Editor's Note The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious. The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus,…

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Editor's Note The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious. The recall was initiated after finding that glued connections may loosen before or…

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Editor's Note On April 17, electronic health records (EHR) vendor Epic and Microsoft announced a partnership to train Azure OpenAI on a large collection of information so it can “asynchronously draft responses to patient messages for providers,” Becker’s Health IT May 25 reports. According to Becker's, there are four major…

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Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…

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The Association for the Advancement of Medical Instrumentation (AAMI) has revised the ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. This revised standard provides healthcare professionals with a better understanding of the barrier protection properties of available protective apparel. The…

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Surgical site infection (SSI) surveillance has rapidly grown in the ambulatory setting over the last decade, with the expansion of the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network’s (NHSN) Outpatient Procedure Component (OPC). OPC-SSI is designed to track and monitor SSIs in ambulatory surgery centers (ASCs)…

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Editor's Note ECRI, on May 18, announced the winners of its annual 2023 Alerts Impact Award. The Award is given to members of ECRI’s Alerts Workflow system for excellence in recall management. The system’s software is used by supply chain, clinical engineering, IT, pharmacy, lab, clinical departments, and ancillary-care points…

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Editor's Note Cybersecurity remains a top concern and potential hazard for patient data. In February, Lehigh Valley Health Network in Allentown, Pennsylvania, was attacked by a ransomware gang BlackCat, which has ties to Russia, Becker’s Health IT reports. The health system has since notified 627 individuals and will continue to…

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Editor's Note According to a May 14 Government Accountability Office (GAO) report, the US Department of Health and Human Services (HHS) is continuing with the persistent, systemic problems that impaired its ability to respond to the COVID-19 pandemic as well as other public health crises, such as H1N1 influenza, Zika,…

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Editor's Note Estimates from the Centers for Disease Control and Prevention find the emerging COVID-19 Omicron subvariant XBB.1.16, dubbed Arcturus, is responsible for more than 14% of COVID-19 cases in the US over the past 2 weeks, up from nearly 7% in the prior 2 weeks, according to the May…

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