EO has been an essential life-saving sterilization method used for decades to ensure the safety and sterility of medical devices and supplies throughout the healthcare industry.
EO exists naturally in the air around us and comes from a variety of sources, including the human body, among other natural and everyday sources. Over 20 billion medical products in the United States are sterilized using EO every year. The safe use of EO for medical supply sterilization is highly regulated by major regulatory agencies such as the EPA, FDA, OSHA and others. In 2018, ethylene oxide sterilization became the subject of regulatory and media scrutiny due to the release of a controversial and highly conservative EPA risk assessment as well as a significant misunderstanding of the facts. As a result, Sterigenics and other medical supply sterilization companies have been subjected to hundreds of personal injury claims and related tort lawsuits citing alleged injury due to long term environmental exposure from emissions from sterilization facilities. Sterigenics has and will continue to vigorously defend against these claims. The litigation and related pressure on the EO sterilization process have created risks to public health as disruptions to the supply chain have affected the delivery of medical supplies to hospitals and patients. Sterigenics operates safely and in compliance with regulatory requirements and continues to invest in voluntary emission controls to perform better than even the strictest of regulations. The pages and links that follow provide information for a more complete understanding of the critical role of EO sterilization in healthcare and the safe practices Sterigenics follows every day.