Regulations/Legal

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February 2018
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FDA issues Safety Alert for Zoll LifeVest 4000 Wearable Cardioverter Defibrillator

Editor's Note The Food & Drug Administration (FDA) on January 17 issued a Safety Alert for the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator because of concerns that the device may fail to deliver treatment to patients if the device is not replaced soon after displaying “Call for service: Device has…

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By: Judy Mathias
January 17, 2018
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FDA updates Safety Alert for Cortrak 2 Enteral Access System

Editor's Note The Food & Drug Administration (FDA) on January 12 updated a Safety Alert about pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems (Buffalo Grove, Illinois). Several of the events were associated with cardiopulmonary arrest, and there were…

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By: Judy Mathias
January 17, 2018
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CMS proposes coverage change for MRI with implanted cardiac devices

Editor's Note The Centers for Medicare & Medicaid Services on January 11 issued a proposal to modify its national coverage determination for magnetic resonance imaging (MRI) to include patients who have implanted cardiac devices. Proposed changes include the expansion of coverage for patients with cardiac devices that are approved or…

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By: Judy Mathias
January 16, 2018
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FDA delays UDI compliance dates for class I, unclassified devices

Editor's Note The Food and Drug Administration (FDA) on January 12 announced a delay in enforcement of unique device identification (UDI) requirements for class I and unclassified devices until September 24, 2020. The FDA also will not enforce direct mark requirements for these devices until September 24, 2022. The guidance…

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By: Judy Mathias
January 16, 2018
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CDC updates data on HAIs

Editor's Note The Centers for Disease Control and Prevention (CDC) on January 5 updated its data on healthcare-associated infections (HAIs). Central line-associated bloodstream infections (CLABSIs) have dropped 50% since 2008. Catheter-associated urinary tract infections (CAUTIs) have had consistent year-to-year decreases, especially since those caused by yeast were deleted from the…

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By: Judy Mathias
January 12, 2018
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FDA: Class I recall of Certitude Delivery System

Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall by Edwards LifeSciences (Irvine, California) of its Certitude Delivery System as Class I, the most serious. The system is used for delivery of the Edwards SAPIEN 3 transcatheter aortic heart valve. The recall was issued because…

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By: Judy Mathias
January 12, 2018
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CMS announces new voluntary bundled payment model

Editor's Note The Centers for Medicare and Medicaid Services (CMS) on January 9 announced a new voluntary bundled payment model called, “Bundled Payments for Care Improvement Advanced” (BPCI Advanced). Participants in BPCI Advanced will receive payments for performance on 32 (29 inpatient, 3 outpatient) different clinical episodes. The first cohort…

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By: Judy Mathias
January 10, 2018
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Joint Commission: New requirement for maternal status assessment and documentation

Editor's Note The Joint Commission on January 10 announced that three new requirements for maternal status assessment and documentation will become effective July 1, 2018, for accredited hospitals and critical access hospitals that offer obstetric services, specifically labor and delivery. The new requirements were designed to: Document or assess the…

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By: Judy Mathias
January 10, 2018
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Joint Commission, CDC announce new infection prevention guides for outpatient settings

Editor's Note The Joint Commission and Centers for Disease Control & Prevention (CDC) have been collaborating since late 2015 on a 3-year project titled, “Adaptation & Dissemination of Outpatient Infection Prevention (ADOPT).” The goal of the project is to adapt, enhance, and disseminated current CDC guidance on infection prevention and…

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By: Judy Mathias
January 9, 2018
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FDA Commissioner updates drug shortage efforts in Puerto Rico

Editor's Note Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, on January 4 issued a statement, updating the continued efforts to mitigate the IV saline and amino acids for injection shortages caused by Hurricane Maria. The FDA expects the IV saline shortage to improve in early 2018. Just before…

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By: Judy Mathias
January 9, 2018
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