SGNA Resources

• FDA Safety Communication: Use Duodenoscopes with Innovative Designs to Enhance Safety (April 5, 2022)
• FDA News Release: FDA Clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection (November 15, 2019)
• FDA Safety Communication: Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety (August 29, 2019)
• FDA Letter to Healthcare Providers: UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures (May 23, 2019)
• FDA Safety Communication: The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions (April 12, 2019)
• FDA Safety Communication: Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk (April 12, 2019)
• FDA Safety Communication: 

  The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings (December 10, 2018)

• CDC Guidance: Essential Elements of a Reprocessing Program for Flexible Endoscopes - Recommendations of the Healthcare Infection Control Practices Advisory Committee (June 28, 2017)
• FDA Safety Communication: UPDATE: Use of Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing of Certain Duodenoscopes (April 10, 2018)
• FDA Safety Communication: Updated Status of FUJIFILM Medical Systems, U.S.A,Inc. Model ED-530XT Duodenoscops: FDA Safety Communication (July 21, 2017)
• FDA Safety Communication: ED-3490TK Video Duodenoscope by Pentax- UPDATE- Follow Pentax Validated Reprocessing Instructions (January 17, 2017)
• FDA Safety Communication: FUJIFILM Medical Systems, U.S.A, Inc. removes certain older duodenoscope models from clinical use (January 13, 2017)
• FDA Safety Communication: Updated Status of Pentax Medical Duodenoscope Model ED-3490TK (February 7, 2018)
• FDA: Duodenoscope Surveillance Sampling & Culturing (February 26, 2018)
• FDA: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015)

For more news on Infection Prevention, please scroll down and see below.

SGNA shares these important resources on quality and safety.  Many of the resources help to raise awareness among healthcare professionals, including those working in reprocessing units in healthcare facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing:

Facility CRE Risk Assessment Tool
Use this tool as a framework to assess your facility's risk specific to CRE transmission related to ERCP procedures.

Surveillance FAQs
This document provides general information specific to the surveillance of gastrointestinal endoscopes.

Gas Sterilization of Endoscopes FAQs
This document provide general information specific to the gas sterilization of gastrointestinal endoscopes.

SGNA Standard of Infection Control in Reprocessing of Gastrointestinal Endoscopes

SGNA Standard of Infection Prevention in the Gastroenterology Setting

SGNA Statement on Reprocessing of Accessories and Valves

The SGNA Infection Prevention Champions Program
The Infection Prevention Champions Program details a systematic approach to evaluate your unit, and then develop a clear plan for improvement. Your Infection Prevention Champion will partner with the nurse manager and appropriate infection prevention stakeholders to evaluate current practices and areas for improvement, guided with SGNA resources along the way. Learn more and apply at www.sgna.org/InfectionPrevention.

SGNA High-Level Disinfection Module
Infection prevention is an imperative part of GI/endoscopy nursing. The SGNA High-Level Disinfection Module interprets widely endorsed scientific theory into understandable, step-by-step guidelines. The sixth edition incorporates the most current practice documents pertinent to reprocessing. To order, visit the SGNA Marketplace.

Additional Resources:

ASGE

• ASGE Video — Steps You Can Take Now featuring Dr. Bret Petersen 
• ASGE Video — Patient information on ERCP and CRE featuring Dr. Colleen Schmitt 

CDC

• CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfection and Sterilizing Reusable Medical Devices (October 2, 2015)

FDA

• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015)
• Information about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation
• Information About Automated Endoscope Reprocessors (AERs) and FDA's Evaluation (Updated November 2, 2016)
• FDA Safety Communication: FUJIFILM Medical Systems, U.S.A, Inc. removes certain older duodenoscope models from clinical use (January 13, 2017)
• FDA Safety Communication: ED-3490TK Video Duodenoscope by Pentax- UPDATE- Follow Pentax Validated Reprocessing Instructions (January 17, 2017)
• FDA Safety Communication: Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED-530XT Duodenoscopes: FDA Safety Communication

AJIC

• Effectiveness of SYSTEM 1E Liquid Chemical Sterilant Processing System for reprocessing duodenoscopes (February 29, 2016)