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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.
Journal Article > Study
Al Mohajer M, Joiner KA, Nix DE. Acad Med. 2018;93:1827-1832.
The Hospital-Acquired Condition Reduction Program (HACRP) was established by the Centers for Medicare and Medicaid Services (CMS) and withholds payment to hospitals for several hospital-acquired conditions deemed to be preventable sources of patient harm. Prior research has shown that teaching hospitals, hospitals caring for more complicated and high-risk patients, and safety-net hospitals may be more likely to experience financial penalties under HACRP compared to nonteaching hospitals caring for less sick patients. These findings raised concerns regarding the possible unintended consequences related to pay-for-performance. Researchers sought to identify factors associated with HACRP performance and penalties. They found that teaching institutions and hospitals with higher case-mix index, length of stay, and those located in the Northeast or Western United States were more likely to receive penalties under the CMS program. A previous WebM&M commentary discussed the unintended consequences associated with publicly reported health care quality measures.
Aston G. Hosp Health Netw. September 9, 2014.
Salt Lake City, UT: Utah Department of Health, Utah Hospitals & Health Systems Association, and HealthInsight; March 10, 2010.
This brief provides information on 101 sentinel events reported to the state of Utah in 2009. The report also includes background on efforts to address such incidents.