Duodenoscopes are widely used reprocessed devices for ERCP. Improper cleaning and disinfection of duodenoscopes is the cause of several incidences of infections including MRSA episodes annually. At a recent FDA Advisory Committee meeting, the risk and safety issues related to these devices were discussed. The gastroenterology and urology devices advisory panel of FDA observed that though the rate of infections are low given the total number of ERCP cases performed annually across the US, it’s quite alarming as infections were traced despite strict compliance with the FDA recommendations for cleaning. The panel recommended the sterilization or using newer more efficient disinfectants. Many experts suggested updates of the device design to make them easier to disinfect and clean. However, the panel unanimously agreed not to ban use of duodenoscopes as currently used since its benefits far outweighed the risks associated. Previously, FDA had issued a safety alert related to duodenoscopes in February, 2015. In that alert, FDA recommended “effective” reprocessing thorough step-by-step process to disinfect or sterilize these devices. The advisory panel recommended that patients be informed of the risk of infection with use of duodenoscope. This is not an isolated incidence of risk of reprocessed devices and it sure won’t be the last one. Stay tuned.
Article Source: Need to innovate the design of duodenoscope to enable infection free reprocessing
