Editor's Note The Food and Drug Administration (FDA), on January 3, identified the recall by Covidien of its Puritan Bennett 980 Series Ventilator as Class I, the most serious. The recall was initiated because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop…

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Editor's Note This study by Chinese researchers finds a high percentage of asymptomatic COVID-19 infections worldwide, which highlights the potential transmission risk of asymptomatic infections in communities. In this review and meta-analysis of 95 studies, which include nearly 30 million individuals undergoing testing, the percentage of asymptomatic infections was 0.25%…

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Editor's Note The Food and Drug Administration, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The IABPs are cardiac assist devices used in patients having cardiac and noncardiac surgery and to treat patients…

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Editor's Note This case-controlled study by researchers from White River Junction Veterans Affairs Medical Center, White River Junction, Vermont, and Dartmouth School of Medicine, Hanover, New Hampshire, finds that mRNA vaccine effectiveness against COVID-19 decreases significantly after about 6 months. In this analysis of 14,238 male veterans aged 65 or…

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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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