ARTICLE SUMMARY:
The Environmental Protection Agency isn’t often the top federal agency on the medtech sector’s radar, but the next few weeks could be an exception, with proposals anticipated on new requirements for the use and emission of ethylene oxide that have the potential to severely impact medical device production.
The Environmental Protection Agency is expected to publish proposals soon to update its policies around ethylene oxide (EtO) that could have significant implications for device companies that use the gas for product sterilization. Industry advocates engaging on the issue say they welcome stricter emission standards but are urging EPA to allow maximum flexibility for how facilities achieve them and sufficient time to adjust.
EtO is used to sterilize about half of all sterile medical devices (about 20 billion) each year, according to FDA. And device industry groups say if EPA’s impending updates are too prescriptive, it risks causing some sterilization facilities to shut down and lead to supply chain disruptions. “With 80 percent of surgical kits alone sterilized using EtO, any shutdown-induced disruption could reverberate from screening to the operating room to post-operative care,” AdvaMed CEO Scott Whitaker warned in a letter to President Biden in January.
Whitaker penned the letter in anticipation of an EPA National Emission Standards for Hazardous Air Pollutants (NESHAP) proposed rule that will update decades-old federal EtO emission requirements for commercial sterilizers. In addition to the proposed rule, which is expected to be released by next week, EPA is planning to publish a separate “proposed interim decision” under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which could spell out updated expectations for labeling and handling of EtO supplies. AdvaMed and other groups and company executives have been meeting regularly with EPA officials over the past several years to underscore the potential healthcare impact of rules that restrain EtO sterilization efforts.
