Tag: FDA

ANA survey: Nurses support COVID-19 vaccinations, mandates, boosters

Editor's Note Data from a new survey of more than 4,500 nurses conducted by the American Nurses Association (ANA) in conjunction with the Johnson & Johnson-sponsored “COVID Vaccine Facts for Nurses” campaign finds that about 90% are vaccinated against COVID-19 or plan to be vaccinated. Other findings from the survey…

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By: Judy Mathias
August 19, 2021
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Study: Monoclonal antibodies help prevent hospitalization in high-risk COVID-19 patients

Editor's Note In this study by Mayo Clinic researchers, two monoclonal antibodies administered separately helped prevent hospitalization in high-risk COVID-19 patients. Included in the analysis were 2,747 patients who received bamlanivimab and 849 patients who received casirivimab-imdevimab from November 19, 2020, to February 11, 2021. After 28 days, all cause…

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By: Judy Mathias
July 22, 2021
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CDC, FDA release joint statement on COVID-19 boosters

Editor's Note The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) issued a joint statement on July 8 saying that fully vaccinated Americans do not need COVID-19 booster shots at this time. The statement says the CDC, FDA, and National Institutes of Health are engaged…

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By: Judy Mathias
July 12, 2021
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FDA: Class I recall of Medtronic angiographic guidewire

Editor's Note The Food and Drug Administration (FDA) on July 2 identified the recall by Medtronic Vascular of its angiographic guidewire component as Class I, the most serious. The recall was initiated because the devices were not sterilized before being shipped to hospitals. The guidewire is used during angiography or other interventional…

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By: Judy Mathias
July 6, 2021
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FDA revokes EUA for non-NIOSH-approved respirators

Editor's Note The Food and Drug Administration (FDA) on June 30 announced that it is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (including N95s), effective July 6. The announcement also revokes EUAs for decontamination and bioburden reduction systems for disposable respirators, effective immediately. The FDA says the…

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By: Judy Mathias
July 1, 2021
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FDA: Class I recall of Avid Medical convenience kits

Editor's Note The Food and Drug Administration on June 25 identified the recall by Avid Medical of its convenience kits for medical-surgical procedures as Class I, the most serious. The company is recalling those kits that contain BD/Carefusion’s Chloraprep 3 mL applicator because of the risk of contamination of the…

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By: Judy Mathias
June 30, 2021
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Growing number of hospitals, healthcare systems mandating COVID-19 vaccinations for HCWs

Editor's Note The number of hospitals and healthcare systems mandating COVID-19 vaccinations for their healthcare workers (HCWs) is growing, the June 29 Becker’s Hospital Review reports. In chronological order, the organizations that have announced mandates as of June 29 are: Henry Ford Health System, Detroit, will require its workforce of…

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By: Judy Mathias
June 29, 2021
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FDA: Class I recall of DeRoyal surgical procedure packs

Editor's Note The Food and Drug Administration (FDA), on June 25, identified the recall of DeRoyal Industries’ surgical procedure packs as Class I, the most serious. The recall was initiated because the packs contain 1% lidocaine that had been mislabeled as 0.5% bupivacaine. The procedure packs are used for cardiac…

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By: Judy Mathias
June 28, 2021
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Researchers raise the alarm on splashing during reprocessing--Part 1

Does it really matter if surgical instruments are submerged in cleaning solution when technologists or nurses scrub them after a case? Is there a reason for the 3-foot separation between dirty and clean areas? Do germs stop at the red line? During the COVID-19 pandemic, much attention has been focused…

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By: Judith M. Mathias, MA, RN
June 22, 2021
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Study: HCQ, AZM boost survival of ventilated COVID-19 patients by 200%

Editor's Note This observational study by researchers at Saint Barnabas Medical Center, Livingston, New Jersey, and the Smith Center for Infectious Diseases & Urban Health, East Orange, New Jersey, finds that the use of weight-adjusted hydroxychloroquine (HCQ) and azithromycin (AZM) improved the odds of survival of ventilated COVID-19 patients by…

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By: Judy Mathias
June 15, 2021
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