As previously shared with our members late last year, the U.S. Food and Drug Administration (FDA) reported on preliminary data from manufacturer testing of duodenoscopes following reprocessing (cleaning). The report showed that, in about 5 percent of cases, samples tested positive for “high concern” bacteria after the scopes had been reprocessed as recommended. According to FDA, these are bacteria that are more often associated with disease. The final results and more granular detail are expected later this year.
This is a serious and complex issue for our patients and our practices. Duodenoscopes are necessary for performing endoscopic retrograde cholangiopancreatography (ERCP). This minimally invasive procedure is typically performed in patients with diseases of the liver, pancreas and gallbladder and obviates the necessity for more morbid surgical and radiologic procedures.
A recent article in The New York Times reviewing this issue largely understated the value of duodenoscopes and the procedure for which they are used. This is a potentially life-saving procedure for nearly 700,000 patients each year in the U.S. When a doctor recommends ERCP, it often is because the patient is seriously ill, and the benefits of the procedure far outweigh the risks. ERCPs also spare patients more invasive alternatives, including surgery. Withdrawal of these instruments from the marketplace is simply not feasible and would be a major step backwards in our ability to treat common and complex disease in the most beneficial manner.
We do agree and support the identification and development of safe and effective solutions that eliminate risk of infection transmission as a top priority. This cannot happen overnight: we cannot adopt new technologies, such as disposable duodenoscopes, without first understanding the new and unintentional risks we may be introducing to our patients such as an increased risk of procedural failure, perforation or pancreatitis.
The GI societies have been working closely with FDA and industry to identify and properly vet potential solutions. FDA has already reviewed and cleared new reprocessing and sterilization technologies and revised designs for some duodenoscopes; all are intended to enhance ease of cleaning and reprocessing thereby improving safety from transmitted infection. Other redesigns and new technologies for endoscope reprocessing, as well as single-use instruments, are in the pipeline. All of these options, and others, will likely enter the marketplace in the coming months and years after FDA vetting and approval and with post-marketing studies to ensure the efficacy of the technology and patient safety.
AGA is currently seeking feedback from AGA members to provide to FDA for consideration as they make upcoming review and approval decisions. If you are concerned about losing access to ERCP, a valuable procedure, please share your comments in the AGA Community. We will be sharing these comments with FDA to ensure their decisions reflect the needs of our members.
Since it was discovered several years ago that cases of infection transmission associated with duodenoscopes had been experienced by hospitals in the U.S. and Europe, health care organizations across the board recognized the need to escalate infection control efforts and to swiftly identify and disseminate best practices. FDA, the Centers for Disease Control and Prevention, state and local health departments, scope manufacturers and medical societies have collaborated continuously to determine best practices for identifying and reporting sources of infection and effectively cleaning equipment.
Since this problem was identified, vigilance has been raised and infection rates have improved. As with all medical procedures, physicians should discuss the risks and benefits with their patients who require ERCP.
This article was developed in collaboration with American Society for Gastrointestinal Endoscopy (ASGE) and the Society of Gastroenterology Nurses and Associates (SGNA).