The FDA has issued an emergency use authorization for the Battelle Critical Care Decontamination System, which can decontaminate tens of thousands of respirator masks per day so that health personnel can reuse them. The Columbus, Ohio-based nonprofit tech development company announced on March 28 that it began rapid manufacturing of its system to decontaminate N95 […]
Medline reopens Illinois medtech sterilization plant
Medline Industries resumed sterilization operations at its Waukegan, Ill., plant on Friday, following state certification of the company’s $10 million in emission-control upgrades, the company announced. The Waukegan plant reopening follows the decision this week by officials in Cobb County, Ga., to allow an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize devices and products […]
FDA clears new Conformis VHP sterilizers
Conformis (NSDQ:CFMS) has secured an FDA 510(k) clearance for its new vaporized hydrogen peroxide (VHP) sterilizers, the company said in an SEC filing filed this week. In December 2019, Conformis announced that it received a warning from the FDA regarding issues related to the VHP sterilizers that it uses as an alternative sterilization method for a […]
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 […]
Sterigenics accused of moving $1.3 billion to avoid ethylene oxide payouts
Attorneys for Illinois plaintiffs suing Sterigenics claim the company deliberately shuffled $1.3 billion in assets to investors to avoid compensating people sickened by exposure to ethylene oxide (EtO). The attorneys representing 75 people who lived or worked near the company’s now-shuttered Willowbrook, Ill., medtech sterilization plant filed an amended complaint in Cook County, Ill. on […]
Owens & Minor’s ArcRoyal warns of excess ethylene oxide in tubing sets
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 […]
- 1
- 2
- 3
- …
- 16
- Next Page »
