FDA News

FDA: Design of ERCP endoscopes may hinder effective cleaning

The complex design of endoscopic retrograde cholangiopancreatography duodenoscopes may cause challenges for effective cleaning and disinfection, according to an FDA safety communication released today.

The message follows recent medical publications and adverse event reports that found endoscopic retrograde cholangiopancreatography (ERCP) procedures with reprocessed duodenoscopes were associated with multidrug-resistant bacterial infections, even when manufacturer reprocessing instructions were followed, the document said.

A recent FDA engineering assessment and other publications have identified design issues that complicate reprocessing, such as the elevator mechanism, which contains difficult-to-clean microscopic crevices that may harbor residual body fluids and organic debris, even after cleaning and disinfection.

From 2013 to 2014, the FDA received 75 medical device reports involving an estimated 135 patients regarding possible microbial transmission from reprocessed duodenoscopes, according to the document. The FDA is closely monitoring the association between these devices and transmission of infectious agents, including multidrug-resistant bacterial infections caused by carbapenem-resistant Enterobacteriaceae such as Klebsiella species and Escherichia coli.

The FDA recommends that health care facilities and staff that reprocess ERCP duodenoscopes closely adhere to manufacturer instructions for cleaning and processing and to endoscope reprocessing guidelines established by the infection control community and endoscopy professionals. The benefit of additional cleaning accessories such as channel flushing aids, brushes and cleaning agents is unknown, the document said. Additional best practices include meticulously cleaning the elevator mechanism and surrounding recesses by hand, even when using an automated endoscope reprocessor, and implementing a quality control program for reprocessing duodenoscopes.

The FDA also recommends that health care providers inform patients of the benefits and risks of ERCP and consider taking a duodenoscope out of service until it is verified to be free of pathogens if a patient develops an infection that is suspected of being linked to the device.

The agency is currently collaborating with other government agencies, including the CDC, and device manufacturers to identify the causes and risk factors for transmission of infectious agents via reprocessed duodenoscopes to develop solutions to minimize patient exposure, according to the document.

The complex design of endoscopic retrograde cholangiopancreatography duodenoscopes may cause challenges for effective cleaning and disinfection, according to an FDA safety communication released today.

The message follows recent medical publications and adverse event reports that found endoscopic retrograde cholangiopancreatography (ERCP) procedures with reprocessed duodenoscopes were associated with multidrug-resistant bacterial infections, even when manufacturer reprocessing instructions were followed, the document said.

A recent FDA engineering assessment and other publications have identified design issues that complicate reprocessing, such as the elevator mechanism, which contains difficult-to-clean microscopic crevices that may harbor residual body fluids and organic debris, even after cleaning and disinfection.

From 2013 to 2014, the FDA received 75 medical device reports involving an estimated 135 patients regarding possible microbial transmission from reprocessed duodenoscopes, according to the document. The FDA is closely monitoring the association between these devices and transmission of infectious agents, including multidrug-resistant bacterial infections caused by carbapenem-resistant Enterobacteriaceae such as Klebsiella species and Escherichia coli.

The FDA recommends that health care facilities and staff that reprocess ERCP duodenoscopes closely adhere to manufacturer instructions for cleaning and processing and to endoscope reprocessing guidelines established by the infection control community and endoscopy professionals. The benefit of additional cleaning accessories such as channel flushing aids, brushes and cleaning agents is unknown, the document said. Additional best practices include meticulously cleaning the elevator mechanism and surrounding recesses by hand, even when using an automated endoscope reprocessor, and implementing a quality control program for reprocessing duodenoscopes.

The FDA also recommends that health care providers inform patients of the benefits and risks of ERCP and consider taking a duodenoscope out of service until it is verified to be free of pathogens if a patient develops an infection that is suspected of being linked to the device.

The agency is currently collaborating with other government agencies, including the CDC, and device manufacturers to identify the causes and risk factors for transmission of infectious agents via reprocessed duodenoscopes to develop solutions to minimize patient exposure, according to the document.