Key Points/Overview
EO is most commonly used in the production of other chemicals and products, including solvents, antifreeze, detergents, adhesives, polyurethane foams and pharmaceuticals.
An important use of EO is the sterilization of medical equipment, including personal protective equipment used by health care professionals and hospitals. It is estimated that ethylene oxide sterilizes 20 billion medical devices each year, helping to prevent disease and infection.
EPA standards for EO production and use require emission reducing and monitoring devices, on-site testing, site-specific operating parameters, and regular reporting and record keeping. Facilities where EO is produced work to meet and exceed EPA standards.
In workplaces where EO is present, the OSHA standard applies in many circumstances and requires employers to monitor employee exposure and provide appropriate protective clothing and equipment to employees who may be exposed to EO.
There is minimal health risk for the general population because most people are not exposed to significant quantities of EO.
Ethylene Oxide Sterilization
A small but important use of ethylene oxide is the sterilization of medical equipment, including the sterilization of personal protective equipment used by doctors and hospitals across the country. It is estimated that ethylene oxide sterilizes 20 billion medical devices each year, helping to prevent disease and infection.1 The sterilization process is tightly controlled, and the ethylene oxide gas is removed from the products before they are used. According to the U.S. Food and Drug Administration (FDA), “These standards help ensure levels of ethylene oxide on medical devices are within safe limits.”2
Read about more ethylene oxide uses.
Uses & Benefits
Ethylene oxide is most commonly used in the production of other chemicals, including the production of solvents, antifreeze, detergents, adhesives, polyurethane foam, and pharmaceuticals. Ethylene oxide is also used in the following applications:
Product and Industrial Applications
Most ethylene oxide is used as an intermediate in the production of other chemicals used to manufacture products, such as fabrics for clothes, upholstery, carpet and pillows. It is used to produce ethylene glycols for engine antifreeze that keeps our automobiles performing.
Other ethylene oxide derivatives are used in household cleaners and personal care items such as cosmetics and shampoos.
Ethylene glycol, which is derived from ethylene oxide, is used to manufacture fiberglass used in products ranging from jet skis to bathtubs to bowling balls, as well as polyethylene terephthalate (PET) plastic resin to make beverage containers and packaging film.
Ethylene oxide derivatives are used as ingredients in industrial cleaners, heat transfer liquids, polyurethanes and plasticizers.
Medical Applications
Ethylene oxide sterilization processes can sanitize medical and pharmaceutical products that cannot support conventional, high-temperature steam sterilization procedures. Delicate, heat-sensitive medical devices that incorporate plastics and electronics could be warped or otherwise damaged by steam sterilization. A low-temperature sterilizer, ethylene oxide gas will not damage these types of medical devices.3
Ethylene oxide also is used to sterilize other healthcare products, such as bandages and ointments, reducing potential damage to the product that may occur from other means of sterilization.
Approximately 50 percent of medical supplies are sterilized with ethylene oxide, making it critical to the U.S. healthcare industry.4
Safety Information
Ethylene Oxide Exposure
Any potential association between ethylene oxide and cancer is linked only to chronic exposure. There is minimal health risk for the general population because most people are not exposed to significant quantities of ethylene oxide.
The Occupational Safety and Health Administration’s (OSHA) ethylene oxide standard requires employers where ethylene oxide is present in the workplace to monitor employee exposure.5 Under the OSHA standard, employers must provide appropriate protective clothing and equipment to employees who may be exposed to ethylene oxide. The National Institute of Occupational Safety and Health6 and the American Conference of Governmental Industrial Hygienists7 also provide guidance for industrial exposure to ethylene oxide.
Regulations
Industrial sources of ethylene oxide emissions to the atmosphere are regulated under EPA’s National Emission Standards for Hazardous Air Pollutants (NESHAP) rules.8 These standards require, among other things, installation of control devices to reduce emissions, emissions monitoring, performance testing, site-specific operating parameters, and continued reporting and recordkeeping. The 2014 EPA National Emissions Inventory (NEI) reported a downward trend in national ethylene oxide emissions for the industrial sector (from 716.49 tons per year in 2002 to 153.16 tons per year in 2014).
Additionally, companies that make and work with ethylene oxide invest in research and product stewardship technologies so that they can continue to help protect communities, with advanced technologies to track and manage emissions. Manufacturers also share best practices for responsibly producing, shipping, and handling ethylene oxide.
Sources
- AdvaMed: https://www.advamed.org/industry-updates/hot-topics/sterilization-ethylene-oxide/
- FDA – https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices
- CDC – Disinfection and Sterilization: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html
- FDA – https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures
- OSHA – Occupational Safety and Health Administration’s (OSHA) ethylene oxide standard
- NIOSH – https://www.cdc.gov/niosh/npg/npgd0275.html
- American Conference of Governmental Industrial Hygienist – https://www.acgih.org/
- EPA – EPA’s National Emission Standards for Hazardous Air Pollutants (NESHAP)
- Research Gate – https://www.researchgate.net/publication/24415937_Mortality_Study_Update_of_Ethylene_Oxide_Workers_in_Chemical_Manufacturing_A_15_Year_Update
- Fox News West Michigan – https://www.fox17online.com/2019/07/24/state-no-unusual-cancer-stats-near-grand-rapids-medical-manufacturer/
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