Editor's Note:  Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…

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Editor's Note Introduced by a bipartisan group of Senators, the Healthcare Cybersecurity Act aims to bolster the cyber-defenses of healthcare entities through the collaboration of the U.S. Department of Health and Human Services (HHS) and the Cybersecurity and Infrastructure Security Agency (CISA). According to a July 16 report in HealthExec,…

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Editor's Note Epic has the largest market share for hospital electronic health record (EHR) systems in the world, according to a July 8 report from Becker’s Health IT. The company took the top spot after adding 203 hospitals and 24,117 beds outside the U.S. in 2023, with significant growth in…

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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 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 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 Alarm failures and missing details in instructional materials prompted the US Food and Drug Administration (FDA) to issue class 1 recalls—the most severe category indicating risk of serious injury or death—for two different ventilator models on June 27. According to the report, failure in the Ventilator Inoperative alarm…

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Editor's Note Using a device they call a “space hairdryer,” researchers in Austria applied gentle shockwaves to regenerate heart tissue after coronary artery bypass graft surgery (CABG) in a study with potential implications for millions of patients, BBC News reported June 20. Researchers are now seeking larger trials, European regulatory…

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