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FDA Innovation Challenges: 

Identify Sterilization Alternatives and Reduce 

Ethylene Oxide Emissions 

Chris Dugard 

Scientific Reviewer

Office of Surgical and Infection Control Devices

Steve Elliott 

Scientific Reviewer

Office of Surgical and Infection Control Devices

Center for Devices and Radiological Health
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• Overview of Ethylene Oxide Sterilization 

• The FDA’s Efforts to Address Issue

• Overview of the Innovation Challenges

• Tips for Potential Applicants

• Resources 

• Questions

Agenda
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• Sterilization is a process intended to render devices free of viable 

microorganisms.

• Medical devices are sterilized to prevent patient exposure to pathogenic 

microorganisms.

• Processes to sterilize medical devices include:

– Thermal: Moist heat (steam), dry heat

– Chemical: Ethylene oxide gas, vaporized hydrogen peroxide, chlorine dioxide 

gas

– Irradiation: Gamma, x-ray, electron beam

• Sterilized medical devices are critical to our health care system and patient 

safety.

Overview of Ethylene Oxide 

Sterilization
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Ethylene oxide (EtO)

• Common sterilant for medical devices

– Is used to sterilize ~50% of medical devices provided sterile (sterilized by 

manufacturer or contract sterilizer). 

– Can penetrate multiple layers of packaging.

– Compatible with a broad range of device materials.

• Involves exposure of product to EtO gas under vacuum in a sealed chamber 

with defined temperature and humidity conditions.

Overview of Ethylene Oxide 

Sterilization
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• Process Challenges:

– Multiple variables (critical parameters) to address

– Long turnaround times

– Highly flammable and explosive

– Carcinogen

– Emission of ethylene oxide (EtO) gas resulting from sterilization is an identified 

concern:

• The Environmental Protection Agency identifies ethylene oxide as a hazardous 

air pollutant.

• To date, we are aware of one industry EtO sterilization facility that has been 

closed on the basis of ethylene oxide emissions.

• There are concerns associated with manufacturing and processing of devices 

historically sterilized with EtO. 

Overview of Ethylene Oxide 

Sterilization
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• Unavailability of EtO as an industrial sterilant for medical devices is a concern

– The effectiveness of the technology for broad spectrum antimicrobial 

sterilization is well established

– The high throughput/low cost of this technology allows for large sterilization 

capacity which guarantees the supply chain of medical devices sterilized 

using the technology is preserved

– EtO is the only acceptable sterilization method for a large number of delicate, 

complex, and sophisticated medical devices manufactured with sensitive 

materials and removal of EtO as an option could lead to device shortages

Medical Device Public Health Impact
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• The FDA is actively working with sterilization experts, medical device 

manufacturers, and other government agencies to:

– Advance medical device sterilization using EtO

– Prevent potential for medical device shortages due to a lack of alternatives to 

EtO

• Advisory Committee: The FDA plans to hold an advisory committee on 

November 6-7, 2019 to obtain panel recommendations regarding challenges 

and opportunities for ethylene oxide reduction and the use of alternative 

strategies to inform the FDA’s decision-making.

Examples of FDA’s Efforts to Address the Issue
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Overview of the Innovation Challenges

Challenge Goals:

Challenge 1: Identify New Sterilization Methods and Technologies

Identify safe and effective sterilization methods or technologies for 

medical devices that do not rely on ethylene oxide 

Challenge 2: Reduce ethylene oxide emissions

Develop strategies or technologies to reduce emissions to as close 

to zero as possible from the ethylene oxide sterilization process.
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Eligibility

• Any safe and effective alternative methods or technologies to ethylene 

oxide sterilization for medical devices.

• Any innovative strategies or procedures in any stage of the ethylene oxide 

sterilization process that are demonstrated to reduce ethylene oxide 

emissions to near zero. 

Overview of the Innovation Challenges
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Examples that would be considered within the challenge scope:

• Methods that can sterilize a wide range of polymeric materials without changing 

the chemical and physical properties of the polymers by degrading them (e.g., 

through oxidization, chain scission, or other unfavorable reactions) or by 

generating unacceptable levels of toxic by-products such as leachables

• Materials or medical devices that are typically sterilized by Ethylene Oxide that 

can be shown to be sterilized using other modalities

• Methods that can or have potential to sterilize bulk volumes/large loads of 

products 

• Methods that employ the use of technologies and infrastructure that is readily 

accessible or can be rapidly deployed to medical device manufacturers and 

sterilization providers in the US

Challenge 1 
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Examples that would be considered within this challenge scope:

• Methods that do not negatively impact throughput of current Ethylene Oxide sterilization 

processes 

• Methods that employ the use of technologies and infrastructure that is readily accessible or can 

be rapidly deployed to medical device manufacturers and Ethylene Oxide sterilization providers 

in the US

• Strategies to control or reduce bioburden prior to sterilization 

• Incorporation of processes that use lower levels of Ethylene Oxide while assuring that requisite 

sterility assurance/sterilization is attained

• Capture of Ethylene Oxide emissions and transformation to harmless byproducts

• Detection, measurement, tracking, and containment of Ethylene Oxide emissions or byproducts 

to minimize or prevent dissemination into the sterilization facility and environment

• Allowing for the safe use of Ethylene Oxide while minimizing exposure to sterilization workers or 

nearby communities

Challenge 2
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Overview of the Innovation Challenges

Who can apply?

• Sterilization companies

• Medical Device companies or distributors

• Technology manufacturers (including Start-up companies or 

labs)

• Academic and research institutions 

• Health care facilities

• Professional societies 

• Foundations and other non-profits 

• Other
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• The development plan for the method or technology

• The development team

• The scientific basis and/or preliminary data to support the 

proposed method or technology

• Anticipated benefit of the technology or method

• Impact of the method or technology on public health

• Compatibility of the method or technology with medical device 

materials

• Capability of the method or technology to ensure scalability and 

high throughput for safe and effective sterilization of large 

volumes of devices 

Overview of the Innovation Challenges

Submissions for either challenge should describe:
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• Potential public health benefit

• Frequent interactions with FDA during development phase

• Accelerated development and review of technology

• FDA recognition

Incentives
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Challenge Timeline:

• Challenge begins: July 15, 2019

• Submission period: July 15, 2019-October 15, 2019

• Submit applications to: 

CDRH-Innovation-Sterilization@fda.hhs.gov

• Judging period: October 16, 2019 – November 16, 2019 

We intend to announce applications selected for the 

challenge in December 2019.

Overview of the Innovation Challenges
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• Applications should be no longer than 20 pages (including cover page and executive summary)

• Should include a cover page with 

– Company name, address, and primary contact with name, phone number, and e-mail

– Name of the alternative sterilization method or technology

– FDA regulatory history, if appropriate

– Name of the challenge you are addressing

• Executive summary (limit to 1 page)

– Summary of the method or technology

– Significance of the problem it will solve

– Summary of the proposed development plan

• You may submit more than one application if you have more than one eligible device or concept

• There is no official application form. The application format is outlined on the challenge web 

pages.

Application Format/Tips for Potential Applicants
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If Your Application is Selected:

- Expect confirmation from FDA and instructions on 

next steps.

- Potential for web presentations to evaluate 

finalists.

Overview of the Innovation Challenges
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• Ethylene Oxide Sterilization page

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxidesterilization-medical-devices

• Challenge 1 page:

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

• Challenge 2 page:

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovationchallenge-2-reduce-ethylene-oxide-emissions

• FDA Voices:

https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/preventingmedical-device-shortages-ensuring-safe-and-effective-sterilization-manufacturing

Resources
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Questions?

About the Innovation Challenge:

CDRH-Innovation-Sterilization@fda.hhs.gov

About Medical Device Regulation:

Division of Industry and Consumer Education 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be 

available at: 

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; 

Subheading: Sterility