Weekly Policy Blog: Ethylene Oxide – EPA’s Proposed Rules 

Ethylene Oxide (EtO or EO) is a colorless gas used commercially in a wide variety of ways. It is one of the most common and proven ways to sterilize medical devices. EtO’s proven effectiveness means this method sterilizes approximately 50% of all medical devices — 20 billion — in the U.S. each year. Other methods of sterilization include ionizing radiation, steam (autoclaving), and chemical agents (such as hydrogen peroxide or peracetic acid), but these methods pose challenges which hinder their usability and effectiveness for the sterilization of many medical devices and supplies — which has led innovators in the MedTech community to work on alternative methods for sterilization. Many devices cannot currently be effectively sterilized by methods other than EtO sterilization, though, so EtO is crucial to ensuring patient access to life-saving medical technologies and other medical products. 

EtO sterilization is a highly regulated process. Device manufacturers, hospitals, and third-party…
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