Duodenoscope Cleaning and Disinfection Checklist

TJF-Q180V Duodenoscope Cleaning and Disinfection Checklist This checklist is designed for use solely as a customer educational tool and is not intended to replace or in any way modify the Olympus instruction manual/reprocessing manual. Be sure to follow the detailed steps outlined in the reprocessing manual that was included with your Olympus equipment when purchased. While Olympus' training may be used in support of a facility's overall competency program, it shall not constitute certification of the facility's CDS protocol. Olympus shall in no event be held responsible for a facility's proper performance of CDS protocol nor for a facility staying current with ongoing CDS instructional changes and corresponding training updates. Facility owners of Olympus equipment are fully responsible for complying with industry CDS standards and manufacturer's proper use and CDS instructions.

Facility name Date Endoscope Models: Check each model reviewed during this session.  TJF-Q180V Facility-verified Competency (Authorised Staff Member Name) Instructor Name Title Signature Date

Staff Member Name Signature Date

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Pre Cleaning: Immediately following the patient procedure 1. Wear appropriate Personal Protective Equipment (PPE). 2. Prepare a clean 1,000 ml container of water. 3. Wipe down the insertion tube with a water-soaked lint-free cloth or sponge. Wipe from the

Demonstrated

boot at the control section toward the distal end.

4. Lower the forceps elevator by turning the elevator control lever. 5. Immerse the distal end of the insertion section into the water, depress the suction valve (MH-443) and suction the water through the endoscope for 30 seconds

6. While continuing the immersion and the aspiration, raise and lower the forceps elevator three times, by turning the elevator control lever.

7. Remove distal end from the water. Depress the suction valve, and aspirate air for 10 seconds.

8. On the Light Source turn the air off. Attach the air/water cleaning adaptor (MH‐948). Set the air flow to “high” and turn on the air. Detach the air/water valve (MH438) from the endoscope, and place it in the detergent solution.

9. Attach air/water channel cleaning adaptor (MH-948) to the air water cylinder of the endoscope.

10. Immerse the distal end of the insertion section in the water. 11. Set the airflow regulator on the light source to maximum output ”HIGH”. 12. Depress the button of the air/water channel cleaning adaptor, and flush the air channel with water from the water container for 30 seconds

13. Release the air/water channel cleaning adaptor button to flush air for 10 seconds. 14. Turn OFF the light source. Disconnect all removable and reusable parts from the endoscope. When using the single use biopsy valve (MAJ-1555), detach the single-use biopsy valve from the endoscope and discard it.

15. Detach the endoscope from the light source. 16. Confirm that the water-resistant cap is dry and free of debris, and attach the waterresistant cap.

17. Transport to reprocessing area. Use a covered container if required by local policy. 18. Place valves and air-water channel cleaning adaptor in detergent solution. Comments:

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Leakage Testing 1. Wear appropriate Personal Protective Equipment (PPE). 2. Perform the leak test in the reprocessing area, prior to reprocessing each endoscope. 3. Fill a clean large basin with water. 4. Confirm that there is no moisture inside the leakage tester’s connector cap (MB-155). 5. Connect the leakage tester (MB-155) to the output socket of the MU-1 (air supply). 6. Turn on leakage tester maintenance unit (MU-1) and confirm that air is being emitted by

Demonstrated

gently depressing the pin located inside the leakage tester connector cap.

7. Connect the leakage tester cap to the venting connector on the water resistant cap on the endoscope and confirm the bending section inflates before immersing in water.

8. Completely immerse the endoscope in water and observe for 30 seconds. Look for any air bubbles that would indicate a potential leak.

9. Manipulate the angulation knob (U/D, R/L) checking for a potential leak. 10. Raise and lower the forceps elevator by moving the endoscope’s elevator lever 3 times, checking for a potential leak.

11. Remove the endoscope from the water with the leakage tester still attached and turn the leak tester maintenance unit (MU-1) off.

12. Disconnect the leakage tester (MB-155) from the maintenance unit (MU-1). 13. Wait 30 seconds, or until the bending section contracts to its pre-expansion size. 14. Disconnect the leakage tester connector cap from the endoscope. 15. Thoroughly dry the leakage tester by using a clean, lint-free cloth. Comments:

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Manual Cleaning 1. Fill a clean, large sized basin with fresh detergent solution prepared as recommended by the

Demonstrated

manufacturer.

2. Completely immerse the endoscope in freshly prepared detergent solution. 3. Use a soft brush, lint-free cloth, or sponge to thoroughly clean all external surfaces, paying particular attention to the air/water nozzle opening and the objective lens on the distal end of the insertion section, and ensure that all surfaces of the distal end are thoroughly cleaned.

4. Lower the forceps elevator by turning the elevator control lever in the opposite direction of the “◄U” direction until the forceps elevator stops.

5. Straighten the bending section of the endoscope. Brush the forceps elevator, including the guide wire-locking groove and the forceps elevator recess, with the single-use channel-opening cleaning brush (e.g. BW-412T) as follows: a. Insert the brush into the forceps elevator recess along the forceps elevator until the brush handle touches the distal end of the endoscope, and pull the brush out the forceps elevator recess. Repeat the insertion and pulling out three times. b. Brush the guide wire-locking groove.

6. Raise the forceps elevator by turning the elevator control lever in the “◄U” direction until the forceps elevator stops.

7. While holding the distal end, brush the forceps elevator and the forceps elevator recess with the single-use channel-opening cleaning brush (e.g. BW-412T) as follows:

a. Insert the brush into the forceps elevator recess along the back of the forceps elevator until the distal end of the brush touches the bottom of the forceps elevator recess, and pull the brush out of the forceps elevator recess.

b. Insert the brush into the forceps elevator recess, rotate the brush one full revolution.

c. Pull the brush out of the forceps elevator recess. 8. Operate the elevator control lever to raise and lower the forceps elevator in the detergent solution three times.

9. Clean the bristles of the brush in detergent solution by using your gloved fingertips to remove any debris.

10. Lower the forceps elevator by turning the elevator control lever in the opposite direction of the “◄U” direction until it stops.

11. Brush the distal end of the endoscope, except the forceps elevator and the forceps elevator recess, by using the single use channel-opening cleaning brush (BW-412T) until no debris is observed upon inspection of the endoscope.

12. Use endoscope model-specific brushes to brush channels/cylinders/ports until no visible debris remains.

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13. Insert the brush at a 45° angle into the opening located in the side wall of the suction cylinder. Using short strokes, feed the brush through the instrument channel until it emerges from the distal end of the endoscope’s insertion section.

14. Inspect whether there is debris on the bristles when the brush emerges from the distal end. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.

15. Carefully pull the brush back through the channel end and out of the suction cylinder. Inspect whether there is debris on the bristles when the brush emerges from the suction cylinder. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.

16. Repeat steps 13 through 15 until no debris is observed upon inspection of the brush. 17. Insert the brush straight into the suction cylinder. Using short strokes, feed the brush through the suction channel until it emerges from the suction connector on the endoscope connector.

18. Inspect whether there is debris on the bristles when the brush emerges from the suction connector. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.

19. Carefully pull the brush back through the channel and out of the suction cylinder. Inspect whether there is debris on the bristles when the brush emerges from the suction cylinder. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.

20. Repeat steps 17 through 19 until no debris is observed upon inspection of the brush. 21. Brush the suction cylinder – insert the stubby brush (BW-412T) into the suction cylinder, until half of the brush section is inserted. Rotate the inserted brush one full rotation.

22. Pull the brush out of the cylinder. Inspect whether there is debris on the bristles when the brush emerges from the suction connector. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.

23. Repeat these steps 21 through 22 until no debris is observed upon inspection on the brush. 24. Brush the instrument channel port – insert the stubby brush (BW-412T) into the instrument channel port, until half of the brush section is inserted. Rotate the inserted brush one full rotation.

25. Pull the brush out of the instrument channel port. Inspect whether there is debris on the bristles. Clean the bristles in the detergent solution using your gloved fingertips to remove any debris.

26. Repeat steps 24 through 25 until no debris is observed upon inspection on the brush. Dispose of brush.

27. Remove the endoscope from the detergent solution. 28. Attach the suction cleaning adaptor (MH-856) to the instrument channel port. 29. Connect the suction tube from the suction source to the suction connector on the endoscope. 30. Turn the suction pump ON. 31. Confirm that the forceps elevator is lowered. 32. Immerse the distal end and weighted end of suction cleaning adaptor in detergent. 33. Ensure distal end of endoscope and distal end of suction cleaning adaptor remain in detergent solution.

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34. Cover the suction cylinder with your gloved finger, and aspirate detergent solution for approximately 30 seconds.

35. While continuing the immersion and aspiration, raise and lower forceps elevator at least 3 times by turning the elevator control lever.

36. Turn OFF the suction pump. 37. Detach the suction tube and the suction cleaning adaptor. Reprocess the suction cleaning adaptor as described in Olympus instructions, Cleaning, Disinfection and Sterilisation Procedures for Removable Parts and Cleaning/Reprocessing Equipment.

38. Brush the forceps elevator recess. a. Confirm that the forceps elevator is lowered, and straighten the bending section of the endoscope.

b. Brush the forceps elevator and the forceps elevator recess with the single-use soft brush (MAJ-1888), keeping the distal end of the endoscope immersed in the detergent solution.

c. Brush the guidewire locking grove with 3 strokes. d. Brush both groves with 3 strokes. e. Clean the bristles of the brush gently with your fingertips in the detergent solution. f. Raise the forceps elevator by turning the elevator control lever in the “◄U” direction until the forceps elevator stops.

g. Brush the whole back side of the forceps elevator

with the brush (MAJ-1888) three times, keeping the distal end of the endoscope immersed in the detergent solution.

h. Clean the bristles of the brush gently with your fingertips in the detergent solution. i. Insert the brush head slowly into the groove under the forceps elevator until the end of the brush touches the wall behind the elevator.

j. While keeping the distal end of the endoscope immersed in the detergent solution, rotate the inserted brush three revolutions while ensuring that the end of the brush contacts the wall behind the forceps elevator.

k.Pull the brush out slowly and gently clean the bristles in the detergent solution with your fingertips.

l. While immersing the distal end in detergent solution, operate the elevator control lever to raise and lower the forceps elevator three times.

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39. With forceps elevator raised, use the tip of the syringe to flush interior of forceps elevator with 30 mls of detergent solution.

40. Lower the forceps elevator by turning the elevator control lever. Insert the tip of the 30ml syringe into the interior the forceps elevator recess in the detergent solution, flush the interior recess with 30mls of the detergent solution. NOTE: When you use a luer-lock type syringe, the tip of the syringe may not fit into the interior of the forceps elevator recess. In this case, hold the tip of the syringe over the interior of the recess while the syringe contacts the surface of the endoscope.

41. Repeat steps 38i through 40 (note steps 38a through 38h do not need to be repeated). 42. While raising and lowering the forceps elevator, inspect the forceps elevator and the forceps elevator recess for any debris. Repeat brushing and/or flushing the elevator and the elevator recess all debris is gone.

43. Dispose of the brush in an appropriate manner. Comments:

Manual Cleaning-Manually Flushing with a Syringe 1. Attach the biopsy valve cap of the channel plug (MH-944) to the instrument channel port of the

Demonstrated

endoscope.

2. Attach the channel plug to the air/water and suction cylinders of the endoscope. 3. Attach the injection tube (MH-946). 4. Immerse the suction port of the injection tube into the detergent solution prepared as recommended by the manufacturer.

5. Attach a clean 30 ml syringe to the injection tube. Flush 90 ml detergent solution into the air/water channels by pumping the syringe at least 3 times.

6. While the endoscope is immersed in detergent solution, wipe down the endoscope with a lintfree cloth.

7. Soak the endoscope and attachment accessories in detergent solution for the time specified by the detergent manufacturer.

8. Remove the endoscope and equipment from the detergent solution. QR 07.094 V1.0 April 2017

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9. Fill a clean, large basin with the water. 10. Immerse endoscope and attached accessories in clean water, and gently agitate to thoroughly rinse.

11. Immerse the suction port of the injection tube (MH-946) in the water. 12. Flush 90 mls of water through each side of the injection tube with a clean 30ml syringe. 13. Remove the endoscope and equipment from the water. 14. Place the endoscope in a clean basin and cover the distal end and control section with a clean, lint- free cloth to prevent splashing.

15. Using a 30 ml syringe, flush each side of the injection tube with 90 mls of air. 16. Remove the cloth. 17. Disconnect the cleaning equipment. Reprocess as described in Olympus instructions Cleaning, Disinfection and Sterilisation Procedures for Removable Parts and Cleaning/Reprocessing Equipment.

18. Use a clean, lint-free cloth to dry all external surfaces, channel plug, and injection tube. 19. Inspect all items for residual debris. If any debris remains, repeat the entire cleaning process until it is removed.

Comments:

Automated Endoscope Reprocessor (AER) High-Level Demonstrated Disinfection NOTE: Prior to disinfection in the AER, raise the forceps elevator to the intermediate position.

1. Test the disinfectant concentration according to the manufacturer's instructions. 2. Inspect the connections according to the AER manufacturer's instructions. 3. Verify that the proper connector is being used for the endoscope being reprocessed. 4. Operate the AER according to the AER manufacturer's instructions. 5. Remove the endoscope promptly after the AER cycle is completed. 6. Perform the terminal steps that the AER does not perform (e.g. alcohol and air purge). Comments:

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Manual High Level Disinfection

Demonstrated

NOTE Prior to manual disinfection, raise the forceps elevator to the intermediate position.

1. Fill a clean, large basin with disinfectant solution. 2. Test the disinfectant concentration (i.e. Minimal Required Concentration-MRC) according to the manufacturer's instructions.

3. Completely immerse the endoscope and equipment in disinfectant solution. 4. Attach the channel plug (MH-944) and injection tube (MH-946) to the endoscope. 5. Confirm that the suction port of the injection tube (MH-946) is immersed in the disinfectant solution.

6. Attach a clean 30 ml syringe to the suction channel port of the injection tube, and forcefully flush the suction channel with 180 mls of the disinfectant solution, i.e. by pumping the syringe at least six times. Confirm that no air bubbles exit the distal end of the endoscope's insertion section during the sixth flush. If air bubbles still exit, flush the channel with the disinfectant solution until no air bubbles exit.

7. Attach a clean 30 ml syringe to the air/water channel port of the injection tube, and forcefully flush the air/water channel with 180 mls of the disinfectant solution, i.e., by pumping the syringe at least six times. Confirm that no air bubbles exit the distal end of the endoscope's insertion section during the sixth flush. If air bubbles still exit, flush the channel with the disinfectant solution until no air bubbles exit.

8. Remove the biopsy valve cap of the channel plug (MH-944) from the instrument channel port of endoscope, leaving the channel plug attached to the air/water and suction cylinders of the endoscope. Forcefully flush the instrument channel with 180 mls of the disinfectant solution by using the 30 ml syringe, i.e. fill the syringe with the disinfectant solution without air, put the distal end of the syringe in the instrument channel port in the disinfectant solution, and forcefully flush at least six times, minimising disinfectant solution leakage from the port. Confirm that no air bubbles exit the distal end of the endoscope's insertion section during the sixth flush. If air bubbles still exit, flush the channel with the disinfectant solution until no air bubbles exit.

9. With the forceps elevator raised, insert the tip of the 30 ml syringe into the interior of the forceps elevator recess in the disinfectant solution, and flush the interior of the recess with 60 ml of the disinfectant solution.

10. Lower the forceps elevator by turning the elevator control lever. Insert the tip of the 30 ml syringe into the interior the forceps elevator recess in the disinfectant solution, and flush the interior of the recess with 60 mls of the disinfectant solution.

11. Turn the elevator control lever to raise and lower the forceps elevator three times, keeping the distal end of the endoscope immersed in the disinfectant solution.

12. Forcefully flush the instrument channel with 90ml of the disinfectant solution, using the 30ml syringe, i.e. fill the syringe with the disinfectant solution without air, put the distal end of the syringe in the instrument channel port in the disinfectant solution, and forcefully flush at least three times, minimising disinfectant solution leakage from the port. Confirm that no air bubbles exit the distal end of the endoscope's insertion section during the third flush. If air bubbles still exit, flush the channel with the disinfectant solution until no air bubbles exit

13. Repeat Steps 9 through 12. 14. While the equipment and endoscope are immersed in disinfectant, disconnect all equipment from the endoscope.

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15. Remove any bubbles that adhere to the surfaces with a clean lint-free cloth. 16. Cover the basin of disinfectant solution. with a tight fitting lid to minimise the diffusion of disinfection vapors.

17. Soak endoscope and equipment for the time and at the temperature recommended by the disinfectant manufacturer.

18. Reconnect the channel plug and injection tube to the endoscope. 19. Remove the suction port of the injection tube from the disinfectant solution. 20. Attach a 30 ml syringe to each port on the injection tube, and flush with 90 ml of air. 21. Remove the endoscope with attached accessories from the disinfection solution Comments:

Rinsing

Demonstrated

1. Fill a basin with sterile water, filtered water, or tap water. 2. Completely immerse the endoscope and equipment in the water. Detach the channel plug (MH-944) and injection tube (MH-946) from the endoscope.

3. Wipe all external surfaces with a lint-free cloth. 4. Attach the channel plug and injection tube to the endoscope. 5. Immerse the suction port of the injection tube in the rinse water. 6. Use a 30 ml sterile syringe to inject 90 mls of water through each side of the injection. 7. Raise the forceps elevator by turning the elevator control lever. Insert the tip of the 30 ml syringe into the interior of the forceps elevator recess in the rinse water, and flush the interior of the recess with 30 mls of the rinse water.

8. Lower the forceps elevator by turning the elevator control lever. Insert the tip of the 30 ml syringe into the interior the forceps elevator recess in the rinse water, and flush the interior of the recess with 30 mls of the rinse water.

9. Turn the elevator control lever to raise and lower the forceps elevator three times, keeping the distal end of the endoscope immersed in the rinse water.

10. Repeat Steps 5 through 9 above for the necessary number of times, following the rinsing method described in the disinfectant solution manual.

11. By turning the elevator control lever, put the forceps elevator in intermediate position of the range of movement.

12. Remove the endoscope and equipment from the rinse water, and place them in a sterile basin. QR 07.094 V1.0 April 2017

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13. Cover the distal tip with a sterile, lint-free cloth. 14. Use a 30 ml syringe to inject 90 mls of air through each side of the injection tub. 15. Remove the cloth from the endoscope. 16. Detach only the injection tube from the endoscope. 17. Attach a sterile suction tube from the suction pump to the suction connector on the endoscope connector. Turn the suction pump ON and aspirate air for at least 15 seconds. Air will flow through the instrument channel and the suction channel of the endoscope.

18. While continuing the aspiration, raise and lower the forceps elevator three times, by turning the elevator control lever.

19. Turn the suction pump OFF. 20. Detach the suction tube and the channel plug from the endoscope 21. Wipe all external surfaces with a sterile, lint-free cloth to thoroughly dry the endoscope. 22. Using sterile cotton swabs, dry the inside of the suction cylinder, air air/water cylinder, the instrument channel port, and the forceps elevator recess.

Comments:

Alcohol Flush

Demonstrated

1. Fill a small sterile basin with the alcohol. 2. Attach a reprocessed channel plug and injection tube to the endoscope 3. Immerse suction port of injection tube in 70% isopropyl or ethyl alcohol. 4. Cover the distal end and control section with a sterile lint-free cloth to prevent splashing 5. Attach a sterile 30 ml syringe to the suction channel port of the injection tube, and flush the suction channel with 90 mls of the alcohol, i.e. pump the syringe at least three times. 6. Move the syringe to the air/water channel port of the injection tube, and flush the air/water channel with 30 mls of the alcohol.

7. Raise the forceps elevator by turning the elevator control lever. Insert the tip of the 30 mls syringe under the covering cloths and into the interior of the forceps elevator recess, and flush the interior of the recess with 30 mls of alcohol.

8. Lower the forceps elevator by turning the elevator control lever. Insert the tip of the 30 ml syringe under the covering cloths and into the interior of the forceps elevator recess, and flush the interior of the recess with 30 mls of the alcohol.

9. Turn the elevator control lever to raise and lower the forceps elevator three times. QR 07.094 V1.0 April 2017

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10. Remove the suction port from the alcohol. 11. Use a 30 ml syringe to inject 90 mls of air through each side of the injection tube. 12. Remove the cloth(s) from the endoscope. 13. Disconnect all equipment from the endoscope. 14. Thoroughly dry the external surfaces of the endoscope, the channel plug, and the injection tube, by wiping with a sterile, lint-free cloth.

15. Use sterile cotton swabs to dry the inside of the air/water and suction cylinders, forceps recess, and instrument channel port.

Comments:

Sterilisation

Demonstrated

1. Flush and dry all channels of the endoscope, the channel plug, and the injection tube, according to the “Alcohol Flush” instructions.

2. Wipe and dry all external surfaces of the endoscope and accessories by using a sterile, lintfree cloth(s) moistened with alcohol.

3. Thoroughly dry the inside of the suction cylinder, the air/water cylinder, the forceps elevator recess, and the instrument channel port of the endoscope by using a sterile cotton swab(s).

4. Detach the water-resistant cap from the electrical connector. 5. Seal the endoscope and accessories in individual packaging appropriate for ethylene oxide gas sterilisation, according to your institution’s protocol.

6. Sterilise and aerate the packaged endoscope and accessories according to the parameters described in the reprocessing manual. In addition, always comply with the instructions of the steriliser manufacturer.

Comments:

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Endoscope Storage

Demonstrated

1. For a disinfected endoscope, perform the following: a. Remove all valves and removable parts from the endoscope. b. Detach the water resistant cap (MH-553) from the electrical connector on the endoscope connector.

c. Confirm that all surfaces of the endoscope and accessories are dry. d. Store the endoscope in a well-ventilated cabinet. 2.

If storing an endoscope that has been sterilised, record the sterile expiration date on the sterile packaging. Do not damage the packaging. Store the sterilised endoscope and accessories in a proper storage cabinet, following your institutional guidelines. Sterile endoscopes may be stored flat in their sterile packaging.

Comments:

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