Regulations/Legal

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February 2022
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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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The three vaccine mandate deadlines US hospitals need to know

Editor's Note On January 19, a federal court dismissed a lawsuit filed by the state of Texas opposing the federal vaccine mandate. This came just days after the Supreme Court also ruled to uphold the mandate “to promote and protect patient health and safety.” On January 20, CMS issued updated…

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By: Tarsilla Moura
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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Trends in ambulatory care during COVID-19

Editor's Note This study, led by researchers at UCLA David Geffen School of Medicine, finds that the use of ambulatory care services between March 2020 and February 2021 increased after an initial decrease with the onset of COVID-19. However, the rate of increase was significantly lower for Medicaid and/or Medicare…

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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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Supreme Court blocks federal government’s vaccine mandate for large workplaces but not for healthcare facilities

Editor's Note The Supreme Court on January 13 blocked the federal government’s COVID-19 vaccine-or-test requirement for workplaces with 100 or more employees, but the Court is allowing a vaccine mandate for healthcare workers at facilities that receive Medicaid and Medicare funds. The order covers more than 17 million healthcare workers…

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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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February 2022
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