Device shortages update: FDA announces two new innovation challenges on device sterilization

In response to the March 2019 closure of a large device sterilization facility, the Food and Drug Administration (FDA) is taking steps to ensure that hospitals, healthcare providers, and patients have access to medical devices that are safely and effectively sterilized. FDA has announced two Innovation Challenges to encourage the development of new approaches to device sterilization.

FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies. In response to the March 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.

FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions. 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.

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

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

Challenge No. 1

The goal of this challenge is to identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide and that meet these criteria:

·   Compatibility: The method or technology should be compatible with a large cross-section of materials used to manufacture or fabricate medical devices as well as packaging materials or sterile barriers. The materials, devices and barriers of particular interest are those that are compatible with ethylene oxide sterilization.

·   Scalability and High Throughput: The method or technology should have the potential to be scalable and allow for the effective sterilization of large volumes of devices.  

Challenge No. 2

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.

Solutions must be submitted to [email protected] by 12:00 PM Eastern time on October 15, 2019.

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

The FDA intends to announce applications selected for these challenges 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.