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FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
Mohr H, Weiss M. Associated Press. November 27, 2018.
Jewett C. Kaiser Health News. May 3, 2019.
Transparency has been heralded as a cornerstone to improvement in health care. This news article reports on a government alternative summary reporting program that allowed medical device makers to conceal safety events and malfunction reports associated with medical devices. A new program that expands access to information about device-related failures will be put in place.