During medical device manufacturing, sterilization is performed to ensure the equipment can be safely used. While there are many sterilization methods, ethylene oxide is used for approximately 50% of devices in general health care and specialized treatments. This guide will explain why this chemical is so prevalent and why the Food and Drug Administration (FDA) is attempting to phase it out. 

Why Is Ethylene Oxide the Primary Medical Device Manufacturing Sterilization Method?

Today, many medical devices are made from plastic, resin, metal, or glass or have multiple layers of packaging or hard-to-reach areas. Ethylene oxide, a flammable, colorless gas, is widely used to sanitize these products because, unlike other methods—such as steam, dry heat, or vaporized hydrogen peroxide—it can safely penetrate the materials without damaging them.

The FDA ensures devices are effectively sterilized before the products go on the market by requiring manufacturers to validate their process and comply with agreed-upon international standards. Currently, there are two voluntary consensus standards for ethylene oxide sterilization that describe how to apply the chemical and the acceptable residual levels allowed to remain on the device after being sterilized. 

Why Is the FDA Attempting to Phase Ethylene Oxide Out?

There have been growing concerns about ethylene oxide’s effects on people who are exposed to the chemical. In the short term, the chemical can irritate the eyes and mucous membranes and cause central nervous system (CNS) depression, which is what happens when the body’s normal neurological functions slow down. Chronic long-term exposure can lead to skin, nose, throat, and lung irritation as well as brain and nervous system damage. 

The Environmental Protection Agency (EPA) has also ruled that ethylene oxide is a carcinogen—long-term occupational exposure increases the risk of lymphoid and breast cancer. Additionally, as the nonodorous emissions can last in the air for weeks and travel in the wind, the people outside of manufacturing operations can be exposed to it. 

What Are Some Proposed Alternatives?

The FDA has been encouraging academics to come up with new sterilization methods and materials. While options like nitrogen dioxide sterilization and supercritical carbon dioxide sterilization are being tested, no endorsed alternatives are currently available. 

Eliminating ethylene oxide without a proven alternative would result in a massive supply shortage that would put many people in danger. In the meantime, the FDA and EPA are focused on reducing ethylene emissions and ensuring medical device manufacturers meet safety standards.

Ensure your health care facility is in good hands by choosing medical devices produced by Pacific Integrated Manufacturing in Bonita, CA. For over 20 years, they've been the manufacturing company the health and science industry can trust. They offer plastic injection molding and have white rooms specifically for sterilization management. Visit their website to learn more about their services, and call them today at (619) 921-3464 to discuss your project.