Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).
Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide). Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. Learn more about sterilization methods in the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance.
For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide.
Literature shows that about fifty percent1,2,3 of all sterile medical devices in the U.S. are sterilized with ethylene oxide. The types of devices that are sterilized with ethylene oxide range from devices used in general health care practices (for example, wound dressings) to more specialized devices used to treat specific areas of the body (for example, stents).
For ethylene oxide sterilization, two voluntary consensus standards (ANSI AAMI ISO 11135:2014 and ANSI AAMI ISO 10993-7:2008(R)2012) describe how to develop, validate, and control ethylene oxide sterilization processes for medical devices and the acceptable levels of residual ethylene oxide and ethylene chlorohydrin left on a device after it has undergone ethylene oxide sterilization. These standards help ensure levels of ethylene oxide on medical devices are within safe limits since long-term and occupational exposure to ethylene oxide has been linked to cancer. Learn more about the risks of ethylene oxide on the National Institutes of Health web page on ethylene oxide.
State health departments inspect health care facilities that use ethylene oxide to sterilize medical devices. Learn more about guidelines for sterilization in health care facilities on the Centers for Disease Control and Prevention web page.
The US Environmental Protection Agency (EPA) reviews and enforces the Clean Air Act regulations for sterilization facilities that emit ethylene oxide to ensure that they protect the public from significant risk. Learn more about the EPA's Regulations for Ethylene Oxide on EPA's website.
One recommendation from the advisory committee meeting is for device manufacturers to begin, as soon as possible, reducing the amount of paper (such as the labeling and instructions for use manuals) that is included in the sterile device package. An ethylene oxide sterilized medical device must be sealed in a carefully designed gas-permeable package that enables the ethylene oxide gas to enter. When the sterilization load (encompassing all the materials inserted into the sterilizer chamber with the device) includes a large amount of paper with the device, it hinders the ethylene oxide getting to the device and generally means that more ethylene oxide is required. Because of this, the FDA is encouraging device manufacturers to move to electronic materials where feasible and safe for device users. We are committed to working with industry to make this change.
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
Ethylene Oxide (EtO) is a flammable, colorless gas used to make chemicals. Those chemicals are then used to make lots of products we buy, such as cloths, woven fabrics, products made of plastic and cleaning products. Ethylene oxide is also used to sterilize medical equipment and devices. EtO is considered a hazardous air pollutant under the Clean Air Act, which means scientists believe too much exposure to EtO may cause cancer or other serious health problems. The Environmental Protection Agency (EPA) has had a rule since 1994 that says what companies that use EtO to sterilize medical equipment and devices must do to control how much EtO is put into the air.
Ethylene oxide may harm workers, and the harm it may cause varies depending on the situation. Possible harm can involve how much ethylene oxide a worker is exposed to, how long the worker is exposed, and what the worker is doing.
Today, U.S. Representatives Brad Schneider (D-IL-10) and Jody Hice (R-GA-10) announced the formation of a bipartisan congressional task force focused on addressing the threat of ethylene oxide (EtO) emissions and urging the U.S. Environmental Protection Agency (EPA) to act.
Ethylene oxide is an industrial chemical used to sterilize medical equipment and manufacture products such as anti-freeze. In 2016, the EPA listed EtO as a known carcinogen, however the agency has yet to release a rule regulating the use of the chemical by medical sterilizers, nor has the agency engaged with communities affected by EtO emissions. This inaction has created public concern in communities surrounding facilities that use EtO, including sites in Waukegan and Gurnee in the 10th Congressional District (Schneider) and one site in Georgia's 10th Congressional District (Hice).
\"My constituents are rightly concerned about emissions of ethylene oxide, and that is why we need the U.S. EPA to release science-based rules and educate the public on the threat of EtO so that local families can have confidence in the air they breathe,\" said Congressman Schneider. \"With my colleagues in the Illinois congressional delegation, I have urged the U.S. EPA to do its job, but this is a problem with scope beyond just our state. I am thrilled to form this bipartisan congressional task force with my colleague Jody Hice to coordinate the federal response of communities across the country to this threat and concentrate pressure on the U.S. EPA to act. Public health is not a partisan issue, and we will be working to expand our task force with more affected communities.\"
There are, however, some promising alternatives that could be used in place of ethylene oxide. FDA needs to continue to prioritize the development of methods for sterilization processes including using radiation, vaporized hydrogen peroxide, and vaporized paracetic acid to help ease the transition away from ethylene oxide and make our communities safer.
Ethylene oxide (EtO) is a flammable, colorless gas used to make other chemicals necessary in the production of a range of products, including antifreeze, textiles, plastics, detergents and adhesives. Ethylene oxide also is used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment.
Evonik manufactures specialty chemicals, primarily sold as components to formulators and commonly known as surfactants. Surfactants are compounds that lower the surface tension between two liquids, a liquid and a gas or a liquid and a solid. The resulting products are used as components in household, industrial and institutional cleaners as well as mining, roof coatings, asphalt and other industrial applications. This facility is regulated under Wisconsin's state air toxics rule (NR445) [exit DNR], and the state has worked with the this location since 2010 to reduce emissions and obtain the best annual emission estimates for ethylene oxide (EtO).
CARB identified ethylene oxide as a toxic air contaminant in 1987. Subsequently, in 1990, CARB adopted an airborne toxic control measure (ATCM) to reduce ethylene oxide emissions from applicable commercial and non-commercial sterilyzers and aerators in California. The ATCM includes control and compliance requirements for facilities that use ethylene oxide. See the supporting documents below.
The Delaware Memorial Bridge was closed to traffic as a precautionary measure due to the potentially hazardous nature of ethylene oxide, which is flammable and toxic. The bridge was cleared to be reopened at approximately 11:05 p.m. after the release had been stopped. The decision was made by the Incident Commander.
Based on the results of the investigation, the use of an improper flange gasket in the construction of the EO Plant was the cause of the release on November 25, 2018. Throughout the incident, a water deluge system was used to minimize the ambient air concentration of ethylene oxide and to minimize the risk of explosion or ignition of the released ethylene oxide.
Ethylene oxide (C2H4O) is a flammable, colourless gas at temperatures above 10.7 Degrees Centigrade C that smells like ether at toxic levels. We have a wide variety of ethylene oxide gas detector available. Our ethylene oxide detectors use industry leading long life sensor technology and our ground breaking Sentinel+ addressable communication. See below to learn more about ETO and our detector options. Click here to contact our team today.
It is also used as a fumigant in certain agricultural products. As a poison gas that leaves no residue on items it contacts, pure ethylene oxide is also employed as a sterilant for medical equipment and supplies that cannot support conventional high temperature steam sterilisation. Examples are devices that incorporate electronic components, plastic packaging or plastic containers. It also infiltrates packages as well as products themselves to kill micro organisms that are left during production or packaging processes.
EPA hosted a virtual Lakewood community meeting on Sept. 22, 2022. EPA presented their 2022 ethylene oxide risk modeling analysis for the Terumo BCT Sterilization Services facility. This map outlines the area EPA estimates to have greater than 100 in a million estimated lifetime cancer risk from breathing air containing ethylene oxide from the facility. This estimate is a worst-case scenario based on an individual breathing outdoor air 24 hours a day, 7 days a week, for 70 years. Actual risk depends on how close people are, how much ethylene oxide they breathe, and how long they are in this area. These estimates cannot predict whether an individual person will develop cancer, but indicate an elevated risk based on the exposure outlined above. 59ce067264