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US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.
Journal Article > Commentary
The Food and Drug Administration's initiative for safe design and effective use of home medical equipment.
Weick-Brady M, Singh S. Home Healthc Nurse. 2014;32:343-348.
Medical devices are increasingly being used outside clinical facilities, and this can present unique safety challenges for both untrained and skilled personnel. This commentary describes FDA efforts intended to enhance safety of medical equipment use at home, including a guidance which focuses on factors relating to the user, environment, and labeling along with a campaign to increase public awareness of the risks associated with inappropriate device use.
Rockville, MD: US Food and Drug Administration; November 9, 2010.
This notice analyzes findings from a government initiative on CT scan injuries and provides recommendations to enhance safety and prevent such incidents.
Food and Drug Administration (FDA) Patient Safety News. Show #61. March 2007.
This video story alerts providers to a possible problem with an asthma inhaler, which could indicate remaining doses incorrectly if the user forcefully twists the cap.