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 […]
Sterilization / Calibration
Nephros acquires GenArraytion pathogen detection tech
Nephros (Nasdaq: NEPH) announced today that it has acquired almost all of the assets of Rockville, Md.–based GenArraytion. The financial terms of the deal were not disclosed. Nephros officials said the purchase will give their company access to a host of GenArraytion proprietary assays, multiplexing technology, and selection methods for detecting waterborne pathogens and other […]
Italian sterilization plants falsified records for years, FDA says
An Italian medtech sterilization company falsified records of various FDA-regulated products since 2016, the agency said today. The company, Steril Milano, falsified graphs and parameters of sterilization certificates for devices processed at its Reggiolo and Monza ethylene oxide (EtO) plants, the FDA said. Steril Milano on March 9, 2021, announced the temporary closure of the Monza […]
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 […]
FDA tells hospitals: Stop reusing disposable masks
The FDA issued guidance today recommending that healthcare personnel and facilities cease the reuse of disposable masks. According to the recommendations, healthcare personnel and facilities should transition away from crisis capacity strategies like decontaminating or bioburden reducing disposable respirators for reuse. The CDC’s National Institute for Occupational Safety & Health (NIOSH) approved an increased domestic […]
BD plans $65M plant in Arizona
BD (NYSE:BDX) announced today that it will invest $65 million to build a state-of-the-art supply chain hub in Tucson, Ariz. Franklin Lakes, N.J.-based BD’s new 120,000 square-foot facility is slated to become a hub for the company’s supply chain by serving as a final-stage manufacturing and sterilization center, according to a news release. Get the full […]
BD expands recall of ChloraPrep 3 ml applicator
BD announced that it revised a previous press release from last week to expand a voluntary recall of its ChloraPrep 3 mL applicator. Franklin Lakes, N.J.-based BD initiated the recall for specified catalog numbers of the applicator device on June 23, 2020, due to possible fungal contamination under certain environmental conditions, according to a news […]
Calumeo launches dry-heat N95 reprocessor
Calumeo today announced the U.S. launch of a point-of-care N95 mask reprocessing device. The Morgan Hill-Calif.-based company said its Calumeo Clean countertop device uses dry heat to decontaminate N95 masks for reuse, without the use of toxic chemicals. The process takes just over an hour. The device can process six masks at a time and each […]
Sotera Health buys BioScience Laboratories to boost Nelson Labs business
Sotera Health (NASDAQ:SHC) recently announced that it has acquired Bozeman, Mont.–based BioScience Laboratories in a deal that will expand the U.S.-based antimicrobial and antiviral testing capabilities of Sotera Health’s Nelson Labs business. The financial terms of the deal were not disclosed in the March 10 announcement. BioScience Laboratories provides topical antimicrobial product testing in the […]
WellAir acquires UV Innovators, former TransEnterix CEO appointed to corner office
WellAir announced today that it has acquired UV Innovators in a deal that combines WellAir’s FDA-cleared portable air cleaning system with UV Innovators’ medical-grade handheld UVC disinfection technology. The financial terms of the deal were not disclosed. Todd Pope, who has been executive chairman of Cary, N.C.–based UV Innovators since 2017, has been appointed CEO […]
