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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
- Medical Device Design
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.
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.
Journal Article > Commentary
The Food and Drug Administration's initiative for safe design and effective use of home medical equipment.
Weick-Brady M, Singh S. Home Healthc Nurse. 2014;32:343-348.
Medical devices are increasingly being used outside clinical facilities, and this can present unique safety challenges for both untrained and skilled personnel. This commentary describes FDA efforts intended to enhance safety of medical equipment use at home, including a guidance which focuses on factors relating to the user, environment, and labeling along with a campaign to increase public awareness of the risks associated with inappropriate device use.
Web Resource > Multi-use Website
Medical Product Safety Network. Silver Spring, MD; US Food and Drug Administration.
This Web site provides information about tubing misconnections and how to prevent them.
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.
Journal Article > Commentary
Kaufman D, Weick-Brady M. Home Healthc Nurse. 2009;27:300-307.
This article surveys the main concerns in using medical devices at home and focuses on two initiatives by the US Center for Devices and Radiologic Health that help home health care workers report medical device failures and near misses.
Food and Drug Administration (FDA) Patient Safety News. Show #61. March 2007.
This video story alerts providers to a possible problem with an asthma inhaler, which could indicate remaining doses incorrectly if the user forcefully twists the cap.
Food and Drug Administration (FDA) Patient Safety News. Show #57. November 2006.
This video news segment recaps concerns over the use of an infusion pump with an identified design defect.
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.
Center for Devices and Radiological Health. Bethesda, MD: Food and Drug Administration, US Dept of Health and Human Services; 2006.
This document provides background on hospital bed injuries, identifies potentially dangerous design flaws, and offers assessment tools to reduce entrapment incidents.
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.