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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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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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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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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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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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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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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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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Editor's Note Members of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee during a June 10 meeting were split on whether COVID-19 vaccines should be granted emergency use authorization (EUA) for children under 12 years of age, the June 11 Regulatory Focus reports. Some members…

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Editor's Note The Food and Drug Administration (FDA), on June 10, announced the Class I recall of Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test. The test, which claimed to determine if a person has an active COVID-19 infection, has not been authorized, cleared, or approved by the FDA for…

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