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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 pump

Heart Valves/Pacemakers

first aid kit

Surgical Kits

hospital gown

Gowns & Drapes

ventilator machine

Ventilators

syringe

Syringes

catheter

Catheters

 

 

Key Facts

monitoring device More than 50 percent of all medical device types are sterilized using EtO, totaling more than 20 billion devices annually.

 

water passing Most surgeries involve at least one device that has been sterilized by EtO. 

 

molecular diagram 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. 

 

explanation point on notepad 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 Information

Fact Sheet: Essential Devices Sterilized by Ethylene Oxide

Managing Ethylene Oxide: An Air Quality Professional's Perspective - The Heartland Institute

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

Regulatory Comments

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

What The Scientific Experts Are Saying About EtO

"[T]here is no cancer threat from the tiny amounts of ethylene oxide released from these sterilization plants."

— Gail Charnley, PhD, Senior Toxicologist, HealthRisk Strategies LLC

 

"To be clear – there are no actual scientific data that show that these [EtO] exposure levels result in cancer."

— Lucy H. Fraiser, board-certified toxicologist (Diplomate of the American Board of Toxicology)

 

"Ethylene oxide has been, and is, extensively regulated. The rules that EPA first put into place to establish ethylene-oxide sterilization procedures were carefully designed and extremely stringent... As a result of these regulations, ethylene-oxide emissions remain incredibly low—far lower than a number of other potentially harmful HAPs, in fact."

— Richard J. Trzupek, The Heartland Institute

 

"…Ethylene oxide is a commonly used method of medical device sterilization. It’s considered a safe and effective method that helps ensure the safety of medical devices and helps deliver quality patient care."

— Dr. Scott Gottlieb, former FDA commissioner

 

"There are avenues that might lead to replace ethylene oxide, but the standards aren’t there yet. If we’re going to get rid of [EtO] it’s going to take 10-20 years."

— Gary Secola, president, HIGHPOWER Validation Testing & Lab Services; member of FDA’s General Hospital and Personal Use Panel of the Medical Devices Advisory Committee

 

"If there’s an ubiquitous ban on ethylene oxide today, we’re going to have a health crisis on our hands, because in very short time and order, sterile products won’t be available, and we don’t have an alternative to replace that today."

— Marcus Schabacker, MD, PhD, President and CEO, the ECRI Institute

 

"Currently, there are no validated industrial sterilisation alternatives that could completely replace EtO sterilisation, so additional closures of EtO processing facilities would have the potential to impair the U.S. healthcare system."

— Dr. Amanda Sivek, principal project engineer, health devices, also of the ECRI Institute