Halyard Health (NYSE:HYH) is battling a 60 Minutes story from CBS accusing Halyard of providing defective Microcool surgical gowns, meant to protect workers from blood transmitted diseases, to health care workers during the Ebola outbreak of 2014. The show reported that the gowns, which are recommended by the Centers for Disease Control and have AAMI Level […]
Sterilization / Calibration
BD launches Genesis low-temp sterilization containers
Becton Dickinson & Co. (NYSE:BDX) said today it launched its Genesis low temperature rigid sterilization container system designed for surgical instrument sterilization. The Genesis container system is validated for low-temperature sterilization processes and systems from sterilizer manufacturers, Franklin Lakes, N.J.-based BD said. “Our new containers have the same trusted functionality that our customers in the sterile […]
Sterigenics acquires Nelson Labs
Sterigenics said yesterday it picked up microbiology testing service provider Nelson Laboratories for an undisclosed amount. Salt Lake City, Utah-based Nelson Labs provides microbiology testing services for the medical device, pharmaceutical and tissue industries and employs 570 individuals, including 300 scientists and 60 registered specialist microbiologists. “This is a significant strategic acquisition to help build out […]
B. Braun, ICU Medical ink long-term distro deal
ICU Medical (NSDQ:ICUI) said today it inked a long-term distribution deal with B. Braun Medical for ICU’s SwabCap disinfecting cap for needlefree connectors for select countries outside the U.S. San Clemente, Calif.-based ICU Medical’s SwabCap is a disposable cap designed for disinfecting needlefree connectors with 70% isopropyl alcohol when attaching them to an intravenous catheter. “We look […]
Olympus updates reprocessing instructions for Duodenoscopes
The FDA yesterday released updated reprocessing instructions it received from Olympus (TYO:7733) in relation to its TJF-160F and TJF-160VF duodenoscopes. Olympus has been working on refining its reprocessing instructions since March last year, the FDA said, and only in January did the agency clear the updated reprocessing models as adequate. The updated reprocessing instructions include a […]
FDA warns SureTek on sterilization, QC issues
The FDA issued a warning letter it sent to single use device reprocessor SureTek Medical earlier this month over issues with the company’s cleaning and validation processes. The letter was in response to an inspection performed between October and November last year, which SureTek Medical responded to 3 times to address the federal watchdog’s concerns […]
Cantel Medical closes $13.5m buy of NAMSA’s sterility assurance biz
Cantel Medical (NYSE:CMN) said today it closed its $13.5 million buy of North American Science Associates sterility assurance business, which Cantel said it plans to fold into its Crosstex division. The NAMSA operation, which posted sales of $5.7 million last year, makes biological and chemical indicators designed to monitor the effectiveness of sterilization procedures. Little Falls, […]
Cantel Medical buys NAMSA’s sterility assurance biz for $14m
Cantel Medical (NYSE:CMN) and North American Science Associates said they agreed to a $13.5 million cash deal for NAMSA’s sterility assurance business, which Cantel said it plans to fold into its Crosstex division. The NAMSA operation, which posted sales of %5.7 million last year, makes biological and chemical indicators designed to monitor the effectiveness of sterilization procedures. […]
Stericycle agrees to $29m settlement in False Claims Act case
A federal judge in Illinois yesterday approved a settlement agreement between Stericycle (NSDQ:SRCL) and the plaintiff in a whistleblower lawsuit accusing the medical waste disposal company of overbilling federal and state governments to the tune of some $13.6 million. Jennifer Perez, a government customer relations specialist at Lake Forest, Ill.-based Stericycle from 2004 until March 2008, filed a qui tam lawsuit […]
FDA to offer webinar on new final guidance on sterility
The FDA said yesterday it will host a webinar covering newly released guidance concerning sterilization. The federal watchdog yesterday issued a final guidance on sterilization, outlining adequate sterilization methods for sterile-labeled 510(k) devices and the appropriate documentation necessary for the premarket review of novel sterilization processes. The Agency said its final guidance also included details […]
Steris gains on post-Synergy merger outlook
Steris (NYSE:STE) shares are up nearly 8% since the company last week issued its 1st post-merger guidance since its $2 billion merger with the U.K.’s Synergy Health, as investors reacted to a top-line growth forecast of 21% to 22% for fiscal 2016. Mentor, Ohio-based Steris closed the Synergy merger Nov. 2 in a so-called inversion deal, in which it re-incorporated as a […]