In wake of UCLA Health outbreak, the US Food and Drug Administration releases report highlighting risk of inadequately sterilized endoscopic retrograde cholangiopancreatography (ERCP) equipment.Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.
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.
Mistakes due to small-bore Luer connector similarities can contribute to patient harm. This guidance provides ways for manufacturers, policy makers, and product designers to prevent misconnections, including recommendations regarding improvements for labeling, user testing, and risk assessment.
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.
Do split-side rails present an increased risk to patient safety?
Hignett S, Griffiths P. Qual Saf Health Care. 2005;14:113-116.
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.
Center for Devices and Radiological Health. Bethesda, MD: Food and Drug Administration, US Dept of Health and Human Services; 2006.
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Medical gas containers and closures; current good manufacturing practice requirements.
Federal Register. April 10, 2006;71:18039-18053.