Transmission of multi-drug resistant bacteria via ERCP

Patient safety is a primary concern for the American Society for Gastrointestinal Endoscopy (ASGE). As recently reported, transmission of carbapenem-resistant Enterobacteriacae (CRE) has occurred through an advanced, highly technical procedure called ERCP. CRE is a type of multi-drug resistant bacteria, sometimes referred to as "superbugs."

ASGE physician members, gastrointestinal endoscopists, perform the vast majority of ERCPs across the country and throughout the world. ERCP is an important and potentially life-saving procedure, and one that should not be seriously constrained, lest patients lose access to its benefits.

As the leader in patient safety and quality in gastrointestinal endoscopy, ASGE convened the Duodenoscope Infection Control Summit in Washington, DC in 2015, and has defined a research agenda to study this critically important issue. We have worked actively with many stakeholder groups to solve this critically important issue, including the FDA, CDC, and others, and we are committed to keeping our members informed of all relevant guidelines, requirements and recommendations.

Visit this page often for the latest updates on this critically important topic.

Below are resources that may be helpful to physicians, patients and the media.

Important News

• GI Societies advise FDA on duodenoscope reprocessing (November 2019)
• FDA Informs Healthcare Facilities of Results of Validation Testing for Custom Ultrasonics System 83 Plus Automated Endoscope Reprocessors (AERs)  (4/11/2018)
• ASGE Appeals to FDA for Clarification Regarding ERCP; FDA Promptly Issues Update (3/4/2015)
• Executive Summary from ASGE 2015 Duodenoscope Infection Control Summit

Physician Resources

• GI Societies advise FDA on duodenoscope reprocessing (November 2019)
• Member Alert - ASGE's Interim Guidance (3/17/2015)
• FAQ: Handout to Patients (Updated: January 2016)

Media Resources

• Experts Convene to Explore the State of the Science and Set Priorities for Preventing Antibiotic-Resistant Infections Associated With Advanced Endoscopic Procedures (April 2, 2015)

Important clarifications for accurate reporting:
- ERCP is NOT a "routine" or "common" endoscopic procedure. It is a highly advanced procedure.
- It is estimated that 500,000 ERCPs are performed annually. This number refers to procedures, not patients. Some patients need multiple ERCPs.

Patients

From the CDC

• CDC CRE Toolkit
• Healthcare Associated Infections - Outbreaks
  (This page provides interim protocols for surveillance, sampling and culturing.)
• CRE infographic

From the FDA

• FDA Issues Safety Communication Regarding Voluntary Recall of Pentax ED-3490TK Duodenoscopes (2/7/2018)
• FDA Safety Communication: Fujifilm ED-530XT Duodenoscopes: Recall Issued (7/21/2017)
• Information about Automated Endoscope Reprocessors and FDA’s Evaluation (2/2/2016)
• FDA Medwatch Safety and Adverse Event Reporting Program

Reprocessing

• ASGE Multisociety Reprocessing Guideline (2016)
• CDC Infection Control Guidelines
• SGNA Standard of Infection Control in Reprocessing of Gastrointestinal Endoscopes
• SGNA Statement on Reprocessing of Accessories and Valves

Related Information:

• ASGE Letter of Support for Preventing Superbugs and Protecting Patients Act (2/4/16)