Editor's Note On December 1, the first case of COVID-19 attributed to the Omicron variant was reported in the US, according to the Centers for Disease Control and Prevention (CDC). As of December 8, Omicron variant cases had been reported in 22 states, including some that indicated community transmission. Of…

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Editor's Note On December 8, Pfizer said its COVID-19 booster was found to provide significant protection against the Omicron variant in a laboratory study, the December 8 Becker’s Hospital Review reports. Blood samples from those who received three doses of the vaccine saw similar neutralization against the Omicron variant as…

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Editor's Note The Food and Drug Administration (FDA) on December 7 announced that Edge Pharma, LLC (Colchester, Vermont) has issued a nationwide recall of all drug products. The recall was initiated because of process issues that could lead to a lack of sterility assurance for products intended to be sterile…

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Editor's Note In this study, researchers from Stanford University School of Medicine find that the initial COVID-19 shutdown from March through April 2020 resulted in a decrease in surgical volume to nearly half of baseline rates. After the reopening, surgical volume rebounded to 2019 levels, and the trend was maintained.…

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Editor's Note The Food and Drug Administration (FDA), on November 30, identified the worldwide recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as Class I, the most serious. The device, which is used for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts, was…

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Editor's Note The Food and Drug Administration (FDA), on November 15, announced the nationwide recall by SterRx, LLC, of 240 lots of its drug products. The recall was initiated because of the lack of sterility assurance due to equipment and process issues. The recalled drugs include: l mg/ml Midazolam in…

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Editor's Note The Food and Drug Administration (FDA), on November 9, identified the recall by Aligned Medical Solutions of its custom convenience kits as Class I, the most serious. The recall was initiated because of the potential for the plunger in Cardinal Health's Monoject Flush Prefilled Syringe (0.9% sodium chloride),…

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Editor's Note The Food and Drug Administration (FDA), on September 29, announced that healthcare facilities and providers should not purchase or use imported surgical and patient examination gloves from companies included on Import Alert 80-04. Companies are listed on an import alert when the FDA has enough evidence that they…

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Editor's Note The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious. The recall was initiated because of the risk of the battery failing and having a shortened run time, which…

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Editor's Note The Food and Drug Administration (FDA), on October 6, identified the recall by Deroyal Industries of its procedure packs containing Smiths Medical Normoflo irrigation warming sets as Class I, the most serious. The recall was initiated because of the possibility of harmful levels of aluminum leaching into the…

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