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 […]
Sterilization / Calibration
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 […]
Steris beats The Street, announces leadership change
Steris (NYSE:STE) beat The Street on both sales and profits in its fiscal third quarter and announced that CEO Walt Rosebrough will step down July 29, 2021. The Dublin, Ireland-based sterilization and surgical products company posted profits of $114.5 million or $1.33 per share, on sales of $808.9 million for the three months ended Dec. 31, […]
FDA says to limit mask decontamination to 4 cycles
Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media […]
BREAKING: Steris to acquire Cantel Medical in $4.6B deal
Steris (NYSE:STE) announced today that it will acquire Cantel Medical (NYSE:CMD) for $4.6 billion — a major merger in the infection prevention space. The deal is expected to close by June 30, pending customary closing conditions, regulatory approvals and an OK by Cantel shareholders. News of the merger comes a month and a half after Steris closed […]