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- Government Resource
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.
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.
Grant > Government Resource
Patient Safety Learning Laboratories: Pursuing Safety in Diagnosis and Treatment at the Intersection of Design, Systems Engineering, and Health Services Research (R18).
Rockville, MD: Agency for Healthcare Research and Quality. RFA-HS-19-001.
Tools/Toolkit > Government Resource
Rockville, MD: Agency for Healthcare Research and Quality; 2017.
Both organizational culture and the physical environment affect the safety of care delivery. This toolkit provides resources to help organizations assess hazards related to the design of their facilities. The toolkit focuses on six areas of safety: infections, falls, medication errors, security, injuries of behavioral health, and patient handling.
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 Draft guidance for industry and Food and Drug Administration staff.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.
Zheng K, Ciemins EL, Lanham HJ, Lindberg C. Rockville, MD: Agency for Healthcare Research and Quality; July 2015. AHRQ Publication No. 15-0058-EF.
Ineffective implementation of health information technology (IT) can result in workarounds and other workflow changes that disrupt care delivery. This report examines how health IT implementation can affect clinician and staff workload in the ambulatory care environment, including increase interruptions and multitasking, and recommends workload considerations to enable staff to adapt to changes in practice.
Special or Theme Issue
Agency for Healthcare Research and Quality. Health Care Innovations Exchange. June 18, 2014.
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.
Incorporating Health Information Technology Into Workflow Redesign: Request for Information Summary Report.
Carayon P, Karsh B-T, Cartmill RS, et al. Rockville, MD: Agency for Healthcare Research and Quality; October 2010. AHRQ Publication No. 10-0098-EF.
The report summarizes evidence related to the impact of health information technology on workflow in outpatient settings.
Rockville, MD: Agency for Healthcare Research and Quality; September 2007. AHRQ Publication No. 07-0076-1.
This video uses the experiences of three US hospitals to demonstrate how the quality and safety of each hospital's patient care services were improved by implementing evidence-based hospital design into recent construction and renovation projects.
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.
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.