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- Human Factors Engineering
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- Device-related Complications 6
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- Medical Complications 3
- Medication Errors/Preventable Adverse Drug Events 2
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Health Care Providers
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Search results for "Governmental Reporting"
- Governmental Reporting
- Human Factors Engineering
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.
Mohr H, Weiss M. Associated Press. November 27, 2018.
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.
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.