Supply Chain/Technology

Latest Issue of OR Manager
February 2018
Home Supply Chain/Technology

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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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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Growth predicted for minimally invasive spine surgery market

Editor's Note A Healthcare Market Reports analysis predicts the minimally invasive spine surgery market will see a compound annual growth rate of 7.57% through 2020, the January 4 Becker’s Spine Review reports. The increasing incidence of spinal disorders is boosting the market, and a key market trend is the minimally…

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By: Judy Mathias
January 8, 2018
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Research report predicts growth for arthroscopic devices market

Editor's Note A Persistence Market Research report predicts the global arthroscopic devices market will exceed $1.7 billion by 2022, with a 5.1% compound annual growth rate, according to the January 3 Becker’s Spine Review. A rising demand for minimally invasive procedures and an increasing geriatric population are the main contributors…

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By: Judy Mathias
January 5, 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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