2015-02-19 18:49:25 UTC

Continued Infection Risk with Duodenoscopes Used for ERCP is Unacceptable

Feb. 19, 2015

According to recent reports, patient-to-patient infections linked to ERCP procedures continue to occur. AGA and gastroenterologists will not tolerate any procedure-related infections. Any cases of patient infection tied to duodenoscopes are not acceptable and need to be thoroughly investigated with solutions developed.

Through the AGA Center for GI Innovation and Technology, we are uniquely positioned to work with FDA device branch and endoscope manufacturers. We have offered our help to resolve and monitor this issue. Our goal is safe patient care with no preventable infections.

Transmissions of carbapenem-resistant Enterobacteriaceae (CRE) linked to duodenoscopes have been reported in additional medical facilities. The events have brought to light concerns that these infections occurred despite the fact that endoscope reprocessing followed manufacturer’s directions.

This strain of bacteria is resistant to current cleaning solutions and antibiotics. The problem of infection transmission lies in the complex design of duodenoscopes where the elevator channel can allow bacteria to remain after cleansing, even if reprocessing follows accepted procedures.

FDA Safety Communication

AGA leadership has worked with FDA to develop a safety communication, which was released today, “Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning.”

The safety communication provides recommendations for health-care providers, including:

  • Inform patients of the benefits and risks associated with ERCP procedures.
  • Discuss with your patients what they should expect following the ERCP procedure and what symptoms should prompt additional follow-up.
  • Consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection. 
  • Submit a report to the manufacturer and to the FDA via MedWatch if you suspect that problems with reprocessing a duodenoscope have led to patient infections.

Read the FDA Safety Communication for more information about the issue, as well as recommendations for facilities and patients who undergo ERCP.

For patients who need it, ERCP is a critical and life-saving procedure. The infectious complication rate for ERCP overall is in total only about 1 percent, but that includes all types of bacteria and these few CRE cases do not change the overall risk. Read more.

AGA Workshop on Scope Safety

AGA is planning a workshop on Saturday, March 21, 2015, to take a critical look at the issue of effective scope cleaning. The workshop will bring gastroenterologists together with representatives from FDA and other key stakeholders to collectively discuss the issues and develop short- and long-term solutions to address the proper cleansing of duodenoscopes. The workshop will take place in conjunction with the 2015 AGA Tech Summit: Fostering Innovation & Technology in Digestive and Metabolic Diseases, San Francisco, CA. Continue to read AGA eDigest to learn more.

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