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FDA: Class I recall of Zimmer Biomet spinal fusion, long bone stimulators

Editor's Note The Food & Drug Administration (FDA) on November 26 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and SpF-XL Implantable Spinal Fusion Stimulator as Class I, the most serious. The recall was initiated because of the…

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By: Judy Mathias
November 28, 2018
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Reliability of measuring surgeon spending for MIPS

Editor's Note The Centers for Medicare & Medicaid Services should measure surgeon spending at a group level or incorporate multiple years of data to reduce misclassification of surgeon performance in its Merit-based Incentive Payment System (MIPS) program, this study finds. University of Michigan researchers found that annual cost-profiles of individual…

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By: Judy Mathias
November 27, 2018
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FDA plans big changes to 510(k) pathway

Editor's Note The Food and Drug Administration (FDA) on November 26 announced that it plans to modernize its 510(k) approval pathway by pushing device manufacturers to rely on predicate devices that are not older than 10 years. Under the existing pathway, manufacturers can pursue expedited approval for devices that are…

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By: Judy Mathias
November 27, 2018
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Multimodal program reduces job stress in ICU nurses

Editor's Note In this study, a multimodal program that included education, role-play, and debriefing resulted in a lower prevalence of job stress in intensive care unit (ICU) nurses. A total of 198 ICU nurses from 8 hospitals in France were randomized to the multimodal program intervention group (101 nurses) or…

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By: Judy Mathias
November 26, 2018
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FDA: Fresenius Kabi recalls sodium chloride injection

Editor's Note The Food and Drug Administration (FDA) on November 20 announced the nationwide recall by Fresenius Kabi USA (Lake Zurich, Illinois) of 163 lots of sodium chloride injection, USP, 0.9%, 10 mL and 20 mL vials. The recall was initiated because the product insert incorrectly states that the vial…

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By: Judy Mathias
November 26, 2018
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HHS updates physical activity guidelines for Americans

Editor's Note The Department of Health and Human Services (HHS) published a summary of its new Physical Activity Guidelines for Americans, online November 12 in the Journal of the American Medical Association. The updated guidelines provide information on types and amounts of physical activity that provide substantial health benefits. For…

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By: Judy Mathias
November 13, 2018
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93% of eligible clinicians received MIPS payment under QPP last year

Editor's Note New data from the Centers for Medicare & Medicaid Services (CMS) shows that 93% of eligible clinicians who participated in the Merit-Based Incentive Payment System (MIPS) under the Quality Payment Program (QPP) received positive payment adjustments for their performance last year, the November 9 EHR Intelligence reports. Only…

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By: Judy Mathias
November 13, 2018
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Endoscopic vs open vein-graft harvesting for CABG

Editor's Note In patients having coronary artery bypass grafting (CABG) surgery, no significant difference was found in the risk of major adverse cardiac events between open and endoscopic vein-graft harvesting procedures, this study finds. In this analysis of 1,150 patients at 16 Veterans Affairs centers over a median follow-up of…

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By: Judy Mathias
November 13, 2018
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US smoking rates at record low

Editor's Note Cigarette smoking rates in the US have dropped to the lowest level ever recorded, according to the November 9 Morbidity and Mortality Weekly Report. The smoking rate for adult smokers fell from 15.5% in 2016 to 14% in 2017, a rate 67% lower than it was in 1965.…

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By: Judy Mathias
November 13, 2018
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Association of nurse workload with missed care

Editor's Note A nurse’s ability to provide optimal patient care is influenced by a variety of factors, not just nurse to patient ratios, this study finds. In this study of 136 neonatal intensive care nurses caring for 418 infants during 332 12-hour shifts, subjective workload was the one variable that…

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By: Judy Mathias
November 13, 2018
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