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September 2016

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  • First Human Case of West Nile Viral Disease in NYC in 2016

    Monday, September 12, 2016

    West Nile viral activity continues to increase in New York City in mosquitoes. The first human case of West Nile viral disease was identified in a Brooklyn man. West Nile virus positive mosquito pools have been identified in all five boroughs.

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  • FDA MedWatch: Recall of six batches of GlucaGen® HypoKit®

    Friday, September 9, 2016

    Novo Nordisk Inc. is recalling six batches of the GlucaGen® HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI).

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  • New CMS Emergency Preparedness Rules

    Thursday, September 8, 2016

    The Centers for Medicare & Medicaid Services (CMS) finalized rules to establish consistent emergency preparedness requirements for healthcare providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and man-made disasters. These new rules will require certain participating providers and suppliers to plan for disasters and coordinate with federal, state, tribal, regional, and local emergency preparedness systems to ensure that facilities are adequately prepared to meet the needs of their patients during disasters and emergency situations. The effective date will be November 16, 2016 and the implementation date will be November 16, 2017.

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  • FDA MedWatch: VASCU-GUARD Peripheral Vascular Patch by Baxter

    Thursday, September 1, 2016

    The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu- Guard patch) during carotid endarterectomy (CEA). These reports from 2016 include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related to this issue that occurred shortly after CEA surgery. The device manufacturer, Baxter International, Inc., alerted the FDA to these adverse events.

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