Mass Spectrometers by Sciex: Safety Communication

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Meeting Notice: October 5, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1660] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice; establishment of a public docket; request for comments. SUMMARY:  The Food and Drug Administration…

Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers

September 1, 2016 Dear Vascular Surgeons, General Surgeons, Cardiothoracic Surgeons, and Neurosurgeons: 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…

Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication

September 1, 2016 Audiences: Laboratory professionals and State Health Laboratories who use Sciex (previously known as AB Sciex) mass spectrometers Health care professionals who rely on test results provided by Sciex mass spectrometers Medical Specialties: All specialties may be impacted but tests using mass spectrometers may be particularly common for Anesthesiology, Neurology, Pain Management, Medical…

Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication

[Posted 08/31/2016] AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths.  Opioids are used to treat pain and…

Webinar – Final Guidance on Patient Preference Information

  On August 23, 2016, the FDA published the final guidance on Patient Preference Information – Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling. It outlines recommendations on patient preference studies that may result in valid scientific evidence and how stakeholders, including industry and…