Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy

Table of Contents

• Introductory Statement
• Executive Summary
• PART I. PURPOSE
• PART II. TRANSMISSION OF INFECTION BY FLEXIBLE ENDOSCOPY
  • 1. Background
    • 1.1. Spaulding Classification for Medical Devices
  • 2. Overview
  • 3. Microbial Sources
    • 3.1. Endogenous
    • 3.2. Exogenous
  • 4. Specific Microorganisms Transmitted or Shown to Contaminate Flexible Endoscopes
  • 5. Occupational Infection Related to Endoscopy
  • 6. Classic and Variant Creutzfeldt-Jakob Disease
  • 7. Factors That Contribute to Survival of Microorganisms in Reprocessed Flexible Endoscopes
    • 7.1. Wet Storage
    • 7.2. Biofilm Formation and Organic Debris
    • 7.3. Equipment Design Flaws
  • 8. Errors in Reprocessing
• PART III. FLEXIBLE ENDOSCOPES: STRUCTURE and FUNCTION
• PART IV. ISSUES RELATED TO REPROCESSING FLEXIBLE ENDOSCOPES
  • 1. Reprocessing of Flexible Endoscopes and Accessories
    • 1.1. Pre-Cleaning
    • 1.2. Leak Test
    • 1.3. Manual Cleaning and Rinsing
    • 1.4. Disinfection and Sterilization
      • 1.4.1. Selection of a High Level Disinfectant Product
      • 1.4.2. Liquid Chemical Agents
      • 1.4.3. Low Temperature Gas and Gas Plasma Sterilization
      • 1.4.4. Automated Endoscope Reprocessors (AERs)
      • 1.4.5. Reprocessing Endoscopic Accessories
      • 1.4.6. Valves and Water Bottles
  • 2. Sheathed Endoscopes
  • 3. Storage of Flexible Endoscopes
  • 4. Quality Management
    • 4.1. Staff Training
    • 4.2. Preventative Maintenance and Repair
    • 4.3. Monitoring Microbial Bioburden in Flexible Endoscope Channels
  • 5. Healthcare Worker Protection During Endoscopy/Bronchoscopy and During Equipment Reprocessing
    • 5.1. Hazards During Endoscopy
    • 5.2. Hazards During Reprocessing
    • 5.3. Infection Prevention and Control Practices and Precautions
    • 5.4. Occupational Health and Safety Considerations
    • 5.5. Environmental Controls
  • 6. Endoscopy Unit Design
  • 7. Surveillance and Outbreak Investigation and Management
  • 8. Investigation of a Reprocessing Problem
• PART V. RECOMMENDATIONS FOR REPROCESSING FLEXIBLE ENDOSCOPES
  • 1. Administrative Recommendations
    • 1.1. Policies and Procedures
  • 2. Recommendations for Endoscopy and Endoscopy Decontamination Equipment
  • 3. Recommendations For Reprocessing Endoscopes and Accessories
    • 3.1. Preparing the Endoscope for Cleaning
    • 3.2. Leak Testing
    • 3.3. Manual Mechanical Cleaning in the Reprocessing Area
    • 3.4. Sterilization and High Level Disinfection
    • 3.5. Recommendations for Accessories
    • 3.6. Storage and Transport
  • 4. Recommendations for Endoscopy Unit Design
  • 5. Recommendations for Quality Management
    • 5.1. Personnel Education and Training
    • 5.2. Worker Health and Safety
    • 5.3. Reprocessing Program
  • 6. Recommendations for Outbreak Investigation and Management
  • 7. Recommendations for Classic and Variant Creutzfeldt-Jakob Disease (CJD and vCJD)
• APPENDIX A - PHAC IP&C Guideline Development Process
• APPENDIX B - Glossary of Terms
• APPENDIX C - Spaulding Classification System (archived)
• APPENDIX D - Bioburden Test Method
• APPENDIX E - Sample Audit Checklist for Reprocessing of Medical Equipment/Devices
• APPENDIX F- Sample Audit Tool for Reprocessing of Endoscopy Equipment/Devices
• APPENDIX G - Verification of Training Stages for Endoscope Reprocessing
• APPENDIX H - Guideline for Outbreak Investigation Related to Endoscopic Procedures
• APPENDIX I - PHAC Guideline Rating System