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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
- Surgical Complications
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.
Journal Article > Study
Magill SS, O'Leary E, Janelle SJ, et al; Emerging Infections Program Hospital Prevalence Survey Team. N Engl J Med. 2018;379:1732-1744.
Health care–associated infections (HAIs) are a key cause of preventable harm in hospitals. Successful programs to avert HAIs include the comprehensive unit-based safety program to reduce catheter-related bloodstream infections and the AHRQ Safety Program for Surgery to prevent surgical site infections. This survey of 12,299 patients at 199 hospitals on a single day enabled researchers to estimate the prevalence of HAIs in the United States. In 2015, 3.2% of hospitalized patients experienced an HAI, a 16% decrease compared to a similarly derived estimate in 2011. The most common HAIs were pneumonia and Clostridium difficile infections, while the biggest reductions were in urinary tract and surgical site infections. This data emphasizes the importance of identifying strategies to combat pneumonia in nonventilated patients, which remains common and less well-studied than other HAIs. A past PSNet perspective discussed the history around efforts to address preventable HAIs, including federal initiatives.
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.
Web Resource > Multi-use Website
Council on Surgical & Perioperative Safety.
This initiative provides information on surgical fires and makes recommendations to address the risk of fires during surgery.
Web Resource > Multi-use Website
Food and Drug Administration and the International Anesthesia Research Society.
This Web site hosts advice, news, events, and interviews related to anesthetic medication safety for pediatric patients.
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.