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Search results for "Press Release/Announcement"
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.
FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
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.
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.
Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 15, 2012.
This announcement reveals risks associated with administering codeine after a common pediatric procedure.
New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; September 15, 2010.
This announcement describes revised dosing recommendations designed to prevent overdosing immunocompromised pediatric patients.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; April 18, 2007.
This announcement alerts health care providers and consumers to potential contamination of medical devices from one manufacturer.