Introductory statement: Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy
The Public Health Agency of Canada (PHAC) develops national infection prevention and control guidelines to provide evidence-based recommendations to complement provincial/territorial governments’ efforts in monitoring, preventing, and controlling healthcare-associated infections. National guidelines support infection control professionals, healthcare organizations and healthcare providers in the development, implementation and evaluation of infection prevention and control policies, procedures and programs to improve the quality and safety of health care and patient outcomes.
The purpose of the PHAC Guideline Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy is to provide a framework within which those responsible for endoscopes in all settings, where endoscopy is performed, may develop policies and procedures to ensure that the critical elements and methods of cleaning, disinfection, and/or sterilization of these devices between patient uses are consistent with national guidelines.
Guidelines, by definition, include principles and recommendations, and should not be regarded as rigid standards. This guideline, whenever possible, has been based on research findings. In some areas, where there is insufficient published research, a consensus of experts in the field has been used to provide recommendations specific to practice.
The information in this guideline was current at the time of publication. Scientific knowledge and medical technology are constantly evolving. Research and revisions to keep pace with advances in the field are necessary.
This guideline is intended to assist infection prevention and control professionals and all other healthcare providers responsible for using and reprocessing flexible gastrointestinal endoscopes and flexible bronchoscopes in all settings in which endoscopy is performed, whether in hospitals, clinics, physician offices, or stand-alone endoscopy centres.
Guideline Working Group
The Public Health Agency of Canada’s Infection Prevention and Control Program developed this guideline with expert advice from a working group. The Guideline Working Group was comprised of members representing clinical microbiologists, endoscopy nurses, gastroenterologists, hospital epidemiologists, infectious disease specialists, infection prevention and control professionals, biomedical technicians and the medical instrument reprocessing sector. The multidisciplinary Guideline Working Group reflected a balanced representation of the regions of Canada.
The following individuals formed the Guideline Working Group:
- Dr. Jonathan R. Love, Co-chair, Clinical Associate Professor of Medicine,
Division of Gastroenterology, University of Calgary, Calgary, Alberta
- Dr. Anne Matlow, Co-chair, Director, Infection Prevention & Control Program
The Hospital for Sick Children, Toronto, Ontario
- Dr. Michelle Alfa, Assistant Director, Microbiology Lab, St Boniface General Hospital, Winnipeg, Manitoba
- Sandra Boivin, Agente de planification, programmation et recherche, Direction de la Santé publique des Laurentides, St-Jérôme, Québec
- Cindy E. Hamilton, Writer, Hamilton, Ontario
- Linda Jakeman, Manager, Sterile Processing, Capital District Health Authority, Dartmouth General Hospital, Dartmouth, Nova Scotia
- Lorie McGeough, President, Canadian Society of Gastroenterology Nurses & Associates, Regina, Saskatchewan
- Cathy Oxley, Writer, Ottawa, Ontario
- Dr. Alice Wong, Infection Control Officer, Saskatoon Health Region, Department of Medicine, Royal University Hospital, Saskatoon, Saskatchewan
- Curtis Yano, Biomedical Technician, Royal Alexandra Hospital, Edmonton, Alberta
The Public Health Agency of Canada’s team for this guideline included:
- Luna Bengio, Director, Blood Safety Surveillance and Health Care Associated Infections, Centre for Communicable Diseases and Infection Control
- Kathleen Dunn, Manager, Infection Prevention and Control Program
- Christine Weir, Nurse Epidemiologist and Acting Manager, Infection Prevention and Control Program
- Frederic Bergeron, Nurse Consultant
- Rolande D’Amour, Nurse Consultant
- Judy Foley, Literature Database Officer
- Jennifer Kruse, Nurse Consultant
- Louise Marasco, Editing and Quality Control Officer
- Laurie O’Neil, Nurse Consultant
- Shirley Paton, Senior Technical Advisor
- Carole Scott, Publishing Officer/Literature Database
In collaboration with Health Canada:
- Melanie Weger, Reference Librarian
Guideline Issuance and Review
This guideline was issued in 2011 and will be reviewed in 2013, or sooner if new evidence becomes available. Any amendments to this guideline in the interim period will be noted on the PHAC website. Comments are invited to assist the review process.
Please refer to Appendix A for a summary of the PHAC Infection Prevention and Control Guideline Development Process.
This document is part of the PHAC series of Infection Prevention and Control Guidelines and is intended to be used with the other Infection Prevention and Control Guidelines. The series is available at: Infection Prevention and Control Guidelines
For information regarding the Infection Prevention and Control Guidelines series, please contact:
Centre for Communicable Diseases and Infection Control
Blood Safety Surveillance and Health Care Associated Infections Division
Infection Prevention and Control Program
Tel: 1-800-622-6232 (1-800-O’CANADA)
Infection Prevention and Control Program
This document, Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy, has been prepared by the Public Health Agency of Canada’s Blood Safety Surveillance and Health Care Associated Infections Division of the Centre for Communicable Diseases and Infection Control. Itis intended to assist infection prevention and control personnel and all other healthcare providers responsible for both using and reprocessing flexible gastrointestinal endoscopes and flexible bronchoscopes in all settings in which endoscopy is performed, whether in hospital clinics, physician offices, or stand-alone endoscopy centres. The recommendations provide a framework within which those responsible for endoscopy in any setting may develop policies and procedures to address their needs, and to ensure that the critical elements and methods of cleaning, disinfection, and/or sterilization of these devices between patient uses are consistent with national guidelines.
Numerous types of flexible endoscopes are available (e.g., gastrointestinal, bronchoscopic, urological, laparoscopic surgical, etc). This Guideline will focus solely on flexible gastrointestinal and bronchoscopic endoscopes and their respective accessories. Instruments such as transesophageal or rectal ultrasounds, cystoscopes, laparoscopes and others are examples of instruments that will not be addressed. For purposes of this document, ‘patient’ includes patient, client or resident. The Public Health Agency of Canada guidelines provide evidence-based recommendations. Where scientific evidence is lacking, the consensus of experts is used to formulate a recommendation. As new information becomes available, the recommendations in this document will be reviewed and updated.
Parts I and II describe the purpose of this Guideline and provide background information on the epidemiology, etiology, and pathogenesis of infections associated with flexible endoscopy, in order to bring an understanding of how disease can be transmitted by these instruments. Briefly, endoscopy-related infections can result from 1) the patient’s own (endogenous) microbial flora, or 2) microorganisms acquired a) exogenously from a contaminated endoscope, and/ or b) transmitted between the patient and the healthcare provider. Each category is reviewed in the document, with a focus on the sources and modes of acquisition of exogenously acquired microorganisms and specific microorganisms and problems (e.g., breaches in disinfection or sterilization processes) associated with transmission of disease attributed to a contaminated endoscope.
Part II further elaborates on the factors that contribute to the survival of microorganisms in reprocessed endoscopes. Common errors in reprocessing are highlighted. The Guideline emphasizes the steps required to address these factors, and points out the critical need for appropriate training and ongoing competency assessment for staff in the reprocessing area.
Part III describes the structure and function of the endoscope with corresponding illustrations.
Part IV provides detailed instructions on the critical steps required for reprocessing endoscopes and describes the barriers to adequate reprocessing that may lead to transmission of infection. Endoscope reprocessing is a three-stage process that includes: 1) cleaning the endoscope and its detachable parts using a detergent solution and brushes; 2) high level disinfection or sterilization of the endoscope using a product, most often a liquid chemical agent, approved for use in Canada, followed by thorough water rinsing to remove residual product from the instrument; and 3) post-processing, which includes proper handling and storage of the endoscope. In Part IV, major attention is given to the safe use of automated endoscope reprocessors, the proper reprocessing of endoscopic accessories, and the storage requirements for flexible endoscopes.
Part IV also includes important sections on quality management, healthcare worker protection, health and safety considerations related to endoscopy and equipment reprocessing, appropriate endoscopy unit design, outbreak investigation and management, and finally, investigation and action required if a reprocessing problem is identified. These sections of the document are intended to provide the user with the knowledge and tools to ensure that the endoscopy working environment is safe for patients and staff, that staff are appropriately trained and competency assessment is ongoing, and that potential outbreaks of infection or reprocessing problems are identified and managed effectively and in a timely fashion.
Part V sets forth evidence-based recommendations for reprocessing flexible gastrointestinal endoscopes and flexible bronchoscopes, including recommendations for administrative policies and procedures, cleaning, leak testing, sterilization and high level disinfection, and storage and transportation. The recommendations in this Guideline take into account guidelines and recommendations published by other national and international societies and organizationsFootnote 1 Footnote 2 Footnote 3 Footnote 4 Footnote 5 Footnote 6 Footnote 7 Footnote 8 Footnote 9 Footnote 10.The recommendations elaborate on quality management, specifically, education and training requirements, worker health and safety considerations, and the quality assurance elements of a reprocessing program. Other recommendations deal with classic and variant Creutzfeldt-Jakob Disease, outbreak investigation and management, and endoscopy unit design.
Appendix A. The “PHAC Infection Prevention and Control Guideline Development Process” provides a summary of the guideline development process.
Appendix B. The “Glossary of Terms” provides definitions of terms used throughout these guidelines.
Appendix C. The “Spaulding Classification System” is used for making decisions about whether to use sterilization or high level disinfection on endoscopic equipment between each patient use.
Appendix D. The “Bioburden Test Method” describes a procedure for microbiologic testing of endoscopes that may be undertaken as part of an outbreak investigation.
Appendix E and F. These two sections, “Sample Audit Checklist/Tools for Reprocessing of Endoscopy Equipment/Devices”, provide examples of quality assurance tools to audit reprocessing practices to verify that equipment/devices are being reprocessed according to established guidelines. They may be adapted for individual facility use.
Appendix G. The “Verification of Training Stages for Endoscope Reprocessing” provides an example of an audit tool to verify that staff training and education have been completed and that competency with procedures has been established. It may be adapted for individual facility use.
Appendix H. The “Guideline for Outbreak Investigation Related to Endoscopic Procedures” outlines steps to be taken if an outbreak investigation is undertaken. Some steps may be carried out concurrently and a thorough risk assessment should be conducted to determine if patient notification is required.
Appendix I. The “PHAC Guideline Rating System” describes the system for ranking the strength of the evidence used to support the recommendations made in this Guideline.
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