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FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions

FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions

The FDA is sponsoring two public innovation challenges to encourage the development of new approaches to medical device sterilization. Challenge 2 is focused on developing strategies to reduce ethylene oxide (EtO) emissions.

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Goal of this Challenge: Reduce Emissions

In response to the February 2019 closure of a large device sterilization facility, the FDA is taking steps to ensure that hospitals, health care providers, and patients have access to medical devices that are safely and effectively sterilized. 

The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.

Innovative strategies may entail changing current sterilization processes or workflow, such as changes in the supply chain, transportation of medical devices, or procedures in the sterilization site. Strategies may also include making alterations to ethylene oxide process waste to reduce emissions.

The strategies or technologies may allow for the:

  • Use of lower levels of ethylene oxide while maintaining assurance that devices are safely and effectively sterilized
  • Capture of ethylene oxide emissions and/or transformation to harmless byproducts
  • Detection, measurement, tracking, and containment of fugitive emissions to prevent or minimize emissions into the sterilization facility or environment
  • Safe use of ethylene oxide while minimizing harmful exposure (such as toxicity and carcinogenicity) to sterilization workers and nearby communities.

Timeline and Deadlines

Solutions must be submitted to CDRH-Innovation-Sterilization@fda.hhs.gov by 12:00 PM Eastern time on October 15, 2019.

  • Challenge begins: July 15, 2019
  • Submission period: July 15, 2019-October 15, 2019
  • Judging period: October 16, 2019 – November 16, 2019

The FDA intends to announce applications selected for this challenge in December 2019. As many meritorious applications as resources permit will be selected. Following completion of the review, applicants will be notified of their application status.

The FDA will obtain consent from selected applicants before publicly disclosing any proprietary information contained in their application.

Selected applicants will work with the FDA to accelerate the development and review of technology.

Challenge Participants

The FDA encourages participation in this challenge from organizations such as:

  • Sterilization companies
  • Medical device companies or distributors
  • Technology manufacturers (including start-up companies or labs)
  • Academic and research institutions
  • Healthcare facilities
  • Professional societies
  • Foundations and other non-profits

Basic Criteria for Challenge Submissions

The challenge submissions should succinctly describe:

  • Anticipated benefit of the strategy or technology
  • Impact of the strategy or technology on public health as compared to other available alternatives
  • Compatibility of the strategy or technology with medical device materials
  • Capability of the strategy or technology to ensure scalability and high throughput for safe and effective sterilization of large volumes of devices

 The FDA will also consider factors such as:

  • Feasibility of the strategy or technology
  • Impact of the FDA's involvement

Elements that would be considered within this challenge scope:

  • 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 rapidly developed to medical device manufacturers and 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

Application Format

Applications should be no longer than 20 pages using Times New Roman, 12-point font. All content should be written in English, converted to PDF format, and emailed to CDRH-Innovation-Sterilization@fda.hhs.gov.

Cover Page

  1. Company name, address, name of a contact person including their phone number and email address.
  2. Name of strategy or technology for reducing emissions.
  3. FDA regulatory history, if appropriate.
  4. The name of the challenge: Challenge 2: Reduce Ethylene Oxide Emissions.
    Note: If your challenge submission involves ethylene oxide in any way (sterilization, mitigation, etc.), your submission should be directed to Challenge 2.

Executive Summary (limit to 1 page)

  1. A summary of what the strategy or technology is intended to do.
  2. The significance of the problem it will solve.
  3. A summary of the proposed development plan.

Proposal: Should address all the following topics:

  • The development plan for the strategy or technology
  • The development team (including names of essential team members and prior experience of each team member in sterilization strategies or technologies)
  • The scientific basis and/or preliminary data supporting the proposed strategy or technology
  • Anticipated benefit of the strategy or technology
  • Impact of the strategy or technology on public health as compared to other available alternatives
  • Compatibility of the strategy or technology with medical device materials
  • Capability of the strategy or technology to ensure scalability and high throughput for safe and effective sterilization of large volumes of devices

For more information

On Tuesday, August 13, 2019, the FDA sponsored a webinar on the challenges, including details on submission requirements and what to expect if you participate in a challenge. View webinar materials.

If you have questions about this challenge, email CDRH-Innovation-Sterilization@fda.hhs.gov.