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Infection Prevention and Control Guideline for Flexible

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Infection Prevention and Control Guideline for Flexible INFECTION PREVENTION AND CONTROL GUIDELINE for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy To promote and protect the health of Canadians through leadership, partnership, innovation and action in public health. — Public Health Agency of Canada Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy is available on Internet at the following address: http://www.phac-aspc.gc.ca Également disponible en français sous le titre : Lignes directrices pour la prévention et le contrôle des infections transmises par les appareils souples d'endoscopie digestive et de bronchoscopie. This publication can be made available in alternative formats upon request. © Her Majesty the Queen in Right of Canada, 2010 Cat.: HP40-55/2010E-PDF ISBN: 978-1-100-17223-1 Table of Contents Introductory Statement.................................................................................................................... 5 Executive Summary........................................................................................................................ 8 PART I. PURPOSE .................................................................................................................... 11 PART II. TRANSMISSION OF INFECTION BY FLEXIBLE ENDOSCOPY ....................... 12 1. Background........................................................................................................................... 12 1.1. Spaulding Classification for Medical Devices.............................................................. 12 2. Overview............................................................................................................................... 12 3. Microbial Sources ................................................................................................................. 13 3.1. Endogenous................................................................................................................... 13 3.2. Exogenous..................................................................................................................... 14 4. Specific Microorganisms Transmitted or Shown to Contaminate Flexible Endoscopes...... 16 5. Occupational Infection Related to Endoscopy...................................................................... 19 6. Classic and Variant Creutzfeldt-Jakob Disease .................................................................... 20 7. Factors That Contribute to Survival of Microorganisms in Reprocessed Flexible Endoscopes ............................................................................................................................................... 21 7.1. Wet Storage................................................................................................................... 21 7.2. Biofilm Formation and Organic Debris ........................................................................ 22 7.3. Equipment Design Flaws.............................................................................................. 22 8. Errors in Reprocessing.......................................................................................................... 22 PART III. FLEXIBLE ENDOSCOPES: STRUCTURE and FUNCTION ................................ 24 PART IV. ISSUES RELATED TO REPROCESSING FLEXIBLE ENDOSCOPES............... 29 1. Reprocessing of Flexible Endoscopes and Accessories........................................................ 29 1.1. Pre-Cleaning ................................................................................................................. 35 1.2. Leak Test....................................................................................................................... 35 1.3. Manual Cleaning and Rinsing....................................................................................... 36 1.4. Disinfection and Sterilization ....................................................................................... 37 1.4.1. Selection of a High Level Disinfectant Product ....................................................... 38 1.4.2. Liquid Chemical Agents ........................................................................................... 38 1.4.3. Low Temperature Gas and Gas Plasma Sterilization ............................................... 39 1.4.4. Automated Endoscope Reprocessors (AERs)........................................................... 44 1.4.5. Reprocessing Endoscopic Accessories ..................................................................... 45 1.4.6. Valves and Water Bottles.......................................................................................... 47 2. Sheathed Endoscopes............................................................................................................ 47 3. Storage of Flexible Endoscopes............................................................................................ 47 4. Quality Management............................................................................................................. 48 4.1. Staff Training................................................................................................................ 49 4.2. Preventative Maintenance and Repair .......................................................................... 50 4.3. Monitoring Microbial Bioburden in Flexible Endoscope Channels............................. 50 5. Healthcare Worker Protection During Endoscopy/Bronchoscopy and During Equipment Reprocessing......................................................................................................................... 51 5.1. Hazards During Endoscopy .......................................................................................... 51 5.2. Hazards During Reprocessing....................................................................................... 51 5.3. Infection Prevention and Control Practices and Precautions........................................ 52 5.4. Occupational Health and Safety Considerations........................................................... 52 5.5. Environmental Controls................................................................................................ 53 6. Endoscopy Unit Design ........................................................................................................ 53 3 7. Surveillance and Outbreak Investigation and Management ................................................. 54 8. Investigation of a Reprocessing Problem ............................................................................. 54 PART V. RECOMMENDATIONS FOR REPROCESSING FLEXIBLE ENDOSCOPES...... 57 1. Administrative Recommendations........................................................................................ 57 1.1. Policies and Procedures................................................................................................ 57 2. Recommendations for Endoscopy and Endoscopy Decontamination Equipment................ 58 3. Recommendations for Reprocessing Endoscopes and Accessories...................................... 60 3.1. Preparing the Endoscope for Cleaning ......................................................................... 60 3.2. Leak Testing.................................................................................................................. 61 3.3. Manual Mechanical Cleaning in the Reprocessing Area.............................................. 61 3.4. Sterilization and High Level Disinfection .................................................................... 62 3.5. Recommendations for Accessories............................................................................... 64 3.6. Storage and Transport................................................................................................... 65 4. Recommendations for Endoscopy Unit Design.................................................................... 65 5. Recommendations for Quality Management ........................................................................ 66 5.1. Personnel Education and Training................................................................................ 66 5.2. Worker Health and Safety............................................................................................. 67 5.3. Reprocessing Program.................................................................................................. 68 6. Recommendations for Outbreak Investigation and Management......................................... 69 7. Recommendations for Classic and Variant Creutzfeldt-Jakob Disease (CJD and vCJD))... 70 APPENDIX A – PHAC IP&C Guideline Development Process ................................................. 72 APPENDIX B – Glossary of Terms ............................................................................................. 74 APPENDIX C – Spaulding Classification System ....................................................................... 77 APPENDIX D – Bioburden Test Method..................................................................................... 78 APPENDIX E – Sample Audit Checklist for Reprocessing of Medical Equipment/Devices...... 81 APPENDIX F – Sample Audit Tool for Reprocessing of Endoscopy Equipment/Devices......... 84 APPENDIX G – Verification of Training Stages for Endoscope Reprocessing .......................... 87 APPENDIX H – Guideline for Outbreak Investigation Related to Endoscopic Procedures........ 90 APPENDIX I – PHAC Guideline Rating
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