Tag: Patient Safety

FDA issues Class I alert for Abiomed Impella heart device over cybersecurity risks

Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…

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By: Tarsilla Moura
October 10, 2025
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Study finds Medicare paid nearly $2 billion for unnecessary back surgeries

Editor's Note More than 200,000 older Americans underwent back surgeries they likely did need, costing Medicare and Medicare Advantage a combined $1.9 billion, Axios October 9 reports. The findings, based on an analysis by the Lown Institute, raise new concerns about overuse of high-cost procedures with limited benefit, as federal…

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By: Tarsilla Moura
October 10, 2025
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FDA accelerates medical device safety alerts to reach public within days

Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…

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By: Tarsilla Moura
October 10, 2025
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California’s worsening nurse shortage fuels burnout, safety concerns amid management tensions

Editor's Note The nursing shortage in California is deepening, with RN vacancies projected to grow from 3.7% in 2024 to 16.7% by 2033, HealthLeaders and KFF Health News October 8 report. The researchers cite inadequate training and retention pipelines, while nurses on the front lines say mismanagement, understaffing, and profit…

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By: Tarsilla Moura
October 9, 2025
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AI is turning medical devices into learning systems, Google Cloud exec says

Editor's Note Artificial intelligence (AI) is driving medical technology from reactive tools to adaptive learning systems, Medical Device Network October 6 reports. Shweta Maniar, Google Cloud’s global director of healthcare and life sciences, said that advances in agentic AI are enabling medtech devices to anticipate patient needs, simplify operations, and…

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By: Tarsilla Moura
October 9, 2025
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OR Manager Conference delivers ready-to-use solutions for perioperative leaders

Editor's Note This year, the OR Manager Conference promises playbooks attendees can put to work the day they return home. The event, being held in Anaheim on October 28–30, targets the system-level goals perioperative leaders are accountable for: capacity, cost, culture, and safety across multi-site enterprises. Attendees will get concrete…

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By: Tarsilla Moura
October 8, 2025
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The Joint Commission set to spotlight hospitals’ strengths with new SAFEST initiative

Editor's Note The Joint Commission will launch a new initiative in January 2026 to highlight high-performing practices observed during accreditation surveys, according to an October 1 release from the organization. Called Survey Analysis For Evaluating STrengths (SAFEST), the program aims to provide more balanced feedback to accredited organizations while building…

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By: Tarsilla Moura
October 8, 2025
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Study: Outpatient surgery costs hinge on site of care, network status

Editor's Note Patients and insurers pay far less for outpatient surgical procedures performed at in-network ambulatory surgery centers (ASCs) than at hospital outpatient departments (HOPDs), the American Journal of Managed Care October 6 reports. This study, led by Xiaoxi Zhao, PhD, Christopher Whaley, PhD, and colleagues, analyzed commercial claims data…

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By: Tarsilla Moura
October 8, 2025
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CDC shifts COVID-19 vaccination to individual decision-making, separates chickenpox shot for toddlers

Editor's Note The Centers for Disease Control and Prevention (CDC) has updated its immunization schedules to emphasize individual-based decision-making for COVID-19 vaccination and to recommend that toddlers receive a standalone varicella (chickenpox) vaccine rather than the combined measles, mumps, rubella, and varicella (MMRV) shot, a CDC October 6 release reports.…

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By: Tarsilla Moura
October 7, 2025
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31,000 Kaiser nurses, healthcare workers prepare for historic strike

Editor's Note More than 31,000 Kaiser Permanente nurses and healthcare professionals are set to walk off the job on October 14 in what could be one of the largest healthcare strikes in recent history, Nurse.org October 7 reports. The 5-day strike, led by the United Nurses Associations of California/Union of…

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By: Tarsilla Moura
October 7, 2025
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