According to the article published by AdvaMed in 2023, Ethylene oxide (EtO) sterilization is thepreferred method for approximately 50 percent of all medical device types, with over 20 billion devices sterilized annually. Its effectiveness in sterilizing a wide range of medical devices, including those with complex geometries and heat-sensitive materials, makes it a vital part of modern healthcare. Most surgeries involve at least one device that has been sterilized using Ethylene oxide (EtO), ensuring patient safety and infection control. In compliance with FDA's Quality System regulation and international standards, manufacturers must validate their Ethylene oxide (EtO) sterilization processes to guarantee they meet the highest levels of safety and efficacy, further underscoring Ethylene oxide (EtO) critical role in the medical device industry.
