U.S. FDA Issues Warning about Certain Type of Endoscope

Posted on February 20th, 2015 by

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication about a certain type of endoscope­—specifically the device used in endoscopic retrograde cholangiopancreatography (ERCP). According to the FDA, the device may be difficult to clean effectively and may spread dangerous bacteria among patients.

An endoscope is thin, tube-like instrument that’s used to look at tissues inside the body. An endoscope has a light and a small video camera on the end that transmits pictures to a computer screen. It may also have a tool to remove tissue to look for signs of disease (biopsy). There are specific types of endoscopes designed for looking at different parts of the body. An endoscope can be used in the prevention, early detection, diagnosis, staging, and treatment of cancer as well as in the diagnosis and treatment of gastrointestinal issues including abdominal pain, nausea, vomiting, or difficulty swallowing and to detect inflammation and ulcers.

This current safety issue concerns a type of endoscope used in ERCP. This is a procedure that combines upper gastrointestinal (GI) endoscopy and X-rays to treat problems of the bile and pancreatic ducts.

The purpose of the FDA Safety Communication is to raise awareness among healthcare professionals and patients that, due a complex design, it can be difficult to effectively sterilize ERCP endoscopes between patients—even when healthcare facilities carefully follow cleaning instructions. As a result, there have been cases where drug-resistant bacterial infections have been spread from one patient to another.

The FDA will continue to closely monitor the incidence of bacterial infections spread through ERCP endoscopes. The agency also has published recommendations for reducing the risk of spreading infections.

  • Firstly, the FDA recommends that healthcare facilities strictly follow ERCP endoscope manufacturer cleaning instructions. This may not eliminate the risk of infection, but will minimize it.
  • They ask that facilities report and problems with cleaning the device to the manufacturer and the FDA.
  • The FDA recommends that providers discuss the benefits and risks of ERCP with patients, as well as what patients should expect after the procedure.
  • Discuss with patients symptoms of infection, including: fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools.
  • Discuss with patients the importance of follow-up, especially if they experience any of the above symptoms.
  • If a patient develops an infection with a drug-resistant bacteria following ERCP, providers are encouraged to stop using that endoscope until it’s been tested and is free of bacteria.

Reference: Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm. Accessed February 20, 2015.

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