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Today’s Topic: 

Medical Device Sterilization Town Hall: 

Overview of Sterilization Landscape and Role of Ethylene Oxide 

January 10, 2024
Medical Device Sterilization Town Hall 

Overview of Sterilization Landscape and Role of 

Ethylene Oxide

Suzanne Schwartz, MD, MBA

Director

Office of Strategic Partnerships and Technology Innovation

Aftin Ross, PhD

Deputy Director

Division of All Hazards Response, Science and Strategic Partnerships

Office of Strategic Partnerships and Technology Innovation

Ryan Ortega, PhD 

Regulatory Advisor

Regulatory Policy and Combination Products Staff

Office of Product Evaluation and Quality

Tammy Beckham, DVM, PhD 

Associate Director

Resilient Supply Chain Program

Office of Strategic Partnerships and Technology Innovation

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Suzanne Schwartz, MD, MBA

Director

Office of Strategic Partnerships and Technology Innovation

3
Opening Remarks

4
Aftin Ross, PhD

Deputy Director

Division of All Hazards Response, Science and Strategic Partnerships

Office of Strategic Partnerships and Technology Innovation

5
Learning Objectives

• Discuss medical device sterilization challenges and the activity 

timeline since 2019 

• Describe FDA’s 2019 Advisory Committee Meeting and related 

FDA activities 

• Describe the medical device sterilization landscape and supply 

chain integrity

• Describe the need for forward - looking activities and the role of 

FDA’s new series of sterilization town halls

6
What happened in 2019 that impacted 

medical device sterilization?

• February 15, 2019: Illinois Environmental Protection Agency 

(EPA) issued a Seal Order to stop the Sterigenics facility in 

Willowbrook, Illinois from producing ethylene oxide (EtO)-

sterilized medical products due to facility emission concerns. 

• This closure and the subsequent closure of 5 additional 

facilities resulted in increased supply chain shortage risks to 

100+ types of medical devices.

7
Activity Timeline

FEBRUARY 2019 

Sterigenics 

closure

2019

JULY 2019 

Innovation Challenge 1: Alternatives to EtO Sterilization

Innovation Challenge 2: Reducing EtO Emissions

NOVEMBER 2019 

FDA Advisory Committee Meeting

NOVEMBER 2019 

EtO Sterilization Master File Pilot 

Program for PMA Holders

NOVEMBER 2019 

FDA Statement on steps to 

advance medical device 

sterilization with EtO

2020

MARCH 2020 

COVID Public Health 

Emergency, CARES Act & 506J

Notifications

2021

MAY 2022 

510(k) Sterility Change 

Master File Pilot Program

2022

AUGUST 2022 

FDA statement supporting 

innovation in medical device 

sterilization

MARCH 2023 

FDA forms EtO 

Tiger Team

2023

APRIL 2023 

Radiation Sterilization 

Master File Pilot Program for 

PMA Holders

JULY 2023 

CDRH Announces New Standards 

Recognition to Support Innovation 

in Medical Device Sterilization

JANUARY 2024 

First FDA Medical Device 

Sterilization Town Hall

JANUARY 2024 

Update to 510(k)

Sterility Guidance

2024

8
Ryan Ortega, PhD 

Regulatory Advisor

Regulatory Policy and Combination Products Staff

Office of Product Evaluation and Quality

9
FDA’s 2019 Advisory Committee 

Meeting and Related FDA Activities

10
2019 Advisory Committee Meeting

The General Hospital and Personal Use Devices Panel of the 

Medical Devices Advisory Committee met November 6-7, 2019

Goal Topics

• Overview of EtO sterilization processes 

• Methods to reduce EtO emissions 

• Alternative modalities 

• Shortages, supply chain impacts, 

clinical impacts

Obtain recommendations on how to 

reduce or eliminate EtO emissions 

secondary to medical device sterilization 

without compromising assurance of 

sterility for medical devices

11
2019 Advisory Committee Meeting 

Discussion Points

• Patients would suffer from abrupt unavailability of devices sterilized 

using EtO 

• The current sterilization ecosystem cannot absorb additional facility 

shutdowns 

• Promising alternative sterilization methods exist but may have 

challenges (such as material compatibility, infrastructure needs, 

packaging)

• Opportunities may exist to optimize EtO cycle time and reduce EtO 

use (such as using e - labeling to decrease the amount of paper that is 

sterilized) 

• Movement away from EtO would take many years

12
Incentive Structures and 

Partnering with Industry 

Stakeholders

• Sterility Master File Pilot Programs 

– Intended to streamline the regulatory processes 

for sterilizers and manufacturers to make process 

changes 

• EtO Sterilization Master File Pilot Program for PMA Holders (2019) 

• 510(k) EtO Sterility Change Master File Pilot Program (2022) 

• Radiation Sterilization Master File Pilot Program (2023) 

• Innovation Challenges 

– Challenge 1: Alternatives to EtO Sterilization 

– Challenge 2: Reducing EtO Emissions

Sterilization for Medical Devices | FDA 13
Tammy Beckham, DVM, PhD 

Associate Director

Resilient Supply Chain Program

Office of Strategic Partnerships and Technology Innovation

14
Current State of 

Medical Device Sterilization

15
Sterilization Industry Current State

• In U.S., 50% of medical devices (~20 billion/year) are sterilized using EtO, 

~40 - 45% gamma, and 5 - 10% other modalities 

– Other modalities - moist heat (steam), dry heat, E - beam, X - ray, vaporized 

hydrogen peroxide (VHP), chlorine dioxide (ClO2), and nitrogen dioxide (NO2)

• EtO demonstrated performance: 

1. Efficient logistics for sterilization 

2. Supports broad range of material compatibility 

• The national capacity for EtO sterilization is constrained

• Challenges exist moving from EtO to other modalities

16
Balancing Health Concerns

The FDA shares concerns about the release of EtO at unsafe 

levels into the environment and is interacting collaboratively with 

EPA and other jurisdictions to identify ways to reduce use of EtO 

that maintain safe and effective medical device sterilization 

without compromising patient care.

17
Evolving Challenges

• Supply limitations and lead time 

challenges for equipment and 

monitoring technologies 

• Status of technological capabilities for 

monitoring 

• Sterilization capacity and medical device 

access

• Regulatory considerations

18
Aftin Ross, PhD

Deputy Director

Division of All Hazards Response, Science and Strategic Partnerships

Office of Strategic Partnerships and Technology Innovation

19
Looking Ahead

20
Next Steps

• Since 2019, FDA has dedicated resources to supporting the 

development of alternatives to EtO and has implemented several 

programs and initiatives to support innovation in medical device 

sterilization 

• Collaboration is needed to solve these complex challenges and ensure 

continued availability of safe and effective sterilized medical devices 

• In the next town hall, we’ll share FDA’s 2023 activities, including the 

creation of a cross-functional Tiger Team to support efforts to reduce 

reliance on EtO

21
Medical Device Sterilization 

Town Hall Series

• FDA intends to host a town hall series focused on various 

aspects of medical device sterilization 

• Town Hall Goals

– Share FDA activities

– Discuss potential mitigations

– Gather input / respond to 

questions

• Seeking your input on future topics

22
Resources

Slide 

Number

Cited Resource URL

7

Issue a Seal Order www2.illinois.gov/Pages/news-item.aspx?ReleaseID=19717

8

Sterigenics closure www.epa.gov/il/sterigenics-willowbrook-facility

8

Innovation Challenge 1: Alternatives to EtO 

Sterilization

www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovationchallenge-1-identify-new-sterilization-methods-and-technologies

8

Innovation Challenge 2: Reducing EtO Emissions www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovationchallenge-2-reduce-ethylene-oxide-emissions

8

FDA Advisory Committee Meeting www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-

2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisorycommittee

8

EtO Sterilization Master File Pilot Program for 

PMA Holders

www.federalregister.gov/documents/2019/11/26/2019-25631/center-for-devicesand-radiological-health-ethylene-oxide-sterilization-master-file-pilot-program

8

FDA Statement on steps to advance medical 

device sterilization with EtO

www.fda.gov/news-events/press-announcements/statement-new-steps-advanceinnovation-medical-device-sterilization-ethylene-oxide

8

COVID Public Health Emergency, CARES Act & 

506J Notifications

www.fda.gov/medical-devices/medical-device-safety/medical-device-supply-chainand-shortages

8

FDA statement supporting innovation in medical 

device sterilization

www.fda.gov/news-events/press-announcements/fda-continues-efforts-supportinnovation-medical-device-sterilization

23
Resources

Slide 

Number

Cited Resource URL

8

510(k) Sterility Change Master File Pilot 

Program

www.federalregister.gov/documents/2022/05/20/2022-10925/medical-devices510k-sterility-change-master-file-pilot-program

8

Radiation Sterilization Master File Pilot Program 

for PMA Holders

www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announcesradiation-sterilization-master-file-pilot-program

8

CDRH Announces New Standards Recognition to 

Support Innovation in Medical Device 

Sterilization

www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announcesnew-standards-recognition-support-innovation-medical-device-sterilization

8 Update to 510(k) Sterility Guidance www.fda.gov/regulatory-information/search-fda-guidance-documents/submissionand-review-sterility-information-premarket-notification-510k-submissions-deviceslabeled

8

First FDA Medical Device Sterilization Town Hall www.fda.gov/medical-devices/workshops-conferences-medical-devices/medicaldevice-sterilization-town-hall-overview-sterilization-landscape-and-role-ethyleneoxide

11 2019 Advisory Committee Meeting www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-

2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisorycommittee

13 Sterilization for Medical Devices | FDA www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilizationmedical-devices#MasterFile

16 ~20 billion/year www.fda.gov/news-events/press-announcements/statement-concerns-medicaldevice-availability-due-certain-sterilization-facility-closures

24
Summary

• Medical device sterilization challenges have led to many 

stakeholder activities since 2019 to reduce EtO use and 

encourage the advancement of EtO alternatives

• FDA has worked collaboratively with industry to develop 

programs and initiatives to support medical devices 

sterilization innovation to ensure medical device availability

• FDA intends to continue to engage with stakeholders 

through a series of town halls on medical device sterilization

25

Let’s Take Your Questions and Comments

• To ask a question/share a comment:

• Raise your hand in Zoom

• Moderator will announce your name and invite you to speak

• Unmute yourself when prompted in Zoom to speak

• When asking a question/sharing a comment:

• Keep question/comment as short as possible

• No questions about specific submissions

• After question/comment is addressed:

• Mute yourself and lower your hand

• If you have another question/comment - raise your hand again
Thanks for Joining Today!

• Presentation and Transcript will be 

available at CDRH Learn

• www.fda.gov/Training/CDRHLearn

• Additional questions/comments 

about today’s presentation

• Email:

MedicalDeviceSterilization@fda.hhs.gov

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