The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of 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 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.
More than 500,000 ERCP procedures using duodenoscopes are performed in the United States annually. The procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum). They contain a hollow channel that allows the injection of contrast dye or the insertion of other instruments to obtain tissue samples for biopsy or treat certain abnormalities. Unlike most other endoscopes, duodenoscopes also have a movable “elevator” mechanism at the tip. The elevator mechanism changes the angle of the accessory exiting the accessory channel, which allows the instrument to access the ducts to treat problems with fluid drainage.
Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. 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 Medical Device Reports (MDRs) encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes. It is possible that not all cases have been reported to the FDA. The agency is continuing to evaluate information about documented and potential infections from multiple sources, including MDRs submitted to the FDA, the medical literature, the health care community, professional medical societies, and the CDC.
The recommendations for facilities and staff that reprocess ERCP duodenoscopes include closely following all manufacturer instructions for cleaning and processing. The FDA recommends adherence to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy professionals, as described in the Additional Resources section. In addition, it is important to follow specific reprocessing instructions in the manufacturer’s labeling for each device. Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection. Deviations from the manufacturer's instructions for reprocessing may contribute to contamination. The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known. It is advised that facilities and staff meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor (AER). Also, raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides. Implementation of a comprehensive quality control program for reprocessing duodenoscopes is necessary. The reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure. Compliance personnel for facilities and staff should refer to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 consensus document for evidence-based recommendations for endoscope reprocessing.
Health care providers should:
- Discuss with patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
- Thoroughly disinfect duodenoscopes between uses and have in place a comprehensive quality program for reprocessing.
- Take a duodenoscope suspected of being associated with a patient infection following ERCP out of service and meticulously disinfect it until it is verified to be free of pathogens.
- Submit a report to the manufacturer and to the FDA via MedWatch, if the provider suspects that problems with reprocessing a duodenoscope have led to patient infections.
The FDA is actively engaged with other government agencies, including the CDC, and the manufacturers of duodenoscopes used in the United States to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure. Recent FDA activities include:
Collaboration with the CDC and the Environmental Protection Agency (EPA) to test the antibiotic-resistant organisms to assess their susceptibility to high-level disinfectants.
Exploration, with the CDC, of additional potential strategies to reduce the risk of infections, such as microbiological surveillance testing of duodenoscopes.
Communication with international public health agencies to study the extent of the problem and identify possible solutions being considered outside the United States.
Reviews of reprocessing validation data from each of the three manufacturers marketing duodenoscopes in the United States (FUJIFILM, Olympus, and Pentax).
The FDA continues to actively monitor this situation and will provide updates as appropriate.
See the FDA Safety Announcement
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?