Ethylene Oxide (EtO) gas is the most common way to sterilize medical devices, a process which is critical for preventing infections and ensuring patients have safe surgeries and medical treatments. EtO sterilization is a highly regulated process, and device manufacturers, hospitals and third-party sterilizers must follow rigorous controls established by FDA, EPA, OSHA and other government agencies to protect patients, workers and the environment.
For many medical devices, due to their size, shape, complexity or material composition, EtO is the only option for sterilization. For these products, alternatives such as steam, radiation or other sterilants do not achieve the needed levels of sterility assurance. In addition, for some medical devices, using non-EtO sterilization methods will results in material degradation, rendering the products potentially unsafe for patients.
While EtO is a recognized hazardous chemical, federal regulations and international guidance on emissions, residuals and worker safety allow for the safe and responsible use of EtO to sterilize medical products. Device manufacturers and sterilizers responsibly capture, remove, and destroy EtO with the best available technologies on the market today. In many instances, companies exceed current mandates of 99% destruction; often achieving levels of 99.9% and higher. Some are as high as 99.999% destruction efficiency. Industry continues to improve its application of abatement technologies and employs continuous improvement activities as appropriate.
Medical Devices That Require EtO Sterilization
Gowns & Drapes
More than 50 percent of all medical device types are sterilized using EtO, totaling more than 20 billion devices annually.
Most surgeries involve at least one device that has been sterilized by EtO.
As part of FDA’s Quality System regulation and other global requirements, manufacturers must validate that their sterilization processes are in compliance with international standards.
To achieve device sterility, many medical devices rely on EtO. Eliminating or severely restricting the use of EtO could put patients at risk by threatening the health care supply chain.
EtO Sterilization and Medical Devices – Key Documents
Background: Ethylene Oxide’s Invaluable Role in Protecting Public Health
EPA’s Ethylene Oxide Iris Assessment: Flawed Science and the Potential for Adverse Public Health Impacts
Editorial: The Truth About Ethylene Oxide
Infographic: EtO Sterilization and Medical Devices
Everyday Items That Emit EtO Above EPA's Benchmark
EtO in the News
Is the EtO scare fake news?
The Rebuttal for Ethylene Oxide
Waukegan chamber chief: Ethylene oxide emissions "a problem that may not exist"
AdvaMed Press Statements
EPA Ethylene Oxide Value at Odds with Public Health, Best Science
Medical Device Manufacturers Raise Public Health Concerns Over EPA Ethylene Oxide Value
AdvaMed Statement on EtO Air Testing by EPA
FDA Warns of “Tipping Point” with Medical Device Supplies and EtO Facility Closures
AdvaMed: Neonatal Products Provided to 80 Percent of U.S. Hospitals Threatened by Potential Medline Shutdown
State Medical Technology Alliance (SMTA) Statement on EtO
AdvaMed Comments on FDA Statement on Potential Device Shortages
Nation’s Premier Surgeons Stress Importance of Ethylene Oxide for Medical Device Sterilization
AdvaMed Statement On BD Sterilization Plant In Georgia
AdvaMed Comments on National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review
AdvaMed Comments on National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations
AdvaMed Comments on General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
AdvaMed Comments to the Chemical Assessment Advisory Committee for the Integrated Risk Information System Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide
AdvaMed Comments to Texas Commission on Environmental Quality on Exposure Assessment
AdvaMed Letter to EPA on Ethylene Oxide