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Medical Device Sterilization Workshop 2024

America/Chicago
Tollestrup Auditorium

Tollestrup Auditorium

Thomas Kroc (FNAL), William Pellico
Description

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
Participants
  • Abbas Nasreddine
  • Adam Tosti
  • Adriana Allen
  • Aftin Ross
  • Aja Thomas
  • Albert (Ted) May
  • Alexander Paczynski
  • Alpa Patel
  • Amanda Benedict
  • Andrew Bent
  • Andrew Brinkdopke
  • Andrew Glaser
  • Andy Diehl
  • Anthony Eisenhut
  • Anthony Piotrkowski
  • anthony piotrkowski
  • Ashley Miller
  • Babita Mahajan
  • Ben Freemire
  • Bert Whitt
  • Beverly Whitaker
  • Bill Brodbeck
  • Brandon Shurdhi
  • Brian Davis
  • Brian Lindsay
  • Briana Potocnik
  • Carter Olson
  • Chris Schuttert
  • Christiane Beerlage
  • Christine Laube
  • Christopher Dugard
  • Christopher Merton
  • Chuntao Cao
  • Cierra Spriggs
  • Claire Briglia
  • Clarence Murray III
  • CLARISSA ZEHRUNG
  • Colin Wang
  • Daan Hoek
  • Damien Prieels
  • Dan Floyd
  • Dana Pomroy
  • Dane Popovski
  • Daniel Badali
  • Daniel Wojtczak
  • Davi Waltz
  • David Dominguez
  • David Opie
  • David Tran
  • Debra Cotton
  • Deepak Namdev
  • Deepak Patil
  • Diane Faivre-Swiat
  • Diane Smith
  • Douglas Bondar
  • Egmont Semmler
  • Elizabeth Claverie
  • Emma Garcia
  • Erika Skluzacek
  • Erin Huber
  • Fanny Poulon
  • FERNANDO LUNA
  • Frederic Dessy
  • George Andrews
  • Gerardo Segovia
  • Grace Bolton
  • GREGORY OBRIEN
  • Günther Burgstaller
  • Hugo Samayoa
  • Ionela Butuc Andreescu
  • Jade Schiesser
  • James Hathcock
  • James Vesper
  • James Whitcomb
  • Jami McLaren
  • Jamie Holdren
  • Jason Lowe
  • Jatin Patel
  • Jayakar Thangaraj
  • Jeffrey Peltier
  • Jennie Davis
  • Jennifer Berg
  • Jennifer Ryan
  • Jennifer Zimmerman
  • Jeremy Brison
  • Jessica Rue
  • Johannetsy Avillan
  • John Fraser
  • John Schlecht
  • John Stansberry
  • Jon Jansson
  • Jon Lee
  • Jonathan Cruz
  • Jose Gonzalez
  • Joseph Connaghan
  • Joseph Marano
  • Josh Earp
  • Juha Mattila
  • Kate McFalls
  • Kathryn Lyons
  • Kelly Foley
  • Kelsey Golk
  • Kevin Donahue
  • Kevin Tschabrun
  • khalid fatouaki
  • Kim Patton
  • Krista Schulte
  • Kumbirai Dhliwayo
  • Kyrstan Polaski-Hancock
  • Leah MacKrell
  • Leo Fifield
  • Leslie Toews
  • Liliane Phan
  • Linda Ly
  • Lionel PINEAU
  • Lisa Simone
  • Liv Arnold
  • Liz Krewson
  • Lorrainne Rivera
  • lucia polakova
  • Lucia Polakova
  • Lydia Dupont
  • Mabel Herrera
  • Macario Moreno
  • Magdalena Pierzchala
  • Mara Senescu
  • Marcelo Trevino
  • Marcos Ruelas
  • Maria Ruiz
  • Mark Bogs
  • Mark Murphy
  • Mark Pasmore
  • Martell Winters
  • Matthew Brochin
  • Mauricio Martinez
  • Mauricio Suarez
  • Megan Frost
  • Meghan Gelerman
  • Michael Jaeschke
  • Michael Sadowski
  • Michelle Bock
  • Mike Neilson
  • Mike Rust
  • Miriam Burke
  • Mohit Gupta
  • Molly Swanson
  • Morgan Beaver
  • Muzammil Ahmed
  • Nameera Wegner
  • Nate Bridgewater
  • Nicholas Brydon
  • Nicholas Brydon
  • Nicolas Ludwig
  • Nissa Rieck
  • Oana Walls
  • Pablo Esquinas
  • Pablo Jimenez Ceciliano
  • Paul Baumgartner
  • Paulo Laranjeira
  • Peter Baker
  • Peter Noverini
  • Peter Rubino
  • Rachel Miller
  • Rachel Montoya
  • Rafael Rodriguez
  • Rebecca Ward
  • Robert Ihlefeldt
  • Rose LaRue-Slater
  • ruchi pandey
  • Ryan Ortega
  • Sarah Campagna
  • Sarah Herold
  • Scott Steffen
  • Shari Formica
  • sharon lunney
  • Shaun Devitt
  • Silvia Cervero
  • Simon Gonzales
  • Sopheak Srun
  • Stephen Anisko
  • Steven Nichols
  • Summer Boland
  • Susan Mickens
  • Thijs Kea
  • THOMAS BUNCH
  • Thomas Kroc
  • VARTIKA AGARWAL
  • Vazir Avdoiani
  • Victor Lopez
  • Vu Lekate
  • Wendy Wangsgard
  • William Andersen
  • Wong Teck Min
  • Xiufeng Jia
  • Yaira Noemi Rivera Jaime
  • Yinfei Cheong
  • Ying Zhang
  • Zabrina Tumaitis-Namba
  • Zachary Dukerich
  • Zhixue Zhu
  • 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.

      Speaker: Thomas Kroc (Fermilab)
    • 3
      Keynote -

      Aftin Ross, PhD
      Deputy Director - Office of Readiness and Response, Office of Strategic Partnerships & Technology Innovation, CDRH

      Speaker: Aftin Ross (Deputy Director - Office of Readiness and Response, Office of Strategic Partnerships & Technology Innovation, CDRH)
    • 4
      Update from the TUV-SUD Scientific Echange
      Speakers: Jan Havel (TÜV-SÜD), Mark Pasmore (Baxter), Martell Winters (Nelson Labs), Vu Lekate (Abbott Vascular)
    • 10:00
      Coffee Break - 20 minutes
    • 5
      TIR 17 Update
      Speaker: Jami McClaren (Boston Scientific)
    • 6
      Alternative Gasses Panel

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

      Speakers: Andrew Brinkdopke (Pureline), David Opie (Noxilizer), Juha Mattila (Steris AST), Tony Eisenhut (NovaSterilis)
    • 7
      UVC Techical Presentation
      Speakers: Fanny Poulon (Germitec), Lionel Pineau (Eurofins-Biotech-Germande)
    • 8
      Morning Wrap-up & Close of Virtual Session
    • 12:10
      Lunch Break - 70 Minutes 327 Building

      327 Building

    • .: Hybrid

      Hybrid Session

    • 9
      Alternative SAL
      Speaker: Martell Winters (Nelson Labs)
    • 10
      What Does Max Dose Mean?
      Speaker: John Williams (Medtronic)
    • 11
      Parametric Release Panel
      Speakers: Juha Mattila (Steris AST), Mike Sadowski (Baxter), Nicholas Brydon (NextBeam)
    • 15:00
      Coffee Break - 30 minutes
    • 12
      Tem Nablo Update
      Speaker: Leo Fifield (PNNL)
    • 13
      Dose Audits with Alternative Modalities
      Speaker: Zubrina Tumaitis (Sterigenics)
    • 14
      Close of Day 1
    • 15
      No-host Social - Two-Brothers Roundhouse Two Brothers

      Two Brothers

  • Wednesday, 25 September
    • .: Hybrid Session
    • 16
      Welcome - Day 1 recap
    • 17
      International Panel
    • 18
      FDA Agency Update
    • 10:25
      Coffee Break - 20 Minutes
    • 19
      Standards Development
    • 20
      UVC Regulatory Perspectives
    • 21
      Morning Wrap-up & Close of Virtual Session
    • 12:00
      Lunch Break - 60 Minutes 327 Building

      327 Building

    • .: 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