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September 2016

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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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  • Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas

    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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  • FDA MedWatch: Drug Safety Label Changes (SLC) Available in New Format

    Thursday, September 1, 2016

    The FDA is pleased to announce its safety labeling change (SLC) data on the Web will now be available in real time for health care providers, health information technology vendors, and the public to view, search, and download. Ultimately, the FDA expects that prompt access to these vital safety data by health care providers and consumers will better promote patient health.

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