Medical Device Sterilization: Understanding the Possibilities

US/Central
Thomas Kroc (FNAL)
Description

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
2019
Participants
  • Aaron Neighbour
  • Aaron Sauers
  • Aaron Tabor
  • Abbas NASREDDINE
  • Adam Griese
  • ADAM WHAITES
  • Adrien Butaud
  • Aftin Ross
  • Aghvan Aydinyan
  • Ajaypreet Sohal
  • Alandrea Cox
  • Alberto Paret
  • Alexandra Stuetzer
  • Amira Zaouak
  • Amit Bhatt
  • AMITKUMAR SUTHAR
  • Andre Adamski
  • Andrew Dierker
  • Andrew Williams
  • Andy D'Esposito
  • Andy Diehl
  • Angela Anandappa
  • Anna Maria Bertasa
  • Anne Charles
  • Annett Heilmann
  • ANTOINE GHILARDI
  • Arianna Kalkandis
  • Art Kurz
  • Artur Podwysocki
  • Barbara Schmitz
  • Barry Sanders
  • Beau Rollins
  • Belkacem Otazaghine
  • Berny Rodriguez
  • Betty Howard
  • Bill Biebesheimer
  • Bill Facemire
  • Bob Stringham
  • Bobbijo Redler
  • Brian Horowski
  • Brian Roche
  • Brooke Small
  • Byron Lambert
  • Cameron Monroe
  • CD Feng
  • Cecily Rivera
  • Chad Kratochwill
  • Charles Golub
  • Cherri Schmidt
  • Chip Starns
  • Chris Boblett
  • Christian Quinto
  • Christiane Beerlage
  • Christina Bernstein
  • Christine Gonzales
  • Christine Sheehy
  • Ciara macsweeney
  • Cindy Chowdhury
  • CLARENCE MURRAY III
  • Cody Wilson
  • Connie Jones
  • Connor Watters
  • Courtney Corsette
  • Curtis Jansen
  • Damien Prieels
  • Daniel Amraen
  • Daniel Badali
  • Daniel Moores
  • Daniel Remmers
  • Daniel Wojtczak
  • Danny Hutson
  • Davi Figueiredo Waltz
  • David Moore
  • David Oakley
  • David Rechberger
  • David Sadler
  • David Schwass
  • David Shim
  • David Tran
  • David Ullmar
  • Debbie Cotton
  • Debby Blaschke
  • Debora Thomas
  • Deborah Havlik
  • Deepak Patil
  • Denise Cleghorn
  • Diana Smith
  • Eddie Hairr
  • Edmund Orr
  • Elan Lopezcuba
  • Elisabeth Vachette
  • Emily Craven
  • Emily Waller
  • Eric Beers
  • Eric Burgett
  • Eric Purviance
  • Fabiano Andreazza
  • FERNANDO LUNA
  • Florent kuntz
  • Frank Flores
  • Frank Yanocha
  • Fransua Muniz
  • Frederic Dessy
  • Gabrielle Wilson
  • Gamal Akabani
  • Gilbert Leung
  • Giuseppe Lantieri
  • Glenn Calvert
  • Günther Burgstaller
  • Haikel Jelassi
  • Hanna Lewandowska
  • Hanzel Lawas
  • Harry Lam
  • Heather Shaffer
  • Helena Wilson
  • Henry Bernard
  • Hernan Parma
  • Ileana Pazos
  • Irina Molochko
  • Irvin Santana
  • J Papp
  • Jackie Somadelis
  • Jade Schiesser
  • Jake Gibbons
  • Jake Gibbons
  • James Fritz
  • James Hathcock
  • James McCoy
  • James Power
  • James Stormont
  • Jami McLaren
  • jan gates
  • Jane Pretkelis
  • Janmeet Anant
  • Jason Hudachek
  • Jason Lubs
  • Jayshree Patel
  • Jeff Sauter
  • Jeffrey Peltier
  • Jeremy Brison
  • Jessica Garigen
  • Jessica Harvey
  • Jessica Rue
  • Jiayi Li
  • Jim Scheid
  • Joanne Skraboly
  • Jocelyn Thornton
  • Jodi Lieberman
  • Joern Meissner
  • John Chen
  • john keyashian
  • John McKenzie
  • John Williams
  • Jon Bergstrom
  • Jonathan Bull
  • Jonathan Spalding
  • Josef Mittendorfer
  • Joseph Wolinski
  • Joyce Hansen
  • Juan Prieto
  • Jun Boneschansker
  • Kanchan P Adhikari
  • Kate Davenport
  • Katelyn Hendricks
  • Katherine McFalls
  • Kathryn Lyons
  • Kathy Lane
  • Katie Schindler
  • Ken Duda
  • Kevin O'Hara
  • Kevin Ott
  • Kimberly Patton
  • Krista Schulte
  • Kristin Benokraitis
  • Lance Garrison
  • Laura Rogas
  • Leigh Taylor
  • Leo Fifield
  • Liliane Phan
  • Lily Jeng
  • Linh Lollis
  • LISE TAN-SIEN-HEE
  • Lorenzo Pedrazzini
  • Lou Tateo
  • lucia polakova
  • Ludovic Eychenne
  • Macario Moreno Matias
  • MAIRA MORA
  • Mandeep Pathania
  • Manon Puister
  • Mara Senescu
  • Maria Bollensen
  • MARIA GARMENDIA-HARO
  • Mark Bogs
  • Mark Murphy
  • Mark Pasmore
  • Mark Simpson
  • Marlo Cinco
  • Martin Comben
  • Mary Marcus
  • María Nazarena Ciávaro
  • Matthew Brochin
  • Matthew Keskula
  • Matthew McCoy
  • Maureen Wanjare
  • Mauricio Suarez
  • Max Blomberg
  • Mayra Hernandez
  • Merk Perreault
  • Mesfin Mengesha
  • Michael Itamura
  • Michael Tucker
  • Michal Daněk
  • Michela Ruinelli
  • Miguel Morales de Castro
  • Mike Flanagan
  • Mike Quesenberry
  • Mike Sadowski
  • Molly Swanson
  • Monika Zuzova
  • MUKTA ACHARYA
  • Nathan Wakefield
  • Nicholas Shoop
  • Nick Troise
  • Nicole Hunter
  • Noel Long
  • Norma Gallardo Hymes
  • Ofir Seletzky
  • Palash Das
  • Patric Klotzbuecher
  • Patrick EVRARD
  • Paul Boentges
  • Paul Lynch
  • Paul Wynne
  • Peter Baker
  • Peter Laurence
  • Peter Noverini
  • Peter Robben
  • Phia Lee
  • Philippe Dethier
  • Rafael Rodriguez
  • Ramiro Gomez
  • Randolph Schwarz
  • René Rangel
  • Reshma Manukonda
  • Revanth Soma
  • Richard Verhaagen
  • Rishabh Jain
  • Robert Diller
  • Robert Sanchez
  • Roger Hendrick
  • Ryan Ortega
  • S Wang
  • Samuel Dorey
  • Sara Gleco
  • Sarah Herold
  • Sarah Norris
  • scott hall
  • Sebestyen Nagy
  • Seth Gustine
  • Sethu Madhavi Dusanapudi
  • Shahab Din
  • Shannon Bellak
  • Shaun Devitt
  • Shaun McGinley
  • Shelly (Michelle) Luebke
  • Shyam Kadakia
  • Slavko Janošo
  • Sonia Schwantes
  • Sopheak Srun
  • Sophie ROUIF
  • Stacy Bohl Wiehle
  • Stephane Cornelis
  • Stephany Unruh
  • Stephen Mele
  • Stephen Sugden
  • Steve Korbly
  • Steve Worley
  • Sudheer Kancherla
  • Susan Mathison
  • Suzanne Butler
  • Sweden Yocom
  • Sławomir Kadłubowski
  • Tai Phan
  • Tate Vangsgard
  • Thomas Bunch
  • Thomas Chen
  • Thomas Kroc
  • Timo Neuamann
  • Timothy Kruger
  • Timothy Meyer
  • Todd Gabele
  • Tom Nguyen
  • Travis Anderton
  • Travis Ward
  • Trisha Pankratz
  • Valeriia Starovoitova
  • Vanessa Hall
  • Vanessa Vargas
  • Vartika Agarwal
  • vu le
  • Wesley Lantz
  • whitney begner
  • William Jeschke
  • Xiao He
  • Yueyang Shen
  • Yvena Pouilh
  • Yves HENON
Event Organizer: Tom Kroc
    • 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
    • 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
    • 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)