FDA

Latest Issue of OR Manager
December 2017

CMS: Two inpatients needed for hospital survey, resurvey

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has issued a new requirement, effective immediately, that a hospital must have at least two active inpatients at the time of survey, or the survey/resurvey will not be allowed to continue, the Joint Commission reported November 15. The new requirement…

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By: Judy Mathias
November 16, 2017
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FDA: Baxter recalls one lot of injectable amiodarone

Editor's Note The Food and Drug Administration (FDA) on November 15 announced the recall by Baxter International (Deerfield, Illinois) of one lot of Nexterone (amiodarone HCL) 150 mg/100 mL premixed injection because of the presence of particulate matter. The particulate matter was identified as polyethylene, the primary constituent of the…

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By: Judy Mathias
November 16, 2017
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FDA clears new, faster CBC test

Editor's Note The Food and Drug Administration (FDA) on November 6 cleared a new complete blood cell count (CBC) test that can be run in more healthcare settings and offers faster results for patients and providers. The FDA granted premarket clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA)…

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By: Judy Mathias
November 10, 2017
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FDA: Safety Alert for Cardinal Health’s Infant/Child Reduced Energy Defibrillation Electrodes

Editor's Note The Food and Drug Administration (FDA) on November 6 issued a Safety Alert saying that Physio-Control (Redmond, Washington) launched a voluntary field action for specific lots of Infant/Child Reduced Energy Defibrillation Electrodes manufactured by Cardinal Health (Dublin, Ohio). There is an issue with the artwork on the electrodes…

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By: Judy Mathias
November 8, 2017
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FDA: Recall of prefilled syringes labeled Midazolam that are actually Ondansetron

Editor's Note The FDA announced on November 3 that Fresenius Kabi USA (Lake Zurick, Illinois) is recalling one lot of Midazolam Injection, USP, 2 mg/2 mL packaged in 2 mL prefilled single-use glass syringes because the packages labeled as Midazolam actually contain syringes that are filled with and labeled as…

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By: Judy Mathias
November 7, 2017
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FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold

Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…

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By: Judy Mathias
October 31, 2017
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FDA: SCA pharmaceuticals recalls certain lots of injectable products

Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products.  The recall was initiated because of the potential for the products to contain microbial contamination.  Many of the recalled products are used in anesthesia,…

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By: Judy Mathias
October 24, 2017
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FDA updates Safety Alert for St Jude defibrillators

Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…

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By: Judy Mathias
October 23, 2017
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FDA clears new surgical robot

  Editor's Note The Food and Drug Administration (FDA) on October 13 cleared the Senhance System (TransEnterix Surgical Inc, Morrisville, North Carolina), a new robotically-assisted surgical device. The design of the Senhance System allows surgeons to sit at a console unit that provides a 3-D high-definition view of the surgical…

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By: Judy Mathias
October 18, 2017
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FDA issues Safety Alert for intraocular TMV injections

Editor's Note The Food & Drug Administration (FDA) on October 3 issued a Safety Alert saying the agency had received an adverse event report on a patient who was diagnosed with bilateral hemorrhagic occlusive retinal vasculitis after being administered injections of a compounded triamcinolone, moxifloxacin, vancomycin (TMV) formulation in each…

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By: Judy Mathias
October 5, 2017
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