Regulations/Legal

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October 2019
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FDA: Class I recall of Getinge’s Maquet/Datascope intra-aortic balloon pumps

Editor's Note The Food & Drug Administration on July 23 identified the recall by Getinge of its Maquet/Datascope intra-aortic balloon pumps (IABPs) as Class I, the most serious. Recall of the Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS 100/100i IABPs was initiated because of reports of the IABP batteries failing…

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By: Judy Mathias
July 24, 2019
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Legal and ethical questions temper excitement about AI--Part 2

As part of a special series on artificial intelligence (AI), OR Manager is taking a deep dive into the many facets of this new technology and its impact on patient care. In this issue we continue our examination of the challenges related to AI, which began in last month’s issue…

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By: Cynthia Saver, MS, RN
July 24, 2019
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FDA: Class I recall of Alaris Infusion Sets

Editor's Note The Food & Drug Administration (FDA) on July 18 identified the recall by Becton Dickinson of its Alaris Infusion Sets for the Alaris Pump Model 8100 as Class I, the most serious. The recall was initiated because of the potential for tube collapse that may cause unintended or…

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By: Judy Mathias
July 22, 2019
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FDA: Class I recall of Neonatal ConchaSmart Breathing Circuit

Editor's Note The Food & Drug Administration (FDA) on July 17 identified the recall by Teleflex of its Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column as Class I, the most serious. The recall was initiated because of complaints of cracks in the swivel wye adaptors, which…

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By: Judy Mathias
July 18, 2019
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CDC: Drug overdose mortality drops for the first time in 20 years

Editor's Note The US drug overdose mortality rate dropped 5.1% to 68,557 deaths last year, compared with 72,224 in 2017, the Centers for Disease Control & Prevention (CDC) reported on July 17. It’s the first time overdose mortality has declined since 1999. The CDC noted that the death counts are…

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By: Judy Mathias
July 18, 2019
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Hospital network participation not linked with improved outcomes, lower costs

Editor's Note Hospital network participation was not associated with improvements in surgical outcomes or Medicare expenditures, compared with hospitals not in a network, this study finds. In this analysis of nearly 2 million Medicare beneficiaries having general, vascular, cardiac, or orthopedic surgery between 2007 and 2014 at network (1,868) or…

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By: Judy Mathias
July 16, 2019
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FDA: Class I recall of Hamilton–G5 Ventilators

Editor's Note The Food & Drug Administration on July 12 identified the recall by Hamilton Medical AG (Bonaduz, Switzerland) of its Hamilton-G5 Ventilators as Class I, the most serious. The recall was initiated because of a software failure that stops the ventilators after displaying an error message, leaving patients to…

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By: Judy Mathias
July 16, 2019
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House to vote on repeal of ACA’s tax on high-cost insurance plans

Editor's Note House Leaders will vote the week of July 15 on a measure to repeal the Affordable Care Act’s 40% tax on high-cost healthcare insurance plans, the July 12 Bloomberg Tax reports. The measure is expected to have wide bipartisan support. Democrat Rep Joe Courtney of Connecticut is the…

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By: Judy Mathias
July 15, 2019
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Disadvantaged neighborhoods linked to higher readmission rates

Editor's Note Residing in a disadvantaged neighborhood in Maryland and being discharged from a hospital serving a large proportion of disadvantaged neighborhoods were independently associated with increased risk of readmission in this study. 2015 data from Maryland hospitals showed a 14.1% 30-day readmission rate for patients living in neighborhoods in…

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By: Judy Mathias
July 11, 2019
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CMS penalty program not linked to hospital safety improvements

Editor's Note The Centers for Medicare and Medicaid Services (CMS) hospital penalization in the Hospital Acquired Condition Reduction Program (HACRP) was not associated with significant changes in rates of hospital acquired conditions (HACs), 30-day readmissions, or 30-day mortality and does not appear to drive meaningful clinical improvements, this study finds.…

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By: Judy Mathias
July 11, 2019
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