Safety/Quality

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October 2024
Home Safety/Quality

FDA: Class I recall of Medtronic HVAD Pump Implant Kit

Editor's Note The Food and Drug Administration (FDA) on June 8 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit as Class I, the most serious. The HVAD System is used as a bridge to cardiac transplants. The Kit was recalled because of a…

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By: Judy Mathias
June 9, 2022
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Outcomes associated with workplace mental health program before, during COVID-19

Editor's Note This study from Spring Health, New York City, and Yale University, New Haven Connecticut, finds that an employer-sponsored mental health benefit was associated with reduced symptoms for employees and positive financial return on investment (ROI) for employers. This cohort study included 1,132 employees participating in a workplace mental…

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By: Judy Mathias
June 9, 2022
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Bill introduced to protect HCWs like airline staff

Editor's Note US Representatives Madeleine Dean (D-Pa) and Larry Bucshon, MD, (R-Ind) on June 7 introduced a Bill to protect healthcare workers (HCWs) from violence that is modeled after protections for airline workers, the June 8 Becker’s Hospital Review reports. The Safety from Violence for Healthcare Employees Act would criminalize…

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By: Judy Mathias
June 9, 2022
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Protection, waning of immunity to COVID-19 after infection, vaccination

Editor's Note This Israeli study finds that individuals previously infected with COVID-19, regardless of whether they had been vaccinated, had more protection against reinfection than those who were vaccinated (Pfizer-BioNTech vaccine) but previously uninfected. Among the findings for the number of COVID-19 cases per 100,000 person days since vaccination or…

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By: Judy Mathias
June 8, 2022
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FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators

Editor's Note The Food and Drug Administration on June 3 identified the recall by Philips Respironics of all V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because an internal power fluctuation may cause the ventilator to shut down unintentionally with or without any…

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By: Judy Mathias
June 8, 2022
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Association of COVID-19 booster and Omicron in the NBA

Editor's Note This study, led by researchers at IQVIA, Durham, North Carolina, finds that in a young, healthy, highly vaccinated cohort of players and staff in the National Basketball Association (NBA), booster vaccinations were associated with a significant reduction in COVID-19 infections during the Omicron wave. Of 2,613 players and…

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By: Judy Mathias
June 7, 2022
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FDA: Class I recall of Atrium Medical’s iCast Covered Stent

Editor's Note The Food and Drug Administration (FDA) on June 2 identified the recall by Atrium Medical Corporation of its iCast Covered Stent System as Class I, the most serious. The recall was initiated because of increased complaints about the separation of the balloon or catheter hub from the delivery…

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By: Judy Mathias
June 7, 2022
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Changes in cancer screening during COVID-19

Editor's Note  This study from the American Cancer Society, Atlanta, finds that the prevalence of breast, cervical, and colorectal cancer screening decreased during COVID-19. A total of 479,248 patients were included in the analysis for breast cancer screening, 301,453 for cervical cancer screening, and 854,210 for colorectal cancer screening. Between…

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By: Judy Mathias
June 6, 2022
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Healthcare employment up in May

Editor's Note Overall healthcare employment in the US was up in May to a seasonally adjusted 16,267,900 workers, the Bureau of Labor Statistics reported on June 3. That’s up 28,300 since April. Hospital employment also was up by 16,300 jobs. The overall unemployment rate for May was 3.6%, for a…

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By: Judy Mathias
June 6, 2022
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Effect of COVID-19 disruptions to in-person care after TKA

Editor's Note This study from the Hospital for Special Surgery, New York City, finds that halting in-person office visits and physical therapy (PT) after total knee arthroplasty (TKA) because of COVID-19 did not affect complication rates or outcomes. A total of 624 study patients who had a TKA between January…

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By: Judy Mathias
June 2, 2022
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