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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.
Journal Article > Study
Tarola CL, Quin JA, Haime ME, et al. JAMA Surg. 2016;151:1183-1186.
Communication breakdowns in the operating room are associated with preventable adverse events. This study examined the potential of a novel workflow management system—a computerized system which used voice recognition and built-in algorithms to ensure important procedural steps were undertaken appropriately—to improve patient safety. The system was able to detect when intraoperative tasks were being performed and successfully identified omitted steps as well.