Editor's Note The Food and Drug Administration (FDA) on May 5 announced that it has limited the authorized use of Johnson & Johnson’s Janssen COVID-19 vaccine to those 18 years of age and older for whom other COVID-19 vaccines are not accessible or clinically appropriate and to those who would…

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Editor's Note In a letter to healthcare providers published on April 27, the US Food and Drug Administration (FDA) alerted it is evaluating the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal…

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Editor's Note The Food and Drug Administration (FDA) on April 4 issued a letter to healthcare providers and users saying the agency is aware that current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being updated by the company. In the letter, the FDA…

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Editor's Note The Food and Drug Administration (FDA), on March 23, identified the recall by Celltrion USA of certain point of care DiaTrust COVID-19 Ag Rapid Test kits (labeled for research use only) as Class I, the most serious. The recall was initiated because the kits were distributed to customers…

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Editor's Note The Food and Drug Administration (FDA) on March 21 identified the recall by Philips Respironics of certain V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because a subset of these devices had parts that were put together using an expired adhesive.…

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Editor's Note According to a March 4 notice filed by NYC Test & Trace Corps, New York City's (NYC’s) initiative for COVID-19 testing and contact tracing, the city is ending universal contact tracing by the end of April, Becker’s Hospital Review March 10 reported. This means that NYC Health +…

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Editor's Note Based on data submitted by Janssen Biotech Inc., a pharmaceutical company wholly owned by Johnson & Johnson, The Food and Drug Administration (FDA) authorized on March 7 the extension of the shelf life for refrigerated Johnson & Johnson COVID-19 vaccines, the American Hospital Association March 14 reported. The…

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Editor's Note The Association for Professionals in Infection Control and Epidemiology (APIC) on March 8 announced the publication of a new report outlining actions needed to successfully battle future pandemics while fighting the rise in healthcare-associated infections (HAIs). Some recommendations in the 66-page report, titled “Between a Rock and Hard…

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Editor's Note The Food and Drug Administration on March 7 posted the recall by Fresenius Kabi USA (Lake Zurich, Illinois) of seven lots of its Sodium Acetate Injection, USP, 400 mEq/100 mL The recall was initiated because of the presence of particulate matter found in reserve and/or stability sample vials.…

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Editor's Note The biggest obstacle to achieving 100% vaccination rate in the US is no longer whether vaccines will be manufactured fast enough, or if there will be enough for the country’s population, Lisa Doggett, senior medical director at HGS AxisPoint Health, told Health Leaders March 8. “Rather, it's concerns…

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