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- Audiovisual 2
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- Legislation/Regulation 1
- Special or Theme Issue 2
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- Press Release/Announcement 4
- Education and Training 5
- Error Reporting and Analysis 4
- Human Factors Engineering 15
- Legal and Policy Approaches 1
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- Device-related Complications 10
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Search results for ""
Risk of electromagnetic interference with medical telemetry systems operating in the 460-470 MHz frequency bands.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 16, 2005.
This announcement notifies health care practitioners of possible interference with medical alarms and patient monitoring systems caused by mobile radio transmitters.
Journal Article > Review
Systematic review: antimicrobial urinary catheters to prevent catheter-associated urinary tract infection in hospitalized patients.
Johnson JR, Kuskowski MA, Wilt TJ. Ann Intern Med. 2006;144:116-126.
The investigators reviewed the literature on two types of antimicrobial urinary catheters and found that the evidence supports their ability to prevent infection.
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.
Food and Drug Administration (FDA) Patient Safety News. Show #57. November 2006.
This video news segment recaps concerns over the use of an infusion pump with an identified design defect.
Grout JR. Rockville, MD: Agency for Healthcare Research and Quality; May 2007. AHRQ Publication No. 07-P0020.
In this report, the author draws from multidisciplinary sources to share examples of practical process and design changes that can mitigate human error in health care.
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.
Kaji AH, Cone DC, eds. Acad Emerg Med. 2008;15:971-1222.
This special issue highlights an AHRQ-funded symposium on the role of simulation in medical education and covers topics such as teamwork training and skill improvement.
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: 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.
Journal Article > Commentary
Henriksen K, Brady J. BMJ Qual Saf. 2013;22(supp 2):1-5.
Web Resource > Multi-use Website
Medical Product Safety Network. Silver Spring, MD; US Food and Drug Administration.
This Web site provides information about tubing misconnections and how to prevent them.
Special or Theme Issue
Agency for Healthcare Research and Quality. Health Care Innovations Exchange. June 18, 2014.
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.
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.
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.
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.
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.
Journal Article > Commentary
Pursuing patient safety at the intersection of design, systems engineering, and health care delivery research: an ongoing assessment.
Henriksen K, Rodrick D, Grace EN, Shofer M, Brady PJ. J Patient Saf. 2019 Feb 9; [Epub ahead of print].
Applying systems engineering strategies from problem analysis through postimplementation evaluation can lead to solutions grounded in actual practice and learning for individuals, teams, and organizations. This commentary discusses the Agency for Healthcare Research and Quality patient safety learning laboratories initiative. The authors, who serve as program officers and oversee the grants, review lessons learned through experiences of grantees.