The FDA has issued a pair of challenges to encourage the development of new approaches to medical device sterilization. The first challenge focuses on identifying alternatives to ethylene oxide (EO) sterilization methods. The second seeks input on reducing EO emissions.
The agency warned of possible medical device shortages in March following the abrupt closure of a Sterigenics EO plant in Willowbrook, Ill. and the industry faces new regulations from the U.S. Environmental Protection Agency in December. That agency published proposed amendments to the National Emissions Standards for Hazardous Pollutants in the Federal Register in February. The EPA’s proposal seeks comment on the science-based health risk of EO.