Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system. The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit […]
EPA
Medline, Sterigenics failed to report EtO emissions to EPA, report says
Two companies that use ethylene oxide (EtO) to sterilize medical devices failed to report emissions of the toxic gas to the U.S. Environmental Protection Agency, according to a report by the Chicago Tribune. Medline Industries and Sterigenics, both headquartered in Illinois, have also operated medtech sterilization operations in the state. Medline continues to do so, and Sterigenics decided in September 2019 not to […]
New ethylene oxide regulations now expected in 2022
The EPA now estimates that it will propose new regulations for medical device sterilizers’ emissions of ethylene oxide (EtO) in 2022. The agency issued an advance notice of proposed rulemaking for the commercial sterilizers in December 2019 but has not produced the proposal. Now the EPA’s inspector general wants the agency to conduct a new residual […]
B. Braun sued in Pa. over ethylene oxide exposure
A Pennsylvania man has filed a lawsuit against B. Braun Medical over emissions of the sterilant gas ethylene oxide (EtO). The man, Adam Akarsoy, lives and works near a B. Braun sterilization plant in Hanover, Pa., and filed the federal lawsuit seeking certification as a class action. Akarsoy claims that B. Braun “has consistently emitted, on average, nearly […]
Medtech sterilization business faces battles on many fronts
As the EPA prepares to issue new regulations for the carcinogenic sterilant gas ethylene oxide, the industry must decide whether to invest in expensive emissions-control upgrades, switch sterilization processes or — in the case of some small sterilization companies — exit the business. Nancy Crotti, Managing Editor In the next few months, the U.S. Environmental […]
11 states ask EPA to crack down on ethylene oxide emissions
Eleven state attorneys general are urging the U.S. Environmental Protection Agency to impose stricter regulations over commercial operations that emit ethylene oxide (EtO), a widely used medical device sterilant gas. The EPA, which considers EtO a carcinogen, has been fielding comments on it in light of public outcry over emissions from medtech sterilization plants during […]
FDA to EPA: Leave us out of your ethylene oxide rule
This article has been updated with comments from the FDA. The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied. In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical device sterilization plants — […]
EPA moves closer to stricter regulation of medtech ethylene oxide sterilization
The Environmental Protection Agency yesterday asked the commercial ethylene oxide (EtO) industry, which includes medical device sterilizers, for input on next year’s updated regulation of emissions of the carcinogenic gas. Specifically, the EPA is requesting comment on available control technologies for reducing EtO emissions and on developments in practices, measurement, monitoring, processes and control technologies for the […]
Congressional task force to press EPA on ethylene oxide emissions standards
Congressmen from Illinois and Georgia have formed a bipartisan task force to pressure the Environmental Protection Agency to place stricter limits on ethylene oxide (EtO) emissions from medtech sterilization and other industrial uses. Illinois Democrat Rep. Brad Schneider and Georgia Republican Rep. Jody Hice put together the task force in support of a bill Schneider introduced in […]
Federal agencies will control the fate of medtech’s most-used sterilization method
The fate of the medical device industry’s most widely used sterilization process lies in the hands of the Environmental Protection Agency. The EPA gave the medtech industry mixed signals in November about the gas used to sterilize billions of devices annually. The agency said it might seek to cut industrial emissions of ethylene oxide (EtO) […]
EPA proposes drastic cuts to EtO emissions nationwide
The EPA has announced plans to greatly reduce industrial emissions of ethylene oxide (EtO), the carcinogenic gas used to sterilize billions of medical devices annually. The agency proposed cutting EtO emissions from industrial facilities by 93% as part of amendments to the Miscellaneous Organic Chemical Manufacturing National Emission Standards for Hazardous Air Pollutants (NESHAP) to reduce hazardous […]
