FDA draft guidance addresses pulse oximeter accuracy, AI devices
Editor's Note The US Food and Drug Administration (FDA) has issued new draft guidance January 6 providing recommendations improving the use of pulse oximeters and supporting the safety of AI-enabled medical devices, among other topics. Released January 6, draft guidance supporting the safety and effectiveness of AI-enabled devices would, if…
Why active implants demand proactive management
What happens when a surgeon uses the monopolar instrument set on 30-W coagulation mode to create an upper midline incision in a patient with a pacemaker? Pacemaker function is interrupted, causing a heart block that results in hemodynamic instability—or at least, this is what could happen without taking the necessary…
FDA designates Class 1 recalls for balloon catheters, radiographic markers
Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…
Infusion pump problems prompt early FDA safety warning
Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…
AI risks top ECRI’s 2025 list of health technology hazards
Editor's Note Artificial intelligence (AI) enabled technologies present the greatest technology risk to healthcare organizations in 2025, according to the latest list from ECRI, a nonprofit organization dedicated to safety in the industry. As detailed in the organization’s December 4 announcement, the annual report highlights critical risks that healthcare organizations…
FDA designates Class 1 recall for insulin syringes
Editor's Note The US Food and Drug Administration (FDA) designated Cardinal health’s recall of certain lots of the Monoject U-100 1 mL Syringe Luer-Lock with Tip Cap Soft Pack a Class 1, the most severe recall category indicating serious risk of injury or death. The product is designed to administer…
Medical device coating could reduce blood clot risks
Editor's Note Researchers at the University of British Columbia (UBC) say their newly created coating could enhance the safety of medical devices by reducing the risks of thrombosis and excessive bleeding in patients. As reported November 30 in Fox News, researchers' findings, published in the journal Nature Materials, highlight how…
FDA pilot program aims to expedite high-risk medical device recall communication
Editor's Note The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness…
FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators
Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…
Practice updates ease steam sterilization balancing act
Reliable and robust enough for daily use on most medical devices, steam is the most common sterilant in healthcare facilities. However, using steam properly requires a balancing act. For example, too much moisture can lead to wet packs, while steam that is too dry might not be sufficient to achieve…
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