The FDA released a safety communication on Thursday, February 19, 2015 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.
SGNA shares these important resources on quality and safety:
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.
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.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015)
- New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes (March 26, 2015)
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication (August 4, 2015)
- FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication (November 13, 2015)
- FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication (December 23, 2015)
- Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes (January 15, 2016)
- PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes (February 19, 2016)
- FDA revised its November 2015 Safety Communication: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscopes Washer/Disinfectors to Alternate Reprocessing (February 23, 2016)
- Olympus Validates Updates Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF (March 15, 2016)
- Information about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation
- FDA Recommends Health Care Facilities Stop Using Custom Ultrasonic's System 83 Plus Automated Endoscope (August 17, 2016)
- 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