Editor's Note The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass. The recall was initiated…

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Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…

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Editor's Note The Food and Drug Administration (FDA), on April 9, sent a letter to healthcare providers recommending they “transition away from crisis capacity conservation strategies,” including disinfection and reuse of N95 masks. Though the FDA believes there is an adequate supply of N95s now to facilitate this transition, the…

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Editor's Note In this study from the University of Denver and the University of Pennsylvania, Philadelphia, respondents to two surveys agreed with the National Academies of Science, Engineering, and Medicine’s prioritization framework for COVID-19 vaccination. Of 4,735 respondents (2,730 to a Gallup survey and 2,005 to a COVID Collaborative survey):…

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Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…

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Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…

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Editor's Note This survey by researchers at the Geisinger Health System, Danville, Pennsylvania, shows a trend of increased intention by healthcare workers to receive a COVID-19 vaccine. A total of 16,292 employees completed the survey, for a response rate of 68.5%. During the period of survey data collection, the researchers…

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Editor's Note The Food and Drug Administration (FDA), on March 17, identified the recall by ACIST of its Kodama Intravascular Ultrasound Catheter as Class I, the most serious. The recall was initiated because the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, broken O-ring pieces…

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Editor's Note This study by researchers from Emory University in Atlanta and the University of Texas Medical Branch in Galveston finds the presence of neutralizing activity of infection- and vaccine-elicited antibodies against COVID-19 variants. The variants included in the analysis were: A.1 (closely resembles Wuhan strain) B.1 (predominant strain found…

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The COVID-19 pandemic has underscored the importance of respiratory protection in healthcare settings and in the community. Healthcare workers at high risk of infection need the most effective respiratory protection, and not all surgical masks and respirators are alike. Checking for proper fit, donning and doffing correctly, and following manufacturers’…

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