Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. In the United States, duodenoscopes are used in more than 500,000 ERCP procedures each year.
Duodenoscopes are complex instruments that contain many small working parts. If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient infection.
FDA has been actively working to develop strategies to better protect patients from the risk of exposure to infections during medical procedures involving scopes.
In November 2009, the FDA issued a joint Safety Communication with the Centers for Disease Control and Prevention and the Veterans Administration which cautioned health care facilities, hospitals, ambulatory care facilities, and private practices about the risks to patients if flexible endoscopes and their accessories are not cleaned properly and recommended steps to reduce these risks.
In 2011, the FDA published a draft guidance document on Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (“Reprocessing Medical Devices guidance”). The Agency received nearly 500 comments on this guidance, each of which FDA carefully considered. Later in 2011, the FDA held a public workshop that focused on factors affecting reprocessing of reusable medical devices as well as a joint summit with the Association for the Advancement of Medical Instrumentation (AAMI) to further identify key challenges and priority actions. In March 2015, the Agency published a final version of the Reprocessing Medical Devices guidance.
In Fall 2013, the Centers for Disease Control and Prevention (CDC) alerted the FDA to a potential association of multi-drug resistant bacteria and duodenoscopes. Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that the users were following proper manufacturer cleaning and disinfection or sterilization instructions.
Since that time, the FDA has been working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to these infections and how to best mitigate them.
Recent steps have included:
- Identifying and studying the devices in question, gathering and reviewing information from facilities where the infections occurred, analyzing medical device adverse event reports submitted to FDA, and reviewing the relevant published scientific literature.
- Working with duodenoscope manufacturers to obtain and analyze data from cleaning studies and validating study protocols, enhance disinfectant protocols, and identify design features that may be contributing to the transmission of infection;
- Publishing a Safety Communication on February 19, 2015, warning that it is difficult to effectively clean and disinfect duodenoscopes between patients;
- Publishing final guidance on Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling;
- Collaborating with CDC on interim protocols on how to perform surveillance cultures on duodenoscopes; and
- Scheduling a meeting of the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee to discuss infections associated with endoscopes and duodenoscopes.
Although the Agency understands the issue better and better each day, there is still much to learn. While duodenoscopes are critical to diagnosing and treating severe, often life-threatening diseases, and the overwhelming proportion of procedures with these devices are carried out safely and effectively, the FDA takes the risk of infection very seriously and is working intensively to address it. Please find links to additional information below