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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.
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.
Tools/Toolkit > Fact Sheet/FAQs
Consumer Updates. Silver Spring, MD: US Food and Drug Administration; December 12, 2012.
Highlighting concerns associated with patients' use of medical devices at home, such as difficulty understanding instructions, this article offers tips for consumers to help reduce risks.
Leeds, UK: Clinical Support Audit Unit, Health and Social Care Information Centre. December 9, 2015. ISBN: 9781783865697.
The NHS Safety Thermometer is a tool developed by the National Health Service to facilitate staff participation in measuring patient harm in various care environments. This report explores the data collected on four types of health care–acquired conditions (pressure ulcers, falls, catheter–associated urinary tract infections, and venous thromboembolisms) in NHS patients over a 1-year period.