Regulations/Legal

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March 2020
Home Regulations/Legal

CDC announces first US case of coronavirus from China

Editor's Note The Centers for Disease Control and Prevention (CDC) on January 21 confirmed the first case of the 2019 Novel Coronavirus (2019-nCoV) from China in the state of Washington. The patient recently returned from Wuhan, China, where an outbreak of pneumonia caused by this virus has been ongoing since…

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By: Judy Mathias
January 22, 2020
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FDA: Quality issues with Cardinal Health surgical gowns, packs

Editor's Note The Food & Drug Administration (FDA) on January 16 announced that Cardinal Health has alerted it customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain the gowns. Cardinal Health and the FDA recommend that customers immediately discontinue use…

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By: Judy Mathias
January 21, 2020
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Study challenges concerns about HRRP

Editor's Note This study from the division of cardiology at Dallas’ University of Texas Southwestern Medical Center and the Yale School of Medicine, New Haven, Connecticut, challenges concerns about Medicare’s Hospital Readmission Reduction Program (HRRP)--ie, that it leaves patients more vulnerable and increases postdischarge mortality rates. Analyzing inpatient and outpatient…

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By: Judy Mathias
January 16, 2020
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Joint Commission announces new website design

Editor's Note The Joint Commission announced on January 15 that it had launched its new website design late last year, with new features that include: a single sign-on for the multiple sites of the Joint Commission enterprise improved mobile viewing and navigation dynamic content organized according to care setting, healthcare…

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By: Judy Mathias
January 16, 2020
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Reproductive hazards for female surgeons in the OR

Editor's Note Reproductive hazards are present in the OR and may contribute to pregnancy complications and infertility in female surgeons, this review finds. Hazards include radiation, surgical smoke, working conditions, sharps injuries, anesthetic gases, and intraoperative use of toxic agents. Studies comparing female surgeons with the general population show increased…

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By: Judy Mathias
January 14, 2020
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Recycling program evolves to sustain gains in waste reduction

Approximately 5.9 million tons of waste annually comes from the healthcare industry, and one-third of that waste comes directly from the OR. Each year, an increasing number of disposable products are used in the OR. To address this dilemma, an OR recycling performance improvement committee was formed at Massachusetts General…

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By: Judith M. Mathias, MA, RN
January 13, 2020
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FDA: Class I recall of Medfusion 4000 Syringe Pumps

Editor's Note The Food & Drug Administration (FDA) on December 19, 2019, identified the recall by Smiths Medical ASD, Inc of its Medfusion 4000 Syringe Pumps as Class I, the most serious. The recall was initiated because of malfunctioning low-battery alarms, which may lead to an interruption of therapy. The…

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By: Judy Mathias
January 7, 2020
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FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator

Editor's Note The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious. The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy…

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By: Judy Mathias
January 7, 2020
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First-year analysis of OR Black Box study

Editor's Note In this first-year analysis of a data capture system called the OR Black Box, frequent intraoperative errors, events, variation in surgeons’ technical skills, and a high amount of environmental distractions were identified. In 132 patients having elective laparoscopic general surgery: auditory distractions occurred a median of 138 times…

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By: Judy Mathias
January 2, 2020
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FDA workshop: Role of AI in radiological imaging

Editor's Note The Food & Drug Administration (FDA) on December 30 announced a public workshop on the “Evolving Role of Artificial Intelligence [AI] in Radiological Imaging, which will take place February 25-26, 2020, at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. The workshop will include discussions on…

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By: Judy Mathias
January 2, 2020
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