FDA Issues Safety Alert for Duodenoscopes

FDA Issues Safety Alert for Duodenoscopes

The FDA wants to raise awareness among healthcare professionals, including those working in reprocessing units in healthcare facilities, that the complex design of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports link multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.

The tip of a duodenoscope. Photo courtesy of the FDA.

The FDA wants to raise awareness among healthcare professionals, including those working in reprocessing units in healthcare facilities, that the complex design of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports link multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.

For more information and recommendations, visit: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm.

For a slide show from ICT on Duodenoscopes and the Dangers of Improper Reprocessing, CLICK HERE.

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