Practice Guidelines Endocopic disinfection & Reprocessing
- 2. Definitions • Cleaning: – Removal of blood, secretions or other debris from endoscopes and accessories. • Disinfection (high-level disinfection) : – Reduction or destruction of all vegetative microorganisms, mycobacteria, small or non-lipid viruses, medium-sized or lipid viruses, fungal spores, and some but not all bacterial spores to a level appropriate for safe use of endoscopes/accessories in a patient.
- 3. Definitions • Sterilization: – The destruction of all microbial life. Validated processes are used to render a device free from all forms of viable microorganisms. • Single-use accessories (disposables): – Disposable devices provided in a sterile state, ready for once-only use. – Once opened a sterile package must be used immediately, as is routine in surgery.
- 4. Infection Control Measures – Disinfection and sterilization of medical equipment – Proper use of personal protective equipment – Personal hygiene – Engineering controls (ventilation, building design, clean water supply) – Cleaning and disinfection of environmental surfaces – Adequate administrative monitoring and support – Training and continuing education – Adequate written protocols
- 5. Basic Steps • Most guidelines for endoscope reprocessing prescribe the following six steps: • Sterilization sometimes replace the disinfection step, but this is not feasible in all cases of flexible endoscopes. CleaningCleaning RinsingRinsing DisinfectionDisinfection DryingDrying RinsingRinsingStorageStorage
- 6. Cleaning must always be performed prior to disinfection
- 7. Disinfection should be carried out immediately after cleaning
- 8. Basic Steps • Principal steps of endoscope reprocessing: – Wiping down the insertion tube – Flushing the air/water channels – Aspirating water through the biopsy/suction channel – Dismantling detachable parts (e.g. valves) – Manual cleaning with detergent followed by rinsing – Disinfection and rinsing in an automatic reprocessor – Drying and appropriate storage
- 9. Hierarchy of Standards • OMGE/OMED introduced guidelines aiming for improved compliance, especially in areas of the world where external factors limit available options (certain resource-sensitive areas ) – Optimal – Normal – minimal standards
- 10. Principles applying to all standards • Pre-cleaning – Pre-clean immediately before detaching from processor • Cleaning – Always perform leak testing and block testing before immersing the endoscope in a detergent or soap solution as this may help prevent expensive repairs later • Rinsing – Always rinse between cleaning and disinfection
- 11. Principles applying to all standards • Disinfection – Always immerse the endoscope and valves in a disinfectant solution of proven efficacy – Always irrigate all channels with a syringe until air is eliminated to avoid dead spaces – Always observe the manufacturer's recommendation regarding the minimum contact times and correct temperature for the disinfection solution – Always observe the manufacturer's recommendations regarding compressed air valves – Always remove the disinfection solution by flushing air before rinsing – Always determine whether the disinfectant solution is still effective by testing it with the test strip provided by the manufacturer
- 12. Principles applying to all standards • Final rinsing – Always discard the rinse water after each use to avoid concentration of the disinfectant and thus damage to mucosa – Never use the same container for the first and final rinsing • Drying – Always dry the endoscope properly before storage to prevent microorganism growth in the endoscope channels • Storage – Never store in a transport container
- 13. Optimal Standard
- 14. Optimal Standard • Pre-cleaning – Clear gross debris by sucking detergent through the working channel (250 ml/min) – Expel any blood, mucus or other debris – Flush the air/water channel and wipe down the insertion shaft – Check for bite marks or other surface irregularities – Detach the endoscope from the light source/videoprocessor – Transport in a closed container to the reprocessing room
- 15. Optimal Standard • Cleaning – Conduct leak testing and block testing – Clean all surfaces, brush channels and valves – Use a disposable brush and disposable swab or tissue – Renew detergent solution for each new procedure – Clean and rinse the container before the next procedure
- 16. Optimal Standard • Disinfection (automatic reprocessing) – Cleaning with appropriate detergent solution – Rinsing – Disinfection – Final rinsing
- 18. • Preliminary cleaning started before the endoscope is detached from the processor as soon as the endoscope has been removed from the patient : – Clear gross debris by sucking detergent through the working channel (250 ml/min) – Ensure the working channel is not blocked – Irrigate the air and water channels with water checking for blockages – Expel any blood, mucus or other debris – Wipe down the insertion shaft – Check for bite marks or other surface irregularities – Detach the endoscope from the light source/videoprocessor – Transfer the endoscope to a reprocessing room with atmospheric extraction facilities – Conduct a leakage test daily to check the integrity of all channels before reprocessing
- 19. • The next stage involves the dismantling of detachable parts of the endoscope whereby valves and water bottle inlets are removed and detachable tips taken off the insertion tube. • Rubber biopsy valve caps are discarded if breached. • Water bottles and suction/air-water valves should be autoclaved.
- 20. • All exposed internal and external surfaces should then be manually cleaned and rinsed according to the following recommendations: – low-foaming detergent specifically designated for medical instruments – appropriate dilution according to the manufacturer's instructions – Flush and brush all accessible channels to remove all organic residues with a disposable brush-tipped wire designed for this purpose – Use brushes of the appropriate size for the endoscope channel, parts, connectors and openings; bristles should have contact with all surfaces – Repeatedly actuate the valves during cleaning to facilitate access to all surfaces – Clean the external surfaces and components of the endoscope with a soft cloth, sponge or brush – Subject reusable endoscopic accessories and endoscope components to ultrasonic cleaning to remove material from hard-to-clean areas – Dispose all cleaning items
- 22. • Disinfection of endoscopes should be performed in dedicated rooms by trained staff at the beginning and at the end of each patient list, as well as between patients.
- 23. • Recommendations for effective disinfection with a liquid chemical germicide include: – Using an automatic endoscope reprocessor – Performing disinfection in a dedicated area with atmospheric extraction facilities – Flushing high-level disinfectant or chemical sterilant throughout the endoscope at the correct temperature and for the correct duration – Concluding disinfection by rinsing with sterile or filtered water or alcohol – Drying each endoscope properly with forced air
- 24. • Disinfectants differ markedly among themselves primarily in their antimicrobial spectrum and rapidity of action.
- 25. Disinfectants • Glutaraldehyde is one of the most commonly used disinfectants in endoscopy units. • It is effective and relatively inexpensive, and does not damage endoscopes, accessories or automated processing equipment. • However, health, safety and environmental issues are of considerable concern. • Adverse reactions to glutaraldehyde are common among endoscopy personnel, reductions in atmospheric levels of glutaraldehyde have been recommended. • In some countries it has been withdrawn from use.
- 26. Disinfectants • Alternative disinfectants and the use of automated washer- disinfectors are being reviewed as ways of eliminating or minimizing glutaraldehyde exposure in endoscopy units. • New automated disinfection machines use glutaraldehyde in very low concentrations, thus reducing staff exposure. • The effectiveness of glutaraldehyde in these machines is maintained by heating acid-based formulations to 45-55°C, and use of fresh materials for each cycle reduces the possibility of contamination and cross-infection.
- 27. Disinfectants • Orthophthalaldehyde is a more stable alternative disinfectant and has a lower vapor pressure than glutaraldehyde. • It is practically odourless, does not emit noxious fumes, and has better mycobactericidal activity than 2% glutaraldehyde. • It does not appear to damage the equipment, but like other aldehydes it can stain and cross-link protein material.
- 28. Disinfectants • Peracetic acid is a highly effective disinfectant which may prove to be a suitable alternative to glutaraldehyde. • Before using alternative disinfectants, information should always be obtained from manufacturers of the equipment as use of an alternative to glutaraldehyde may invalidate guarantees and/or service contracts.
- 29. Disinfectants • Finally, it should be pointed out that in many countries limited budgets do not permit the use of more expensive alternative disinfectants. • In some areas even glutaraldehyde is not affordable, and reprocessing is limited to manual washing with a detergent. • In such settings the use of automatic endoscope reprocessors or even disinfectant does not come into consideration.
- 30. Efficacy • Some pathogens are more difficult to eliminate. • These pathogens are in decreasing order of resistance to disinfectants/sterilization: – prions - e.g. Creutzfeldt-Jakob prion – bacterial spores - e.g. Bacillus subtilis – coccidia - e.g. Cryptosporidium parvum – mycobacteria - e.g. Mycobacterium tuberculosis, Mycobacterium terrae – non-lipid or small viruses - e.g. poliovirus, coxsackie viruses – fungi - e.g. Aspergillus species , Candida species – vegetative bacteria - e.g. Staphylococcus aureus, Pseudomonas aeruginosa – lipid or medium-sized viruses e.g. HIV, herpes viruses,
- 31. Automatic Reprocessing • In automatic endoscope reprocessing (AER) the endoscope and endoscope components are placed in the reprocessor, and all channel connectors attached according to AER and endoscope instructions. • AER ensures exposure of all internal and external surfaces to a disinfectant or chemical sterilant. • If an AER cycle is interrupted, disinfection or sterilization cannot be assured and the entire process should be repeated.
- 32. Automatic Reprocessing • The advantages of automatic reprocessing compared to manual reprocessing are as follows: – Important reprocessing steps are automated and standardized – The likelihood of an essential step being omitted is reduced – All external and internal components of the endoscope are reliably and evenly subjected to thorough disinfection and rinsing – All channels (biopsy, suction, air, water, auxiliary water, CO2 channels) are properly irrigated – Cross-contamination with for example prions by transfer to other reprocessing batches is prevented by the once only use of cleaning, disinfection and rinse solutions – Eye, skin and respiratory tract exposure to the disinfectant is reduced – Atmospheric pollution by the disinfectant is reduced
- 34. Rinsing & Drying
- 35. Rinsing & Drying • The final drying steps greatly reduce the possibility of recontamination of the endoscope with waterborne micro- organisms. • Alcohol drying can be hazardous. It should be noted that in many guidelines an alcohol flush for drying is considered unnecessary if the drying process is carried out properly.
- 36. Rinsing & Drying • The recommended steps are as follows: – After disinfection, rinse the endoscope and flush the channels with water to remove the disinfectant/sterilant. – Discard the rinse water after each use/cycle – Flush the channels with 70-90% ethyl alcohol or isopropyl alcohol – Dry with compressed air • The disinfectant or chemical sterilant must be rinsed from the internal and external surfaces of the endoscope. If tap water is used, a flush with 70% alcohol should be performed with Caution.
- 37. • Colonized water or residual moisture can be a source of microorganisms, and proper drying will remove any moisture from internal and external surfaces of the endoscope. • Drying of endoscopes especially prior to prolonged storage decreases the rate of bacterial colonization. • Forced air drying adds to the effectiveness of the disinfection process.
- 38. – dry with compressed air of defined quality or a 70% alcohol flush Alcohol must be properly stored as evaporation occurs rapidly on exposure to air if the concentration is <70% it cannot be reliably used in the drying process
- 40. Optimal Standard • Storage – Disassemble the endoscope in a well ventilated storage cupboard – Ensure the valves are dry and lubricate if necessary – Store separately
- 41. Storage • The following are recommendations for storage: – Ensure proper drying prior to storage – Hang preferably in a vertical position to facilitate drying – Remove caps, valves and other detachable components according to the manufacturer's instructions – Uncoil insertion tubes – Protect endoscopes from contamination by placing a disposable cover over them – Use a well ventilated room or cabinet for reprocessed endoscopes only – Clearly mark which endoscopes have been reprocessed
- 42. Normal Standard
- 43. Normal Standard • Pre-cleaning – Clear gross debris by sucking detergent through the working channel (250 ml min) – Expel any blood, mucus or other debris – Flush the air/water channel and wipe down the insertion shaft – Check for bite marks or other surface irregularities – Detach the endoscope from the light source/videoprocessor – Transport in a closed container to the reprocessing room
- 44. Normal Standard • Cleaning – Conduct leak testing and block testing – Clean all surfaces, brush channels and valves – Use a disposable or autoclavable brush and disposable swab or tissue – Renew the detergent solution for each new procedure – Clean and rinse the container before the next procedure – Follow the same procedures for all accessories as for endoscope processing
- 45. Normal Standard • Rinsing (manual) – Rinse the endoscope and valves under running tap water of drinking-water quality – Immerse the endoscope and irrigate all channels – Discard the rinsing water after each use to avoid concentration of the detergent and the risk of reduced efficacy of the disinfectant solution – Clean and rinse the container before the next procedure
- 46. Normal Standard • Disinfection (manual) – Immerse the endoscope and valves in a disinfectant solution of proven efficacy (GA, PAA, OPA etc) – Irrigate all channels with a syringe until air is eliminated to avoid dead spaces – Follow manufacturer recommendation for the contact time with the solution – Remove the disinfection solution by flushing air before rinsing
- 47. Normal Standard • Final Rinsing (manual) – Rinse the endoscope and valves under running filtered water – Immerse the endoscope and irrigate all channels – Discard the rinsing water after each use to avoid concentration of the disinfectant and thus damage to mucosa – Drying should be performed after each processing cycle and not just before storage
- 48. Normal Standard • Drying – Ensure correct final drying before storage – Dry with compressed air or a 70% alcohol flush • Storage – Disassemble the endoscope in a well ventilated storage cupboard – Ensure the valves are dry and lubricate if necessary – Store separately
- 49. Minimal Standard
- 50. Minimal Standard • Pre-cleaning – Clear gross debris by sucking water through the working channel (250 ml min) – Expel any blood, mucus or other debris – Flush the air/water channel and wipe down the insertion shaft – Check for bite marks or other surface irregularities – Detach the endoscope from the light source/videoprocessor – Transport in a closed container to the reprocessing room – Brush reprocessing must follow the same procedures as for endoscope reprocessing
- 51. Minimal Standard • Cleaning – Conduct leak testing and block testing – Immerse the endoscope in detergent or a soap solution – Clean all surfaces, brush channels and valves with a clean dedicated brush and a clean swab or tissue – Follow the same procedures for all accessories as for endoscope processing
- 52. Minimal Standard • Rinsing (manual) – Rinse the endoscope and valves under running tap water (must be drinking-water quality) – Immerse the endoscope and irrigate all channels – Discard the rinse water after each use to avoid concentration of the detergent and the risk of reduced efficacy of the disinfectant solution – Clean and rinse the container before the next procedure
- 53. Minimal Standard • Disinfection (manual) – Immerse the endoscope and valves in a disinfectant solution of proven efficacy (GA, PAA, OPA etc) – Irrigate all channels with a syringe until air is eliminated to avoid dead spaces – Contact time with the solution should be according to the manufacturer's recommendation – Disinfection solution should be removed by flushing air before rinsing
- 54. Minimal Standard • Final Rinsing (manual) – Rinse the endoscope and valves in drinking-quality or boiled water by immersing the endoscope and irrigating all channels (nonfiltered water unlike normal standard) – Discard the rinse water after each use to avoid concentration of the disinfectant and thus damage to mucosa • Drying – Ensure correct final drying before storage – Dry with compressed air or if not available inject air with a clean syringe – Drying should be performed after each processing cycle and not just before storage
- 55. Minimal Standard • Storage – Disassemble the endoscope – Store in a well ventilated storage cupboard – Ensure the valves are dry and lubricate if necessary – Store separately or store the endoscope in a clean closed box with the valves
- 56. Sterilization
- 57. Sterilization • Sterilization is used primarily for processing endoscope accessories and is accomplished by either physical or chemical methods. • It is important to note that the term 'sterilization' should not be equated with 'disinfection', and that there is no such state as 'partially sterile'.
- 58. Sterilization • Steam under pressure, dry heat, ethylene oxide gas, hydrogen peroxide, gas plasma, and liquid chemicals are the principal sterilizing methods used in healthcare facilities. • When chemicals are used for the purpose of destroying all forms of microbiological life, including fungal and bacterial spores, they are referred to as chemical sterilants. • These same germicides may also be used for shorter exposure periods in the disinfection process (high-level disinfection).
- 59. Sterilization • Flexible endoscopes do not tolerate high processing temperatures (> 60 °C) and cannot be autoclaved or disinfected using hot water or subatmospheric steam. • They may be sterilized, however, provided they have been thoroughly cleaned and the manufacturer's processing criteria are fulfilled. • Although the value of sterilization would seem to be obvious, there is no evidence available indicating that sterilization of flexible endoscopes improves patient safety by reducing the risk of transmission of infection.
- 60. Take home message • Precleaning starting immediately before detaching endoscope from processor • Leak test and check for bites • Manual cleaning is vital before disinfection • Disinfection according to provided standards • Final rinsing & drying is crucial • Store dried, separately, well ventilated • Accessories are as important • No evidence for sterilization Vs. H.L. disinfection
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