Editor's Note The Food and Drug Administration (FDA), on April 19, identified the recall by Fresenius Kabi USA of its Ivenix Infusion System as Class I, the most serious. The recall was initiated because of a leak in the system that allows fluid to enter the administration set loading area…

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Editor's Note The Food and Drug Administration (FDA), on April 13, updated prescribing information for all opioid pain medications, including requiring all packaging to have updated labeling and safety information. This includes stating that: for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medications, the risk of overdose…

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Editor's Note The Food and Drug Administration (FDA), on April 12, issued a Safety Communication recommending that consumers, healthcare providers, and facilities not use certain surgical N95 respirators and to use caution with certain surgical masks and pediatric face masks, all manufactured by O&M Halyard. The FDA says it is…

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Editor's Note This study from HCA Healthcare, Nashville, Tennessee, finds an increase in healthcare-associated infections (HAIs) in patients with COVID-19, but no increase in patients without COVID-19. More than 5 million hospitalizations in 182 hospitals between 2020 and 2022 were included in the analysis. The incidence of HAIs per 100,…

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Editor's Note In this study, researchers from the Duke Infection Control Outreach Network Surveillance Team, Duke University School of Medicine,  Durham, North Carolina, find that surgical site infection (SSI) rates did not decrease in community hospitals from 2013 to 2018. SSI data was collected from patients having 26 common surgical…

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Editor's Note The Food and Drug Administration (FDA), on April 6, identified the recall by Abbott of its FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems as Class I, the most serious. The recall was initiated because the systems’ reader devices, which use rechargeable…

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Editor's Note This study by researchers from the University of Southern California, Los Angeles, finds substantial adverse maternal outcomes among pregnant patients with COVID-19 at delivery, during the early pandemic period. A total of 2,578,095 patients were analyzed. During the 9-month study period (April to December 2020), 45,425 pregnant patients…

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Editor's Note The Food and Drug Administration, on April 7, identified the recall by Philips Respironics of certain reworked DreamStation continuous positive airway pressure (CPAP) and bileveled positive airway pressure (BiPAP) machines as Class I, the most serious. These machines also were recalled in June 2021. The recall was initiated…

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Editor's Note Researchers at UHealth—the University of Miami Health System and the University of Miami Miller School of Medicine—show that, in two cases, COVID-19 breached the placenta and caused brain injury in the newborn. Both infants tested negative for the virus at birth, but had significantly elevated COVID-19 antibodies in…

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Editor's Note The Joint Commission, on April 5, announced that it had updated its Health Care Equity Accreditation Standards & Resource Center to assist organizations in meeting their healthcare equity standards. The new resources include: Six new Snapshots (brief synopses of approaches used by other organizations) from Cook County Health…

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