Supply Chain/Technology

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May 2025
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FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M

Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…

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By: Judy Mathias
September 13, 2023
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US and UK sanction Russian cybercrime group targeting hospitals, providers

Editor's Note The United States, in coordination with the United Kingdom, has imposed sanctions on 11 individuals linked to the Russia-based cybercrime group known as Trickbot, a US Department of the Treasury September 7 press release reports. These sanctions were issued by the US Department of the Treasury's Office of…

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By: Tarsilla Moura
September 8, 2023
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Study: Redo TAVR procedures safe, effective

Editor's Note This study by researchers at Cedars-Sinai Medical Center, Los Angeles, finds that redo transcatheter aortic valve replacement (TAVR) procedures are both safe and effective. Of 350,591 patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry who underwent TAVR with balloon-expandable valves between November…

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By: Judy Mathias
September 5, 2023
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FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…

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By: Judy Mathias
September 5, 2023
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HCA, Google Cloud bringing generative AI to hospitals

Editor's Note The Healthcare Corporation of America (HCA), on August 29, announced a new collaboration with Google Cloud to bring generative artificial intelligence (AI) to its hospitals. Emergency department physicians at four HCA hospitals are already using Google’s AI technology and Augmedix to create accurate and timely medical notes from…

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By: Judy Mathias
August 31, 2023
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Cleveland Clinic London surgeons perform TKA assisted by augmented reality

Editor's Note The Cleveland Clinic announced, on August 16, that surgeons at its London facility successfully performed a total knee arthroplasty (TKA) with the assistance of an augmented reality-based platform designed with artificial intelligence and machine learning. Augmented reality, which gives a 3D visualization of the joint, helps with planning…

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By: Judy Mathias
August 28, 2023
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SSI rates before, after reuse of PPE during pandemic

Editor's Note This study from Trinity Health, Ann Arbor, Michigan, compares prepandemic surgical site infection (SSI) rates before reusing personal protective equipment (PPE), to pandemic SSI rates after reusing PPE in trauma surgical patients. A total of 48,987 patients were included in the analysis, with half in the postpandemic group.…

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By: Judy Mathias
August 24, 2023
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FDA: Class I recall of Draeger Carina Sub-Acute Care Ventilators

Editor's Note The Food and Drug Administration (FDA), on August 23, identified the recall by Draeger Medical of its Carina Sub-Acute Care Ventilators as Class I, the most serious. The recall was initiated because of the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if the…

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By: Judy Mathias
August 24, 2023
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Study: Transitioning back to reusable surgical gowns

Editor's Note In this study, researchers from the University of California, San Francisco, examine the feasibility of transitioning back to reusable surgical gowns and the corresponding cost savings and reductions in solid waste. Disposable surgical gowns were replaced with polyester reusable surgical gowns with AAMI level III barrier protection that…

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By: Judy Mathias
August 22, 2023
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HHS: ARPA-H project to strengthen healthcare cybersecurity

Editor's Note The US Department of Health and Human Services (HHS) Advanced Research Projects Agency for Health (ARPA-H) announced that it is seeking proposals through September 7 to help fund and develop cybersecurity technologies for healthcare systems, clinics, and healthcare-related devices,  the August 17 WIRED reports. The Digital Health Security…

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By: Judy Mathias
August 22, 2023
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