As patient deaths from carbapenem-resistant Enterobacteriaceae (CRE) gain media attention, disinfection practices for hard-to-clean endoscopes are being scrutinized, specifically duodenoscopes used to diagnose and treat problems in bile ducts and pancreatic ducts.

This free public Resource Center is intended to inform the healthcare community about the latest guidance and recommendations with a focus on technology management, risk management, and patient safety.

ECRI Recommendations

ECRI Institute Recommends Culturing Duodenoscopes as a Key Step to Reducing CRE Infections

This ECRI Institute Hazard Report addresses the serious risk of carbapenem-resistant Enterobacteriaceae (CRE) patient infections associated with the use of duodenoscopes. We believe that this hazard requires immediate action and executive level attention.

ECRI Resources

Health Devices Alerts

• H0245 03: ECRI Institute Provides Perspectives on FDA’s Recent Supplemental Measures to Enhance Duodenoscope Reprocessing, Health Devices Alerts, 8/7/2015
• A23927: Olympus—Model TJF-Q180V Duodenoscopes: Manufacturer Reminds Users of Reprocessing Instructions to Reduce Patient Infection Risk, Health Devices Alerts, 2/25/2015
• H0245: Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: Design May Impede Effective Cleaning, Health Devices Alerts, 2/20/2015
  

In the News: ECRI Comments on CRE

• February 11, 2016: Why Duodenoscopes Are So Tough to Clean, MedTech Intelligence
• December 16, 2015: Following Procedures, Key to Cleaning and Tracking Scopes, Gastroenterology & Endoscopy News
• September 30, 2015: Contaminated Duodenoscopes: The Story of a Chance and Distressing Finding, General Surgery News
• September 17, 2015: FDA Expands Warnings About Contaminated Medical Scopes, Bloomberg Business
• April 28, 2015: More ‘Superbug’ Cases Linked at Virginia Mason, The Seattle Times
• March 18, 2015: Deadly Bacteria Outbreak Inflames Disinfection Concerns, USA Today
• March 12, 2015: FDA Stepping up Oversight of Medical Scopes Linked to Deadly 'Superbug' Outbreaks, The Associated Press
• March 8, 2015: Superbug’ Outbreak Sparks Changes at Region’s Hospitals, The Seattle Times
• March 1, 2015: Scope Maker Olympus Faces Scrutiny Over Patient Deaths, Infections, The Los Angeles Times
• January 31, 2015: Endoscope Infections at Virginia Mason Prompt Broader Safety Fears, Modern Healthcare

External Resources

• Department of Health and Human Services Collaboration: Duodenoscope Surveillance Sampling and Culturing Protocols
• Agency for Healthcare Research and Quality (AHRQ): Carbapenem-Resistant Enterobacteriaceae (CRE) Control and Prevention Toolkit
• The Association for Professionals in Infection Control and Epidemiology (APIC): Summary of State CRE Reporting Requirements
• Congress: S.2503 - Preventing Superbugs and Protecting Patients Act, 2/4/2016
• United States Senate Health, Education, Labor, and Pensions Committee: Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients, 1/13/2016
• The Centers for Disease Control (CDC): Outbreaks and Patient Notifications, 3/9/2015
• The Food and Drug Administration (FDA): Updated Information for Healthcare Providers Regarding Duodenoscopes, 3/4/2015

Questions

We welcome your questions and will respond as quickly as we can. Please contact us at communications@ecri.org.