Medical Device Sterilization Workshop 2023: Past, Present, and Future

20 Sep 2023, 00:00 → 21 Sep 2023, 23:59 America/Chicago

Tollestrup Auditorium

Thomas Kroc

Overview: On September 20 and 21, 2023 the Organizing Committee of the Medical Device Sterilization Workshop will host a hybrid workshop for stakeholders exploring sterilization alternatives using accelerator-based radiation. 

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 12:30 pm - Wednesday, September 20
• 8:00 am CDT to 12:15 pm - Thursday, September 21

Afternoon discussion sessions will be in-person only.

On Wednesday, September 20, there will be a no-host social event at Two-Brothers Roundhouse in Aurora (20 minutes away).

REGISTRATION DEADLINE: September 8, 2023 in-person, September 13, 2023 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 2023
• 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 – Nicholas Butler (NNSA)

• Ryan Ortega, FDA
• Emily Craven, Boston Scientific
• Samuel Dorey, Sartorious
• Vu Lekate, Abbott
• Kim Patton, MedAccred
• Martell Winters, Nelson Labs
• John Williams, Medtronic
• Mark Pasmore, Baxter
• Mara Senescu, Baxter

Organizing Committee

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

01_01_Butler_ORS Med Device Sterilization Workshop_Sept_2023_Final_Clean.pptx

01_02_Geltser_In-line e-Beam Sterilization - Terumo - Industry Needs 2023 09 20.pdf

01_03_Srun_Blom_Wicked Stability update - 5th Medical Device Sterilization Workshop FINAL 2023-09-18.pptx

01_05_Craven_Fermi TIR104.pptx

01_08_Dorey_Fermilab X-Ray Risk Evaluation Guidance v3.pptx

02_01_Winters_SDR Presentation - Final - formatted.pptx

02_02a_Lekate_Fermilab Conference 2023 - Beyond Read & Learn.pptx

02_02_Patton_Introduction to SfSAP - IARC Fermilab.pptx

02_03_Wllliams_Training_Fermi September 2023.pptx

02_04_Funk_Dose Insight Fermilab presentation.pptx

02_05_FDA_Master_file_etc_Slide deck for Submission Discussion (Final).pptx

2023 Fermilab Funk abstract.pdf

230920Butler_rev01.mp4

230920Geltser_rev01.mp4

230920I_R_Panel_rev01.mp4

230920SrunBlom_rev01.mp4

230921Craven_rev01.mp4

230921FDA.mp4

230921FunkBadali.mp4

230921Lekate.mp4

230921Patton.mp4

230921Williams.mp4

230921Winters.mp4

Abstract IARC Fermilab S.Dorey.docx

Butler.docx

Craven.docx

FDA Q-sub followup.docx

Fermilab Abstract - KiiP Packaging and Sterilization.pdf

Winters.docx

Wednesday, 20 September

.: Hybrid

Hybrid Session

.: Safety/Logistics

1 Welcome - Bonnie Fleming, Deputy Director for Science and Technology, FNAL

2 Keynote - Nick Butler, NNSA

Nick Butler, the Deputy Director of the National Nuclear Security Administration’s Office of Radiological Security (ORS), provides an overview of the office’s mission to enhance U.S. and global security by preventing high-activity radioactive materials from being used in acts of terrorism. As part of this mission, ORS promotes the use of non-radioisotopic alternative technologies through research, outreach, education, and complete device replacements in order to reduce global reliance on high-risk radioisotopes in medical, research, and industrial applications. Within the realm of medical device sterilization, ORS supports academia and industry partners by funding research, including through the key collaborative effort of “Team Nablo.” ORS supports and communicates advancements in technology and listens to industry needs and concerns through outreach activities such as the inaugural ORS Industry Day and annual Fermi Medical Device Sterilization Workshops.

3 Medium-energy, Low-power Needs - Ilia Geltser, Terumo BCT

4 Packaging & Sterilization - Kiip, Srun & Blom

It is known that radiation sterilization can result in degradation of certain materials, and of particular concern is molecular changes to the polymers. Because of this, aging studies are typically required for most medical devices and their packaging. However, even though most packaging materials have been well characterized and studied, and there are no known cases where packaging has failed due to shelf life concerns, most medical device companies spend significant time and resources to perform aging studies on their product and packaging. It is known that the presence of antioxidants in a polymer formulation inhibits the degradation that can occur after exposure to radiation. Instead of focusing solely on performing aging studies on every device and packaging combination, we are proposing an alternative approach where device manufacturers could characterize and test their materials for the presence of anti-oxidants as a predictor of material degradation over time. In addition to discussing the science behind this topic, we will also be discussing how we plan to use effective means of collaboration to achieve our goals.

10:20 Coffee Break - 20 minutes

5 International Regulatory Panel - ANVISA, FDA, Health Canada, and TÜV-SÜD

including: ANVISA, FDA, Health Canada, and TÜV-SÜD

6 The evolution of a standard - AAMI TIR104 and beyond, Emily Craven, Boston Scientific

This presentation looks at the drivers behind the creation of industry guidance on the transfer of health care products between radiation sterilization sources. Some information existed within ISO 11137-1 but it was unclear and incomplete. In the process of writing TIR104, the AAMI radiation sterilization working group collaborated to clarify a process to follow when assessing the transfer of doses. An overview of this framework will be presented. The resulting document and data that was published in support of this new guidance has significantly influenced the next revision of ISO 11137-1. We will examine the path forward once ISO 11137-1:2023 is published and which next steps will be of greatest benefit to our industry.

7 Morning Wrap-up & Close of Virtual Session

12:20 Lunch Break - 70 Minutes

.: In-Person Session

Hybrid Session

8 Discussion - TIR 104 - Mark Pasmore, Mara Senescu, Baxter

9 Discussion - FDA Panel

15:30 Coffee Break - 30 minutes

10 Discussion - Risk Evaluations in Implementing X-ray for Single-Use Systems Sterilization, Samuel Dorey, Sartorius

The single-use disposable technologies for biopharmaceutical manufacturing combine single-use holistic processes and facility strategy to overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for many biologics. This industry is facing challenges with irradiation sterilization capacity resulting in assessing X-rays as a suitable and equivalent alternative to gamma. Comparative studies between the effects of different types of radiation and their health impact on the materials/products studied arise. The Bioprocess Systems Alliance (BPSA) published a consensus risk-based qualification approach including materials, physical, functional, chemical, and biological investigation to assess the impact of X-ray vs gamma. The Team Nablo project also proposed a holistic research approach covering several disciplines. To achieve its goals, the team has integrated technological, academic, and industrial research. The BioPhorum X-ray workstream will also publish Guidance for risk evaluation of X-ray irradiation of single-use systems. This will be providing a robust, consistent, and repeatable methodology to assess the inclusion of X-ray irradiation of previously gamma irradiated-treated single-use products. We then propose an insight in the different risk evaluations available currently to simplify the adoption of X-ray for the sterilization purpose.

11 Close of Day 1

12 No-host Social - Two-Brothers Roundhouse

Thursday, 21 September

.: Hybrid Session

13 Welcome

14 Microbiological Resistance / Population C, Martell Winters, Nelson Labs

Population C, also called the Standard Distribution of Resistances (SDR), has been the microbiological benchmark for radiation sterilization since the early 1980s. The development of the SDR should be understood by industry and it provides insights into how the SDR, and associated dosing tables, can be used when investigating sterilization dose establishment or dose audit failures and aberrant bioburden data. Also, analysis of the SDR reveals a potential Achilles heel which is currently being discussed in the industry and is prompting additional guidance that is being proposed in the review of ISO 11137-1.

15 Training - Beyond Read and Learn, Vu LeKate (Abbott), Kim Patton (PRI)

16 Training Resources - John Williams, Medtronic

17 Finding the optimal sterilization configuration using simulations - Funk & Badali, Triple Ring

The dose delivered during radiation sterilization is highly dependent on many factors, such as the orientation of the device relative to the beam, how the devices are arranged in the shipping box, and how devices are positioned within their packaging. Experimentally exploring this trade space to find the best sterilization configuration is a very expensive and time consuming process since it requires relying on trial-and-error measurements and rules-of-thumb. In this presentation, we use simulations to demonstrate that the dose delivered to even a very simple medical device can be strongly influenced by the factors listed above. Simulations offer a powerful way to optimize the sterilization configuration in silico, in order to improve the efficiency of the sterilization validation process.

10:30 Coffee Break - 20 Minutes

18 Engaging with the FDA - Radiation Master File Pilot

Engaging with FDA: Radiation Master File Pilot, Submission Review, Responses, & Misconceptions

This session will build on last year’s FDA mock Q-Submission session and cover several topics related to engaging with FDA.

1) The first topic will be an overview of FDA’s Radiation Sterilization Master File Pilot Program. This program was initiated in April 2023 to pilot a novel way for FDA to support sterilization changes to PMA approved devices such as changing from gamma or ethylene oxide sterilization to x-ray or e-beam sterilization.

2) Next, there will be a panel discussion of some common questions and things to consider when submitting a premarket submission to FDA for a sterilization change to a medical device. The panel discussion will continue for the last set of topics in the session:

3) responding to FDA requests for information during submission review and some common questions and misconceptions about this part of the premarket review process.

19 Engaging wiht the FDA - Submission Review

Engaging with FDA: Radiation Master File Pilot, Submission Review, Responses, & Misconceptions

This session will build on last year’s FDA mock Q-Submission session and cover several topics related to engaging with FDA.

1) The first topic will be an overview of FDA’s Radiation Sterilization Master File Pilot Program. This program was initiated in April 2023 to pilot a novel way for FDA to support sterilization changes to PMA approved devices such as changing from gamma or ethylene oxide sterilization to x-ray or e-beam sterilization.

2) Next, there will be a panel discussion of some common questions and things to consider when submitting a premarket submission to FDA for a sterilization change to a medical device. The panel discussion will continue for the last set of topics in the session:

3) responding to FDA requests for information during submission review and some common questions and misconceptions about this part of the premarket review process.

20 Engaging with the FDA - Responses & Misconceptions

Engaging with FDA: Radiation Master File Pilot, Submission Review, Responses, & Misconceptions

This session will build on last year’s FDA mock Q-Submission session and cover several topics related to engaging with FDA.

1) The first topic will be an overview of FDA’s Radiation Sterilization Master File Pilot Program. This program was initiated in April 2023 to pilot a novel way for FDA to support sterilization changes to PMA approved devices such as changing from gamma or ethylene oxide sterilization to x-ray or e-beam sterilization.

2) Next, there will be a panel discussion of some common questions and things to consider when submitting a premarket submission to FDA for a sterilization change to a medical device. The panel discussion will continue for the last set of topics in the session:

3) responding to FDA requests for information during submission review and some common questions and misconceptions about this part of the premarket review process.

21 Morning Wrap-up & Close of Virtual Session

12:30 Lunch Break - 75 Minutes

.: In-Person Session

22 Discussion - Collaborating w/Kilmer/AAMI - FDA Collaborative Communities

23 Networking

15:30 Coffee Break - 30 Minutes

24 Networking

25 Close of Workshop