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Human Factors Engineering
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Search results for "United States Federal Government"
- Human Factors Engineering
- United States Federal Government
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.
Journal Article > Study
Kahwati LC, Sorensen AV, Teixeira-Poit S, et al. Jt Comm J Qual Patient Saf. 2019;45:231–240.
Labor and delivery is an inherently high-risk care setting. The Agency for Healthcare Research and Quality adapted its Comprehensive Unit-based Safety Program, a best practice toolkit incorporating teamwork, human factors engineering principles, and simulation training, for labor and delivery. In this pre–post evaluation study, staff reported improved safety culture and teamwork. Obstetric trauma and primary cesarean delivery rates declined after the intervention, but neonatal birth trauma rates increased. The authors note that incomplete implementation and lack of sustained program participation observed in the study should be addressed in order to improve obstetric and neonatal care safety. A recent Annual Perspective emphasizes the rising rate of severe maternal morbidity and summarizes national initiatives to improve safety in maternity care.
Journal Article > Study
Quality improvement in ambulatory surgery centers: a major national effort aimed at reducing infections and other surgical complications.
Davis KK, Mahishi V, Singal R, et al. J Clin Med Res. 2019;11:7-14.
Ambulatory surgery centers are increasingly utilized to provide surgical care to patients. Quality improvement approaches utilized in the inpatient setting may need to be modified or adapted to be applicable in the ambulatory surgery environment. Researchers describe efforts to implement a surgical safety checklist and infection control techniques across 665 ambulatory surgery centers recruited for the study. They identified several barriers and conclude that the unique aspects of ambulatory surgery centers must be taken into account when implementing quality improvement initiatives.
Journal Article > Review
Joseph A, Henriksen K, Malone E. Health Aff (Millwood). 2018;37:1884-1891.
The built environment influences the safety and effectiveness of care delivery. This narrative review examines how care facility design can reduce health care–associated infections, falls, and medication errors. The authors provide suggestions regarding a range of facility design strategies and discuss how accreditation, funding, and policy organizations can support design projects as improvement efforts.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
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.
FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.
Journal Article > Study
Viewing prevention of catheter-associated urinary tract infection as a system: using systems engineering and human factors engineering in a quality improvement project in an academic medical center.
Rhee C, Phelps ME, Meyer B, Reed WG. Jt Comm J Qual Patient Saf. 2016;42:447-471.
Catheter–associated urinary tract infections (CAUTI) lead to preventable harm and cost among hospitalized patients. In this quality improvement program, principles of human factors engineering were applied to reduce CAUTI at an academic medical center. Investigators utilized systems approaches to examine the factors related to CAUTI at their institution, including how the physical layout influenced adherence to best practices. They made changes based on this assessment, such as enhancing access to catheter maintenance supplies across all hospital units. The intervention also used technology (automated electronic health record reminders) and training (asynchronous education on catheter insertion) to augment safe catheter use. This multipronged approach led to a steep reduction in CAUTI at the end of the 3-year project compared to the preintervention period. The authors suggest that their results support the use of human factors engineering to decrease health care–associated infections.
Rizk S, Oguntebi G, Graber ML, Johnston D. Research Triangle Park, NC: RTI International; 2016.
Standard term selection tools—like pick lists or drop-down menus—in information technology can create opportunities for user error due to human factors. This publication explores how mistakes such as selecting the wrong drug from an ordering pick list can occur in the ambulatory environment. The report includes recommendations and resources to help enhance medication safety when using these tools.
Agency for Healthcare Research and Quality. Health Care Innovations Exchange. May 18, 2016.
Rockville, MD: Center for Drug Evaluation and Research, US Food and Drug Administration; April 2016.
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.
Leas BF, Sullivan N, Han JH, Pegues DA, Kaczmarek JL, Umscheid CA. Rockville, MD: Agency for Healthcare Research and Quality; August 2015. Technical Brief No. 22. AHRQ Publication No. 15-EHC020-EF.
FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; July 30, 2015.
Look-alike and sound-alike drug names can contribute to confusion and result in medication errors. To raise awareness of potential wrong-patient errors due to similarity between two proprietary names, this announcement describes near misses with the drugs at the prescribing and dispensing stage and suggests clinicians use the generic names for the medications to reduce risk of patient harm.
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.
FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam).
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; May 20, 2015.
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 23, 2015.
Design limitations and production pressure may contribute to insufficient sterilization of complicated medical devices between uses. This announcement raises awareness of risks associated with inadequate cleaning of duodenoscopes that surfaced after a cluster of nosocomial infections at Ronald Reagan UCLA Medical Center.
Legislation/Regulation > Government Resource
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.