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Medical Device Sterilization: Continuing the Conversation

US/Central
Debbie Cotton (Baxter) , John Williams (Medtronic) , Mark Pasmore (Baxter) , Thomas Kroc (FNAL)
Description

Registration is now closed. Webinar connection information will be distributed 24 hours in advance of the event.

 

Overview: On September 17, 2020, the Organizing Committee of the Medical Device Sterilization Workshop will host a virtual meeting for stakeholders exploring accelerator-based sterilization alternatives.

The meeting will provide an update on developments in material characterization and guidance over the past year. We plan to offer three presentations:

  • A reprise of the physics fundamentals of radiation sterilization. How to understand what is actually happening that results in sterilization.
  • An update from Team Nablo*. They have been studying polymers, used in medical devices, in all three radiation modalities, gamma, e-beam, and x-ray.
  • An update on various activities to provide the industry with additional guidance on how to meet the performance and regulatory requirements for using alternative modalities.

There will be multiple Q&A opportunities to provide as much interaction as possible.

 

Organizing Committee

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

 

 

*This “Team Nablo” project, named in memory of Sam Nablo, known by many in the radiation processing industry, is operated by Pacific Northwest National Laboratories (PNNL). This industry collaboration involving PNNL and eight industry players. It explores material compatibility for radiation sterilization (gamma radiation, e-beam and X-ray).

Participants
  • Aaron Sauers
  • AARON STARKEY
  • Abbas NASREDDINE
  • Adam Whaites
  • Alain Strasser
  • Alandrea Cox
  • Alison Bailey
  • Amit Bhatt
  • Anand Tahiliani
  • Andreas Ostrowicki
  • Andrew Dalesandro
  • Andrew Porteous
  • Aymeric Longin
  • Barry Sanders
  • Beau Rollins
  • Bob Stringham
  • Byron Lambert
  • Candice Nagel
  • Charles Cogdill
  • Charles Golub
  • Christophe Malice
  • Christopher Justi
  • Ciara Mac Sweeney
  • Cody Wilson
  • Daniel Wojtczak
  • Davi Waltz
  • Debbie Cotton
  • Deborah Havlik
  • Deepak Namdev
  • Deepak Patil
  • Denise Cleghorn
  • Dessy Frederic
  • Dupuy Nathalie
  • Emily Craven
  • Eric Beers
  • Eric Burgett
  • Eric Nakagawa
  • Eric Peryer
  • FERNANDO LUNA
  • Florent KUNTZ
  • Fransua N Muniz Valentin
  • Gustavo H Costa Varca
  • Harrison Mavric
  • Hilario Negron
  • Isabelle Arts
  • isabelle gay
  • james hathcock
  • James Ludlow
  • Jami McLaren
  • Jeff Sauter
  • Jeffrey Peltier
  • Jeremy Brison
  • Jodi Lieberman
  • John Williams
  • Jordan Fujioka
  • Josef Mittendorfer
  • Joseph Wolinski
  • Juan Prieto
  • Julie Hirata
  • Kanchan P Adhikari
  • Katie Campbell
  • Kelly Mr.
  • ken baker
  • Ken Paddock
  • Kevin Ott
  • Kyle Naumann
  • Kyrstan Polaski
  • Lance Garrison
  • Larry Nichols
  • Laura Wahlen
  • Leo Fifield
  • Lina Nguyen
  • Lodewika van der Merwe
  • lucia polakova
  • MACARIO Moreno
  • Manish Bagre
  • Mara Senescu
  • MARIA GARMENDIA-HARO
  • Maria Ruiz
  • Mariela Picado
  • Mark Murphy
  • Mark Simpson
  • Matthew Keskula
  • Mauricio Suarez
  • Michael Itamura
  • Michael Tucker
  • Michelle (Shelly) Luebke
  • Mike Geelhoed
  • Mike Rust
  • Mike Sadowski
  • MONICA CARDONA
  • Neville Niessen
  • Nick Troise
  • Nicole McLees
  • Nilanjal Misra
  • nina perier
  • Olivier Rosseler
  • Palash Das
  • Paul Wynne
  • Peter Laurence
  • Philippe Dethier
  • Rachel Pytel
  • Rafael Rodriguez
  • Rahul Singh
  • Ram Dhuley
  • Richard Wiens
  • Rishabh Jain
  • Rodney Parker
  • Ruan Souza
  • rupesh gawade
  • Samuel Dorey
  • Sandra Cushnan
  • Sarah Herold
  • Sean Lynch
  • Slavica Grdanovska
  • Stephanie Volk
  • Stephany Unruh
  • Stephen Liu
  • Susana Marina De Leon Rosario
  • Suzanne Butler
  • Thomas Bunch
  • Thomas Kroc
  • Tim Carlson
  • Timo Neumann
  • Valeriia Starovoitova
  • Vartika Agarwal
  • Vartika Agarwal
  • William Jeschke
  • Yenny Ocampo
  • Ying Zhang
  • Yves HENON
  • Zachary Deziel
Event Organizer: Tom Kroc
    • 9:40 AM 9:45 AM
      Meeting Opens 5m
    • 9:45 AM 10:00 AM
      Free-form Q&A 15m
    • 10:00 AM 10:10 AM
      Introduction and Welcome 10m

      Mark Pasmore, Baxter International

    • 10:10 AM 10:40 AM
      Physics of Radiation Sterilization - the Basics That You Need to Know to Consider Your Sterilization Options 30m

      Thomas Kroc, Fermilab

    • 10:40 AM 10:50 AM
      Q&A Session 10m
    • 10:50 AM 11:20 AM
      Update from Team Nablo - Measurements of Effects on Polymers for All Three Radiation Modalities 30m

      Mark Murphy, Pacific Northwest National Lab

    • 11:20 AM 11:30 AM
      Q&A Session 10m
    • 11:30 AM 11:50 AM
      Progress in Providing Guidance for the Industry - AAMI, ASTM, and Others 20m

      John Williams, Medtronic

    • 11:50 AM 12:00 PM
      Q&A Session 10m
    • 12:00 PM 12:30 PM
      Industry Interest in Alternative Radiation Technologies in Light of Current Events – Discussion of the Pre-Conference Survey 30m
    • 12:30 PM 12:35 PM
      Acknowledgements and Next Steps 5m
    • 12:35 PM 1:00 PM
      Free-form Q&A 25m