The Centers for Disease Control and Prevention yesterday released a draft toxicity profile of ethylene oxide (EtO) that treats it as a more far-reaching health threat than the Environmental Protection Agency does. The EPA and the federal Department of Health and Human Services both consider EtO a human carcinogen. The medical device industry relies on […]
U.S. Environmental Protection Agency
Federal rule on ethylene oxide now delayed until 2021
The final federal rule limiting ethylene oxide (EtO) emissions from commercial medtech sterilization plants is now set to come out in 2021, according to the Environmental Protection Agency. Before the COVID-19 pandemic struck, the EPA had expected to issue the rule in May 2020. The agency considers ethylene oxide a carcinogen, and EtO emissions have attracted national […]
6 Georgia residents suing Sterigenics, BD over ethylene oxide exposure
The first six of what attorneys said could be more than 100 lawsuits were filed recently in Georgia against Sterigenics and Becton Dickinson (NYSE:BDX) by people who have lived, worked or attended school near those companies’ medical device sterilization plants. The plants use ethylene oxide (EtO) to sterilize millions of devices per year and reportedly have emitted thousands pounds of the […]
Dems seek to force EPA action on ethylene oxide monitoring
Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from plants that manufacture the toxic gas or use it to sterilize medical devices. The Public Health Air Quality Act of 2020, sponsored by Sen. Tammy Duckworth (Ill.) and Rep. Lisa Blunt Rochester […]
BD Georgia sterilization plant leaked 54 lbs. of ethylene oxide in September
A weeklong valve leak at a Becton Dickinson (NYSE:BDX) medtech sterilization plant in Covington, Ga., released 54 lbs. of ethylene oxide into the air, according to a City of Covington incident report obtained by a local TV station. The plant began experiencing intermittent elevated levels of EO indoors Sept. 15, but inspections and systems checks failed to locate the […]
A ‘rolling effect’ on medtech sterilization plants?
The types of regulatory hurdles that contributed to the permanent closure this week of the Sterigenics medtech sterilization plant in Willowbrook, Ill., have created a “rolling effect” on ethylene oxide (EO) plants around the country, according to an industry official. The state of Illinois temporarily shut down the Willowbrook plant in February over emissions of EO, a […]
U.S. EPA readies new rule on EO emissions
This article has been updated with a comment from AdvaMed. The U.S. Environmental Protection Agency will require medtech sterilization companies to provide information to help it formulate a new rule governing emissions of ethylene oxide. The EPA recently said that in October, it will ask for data on specific sterilization facility characteristics, control devices, work practices […]
Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives
The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide (EO), even though a major EO plant is slated to reopen. Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in […]