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FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device

Editor's Note The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious. The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of…

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By: Judy Mathias
January 11, 2022
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The Joint Commission implements some off-site processes for DSC on-site reviews

Editor's Note The Joint Commission announced January 5, 2022, that, effective immediately, all disease-specific care (DSC) on-site reviews will implement a portion of the off-site review process developed in response to the COVID-19 pandemic. The off-site review process required organizations to upload documentation before the scheduled review, which organizations told…

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By: Judy Mathias
January 6, 2022
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FDA: Class I recall of Puritan Bennett 980 Series Ventilator

Editor's Note The Food and Drug Administration (FDA), on January 3, identified the recall by Covidien of its Puritan Bennett 980 Series Ventilator as Class I, the most serious. The recall was initiated because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop…

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By: Judy Mathias
January 5, 2022
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Meta-analysis finds high global percentage of asymptomatic COVID-19 infections

Editor's Note This study by Chinese researchers finds a high percentage of asymptomatic COVID-19 infections worldwide, which highlights the potential transmission risk of asymptomatic infections in communities. In this review and meta-analysis of 95 studies, which include nearly 30 million individuals undergoing testing, the percentage of asymptomatic infections was 0.25%…

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By: Judy Mathias
December 16, 2021
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FDA: Class I recall of Getinge/Datascope/Maquet Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps

Editor's Note The Food and Drug Administration, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The IABPs are cardiac assist devices used in patients having cardiac and noncardiac surgery and to treat patients…

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By: Judy Mathias
December 16, 2021
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Effectiveness of mRNA vaccines against COVID-19

Editor's Note This case-controlled study by researchers from White River Junction Veterans Affairs Medical Center, White River Junction, Vermont, and Dartmouth School of Medicine, Hanover, New Hampshire, finds that mRNA vaccine effectiveness against COVID-19 decreases significantly after about 6 months. In this analysis of 14,238 male veterans aged 65 or…

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By: Judy Mathias
December 16, 2021
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The Joint Commission updates 2022 ORYX performance measure requirements

Editor's Note The Joint Commission, on December 15, announced that it had updated its 2022 ORYX performance measure reporting requirements for accredited critical access hospitals and hospitals, effective January 1, 2022. Among the updates: The Joint Commission’s new Direct Data Submission Platform (DDSP) will be available for hospitals to submit…

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By: Judy Mathias
December 16, 2021
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Mastering surveys by The Joint Commission, CMS during COVID-19 pandemic

The 2021 OR Manager Conference in Chicago saw John R. Rosing, MHA, FACHE, executive vice president and principal of Patton Healthcare Consulting, Naperville, Illinois, give his annual update on mastering Joint Commission standards and Centers for Medicare and Medicaid (CMS) regulations. The past 2 years of COVID-19 restrictions have delayed…

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By: Judith M. Mathias, MA, RN
December 16, 2021
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CDC: Surveillance of Omicron variant in US

Editor's Note On December 1, the first case of COVID-19 attributed to the Omicron variant was reported in the US, according to the Centers for Disease Control and Prevention (CDC). As of December 8, Omicron variant cases had been reported in 22 states, including some that indicated community transmission. Of…

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By: Judy Mathias
December 15, 2021
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Appeals court upholds halt on COVID-19 vaccine mandate for HCWs

Editor's Note The US Court of appeals for the 8th Circuit, on December 13, affirmed a lower court’s decision to halt the COVID-19 vaccination mandate for healthcare workers (HCWs) at facilities participating in Medicare and Medicaid programs, the December 14 Becker’s Hospital Review reports. The court turned down the Biden…

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By: Judy Mathias
December 15, 2021
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