March 26, 2015
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AGA gives additional suggestions to prevent duodenoscope infections

The American Gastroenterological Association has issued additional practice recommendations for preventing infections associated with endoscopic retrograde cholangiopancreatography, or ERCP, duodenoscopes following a meeting of regulators, manufacturers and gastroenterologists, according to a press release.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” AGA President John I. Allen, MD, MBA, AGAF, said in the release. “The value of these procedures cannot be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

The “Getting to Zero” meeting included gastroenterology, epidemiology and infectious disease experts and representatives from the FDA, CDC, ECRI Institute and endoscope manufacturers Fuji and Pentax, the release said.

Short-term recommendations issued by the AGA following the meeting included:

  • Treat all endoscopes with elevator-channels the same;
  • Follow enhanced reprocessing guidelines;
  • Track elevator-channel endoscopes by patient and device serial numbers;
  • Enact surveillance program to track patients and periodically collect culture surveillance of all such endoscopes;
  • Baseline culturing of all such endoscopes;
  • Standardize reprocessing training and evaluate competency every 6 months; and
  • Contact CDC immediately in the event of suspected infection.

Long-term recommendations include possible device redesigns based on further studies, the release said.

“We must stop device-associated infections. It's a complex issue without an easy solution, but first we need to protect our patients,” Michael Kochman, MD, AGAF, chair of the AGA Center for GI Innovation and Technology, said in the release, adding that this involves patient education, endoscope redesign and alternative cleaning methods.

In response to these ongoing concerns, Olympus today released an “urgent safety notification” to customers detailing new, validated reprocessing instructions for its Olympus TJF-Q180V duodenoscope. The notification also includes instructions for high level disinfection and an announcement that an additional cleaning brush will be made available in May.