As a toxicologist, I have followed the Environmental Protection Agency’s work on ethylene oxide (EtO) closely, and am concerned about how the recent article titled “A Dirty Business: How the medical device sterilization process sickens some to heal others” portrays the EPA’s findings on the sterilization of medical devices using EtO. Inaccurate, incomplete information about EtO can have dangerous repercussions for patient access to safe medical devices across the country. It can unnecessarily scare community members about their health.
The article fails to disclose that the EPA uses a “worst-case scenario,” the agency’s own phrase, of continuous exposure for 70 years, 24 hours a day, a highly unlikely scenario in its estimate of EtO’s cancer risk.
The EPA emphasizes that its own models for estimating the safety of ethylene oxide are just that, models, not actual readings outside a commercial sterilization facility. The EPA also doesn’t consider background air levels of EtO, so emissions from sources other than commercial sterilization facilities aren’t a factor in its calculations, even though sterilization plants are far from being the largest source of EtO.
If every commercial sterilization facility closed tomorrow, the public wouldn’t be appreciably safer from EtO emissions. The emissions from the facilities are that small and getting smaller all the time, as new capture technology becomes available, and facilities buy it and install it.
Modern Healthcare seeks to inform its readers, but reporting without context or clarity is more harmful than useful. Your publication should present the full story on this issue going forward.
Lucy Fraiser, Ph.D
Principal toxicologist
Lucy Fraiser Toxicology Consulting
Fayetteville, Arkansas
