Tag: Patient Safety

FDA: Addition to Class I recall of LivaNova LifeSPARC System Controller

Editor's Note The Food and Drug Administration (FDA) on January 27 posted an addition to the Class I recall by LivaNova (TandemLife) of its LifeSPARC System Controller. The addition to the recall provides information about a software update now available to address the previous software malfunction and recall. The System…

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By: Judy Mathias
January 30, 2023
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Study: Unsafe medical devices gain FDA approval through loophole

Editor's Note A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing…

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By: Tarsilla Moura
January 27, 2023
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FDA: Class I recall of Datascope/Getinge Cardiosave Hybrid, Rescue IABPs

Editor's Note The Food and Drug Administration (FDA) on January 25 identified the recall by Datascope/Gettinge of its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the risk that blood may enter the pump through a damaged balloon…

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By: Judy Mathias
January 26, 2023
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Effect of telehealth on opioid use disorder treatment

Editor's Note This study by researchers from Harvard Medical School, Boston, finds that telehealth is a comparable alternative to in-person care of patients with opioid use disorder (OUD). This cohort study analyzed data on 1,768 clinicians who treated 11,801 patients with OUD via telehealth visits during COVID-19 prepandemic (March 14,…

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By: Judy Mathias
January 26, 2023
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The Joint Commission, NFQ announce Eisenberg Award recipients

Editor's Note The Joint Commission and National Quality Forum (NQF) on January 23 announced the recipients of the 2022 John M. Eisenberg Patient Safety and Quality Awards. The Awards recognize major achievements by individuals and organizations to improve patient safety and healthcare quality. This year’s recipients; Made advancements related to…

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By: Judy Mathias
January 24, 2023
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Study shows ransomware attacks against healthcare are on the rise

Editor's Note In this study conducted by researchers at the University of Minnesota and by Beth Virnig, PhD, MPH, dean of the University of Florida College of Public Health and Health Professions, data shows that ransomware attacks on healthcare organizations have more than doubled from 2016 to 2021, Healthcare Purchasing…

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By: Tarsilla Moura
January 20, 2023
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ASA updates preop fasting guidelines

Editor's Note The American Society of Anesthesiologists (ASA) has updated its 2017 guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration. The new 2023 guidance focuses on topics not addressed in the previous guideline, including ingestion of carbohydrate-containing clear liquids with or…

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By: Judy Mathias
January 18, 2023
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Risk of MI, stroke, mortality in gastric bypass patients

Editor's Note In this study, Swedish researchers, find that gastric bypass was associated with a decreased risk of myocardial infarction (MI), but not ischemic stroke within 10 years of surgery, and it reduced mortality during the first 3 years after surgery but not thereafter. Study participants were divided into obese…

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By: Judy Mathias
January 12, 2023
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Effect of state order curtailing elective surgery on volume during COVID-19

Editor's Note This study from the University of Michigan, Ann Arbor, finds that the introduction and removal of Michigan’s executive order curtailing elective surgery during COVID-19 lagged behind the ramp-down and ramp-up of elective surgery volume. Hospitals had already achieved a 91.7% reduction in case volume before the executive order…

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By: Judy Mathias
January 11, 2023
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The Joint Commission raises healthcare equity standard to NPSG

Editor's Note The Joint Commission on January 10 announced that it had elevated the Leadership (LD) Standard LD.04.03.08, which addresses healthcare disparities as a quality and safety priority, to a National Patient Safety Goal (NPSG), effective July 1, 2023. Current requirements for accreditation will not change, and the intent behind…

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By: Judy Mathias
January 11, 2023
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