrick Anibaldi (Abbott), Ryan Ortega (FDA), Sreekanth Gutala (FDA), Stephen Anisko (FDA)

10:25 → 10:35 Break

10:35 → 11:30 Panel: Mock Pre-Sub Review and Regulators/Informed Bodies Interactions

Conveners: Christopher Dugard (FDA), Clarence Murray (FDA), Kristen Bozzelli (Baxter), Mark Pasmore (Baxter), Patrick Anibaldi (Abbott), Ryan Ortega (FDA), Sreekanth Gutala (FDA), Stephen Anisko (FDA)

11:30 → 12:00 Closing: End of day Questions and Closing

Convener: Debbie Cotton

Friday, 23 September

08:30 → 08:40 Welcome: Recap Day 2 / Agenda Day 3

Convener: Thomas Kroc (FNAL)

08:40 → 09:10 Presentation: Monte Carlo Simulation benefits to Healthcare Product Manufacturers in radiation processing

Conveners: Ludovic Eychenne (Trad), Samuel Dorey (Sartorius)

09:10 → 09:40 Presentation: Design for Sterilization: Harnessing the Power of Virtual Dose Mapping Tools

Convener: Daniel Badali (Triple Ring Technologies, Inc)

09:40 → 10:00 Break

10:00 → 10:30 Presentation: Team Nablo Latest Developments – Polymer Effects Testing and PUFFIn Software Package

Conveners: Leo Fifield (Pacific Northwest National Laboratory), Randy Schwarz (Pacific Northwest National Laboratory)

10:30 → 11:15 Panel: Building Irradiators - Where Do We Go?

Conveners: Chad Rhodes (Sterigenics), Cody Wilson (IBA Group), Eric Beers (Steris), Jason Canaway (Steris), John Williams (Medtronic), Larry Nichols (Steri-Tek), Vu Le (Abbott)

11:15 → 11:45 Closing: End of Day Questions and Closing

Convener: Thomas Kroc (FNAL)