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Search results for "North America"
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.
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.
QualityNet. February 18, 2009.
The Centers for Medicare and Medicaid Services is conducting a field test of nine AHRQ quality and patient safety indicators. Hospitals participating in the review process receive confidential reports on their performance results and national comparative data.
Schultz DG. Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; January 15, 2008.
This notification alerts providers to the potential danger of unretrieved device fragments (UDFs), types of adverse events that may occur, and prevention strategies.
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.
Association of PeriOperative Registered Nurses.
This survey will gather comments from the field regarding The Joint Commission's Universal Protocol to help eliminate wrong site surgeries.
Baltimore, MD: Centers for Medicare & Medicaid Services (CMS) Office of Public Affairs; May 18, 2006.
This fact sheet provides information regarding the Centers for Medicare and Medicaid Services' initiative to better understand and minimize never events.