EO Facts | Sotera Health

EO exists naturally and comes from a variety of sources

Natural Sources

Everyday Sources

EO has a variety of modern uses

EO is primarily used to make other chemicals; and EO, and its derivatives, also help make or supply a variety of products we use every day:

EO exists in the air all around us

Given the variety of sources and modern uses, EO exists at “background levels” across the country.

The average EO level across the U.S.:

Compared to:

ug/m³ = micrograms per cubic meter
U.S. EPA: Ethylene Oxide Ambient Concentrations at National Air Toxics Trends Stations and Urban Air Toxics Monitoring Program stations October 1, 2018 – March 31, 2019

EO is essential to the U.S. health care system

The U.S. Food & Drug Administration (FDA) has stated repeatedly that EO is essential to the U.S. health care system. Hospitals and patients depend on EO sterilization for critical and lifesaving products. Billions of medical products and devices are used every year, and many must be sterile before use to ensure the safety of patients and health care providers.

EO sterilization is widely used to keep medical devices safe.

For many medical devices, EO is the only sterilization method that effectively sterilizes without damaging the device during the sterilization process. Medical devices made from certain polymers (plastic or resin) or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with EO.

The method of sterilization for a particular product or device is determined by the medical product manufacturer based on a variety of considerations, including FDA sterility requirements and internationally agreed consensus standards, the materials used and design of the product being sterilized, and the intended use of the product. Without EO sterilization, infection risk associated with surgical procedures and other forms of care could be meaningfully increased.

>20B

medical devices sold in the U.S. every year are sterilized with EO

~50%

of medical products that require sterilization in the U.S. are sterilized with EO

60%

of essential medical devices used to combat pandemics are sterilized with EO

10/25/2019, Press release

“Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices. It’s important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”

3/20/2020, Press release

“For many medical devices, sterilization with EO may be the only method that effectively sterilizes and does not damage the device during the sterilization process.”

Examples of medical devices sterilized using EO

Gowns/Drapes

Surgical Kits

Syringes

Pacemakers

Ventilators

IV Sets

Heart Valves

Sutures