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- Communication Improvement 1
- Education and Training 2
- Error Reporting and Analysis
- Human Factors Engineering
- Legal and Policy Approaches 3
- Logistical Approaches 1
- Transparency and Accountability 1
- Device-related Complications 8
- Identification Errors 1
- Medical Complications 3
- Medication Errors/Preventable Adverse Drug Events 2
- Nonsurgical Procedural Complications 2
- Surgical Complications 3
- Transfusion Complications 1
- Family Members and Caregivers 2
- Health Care Executives and Administrators 6
Health Care Providers
- Nurses 1
- Non-Health Care Professionals 7
- Patients 6
Search results for "Human Factors Engineering"
- Governmental Reporting
- Human Factors Engineering
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.
Web Resource > Multi-use Website
Human Factors Engineering Team, Center for Devices and Radiological Health, Office of Communication, Education, and Radiation Programs (OCER), Division of Device User Programs and Systems Analysis (DDUPSA), 1350 Piccard Drive, HFZ-230, Rockville, MD 20850.
Human factors engineering (HFE) helps improve human performance and reduce the risks associated with use error. The U.S. Food and Drug Administration (FDA) works with manufacturers to ensure the application of HFE in the design of new products. In addition to providing information on these design issues, this site facilitates the reporting of unsafe incidents with medical devices.
Jewett C. Kaiser Health News. May 3, 2019.
Transparency has been heralded as a cornerstone to improvement in health care. This news article reports on a government alternative summary reporting program that allowed medical device makers to conceal safety events and malfunction reports associated with medical devices. A new program that expands access to information about device-related failures will be put in place.
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.
Mohr H, Weiss M. Associated Press. November 27, 2018.
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.
Aston G. Hosp Health Netw. September 9, 2014.
Bogdanich W. New York Times. January 24, 2010:A1.
First in a series on medical radiation, this news feature and accompanying video investigate patient deaths and injuries following mistakes related to radiation treatment. The journalists discuss the number of radiation therapy errors in New York and reveal that state law does not require public reporting of such mistakes.
May H. Salt Lake Tribune. August 18, 2008.
This article examines 2007 state health data on never events in the context of a label-related medical error that resulted in a recent death.
Journal Article > Study
Increased catheter-related bloodstream infection rates after the introduction of a new mechanical valve intravenous access port.
Maragakis LL, Bradley KL, Song X, et al. Infect Control Hosp Epidemiol. 2006;27:67-70.
The authors report an increased infection rate due to the implementation of a new technology in one U.S. hospital.
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.