FDA: Class I recall of Woodside Acquisitions SARS-CoV-2 antigen rapid test kits
Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall of Woodside Acquisitions Inc’s Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) as Class I, the most serious. The tests are being recalled because they were distributed to…
Increasing face-mask compliance among HCWs during COVID-19
Editor's Note In this study, researchers from Yale School of Medicine, New Haven, Connecticut, find that face-mask compliance remained suboptimal among healthcare workers (HCWs) despite a facility-wide mandate for universal masking during the COVID-19 pandemic. Of 1,561 observations during a 4-week baseline period after universal masking was mandated, median weekly…
ECRI: Time to move to scheduled COVID-19 vaccinations
Editor's Note In a May 18 position statement, ECRI recommends that it’s time to move to a regularly scheduled COVID-19 vaccine booster model. “Moving to a regular vaccine schedule will increase clarity and confidence about what actions to take and when, compared to the current piecemeal, wait-and-see approach,” says Marcus…
FDA: Class I recall of certain Accula SARS-CoV-2 Tests
Editor's Note The Food and Drug Administration (FDA) on May 9 identified the recall by Mesa Biotech, Inc, of certain Accula SARS-CoV-2 Tests as Class I, the most serious. The recall was initiated because certain lots of the PCR test have an increased risk of giving false positive results because…
FDA limits use of J&J COVID-19 vaccine because of TTS risk
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…
FDA alerts healthcare providers of airway device potential risk
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…
FDA: Reprocessing changes for certain Karl Storz urological endoscopes
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…
FDA: Class I recall of certain Celltrion USA COVID-19 test kits labeled for research use only
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…
FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators
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.…
End of universal contact tracing leading to 870+ healthcare layoffs in New York City
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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