FDA safety alerts flag cardiac devices
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
Nearly half of hospital patient harm events go unreported, OIG reveals
Editor's Note Nearly half of hospital harm events—particularly surgical events—were not captured by reporting systems, according to a July 30 TechTarget report on new findings from the Office of Inspector General (OIG). The OIG report examined 299 harm events experienced by a nationally representative sample of 770 Medicare patients discharged…
Nurse, technician report reveals burnout, underpayment, safety concerns
Editor's Note A recent article from HIT Consultant highlights findings from Incredible Health’s 2025 State of US Nursing & Technicians Report, revealing mounting strain across the nursing and healthcare technician workforce. Reportedly based on insights from more than 1 million professionals, findings include: 71% of nurses report that staffing shortages…
FDA designates Class I recall for disposable surgical stapler cartridge correction
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement, the recall…
FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
FDA designates Class I recall for mobile lift component
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
FDA issues safety alert for Baxter Novum IQ large volume pumps
Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus). According to the agency’s July 22…
Report: AI, third-party risks open gaps in healthcare cybersecurity
Editor's Note Serious cybersecurity vulnerabilities remain in healthcare despite significant improvements in recent years, according to a July 16 MedCity News report on recent data from cybersecurity firm Fortified Health Security. Fortified’s research, which reportedly draws on NIST CSF data and first–hand experience from the field, assesses the state of…
Keynote preview video: Healthcare's "Blockbuster moment" with Dr Dan Weberg
Editor's Note The nursing profession has an unprecedented opportunity to redesign systems, influence policy, and elevate care—but only if we can shift from traditional models to a future-focused mindset. That's the message of this exclusive preview of the 2025 OR Manager Conference opening keynote with Dan Weberg, PhD, MHI, RN,…
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