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.
Heart Valves/Pacemakers
Surgical Kits
Gowns & Drapes
Ventilators
Syringes
Catheters
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.
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