FDA Updates Safety Communication Regarding Duodenoscopes

The FDA has issued an updated Safety Communication on the cleaning of medical scopes believed to have caused the spread of a deadly "superbug" at UCLA Medical Center. The Safety Communication, Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning, was issued February 19, 2015, and has been updated twice since then.

The purpose of the communication is to "raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices."

FDA Warns about Medical Scopes after ‘Superbug’ Hits California Hospital http://t.co/h9rklMvtaB #duodenoscopes
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The FDA Safety Communication on Duodenoscopes reads in part:

"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."

Recommendations for patients include:

• Discuss the benefits and risks of procedures using duodenoscopes with your physician. For most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed.
• Ask your doctor what to expect following the procedure and when to seek medical attention. Following ERCP, many patients may experience mild symptoms such as a sore throat or mild abdominal discomfort. Call your doctor if, following your procedure, you have a fever or chills, or other symptoms that may be a sign of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools).

Read the full safety communication on the FDA website.

For more reporting on the topic, see the LA Times and Washington Post.

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