The FDA announced two public innovation challenges to encourage the development of new approaches to medical device sterilization. Challenge 2 was focused on developing strategies to reduce ethylene oxide (EtO) emissions.
On this page:
- List of participants selected for Challenge 2
- What happens next?
- Goal of this challenge: Reduce emissions
- Basic criteria for challenge submissions
- For more information
The FDA received 22 applications from companies large and small to this FDA innovation challenge. After careful review using an established set of criteria, the FDA selected eight participants for this challenge.
|Company||Alternative Technology Category|
|Abbott||Enhanced EtO Cycle Design and Processes|
|Andersen Scientific, Inc.||Use of EtO-Flexible Chamber Technology|
|Becton, Dickinson and Company (BD)||Enhanced EtO Cycle Design and Processes|
|DMB Apparatebau GmbH||Reduced Sterilant Concentration|
|Medtronic plc||Enhanced EtO Cycle Design and Processes|
|Sterigenics U.S., LLC||Enhanced EtO Cycle Design and Processes|
|STERIS||Enhanced EtO Cycle Design and Processes|
|Taiwan Advanced Sterilization Technologies Inc.||Abatement Strategy|
Participants selected for this challenge will work directly with the FDA to accelerate the development and review of innovative technology.
Within 60 days of announcing the participants, the collaboration phase of the process will begin. The goals of the collaboration phase are to:
- Create a mutual understanding of the target technology profile including the important risks and benefits.
- Discuss the development of the technology or potential regulatory pathways going forward.
The FDA will work closely with the participants selected for the challenges. The regulatory standard of demonstrating a reasonable assurance of safety and effectiveness still applies. Review of these challenge submissions does not constitute regulatory acceptance or endorsement of a process associated with a premarket submission. These methods or technologies would still have to be reviewed through the relevant premarket pathway.
For applicants who were not selected, the standard mechanisms for interaction with the FDA's Center for Devices and Radiological Health (CDRH) are available. These sponsors have been encouraged to interact with the agency through the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov. DICE will assist in answering questions on U.S. medical device regulation or to direct sponsors to the appropriate premarket review division.
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.
The challenge submissions were expected to 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 also considered factors such as:
- Feasibility of the strategy or technology
- Impact of the FDA's involvement
Elements that would have been 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 United States
- 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
If you have questions about this challenge, email CDRH-Innovation-Sterilization@fda.hhs.gov.