FDA designates Class 1 recall for angiographic catheter
Editor's Note The US Food and Drug Administration (FDA) has designated Cook’s recent recall of the Beacon Tip 5.0 Fr Angiographic Catheter as a Class 1, the most severe category indicating serious risk of injury or death. The recall was reportedly motivated by reports of tip separation both prior to…
Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula
Editor's Note The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of…
FDA designates Class 1 recalls for aspiration catheter, infusion accessory, endotracheal tubes
Editor's Note The US Food and Drug Administration (FDA) has issued three Class I medical device recalls—the most severe category indicating risk of serious injury or death—for Q’Apel Medical Inc.’s HIPPO 072 Aspiration System and Cheetah catheter, Fresenius Kabi USA’s Blood Products Administration Set with 200 Micron Filter, and Medline…
Revised sterilization standards demand urgent attention from perioperative leaders
Editor's Note New and revised sterilization and reprocessing standards are reshaping the landscape for sterile processing departments, placing greater emphasis on chemical modalities, device-specific protocols, and system-wide quality management, according to the Healthcare Purchasing News May 27 update on compliance and standards. Among the most significant developments is the overhaul…
FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate
Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2, Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…
FDA publishes Baxter update to Novum IQ infusion pump instructions addressing underinfusion risk
Editor's Note Baxter has issued a correction notice for its Novum IQ Large Volume Pump (LVP) after identifying a serious risk of underinfusion linked to the device’s standby mode and power-off conditions. First published on April 24 on the Food and Drug Administration (FDA) website and subsequently reported by Healthcare…
Standards strengthen sterilization, disinfection process chains
Preventing infection from contaminated surgical tools requires attention to every link in a complex chain of processes, from point-of-use pretreatment in the OR to the moment the freshly disinfected or sterilized item arrives at the next patient’s bedside. For those on the front lines, manufacturers’ written instructions for use (IFUs)…
AR headsets are reshaping OR operations with lower costs, higher precision
Editor's Note Surgeons across top US health systems are swapping traditional monitors and even robotic systems for augmented reality (AR) headsets, which are streamlining procedures, enhancing precision, and slashing costs, Modern Healthcare May 27 reports. As detailed in the article, AR headsets are rapidly emerging as valuable surgical tools. From…
Medtech giants move fast to blunt tariff impact without raising prices
Editor's Note Medtech companies are scrambling to contain the financial damage from rising tariffs without passing costs onto hospitals, according to a May 2 report in Modern Healthcare. Executives from industry leaders including Johnson & Johnson, GE HealthCare, and Intuitive Surgical outlined mitigation efforts during recent earnings calls, with most…
Telemedicine transforms postoperative care through safer, faster, patient-centered recovery
Editor's Note Telemedicine is rapidly becoming the standard for postoperative care, offering patients a safer, more convenient recovery experience without compromising clinical outcomes, according to an April 28 report in the Los Angeles Times. The outlet emphasizes that virtual consultations and remote monitoring are no longer just alternatives to in-person…
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