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FDA launches innovation challenge to boost ethylene oxide sterilization alternatives
FDA Monday launched two innovation challenges to incentivize the creation of alternative medical device sterilization methods and methods to reduce ethylene oxide (EtO) emissions.
The move comes months after the Illinois Environmental Protection Agency closed the Sterigenics' Willowbrook plant earlier this year. The Willowbrook plant, which processed sterilization for 594 types of medical devices, closed due to high levels of EtO emissions. In 2016, EPA found EtO to be linked linked to breast cancer, lymphoma and leukemia.
The agency will accept submissions until Oct. 15 for both challenges and plans to announce the winners in December. FDA said it will accept as many ideas as resources allow, but spokesperson Stephanie Caccomo told MedTech Dive the agency can't share "further details on resources that will be allocated."
More than 50% of medical devices are sterilized using EtO instead of steam or radiation due to its unique ability to sterilize certain plastics, resin, metals and glass.
"For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process," FDA wrote in a fact sheet.
The medical device industry has been actively lobbying the government to maintain access to EtO as a sterilant until alternative methods are developed.
"We are supportive of FDA's efforts to encourage development of alternatives to use of EtO to sterilize medical devices and to lessen the use of EtO," AdvaMed spokesperson Mark Brager told MedTech Dive in an email. "These are both laudable long-term goals, and we appreciate the agency's recognition of the importance of EtO in ensuring the sterility of billions of medical devices every year and the fact that for many medical devices no alternative to EtO currently exists."
On top of the innovation challenges, FDA plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage new discoveries in medical device sterilization. The agency also plans to hold a webinar Aug. 13 to answer questions about the innovation challenges.
EPA is also set to release two proposed rules this month on addressing emissions from commercial EtO sterilizers and a risk and technology reviewof the maximum achievable control technology for emissions from the manufacturing of the gas.
The closure of the Willowbrook facility resulted in a temporary shortage of tracheostomy tubes made by Smiths Medical in April, but FDA approved a manufacturing site change to help mitigate the shortage's impact.
"FDA continues to monitor the supply of devices sterilized in facilities that have closed or that may close and is paying special attention to life-saving, life-sustaining, and critical devices," wrote CDRH's Suzanne Schwartz and Captain Elizabeth Claverie-Williams in a blog post.
FDA Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing
PUBLISHED IN medtechdive.com
July 16, 2019