FDA warning dudenscopes

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Recent medical publications and adverse event reports associate 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.

A USA Today investigation concluded, while the design of the device makes it more effective it also makes it more difficult to clean, leading to the development of deadly bacteria in the devices. Following that report, the FDA has recently announced a safety warning for duodenoscopes.  “FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. In total, from January 2013 through December 2014, the FDA received 75 MDRs encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes.