[Posted 08/25/2016] AUDIENCE: Nursing, Pediatrics, Pharmacy, Critical Care Medicine ISSUE: The FDA is informing health care professionals that when using programmable syringe pumps to infuse therapies at low rates (e.g., less than 5 mL per hour, and especially at flow rates of less than 0.5 mL per hour), a lack of flow continuity (i.e., inconsistent…
Syringe Pump Labeling Request Letter
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Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication
Date Issued: August 25, 2016 Audience: Health care professionals who use or who train users on programmable syringe pumps Health care professionals responsible for maintaining programmable syringe pumps Health care professionals who are responsible for how drugs are mixed for use in programmable syringe pumps Specialties: Nurses, nurse practitioners, certified registered nurse anesthetists, physician assistants,…
Webinar – Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies
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Class I Medical Device Recall: Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Device and Discontinuation of the Product line Alere plans to remove the INRatio® and INRatio®2 PT/INR Monitoring System, which includes the INRatio® or INRatio2® PT/INR Monitor and the…
Tune in to Safe Healthcare: Free Continuing Education Webinars from CDC for Healthcare Providers
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Guidance for Industry and Food and Drug Administration Staff – Factors to Consider When Making Benefit
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Patient Preference Information – Voluntary Submission, Review in PMA Applications, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling
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Eyesaline Eyewash by Honeywell: Recall
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Amendment of Notice Announcement : September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] National Mammography Quality Assurance Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the National Mammography Quality Assurance Advisory Committee. This…