Tag: Patient Safety

FDA: Class I recall of Medtronic’s HawkOne Directional Atherectomy System

Editor's Note The Food and Drug Administration (FDA) on January 21 identified the recall by Medtronic Inc of its HawkOne Directional Atherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire within the catheter moving down ward or prolapsing when force…

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By: Judy Mathias
January 24, 2022
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CDC: Those recovered from COVID-19 less likely than vaccinated to get Delta variant

Editor's Note The Centers for Disease Control and Prevention, on January 19, released a study showing that in New York and California, both vaccination and prior infection offered protection against COVID-19, but those who had recovered from COVID-19 were less likely than vaccinated individuals to get infected during the Delta…

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By: Judy Mathias
January 20, 2022
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The Joint Commission to begin surveying for HCW vaccinations

Editor's Note The Joint Commission announced on January 19 that beginning January 27, 2022, for applicable deemed program surveys in progress on that day, it will begin surveying to the “Omnibus COVID-19 Health Care Staff Vaccination” interim final rule published by the Centers for Medicare and Medicaid Services (CMS). As…

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By: Judy Mathias
January 20, 2022
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FDA: Class I recall of Getinge Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems

Editor's Note The Food and Drug Administration (FDA) on January 19 identified the recall by Getinge of its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems as Class I, the most serious. The recall was initiated because of the potential chemical breakdown of Sevoflurane that may result in inhalation…

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By: Judy Mathias
January 20, 2022
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ECRI names Top 10 Health Technology Hazards for 2022

Editor's Note ECRI has named cybersecurity attacks as the number one health technology hazard for 2022. In its report, ECRI notes that all healthcare organizations are subject to cybersecurity attacks, and that the question is not whether they will be attacked but when. A cybersecurity attack could threaten medical devices…

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By: Judy Mathias
January 19, 2022
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CDC: Racial, ethnic disparities in receipt of COVID-19 treatments

Editor's Note This study from the Centers for Disease Control and Prevention (CDC) finds disparate monoclonal antibody (mAb) treatment of COVID-19 in Hispanic, Black, Asian, and Other race patients, compared to non-Hispanic and White patients. Differences in treatment with dexamethasone and remdesivir were less apparent. Analyzing data from 41 healthcare…

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By: Judy Mathias
January 18, 2022
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FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software

Editor's Note The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious. The System aids in precisely locating anatomical structures in neurosurgical procedures. The recall was initiated…

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By: Judy Mathias
January 18, 2022
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Environment key to injury recovery for Black men

Editor's Note This study from the University of Pennsylvania School of Nursing, Philadelphia, finds that social and physical features of the environment impact the survival of injured Black men. Analyzing interviews of 43 injured Black men in a northeastern city identified four themes: Challenges to recovery—feeling uprooted because of having…

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By: Judy Mathias
January 13, 2022
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NIOSH rescinds approval for ALG Health’s N95 respirator masks

Editor's Note The National Institute for Occupational Safety and Health (NIOSH) has honored a request by N95 respirator mask manufacturer, ALG Health (Bryan, Ohio), to rescind all respirator approvals issued to ALG Health, effective immediately. As of January 6, any of the following ALG Health N95 respirators marked with a…

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By: Judy Mathias
January 13, 2022
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Opioid deaths surging in older Black men

Editor's Note In this study from Northwestern University Feinberg School of Medicine, Chicago, researchers find a roughly tenfold increase in opioid deaths in adults 55 years and older, driven primarily by overdoses in Black men. Analyzing data on 79,893 individuals aged 55 years and older who died from opioid overdose…

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By: Judy Mathias
January 13, 2022
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