FDA Warns ERCP Duodenoscopes May be Linked to Serious Infections

FDA Warns ERCP Duodenoscopes May be Linked to Serious Infections

The Food and Drug Administration issued an alert warning health care professionals and the public that the complex design of the ERCP endoscopes (also called duodenoscopes) makes them difficult to clean, disinfect, and sterilize for proper re-use.  This new warning was issued after seven people were infected with drug-resistant bacteria called CRE at a UCLA hospital following an endoscopic retrograde cholangiopancreatography (ERCP) procedure using the device. Two individuals have since died and another 179 have been contacted to alert them of a possible infection.

Duodenoscopes are flexible tubes that can carry a camera and other needed equipment into the body through the mouth.   The scopes are specifically designed for ERCPs and are a less invasive way to treat a variety of problems associated with the pancreas and bile ducts including gallstones, infections, tumors and inflammation of the pancreas.  The alternative to using the scope is to surgically cutting open a patient.

The FDA states, “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.”

The FDA is working closely with the manufacturers of duodenoscopes as well as with government agencies including the CDC and the EPA to find solutions to the problem.  In the meantime, the FDA is strongly encouraging physicians to fully disclose the risks associated with ERCP procedures and the symptoms to watch for in the case of a bacterial infection to their patients. In addition, the FDA recommends doctors remove duodenoscopes from service if any infection is suspected until the device can be verified clean and free of pathogens.

The usual scopes used for Upper and Lower Endoscopies (i.e. EGD and Colonoscopy) are not the same as the Duodenoscopes used for ERCP, and have not been associated with deadly CRE bacteria.  Furthermore, it is always a “risk to benefit” decision in medicine, and ERCP is life saving in someone septic from a jammed Common Bile Duct stone.

Additional coverage of the issue can be found at the LA Times  (2/19, Terhune, Panzar and Petersen), Family Practice News (2/20, Mechcatie), NBC News (2/19, Fox)

Dr. Steven Lipsky

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