Owens & Minor (NYSE:OMI) company ArcRoyal issued an urgent field safety notice in Europe to warn of an issue with ethylene oxide (EtO) residue in custom procedure trays that contain an insufflation tubing set with gas from Karl Storz. Karl Storz initiated the recall, noting that the affected products contained increased residues of the carcinogenic sterilant […]
Medline Industries temporarily halts EtO sterilization at Illinois plant
This article has been updated with a comment from Medela. Medline Industries has temporarily closed its Waukegan, Ill., medical device sterilization operation to install nearly $10 million in emissions upgrades. The privately owned company uses the carcinogenic gas ethylene oxide (EtO) to sterilize its own and other companies’ devices at the plant. Medline did not […]
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 — […]
MD&M West exhibitors you need to know
MD&M West — set for Feb. 11-13, 2020 — is billed as the largest medical device manufacturing event in the world. Now in its 35th year, it showcases hundreds of industry suppliers and attracts thousands of medical device industry insiders. Strolling around the show floor at the Anaheim Convention Center, in Anaheim, Calif., visitors will see […]
BD acknowledges second EtO warehouse in Georgia
Becton Dickinson (NYSE:BDX) failed to disclose to Georgia environmental officials a warehouse that it has leased since May to store medical devices sterilized with ethylene oxide (EtO), the company said on Friday. BD notified the Georgia Environmental Protection Division (EPD) of its use of the 40,000-square-foot warehouse in Covington, Ga., on Friday after the agency cited […]
Georgia cites BD for warehouse ethylene oxide emissions
Georgia state officials claim that Becton Dickinson (NYSE:BDX) has been operating a medical device warehouse without an air quality permit. The Covington, Ga. warehouse stores devices that have been sterilized using ethylene oxide (EtO), a carcinogenic gas. BD signed a consent order with the Georgia Environmental Protection Divisoin (EPD) in October, agreeing to aerate EtO-sterilized devices for 24 hours […]
Conformis warned on sterilization cycle failures
The FDA has issued a warning letter to Conformis (NSDQ:CFMS) about the number of failures in the company’s Wilmington, Mass. vaporized hydrogen peroxide (VHP) system, the company said in a regulatory filing. VHP is used in low-temperature sterilization and is compatible with a wide range of medical instruments and materials, including polypropylene, brass and polyethylene. Unlike ethylene oxide, a […]
Sterigenics’ legal troubles mount in Illinois
Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs. That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five firms involved in the […]
Report: EtO blood levels higher in Illinois neighbors of Medline sterilization plant
This article has been updated with comments from Medline Industries. People who live about a mile away from a Medline device sterilization plant in Waukegan, Ill. have blood levels of the cancer-causing gas ethylene oxide that are about 50% higher than those who live farther away, according to a report by WebMD and Georgia Health News. Environmental health researchers from the […]
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 […]
Viant to cease ethylene oxide sterilization at Michigan plant by year’s end
Viant Medical has signed a consent order to stop sterilizing medical devices using ethylene oxide (EtO) at its plant in Grand Rapids, Mich. by Dec. 31, 2020, according to the Michigan Department of Environment, Great Lakes, and Energy (EGLE). Viant also agreed to stop using ethylene oxide (EtO) at the plant by Jan. 31, to conduct monthly air […]
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