FDA: ERCP Endoscopes Pose Unique Reprocessing Challenges

Effective reprocessing of endoscopes that are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures requires continued vigilance to prevent dangerous infections, according to a US Food and Drug Administration (FDA) advisory panel that met today and yesterday.

The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee met to discuss the unique challenges associated with reprocessing ERCP endoscopes.

At least six outbreaks ― some lethal ― have occurred within recent years despite proper adherence to manufacturers’ instructions and recommendations from professional organizations about the reprocessing of duodenoscopes. Most concerning is that infections have been linked to rare bacteria, especially multidrug-resistant organisms.

More than 600,000 ERCP procedures are performed in the United States each year. In ERCP, a specially trained physician threads a duodenoscope through the esophagus, stomach, and duodenum, then injects contrast media directly into the biliary tree to visualize the biliary and pancreatic duct anatomy. This allows the physician to assess for obstruction or narrowing of the ducts caused by cancer, gallstones, inflammation, infection, or other disorders. The procedure can enable immediate and sometimes life-saving treatment.

The duodenoscope is a reusable, flexible, lighted tube with a hollow channel that enables other instruments to be inserted through it for tissue sampling and treatment of some abnormalities. Its unique features make it difficult to reprocess so that it can be used in subsequent patients. Duodenoscopes have many small parts that are hidden and can be difficult to reach; therefore, meticulous reprocessing is necessary to avoid transmitting infections to subsequent patients.

Several reasons may account for why outbreaks have occurred. Insufficient manual cleaning, failure to follow the manufacturer’s recommended cleaning instructions, or failure to use enough disinfectant may be to blame. Some infections have been linked to contamination from tap water or irrigating solutions. Finally, improper use of automated endoscope reprocessors (AERs), inadequate drying, and defective equipment may all play roles.

One issue is that the design of duodenoscopes may make it difficult to properly reprocess them. Some hospitals use high-level disinfection, which involves use of chemical disinfectants that may not necessarily kill all organisms. Duodenoscopes can be damaged by the high heat commonly used with steam sterilization. Some hospitals use chemical sterilization with ethylene glycol, which raises the issue of toxicity and worker safety.

Even when duodenoscopes are cleaned properly, they may be rinsed improperly with tap water or other liquids, introducing new bacteria. Another issue concerns storage and transfer of the duodenoscopes to the operating room after cleaning, also potential sources of contamination. A third issue concerns proper drying of duodenoscopes and the potential for biofilm formation. Biofilms need water for survival and could potentially contaminate duodenoscopes.