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Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

Date Issued: February 19, 2015
Updated: February 23, 2015

Audience:

  • Gastroenterologists
  • Gastrointestinal surgeons
  • Endoscopy nurses
  • Staff working in endoscopy reprocessing units in health care facilities
  • Infection control practitioners
  • Patients considering endoscopic retrograde cholangiopancreatography (ERCP) procedures

Medical Specialties: Gastroenterology, Infection Control

Device: All ERCP endoscopes (side-viewing duodenoscopes)

Close-up view of an ERCP endoscope tip
Close-up view of an ERCP endoscope tip. Image courtesy by FDA

Summary of Problem and Scope:

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 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 Medical Device Reports (MDRs) submitted to the FDA, the medical literature, the health care community, professional medical societies, and the Centers for Disease Control and Prevention (CDC).

(Read more from FDA)

 
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