Editor's Note The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death. According to FDA’s July 15 announcement, the ventilator…

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Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…

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Editor's Note Electricity outages caused by Hurricane Beryl in Houston and southeast Texas forced healthcare providers to hold discharged patients longer because their homes lacked power, the Texas Tribune reported July 10. Several hospitals had difficulties accommodating new patients, leading to delayed discharges, ambulance shortages, and a backup in 911…

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Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…

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Editor's Note Healthcare industry groups are calling for the federal government to streamline and ease the recently proposed cybersecurity incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA), Fierce Healthcare reported July 8. According to the report, CISA's proposal imposes enhanced reporting requirements for critical infrastructure entities, including…

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Editor's Note On June 27, The Justice Department announced the 2024 National Health Care Fraud Enforcement Action, leading to criminal charges against 193 defendants, including 76 medical professionals across 32 federal districts in the U.S. for their involvement in various health care fraud schemes. These schemes accounted for approximately $2.75…

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Editor's Note Research presented at this year’s Digestive Disease Week in May highlights the potential health risks posed by smoke generated during tissue-cutting ablations in gastrointestinal (GI) endoscopy, Gastroenterology & Endoscopy News May 18 reports. Unlike surgeons in ORs, who follow specific regulations to mitigate smoke exposure, GI endoscopy procedures…

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Editor's Note Although SecurityScorecard gave the US healthcare a “better than expected” B+ rating for cybersecurity in 2024, the supply chain cybersecurity firm also highlighted significant risks in application and endpoint security, HealthcareIT News reported June 25.   Overall, 35% of third-party data breaches in 2023 affected healthcare organizations, the…

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Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…

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Editor's Note Amid continued debate about the best choice of preoperative skin antiseptic, findings published in JAMA June 17 show that povidone iodine in alcohol offers similar outcomes to chlorhexidine gluconate when used in alcohol. The randomized clinical trial included 3,360 patients in 3 tertiary care hospitals in Switzerland, 2,187…

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