Pathogens of concern

1. Pathogens of concern Keeping Our Patients Safe in Endoscopy Holly Knauf RN, MSN, AGTS Clinical Education Specialist MEDIVATORS

2. Disclosures • Successful completion: Participants must complete the entire program and submit required documentation. • Conflict of interest: Planners disclose no conflict; the speaker discloses employment with Medivators, thereby declaring a conflict of interest • Commercial company support: Fees are underwritten by education funding provided by Medivators. • Non-commercial company support: None. • Non-endorsement of products: Accredited status does not imply endorsement by the provider, Educational Dimensions, or ANCC of any commercial products or services from the commercial entity. • Alternative/Complementary therapy: None

3. Learner Objectives Upon completion of this presentation, participants will be able to: • Discuss potential complications resulting from the presence of various pathogens in endoscopy equipment • Discuss the role biofilm plays in contamination of endoscopes • Recognize the impact of infections related to endoscopy • State the steps required to correctly reprocess an endoscope in the clinical area

4. Microbiology • Microorganisms in our environment • Evolution & Purpose • Requirements for growth • Transmission • Types & Location • Bacteria • Viruses • Fungi • Worms & Insects • Pathogens

5. Pathogenic Bacteria • Staphylococcus aureus (“Staph”) • Streptococcus pyogenes • Pseudomonas aeruginosa • Escherichia coli (“E coli”) • Helicobacter pylori (“H. pylori”) • Mycobacterium tuberculosis (TB)

6. Endospores • Resistant, dormant, survival form of bacteria • Spore producing organisms • Bacillus anthractis • Anthrax • Clostridium tetani • Tetanus • Clostridium botulinum • Food poisoning • Clostridium difficile • C diff

7. Four Major C. difficile-Associated Disease (CDAD) Clinical Problems • Inability to prevent CDAD in high-risk settings such as the hospital • Lack of a sensitive and rapid diagnostic test for CDAD • Absence of a treatment that will prevent recurrence of CDAD • Inability to effectively treat fulminant CDAD

8. Viruses • Characteristics • Species specific • Cell specific • Hepatitis B – Liver • HIV – Certain White Blood Cells (WBCs) • Hepatitis C • Cytomegalovirus – AIDS • Cryptosporidium – Diarrhea • Human Papillomavirus (HPV) – Condyloma

9. Unicellular Organisms • Protozoa • Complex organism • Complex life cycles • Mode of transmission • Cause of diarrheal illnesses

10. Unicellular Organisms • Fungi • Exist in yeast or mold • Tinea pedis • Candida albicans

11. Biofilm • Micro-organisms surrounded by the slime they produce • Exists wherever surfaces contact water • Bacteria live in biofilm communities • Interferes with disinfection • All surfaces easily colonized • Difficult to remove • Physical properties

18. Endoscopy Related Infection in the News • 2000 – New Jersey: Reprocessing Machine Malfunction • 2001 – Tennessee: Outbreak! • 2002 – Maryland: Pseudomonas aeruginosa Outbreak at Major Medical Center • 2002 – USA Today: Medical Community Debates Scope Cleaning Procedures • 2002 – Good Morning America: Contamination Controversy: Are endoscopes being disinfected properly?

19. Gastrointestinal (GI) Endoscopy • Benefits • Useful for many GI procedures • Safer than surgery • Patient Safety Considerations • Potential for patient harm • Potential for infection transmission • Identification of Risk

20. Spaulding Classification System • Classification system for device disinfection and sterilization processes • Critical – Sterilization, i.e., reusable biopsy forceps • Semi-critical – Sterilization or high-level disinfection, i.e., endoscopes • Non-critical – Germicide or soap & water, i.e., BP cuffs, stethoscopes

21. Factors Affecting High Level Disinfection and Sterilization Efficacy • Complex endoscope design • Biofilm formation • Cleaning impacts efficacy of disinfection / sterilization • Considerations for use of germicides • Resistant microorganisms to destruction methods

22. Training and Safety • Training & policy development major influencers of infection prevention & safe practice • Reprocessing has narrow margin of safety • Ongoing education • Annual competency requirement • New equipment & instrument training • Strict adherence to policies • Accuracy of documentation • Staff safety considerations

23. Quality Assurance Standards • Highest priority • Documentation requirements • Procedure date and time • Patient’s name & medical record number • Person performing the procedure • Endoscope model & serial number or other identifier • Automated endoscope reprocessor (AER) model & serial number or other identifier • Staff member(s) reprocessing the endoscope

24. Reprocessing Overview • Designated area • Adequate space • Proper airflow • Adequate ventilation • User-friendly work area design • Delineation of clean and dirty areas • Identification mechanism for clean vs dirty scopes • Availability of recommended chemicals • Availability of reprocessing equipment

25. Reprocessing Policy Development • Manufacturer instruction manual • Organizational policy & procedure • Adherence to federal (CDC) and professional standards (AORN & SGNA) • Timing • Use of PPE • Procedural steps • Environmental cleaning

26. Reprocessing Equipment • Personal protective equipment (gloves, eye protection, impervious gown, face shield or simple surgical mask that will not trap vapors) • Leak-testing equipment • Channel cleaning adapters (per OEM) • Large basin or sink • Detergent solution prepared according to manufacturer's instructions • Channel cleaning brushes • Sponge and/or lint-free cloth

27. Precleaning • Wipe down the insertion tube with a detergent-soaked lint free cloth • Immerse distal tip in detergent; depress suction valve to aspirate detergent for 30 seconds • Remove distal tip from detergent solution and depress suction valve to aspirate air for 10 seconds; repeat till clear • Alternating air and suction will assist in removal of debris from channel; flush with clean water • Attach air/water channel cleaning adapter and set the light source airflow to HIGH

28. Precleaning • Immerse the distal tip in clean water; depress air/water channel cleaning adapter and feed water for 30 seconds, release the air/water channel cleaning adapter for 10 seconds or more to let air through the channels • Use a syringe to flush the auxiliary water channel or ERCP elevator channel till clear • Turn OFF light source; attach protective video cap and transport endoscope to the reprocessing area in a covered container

29. Environment • Between patients, the procedure room, equipment (monitors, video processors, light sources) and all surfaces should be wiped clean and disinfected with a surface disinfectant designed for this purpose. • Follow disinfectant contact time recommendations

30. Reprocessing Procedure • Precleaning • Leak Testing • Manual Cleaning • Manual High-Level Disinfection • Automated Endoscope Reprocessors • Drying • Accessories

31. Leak Testing • Remove all valves • Pressurize the instrument using a manual or automated leak tester • Identify that the distal tip is inflated • Submerge the scope in water to observe for leaks • Some automated leak testers may not require submersion • If bubbles are seen, keep scope pressurized • If bubbles are not seen, deflate and disconnect the leak tester from the device

32. Manual Cleaning (1) • Fill a sink or basin with cleaning solution following manufacturer’s recommendations • Immerse the endoscope; wash all debris from the exterior of the endoscope by brushing and wiping the instrument while submerged • Use a small, soft brush to clean all removable parts • Brush all accessible endoscope channels including the body, insertion tube and the umbilicus of the endoscope

33. Manual Cleaning (2) • After each passage, rinse the brush in detergent solution; continue brushing until there is no debris visible on the brush • Attach the endoscope manufacturer’s cleaning adapters for suction, biopsy, air and water channels • Attach the manufacturer’s cleaning adapters for special endoscope channels • Flush all channels with the detergent solution to remove debris

34. Manual Cleaning (3) • Soak the endoscope and its internal channels for the period of time specified by the label, if using an enzymatic detergent or biofilm detaching agent • Thoroughly rinse the endoscope and all removable parts with clean water to remove residual debris and detergent • Purge water from all channels using forced air • Dry the exterior of the endoscope with a soft, lint-free cloth before immersing

35. Manual Reprocessing • Follow manufacturer’s recommendations for use • Make sure the scope is completely submerged in the disinfectant • Using a syringe draw fluid into all channels so that all internal and external surfaces have disinfectant contact • After the recommended contact time remove the scope and rinse with clean water with the number of recommended separate rinses • Use a syringe and flush alcohol through all the channels • Use forced air to dry internal channels after alcohol flush • Dry the external surface with a lint free cloth

36. High Level Disinfection using an Automated Endoscope Reprocessor • Place the endoscope into the AER basin • Connect all appropriate channels to the AER hookups • Test the disinfectant for minimal effective concentration level according to the manufacturer’s recommendations • Determine correct cycle for the endoscope processing and start the cycle • Complete all documentation required for high level disinfection

37. Automated Endoscope Reprocessing • Make sure an alcohol purge and air purge were completed during the AER reprocessing • When removing the endoscope from the AER use a dry lint free cloth to dry any damp areas on the scope surface

38. Time Out: Test Your Knowledge • Why does the ERCP elevator wire channel have to be processed separately? • Most reprocessors do not have adequate pressure to flow this very narrow lumen. Pseudomonas colonized in this channel has been responsible for many infections. • Why is drying such an important part of reprocessing? • If a scope is not completely dry, waterborne bacteria will grow as biofilm in the scope channels.

39. Storage • Scopes should be hung vertically to promote any drainage of residual fluids • Storage area should be well ventilated • All accessories should stay removed from the scope during storage • There should be limited access to the storage area

40. Breaking the Chain of Infection • Following Guidelines and Recommended Practices from professional organizations • Yearly competency testing for staff • Quality Improvement Programs

41. Conclusion • Our patients are at risk • We have a responsibility for consistent adherence to guidelines and practices • Rigid adherence will ensure safety and quality for both patients and staff

42. Resources: • CDC • Guideline for Disinfection & Sterilization in Healthcare Facilities (http://www.cdc.gov) • SGNA • Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (http://www.sgna.org) • AORN • Recommended Practices for Cleaning & Processing Flexible Endoscopes and Accessories (http://www.aorn.org)