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Search results for "Governmental Reporting"
- Governmental Reporting
- Medical Device Design
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.
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.
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.