FDA Looks for New Device Sterilization Methods
Following the closures of contract sterilization facilities that prompted the US Food and Drug Administration (FDA) to alert to the potential for medical device shortages, the agency launched two public innovation challenges Monday to spur sterilization alternatives and reduce emissions.The first innovation challenge is intended to identify methods or technologies as alternatives to ethylene oxide (EtO) sterilization, while the second innovation challenge will look to develop strategies for reducing EtO emissions. The focus of the first challenge speaks to devices that must use the EtO sterilization method, whereas the focus of the second challenge coincides with efforts at the Environmental Protection Agency (EPA) to reduce EtO emissions.
To compete in the first challenge, the method or the technology has to satisfy the listed criteria relating to compatibility, scalability and high throughput. FDA says allowing the use of lower levels of EtO and transforming captured EtO emissions into harmless byproducts are examples of the strategies or technologies that can support the goal of the second challenge. The agency specifies that 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.”
Both challenges come in response to a string of recent closures of EtO contract sterilization facilities, including the March closure of the Sterigenics facility in Willowbrook, IL and the Viant Grand Rapids, MI facility closure shortly thereafter. The string of closures was due to air quality issues and resulted in the temporary shortage of Smith Medical’s tracheostomy tubes in April.
FDA reports that about 50% of all sterile medical devices in the US are sterilized with EtO and those likely to use the method include devices that are made from certain polymers, metals or glass, have multiple packaging layers or hard-to-reach places like catheters. But long-term exposure to elevated EtO levels in the air increases the risk of certain cancers, the EPA says.
The call for applications extends across the medical device ecosystem, from sterilization companies and technology manufacturers to health care facilities. The agency will accept applications for both challenges until 15 October, after which the submitted applications will undergo a month-long judging period prior to announcing applicants selected for participation in December. “As many meritorious applications as resources permit will be selected,” FDA says.
Ethylene Oxide Sterilization for Medical Devices