Following the concern over medical device shortages as a result of the closures of certain facilities that use ethylene oxide to sterilize medical devices, FDA is issuing a challenge to the industry: Either identify new sterilization methods and technologies that do not use ethylene oxide, or develop strategies to reduce ethylene oxide emissions.
At the end of February, the Illinois EPA ordered the shutdown of the Sterigenics facility in Willowbrook, Illinois following the discovery of alarming levels of EtO emissions in surrounding residential and commercial areas. Soon after this was the announcement of the Viant Medical shutdown after receiving violations notices related to EtO emission levels from the Michigan Department of Environmental Quality.
Beginning today and until October 15, organizations can submit applications to FDA under either of the following programs.
The proposed method or technology should address compatibility from a materials standpoint (including device manufacture and packaging) and scalability (will the approach be able to effectively sterilize large volumes of medical devices?). Organizations should also describe the benefit of the technology or method, along with its impact on public health.
FDA’s goal with this challenge is to come up with strategies or technologies that lower ethylene oxide emissions that come from sterilization to as close to zero as possible. The agency gives examples of potential methods that include capturing ethylene oxide emissions and converting them to harmless byproducts; and detecting, tracking and containing emissions to prevent or minimize emissions into the facility or environment.
The FDA has specific guidelines for formatting the application for either of the challenges on its website. The judging period will occur from October 16–November 16.