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…
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.…
Amid outbreaks, vaccine policy shifts, experts offer practical strategies to safeguard OR staff
Vaccine health has been dominating the news amid ongoing measles and whooping cough outbreaks and high influenza activity last season. It is also on the minds of The Joint Commission surveyors, as the organization has updated infection control standards that took effect in July 2024 for hospitals and critical access…
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…
Proposed HHS, NIH budget cuts reveal administration priorities
Editor's Note The Trump administration’s proposed fiscal year 2026 budget calls for slashing the Department of Health and Human Services (HHS) discretionary budget by $32 billion, a nearly 25% cut that brings the total to $95 billion. Fierce Healthcare reported the news June 2. Although many of the proposed cuts…
FDA launches effort to identify, slash outdated healthcare regulations under 10-to-1 rule
Editor's Note The US Food and Drug Administration (FDA) and US Department of Health and Human Services (HHS) have launched a public Request for Information (RFI) to identify and eliminate outdated healthcare regulations, according to a May 13 press release from the FDA. The move supports a broader federal deregulatory…
FDA fast-tracks generative AI rollout amid growing safety concerns
Editor's Note The US Food and Drug Administration (FDA) is deploying generative AI across all its centers by June 30, aiming to accelerate drug reviews and reduce bureaucratic workload even as experts and critics express worries about data security, reliability, and other safety concerns. Medical Design & Outsourcing reported the…
Power loss risks prompt FDA Class 1 recall designation for heart pump accessories
Editor's Note Sudden, unexpected shutdown and restart prompted the US Food and Drug Administration (FDA) to designate a class 1 recall—the most severe category reserved for serious risk of injury or death—for Abbot’s HeartMate Mobile Power Unit, which powers system controllers for the HeartMate 3 Left Ventricular Assist System (LVAS)…
Augmented reality gains FDA nod, 10k-case milestone in orthopedics, strides in outpatient surgery
Editor's Note Augmented reality (AR) guidance keeps surging in perioperative practice: Pixee Medical just secured FDA 510(k) clearance for its Knee+ NexSight system for total knee arthroplasty, while Augmedics’ xvision platform has already guided 10,000 US spine surgical procedures and is rolling out a new CT-Fluoro registration upgrade. According to…
AI monitoring, remote surgery advance
Editor's Note Recent reporting from Fierce Healthcare highlights two notable technology advances that promise to impact surgical patients and caregivers: an AI-driven blood pressure monitoring system and a remote-controlled endovascular robotics platform. The first development, from BD, is designed to help clinicians anticipate and manage dangerous blood pressure drops during…
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