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Search results for "Medical Device Design"
- Press Release/Announcement
- Medical Device Design
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; August 29, 2006.
This news release announces a seizure of infusion pumps that have a "key bounce" defect that could result in over-infusion of medication.
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.
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.
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.
Information Exchange System Alert. Geneva, Switzerland: World Health Organization; July 18, 2007.
This international announcement provides guidance on the safe administration of the chemotherapeutic agent vincristine.
Silver Spring, MD: American Nurses Association; June 18, 2007.
The American Nurses Association announces the results from a survey of more than 1000 nurses on medication error and syringe safety.
Federal Register. April 10, 2006;71:18039-18053.
The U.S. Food and Drug Administration (FDA) is proposing to amend good manufacturing practice to include several strategies for minimizing medical gas-related patient safety incidents. The proposal is open for public comment through July 10, 2006.
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.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 27, 2005.
This announcement alerts patients and practitioners to a problem with glucose meters made by Abbott Diabetes Care. The meters have a measurement setting that, if inadvertently switched, could cause an inaccurate reading.