FDA reports sterilization challenge progress as EPA takes aim at EtO emissions

Ethylene oxide (EtO) gas can penetrate paper and cardboard, doesn’t discolor or harm plastics used in many devices, and can sterilize truckloads of devices at one time. [Photo courtesy of the FDA]

The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities.

The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.

Those innovation challenges are making “encouraging progress,” FDA said, with some facilities cutting EtO emissions by an estimated 20% to 35%.

“In general, manufacturers are targeting an ethylene oxide cycle concentration that is 11-66% less than the typical ethylene oxide concentration range,” the FDA said in a news…

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EPA flags high-cancer-risk EtO sterilization facilities across the country

This map of Richmond, Virginia, shows the EPA’s estimated cancer risk for the area surrounding Sterilization Services of Virginia’s EtO plant. [Image courtesy of the EPA]

The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities.

EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices —  and in some cases it’s the only option. The FDA is seeking safer ways to use EtO and alternative means of sterilization in an effort to reduce EtO emissions due to its cancer risk, particularly blood cancers and breast cancer.

“Exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cance…

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Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia

[Image from U.S. Occupational Health and Safety Administration]

Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city.

The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility over the decades and claim that they never had any notice that they were inhaling air that was potentially endangering their health. Industrial users of EtO, according to the plaintiffs’ lawyers, knew of EtO’s potential dangers by the early 1980s. (The EPA classified ethylene oxide as a human carcinogen in December 2016.)

The people suing KPR U.S. suffered a host of cancers, including breast cancer, B-cell lymphoma, ovarian cancer and colon cancer — as well as miscarriages. In a separately filed l…

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