Transmission of Multi-Drug Resistant Bacteria via ERCP

Patient safety is a primary concern for the American Society for Gastrointestinal Endoscopy (ASGE). As reported in recent years, transmission of multi-drug resistant bacteria, such as CRE, has occurred through an advanced, highly technical procedure called ERCP. ASGE physician members, gastrointestinal endoscopists, perform the vast majority of ERCPs across the country and throughout the world. This procedure is performed with a specially-designed endoscope called a duodenoscope.

ERCP is an important and potentially life-saving procedure, and one that should remain accessible to patients. 

As the leader in patient safety and quality in gastrointestinal endoscopy, ASGE has taken the lead in informing the GI community about this problem. ASGE convened a Duodenoscope Infection Control Summit in 2015 in Washington, DC, and defined a research agenda to study this critically important issue. We have been actively working with many stakeholder groups to solve this critically important issue, including the FDA, CDC, and others. ASGE will continue to monitor this issue and to keep our members informed of the latest knowledge and information available. 

An April 2019 report from the FDA indicated that infections associated with duoedenoscopes have decreased substantially since 2015. ASGE agrees that this is a positive statistic; however, we also believe that, in collaboration with industry, healthcare institutions, the FDA  and other agencies, we must achieve the goal of zero duodenoscope-transmitted infections to our patients.  

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   FDA Safety Communication: A recommendation to transition to duodenoscopes with innovative designs to enhance safety (8/29/2019) FDA Safety Communication: Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings (12/10/2018) FDA Issues Safety Communication Regarding Voluntary Recall of Pentax ED-3490TK Duodenoscopes (2/7/2018) ASGE Releases Interim Guidance (3/17/2015) ASGE Appeals to FDA for Clarification Regarding ERCP; FDA Promptly Issues Update (3/4/2015)  Executive Summary from ASGE Duodenoscope Infection Control Summit
Physician Resources Member Alert - ASGE's Interim Guidance (3/17/2015) VIDEO: CRE Infection, ERCP and Reprocessing FAQ: Handout to Patients (Updated: January 2016)	Media Resources Media backgrounder(Updated:  January 2016) 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   FAQ: Handout to 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 Updated Summary of FDA Activities Related to Reprocessors (2/2/2016) FDA Communication On Supplemental Reprocessing Measures (08/04/2014) FDA Blog: Dr Maisel (02/24/2015)  FDA Medwatch Safety and Adverse Event Reporting Program
Reprocessing ASGE Multisociety Reprocessing Guideline 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) ASGE Supports Legislation re: Strategy for Antimicrobial Resistant Organisms (2/26/2015)