Key takeaways:
- There’s still a growing concern about the exposure to EO with medical device sterilization.
- Regardless of sterilization type, securing vendors has become increasingly more difficult over the past 5-10 years.
- In some cases, X-ray is the more preferred process over EO as well as gamma, which requires the difficult-to-source Cobalt-60 radioactive isotope.
Once released into the air, ethylene oxide (EO) becomes a gaseous wild card. At high-enough concentrations, the colorless, flammable vapor produces a sweet scent that would be easily noticeable. But due in part to increased regulatory scrutiny by the U.S. Food and Drug Administration (FDA) and U.S. Environmental Protection Agency, it’s emitted at smaller amounts that are not as easily detectable. Although it can trigger acute symptoms of respiratory irritation, such as coughing, wheezing, and shortness of breath, short-term exposure to EO does not typically cause significant health maladies — which ironically contributes to the danger it presents to human health and the planet when it’s used to sterilize medical devices.
“There’s still a growing concern about the exposure to EO with medical device sterilization,” says Christy Norman, senior director of quality and regulatory compliance at BioLab Holdings, Mesa, AZ, a biotechnology company that develops and manufactures wound care products.
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