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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.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration. May 29, 2018.
Surgical fires can result in patient harm. This announcement provides information about causes of surgical fires and reviews FDA recommendations to prevent them, such as presurgery fire risk assessment, promoting team communication, and fire management planning. A WebM&M commentary discussed common sources of operating room fires and how to reduce risks.
Agency information collection activities: Assessing the Impact of the National Implementation of TeamSTEPPS Master Training Program; comment request.
Federal Register. Rockville, MD: Agency for Healthcare Research and Quality. August 27, 2013;78:52927-52929.
This notice requests comments on a proposed project to evaluate TeamSTEPPS training and implementation efforts. The comment submission process is now closed.
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.