Regulations/Legal
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…
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…
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…
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…
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…
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…
The Joint Commission revises requirements for informed consent, AV information
Editor's Note The Joint Commission, on January 12, announced that revisions to the Rights and Responsibilities of the Individual (RI) chapter addressing the written policy on informed consent and organizational use of images, films, and recording of patients will become effective July 1, 2022. Among the revisions: A new bullet…
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…
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…
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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