Tag: Patient Safety

FDA announces Class 1 recalls of ventilator, eye injection kits

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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By: Matt Danford
July 16, 2024
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Trump record, Republican National Convention hint at GOP healthcare policy priorities

Editor's Note As the Republican National Convention meets in Milwaukee to nominate Donald Trump, the party is not expected to unveil a detailed healthcare platform. However, a July 15 report in Modern Healthcare covers what plans and past records reveal about the potential direction of health policy under a GOP…

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By: Matt Danford
July 15, 2024
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OR Manager Conference offers perioperative research presentation opportunities

Editor's Note The 2024 OR Manager Conference Poster Gallery provides a forum for presenting completed research, in progress initiatives with preliminary results, or a new approach to a concept to solve a problem related to perioperative leadership. We strive to promote communication and collaborative research among nurses, provide a setting…

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By: Lindsay Botts
July 12, 2024
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FDA announces Class 1 recalls for ventilator software, electrode pads

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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By: Matt Danford
July 12, 2024
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Hurricane disrupts hospitals, delays health services in Texas

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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By: Matt Danford
July 11, 2024
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FDA announces Class 1 recalls for upper airway stimulation system, MRI components

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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By: Matt Danford
July 10, 2024
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Healthcare industry groups criticize federal cybersecurity reporting rule

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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By: Matt Danford
July 9, 2024
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Study: Secondary conditions go unaddressed in female heart surgery patients

Editor's Note Female patients undergoing heart surgery are less likely than male patients to have concomitant procedures—that is, having additional ailments addressed during cardiac procedures—despite guidelines recommending such treatments, according to two studies led by Michigan Medicine. News-Medical.Net reported the news June 28. The first study, involving over 5,000 patients…

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By: Matt Danford
July 3, 2024
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New requirements for ASCs on life safety, patient rights effective August

Editor's Note Starting August 1, ambulatory surgical centers (ASCs) will need to comply with new and revised requirements for Life Safety Code® and patient rights, a June 26 news update from The Joint Commission reports. These updates align with the Centers for Medicare & Medicaid Services (CMS) Conditions for Coverage.…

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By: Tarsilla Moura
July 3, 2024
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Supreme Court decision could lead to legal challenges to payments, risks to healthcare regulation

Editor's Note Food and Drug Administration (FDA) regulations are at risk, and legal challenges to Medicare payments are likely to rise following the Supreme Court’s overturning of the 40-year-old legal precedent Chevron deference, according to a June 28 report in Becker’s Hospital Review. "Chevron deference is the principle that when…

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By: Matt Danford
July 2, 2024
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