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- Communication Improvement 1
- Culture of Safety 1
- Education and Training 3
- Error Reporting and Analysis 4
- Human Factors Engineering 2
- Legal and Policy Approaches 1
- Quality Improvement Strategies 1
- Technologic Approaches 1
- Device-related Complications
- Medical Complications 3
- Medication Safety 2
- Surgical Complications
Search results for "Device-related 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.
Fillo KT. Bureau of Health Care Safety and Quality, Department of Public Health. Boston, MA: Commonwealth of Massachusetts; July 2018.
This report compiles patient safety data documented by Massachusetts hospitals. The latest numbers represent a modest decrease in serious reportable events recorded in acute care hospitals, from 1012 the previous year to 922. This presentation also includes events from ambulatory surgery centers. Previous years reports are also available.
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.
Grant > Government Resource
Rockville, MD: Agency for Healthcare Research and Quality; September 2011.
This AHRQ announcement lists projects funded in 2011 to evaluate how simulation can improve patient safety and health care quality.
Rockville, MD: Agency for Healthcare Research and Quality.
In this annual publication, AHRQ reviews the results of the National Healthcare Quality Report and National Healthcare Disparities Report. Providing a 5-year update on the National Quality Strategy, this report highlights that a wide range of quality measures have shown improvement in quality, access, and cost.
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.
Health Care Inspection. Washington, DC: VA Office of Inspector General; April 10, 2006. Report No. 06-01642-126.
This report shares the results of an inspection into two mistakes at a Veterans Affairs (VA) health facility involving appropriate sterilization of implantable medical devices.