Steris (NYSE:STE) shares ticked up today on fourth-quarter financial results that came in just ahead of the consensus forecast. The infection prevention technology company — headquartered in Dublin, Ireland and run operationally out of Mentor, Ohio — posted profits of $52.3 million, or 52¢ per share, on sales of $1.2 billion for the three months ended […]
Sterilization / Calibration
Getinge wins new infection control contract with HealthTrust
Getinge announced today that national group purchasing organization HealthTrust awarded it an infection control contract. According to a news release, the HealthTrust contract allows the organization’s members to have access to Getinge’s infection control product portfolio for the first time in more than a decade. “We are proud that HealthTrust has awarded their respected infection […]
Cardinal Health officials think their new surgical drape could reduce contamination
Cardinal Health (NYSE:CAH) said today that it has launched the first surgical incise drape using the antiseptic chlorhexidine gluconate (CHG). Dublin, Ohio-based Cardinal Health’s surgical drape includes Avery Dennison Medical’s patented BeneHold CHG adhesive technology designed to reduce the risk of contamination with organisms typically associated with surgical site infections. The company said it designed […]
Everything you need to know about medical device creation
Medtech development is hard. Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining — and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement. The good news is that there is now a whole ecosystem of specialized experts serving the […]
Stryker bets that surgeons won’t forget tagged sponges in surgical sites
Stryker (NYSE:SYK) announced today that it launched its next-generation SurgiCount + safety-sponge system. Kalamazoo, Mich.-based Stryker designed its next-gen surgical sponge counting technology as its most intelligent version to allow healthcare providers to count and scan sponges and connect to hospitals’ electronic medical records (EMR). Get the full story at our sister site, Medical Design […]
Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia
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 […]
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 […]
