Narrow Results Clear All
- Culture of Safety 2
Education and Training
- Students 1
- Error Reporting and Analysis 6
- Human Factors Engineering 8
- Legal and Policy Approaches 3
- Quality Improvement Strategies 4
- Teamwork 1
- Technologic Approaches 1
- Device-related Complications
- Diagnostic Errors 1
- Discontinuities, Gaps, and Hand-Off Problems 1
- Medical Complications 5
- Medication Safety 5
- Nonsurgical Procedural Complications 2
- Surgical Complications 4
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.
Bethesda, MD: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. May 21, 2018. PA-18-790; PA-18-791.
Silver Spring, MD: US Food and Drug Administration; April 2018.
Reliable use of medical devices is an important contributor to safe health care delivery. This report describes the US Food and Drug Administration's plan to raise awareness of problems with devices in the field, develop new devices with better safety and cybersecurity protections, and enhance innovation and the product life cycle through regulation.
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.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; August 29, 2006.
This news release announces a seizure of infusion pumps that have a "key bounce" defect that could result in over-infusion of medication.
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.
Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.
Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.
Special or Theme Issue
Agency for Healthcare Research and Quality. Health Care Innovations Exchange. June 18, 2014.
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: US Food and Drug Administration; November 9, 2010.
This notice analyzes findings from a government initiative on CT scan injuries and provides recommendations to enhance safety and prevent such incidents.
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.
Grant > Government Resource
Rockville, MD: Agency for Healthcare Research and Quality; June 2008.
This announcement describes the 19 projects funded by the Agency for Healthcare Research and Quality in 2006 that studies the potential of simulation to improve patient safety.
Center for Devices and Radiological Health. Bethesda, MD: Food and Drug Administration, US Dept of Health and Human Services; 2006.
This document provides background on hospital bed injuries, identifies potentially dangerous design flaws, and offers assessment tools to reduce entrapment incidents.