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.
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.
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.
PRESS RELEASE/ANNOUNCEMENTView all related resources...
Medical gas containers and closures; current good manufacturing practice requirements.
Federal Register. April 10, 2006;71:18039-18053.