FDA

Latest Issue of OR Manager
February 2018

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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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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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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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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FDA: PharMEDium recalls 55 lots of compounded sterile drugs

Editor's Note The Food and Drug Administration on January 2 announced the recall by PharMEDium Services (Lake Forest, Illinois) of 55 lots (impacting 25,327 units) of compounded sterile drug products because of a lack of sterility assurance. The recalled products were manufactured in PharMEDium’s Memphis location and distributed nationwide to…

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By: Judy Mathias
January 5, 2018
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FDA: AuroMedics recalls Ampicillin and Sulbactam for Injection

Editor's Note The Food and Drug Administration (FDA) on January 4 announced the recall by AuroMedics Pharma LLC (Windsor, New Jersey) of one lot of Ampicillin and Sulbactam for Injection USP 1.5 g in a single-dose vial. The recall was issued because the lot (Lot AFOI 17001-A, Expiry date December…

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By: Judy Mathias
January 4, 2018
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FDA: Class I recall of Agilis Steerable Reprocessed Introducer Sheath

Editor's Note The Food and Drug Administration (FDA) on January 2 classified the recall by Sterilmed (Plymouth, Minnesota) of its Agilis Steerable Reprocessed Introducer Sheath as Class I, the most serious. The sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper…

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By: Judy Mathias
January 3, 2018
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FDA issues guidance on 3D printing of medical devices

Editor's Note Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, issued a statement December 4 on the FDA’s final guidance on medical device additive manufacturing, also known as 3D printing. The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including…

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By: Judy Mathias
December 7, 2017
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