Editor's Note The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious. Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic…

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Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…

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Editor's Note This study, led by nurse researchers at the College of Nursing, University of Wisconsin-Milwaukee, explores the experiences of infection preventionists (IPs) during the COVID-19 pandemic. Responses from 61 IPs surveyed were included in the analysis. Among the findings: The initial phases of COVID-19 was a time of clinical…

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Takeaways • Patient data & safety are at risk: 94% of hospitals have experienced at least one cyberattack. • Less than half of hospitals in the US carry cybersecurity insurance. • Security is a two-part strategy: cybersecurity insurance as well as preventative measures (eg, encrypted backups, patches, and training). When…

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The topic of artificial intelligence (AI) makes headlines almost daily. Eliminating any fatalistic doomsday scenarios, current literature is raising interesting points around the useability of AI and the ethical considerations regular users of AI should not ignore. In the healthcare space, the number one question seems to be, Is it…

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ORs are at the heart of healthcare organizations, where critical decisions are made, often under immense pressure. This pressure has escalated with ever-increasing demands, growing complexities, and the constant requirement for innovative solutions. In today’s rapidly evolving technological landscape, artificial intelligence (AI), machine learning (ML), and the emerging generative AI…

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Healthcare facilities face challenges in the recall process of tissue, non-biologic implants, and medical devices because of their time-sensitive nature and inherent risks to patient safety and compliance. Hospitals often use secondary sources for recall notifications. These lists, however, do not include two critical pieces—the identification of affected patient cases…

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Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering…

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Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…

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Editor's Note The Food and Drug Administration (FDA), on July 18, identified the recall by Medtronic of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. Medtronic is recalling all ICDs and CRT-Ds, with glassed feedthroughs that were manufactured after 2017, as…

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