Ethylene Oxide Sterilization and Medical Devices

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

Heart Valves/Pacemakers

Surgical Kits

Gowns & Drapes

Ventilators

Syringes

Catheters

Key Facts

 More than 50 percent of all medical device types are sterilized using EtO, totaling more than 25 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

Regulatory Comments

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

Press Statements

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

Background Information

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