AHS - IC - Flexible & Semi-Rigid Endoscope Reprocessing

• Conducted on

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• Prepared by

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Environment

• Work flow is unidirectional from the decontaminated area to the clean area and then to the storage area. (3.2.1)

  Yes

  No

  N/A

  Not Observed

• The processing area should be physically separated from the patient procedure rooms.(3.2.2)

  Yes

  No

  N/A

  Not Observed

• An area should be defined for disinfection/sterilization that is separate from the manual cleaning/processing area.(3.2.2)

  Yes

  No

  N/A

  Not Observed

• For manual processing, this could include a designated area for the immersion of the device for disinfection followed by rinsing in accordance with the disinfectant manufacturer’s written IFU. (3.2.2)

  Yes

  No

  N/A

  Not Observed

• For automated processing, the AER, washer-disinfector, or sterilizer forms an essential barrier between the dirty and clean areas of the processing area. Strict unidirectional processing procedures should be in place to reduce risks of cross-contamination following an antimicrobial process. (3.2.2)

  Yes

  No

  N/A

  Not Observed

• here should be a designated drying area, when applicable, to dry the device prior to patient use, storage, or in preparation for packaging and gaseous sterilization. (3.2.2)

  Yes

  No

  N/A

  Not Observed

• A separate area should also be defined and controlled for the storage of devices, either temporarily or more long-term, before patient use. Physical separation of this area from the main processing area is preferred to minimize any risk of cross-contamination during storage. (3.2.2)

  Yes

  No

  N/A

  Not Observed

• Traffic in the processing area should be restricted to authorized personnel.(3.2.3)

  Yes

  No

  N/A

  Not Observed

• In the decontamination area, sufficient space should be allocated for manual clean-up sinks, trash bins, laundry bins, eparate hand wash sinks, an emergency eyewash station, storage of cleaning chemicals and cleaning implements, PPE, automated flushing systems, suction machines, compressed air, adapters, connectors, and gauges. Sink and/or counter space for leak testing should be considered.(3.3.1)

  Yes

  No

  N/A

  Not Observed

• If an AER is being used, sufficient space and utilities for the unit(s) should be allocated. There should be adequate space for storage of chemicals near the AER. (3.3.1)

  Yes

  No

  N/A

  Not Observed

Sinks and accessories (3.3.2)

• Processing areas should have dedicated plumbing and drains.

  Yes

  No

  N/A

  Not Observed

• Sinks should be deep enough to allow complete immersion of the endoscope to minimize aerosolization. The size of the sink should be adequate (i.e., 16 inches x 30 inches) to ensure the endoscope can be positioned without tight coiling. Sinks should not be so deep that personnel have to bend over to clean instruments.

  Yes

  No

  N/A

  Not Observed

• At a minimum, two sinks or one sink with two separate basins should be used, One sink or sink basin should be <br>designated for leak testing and manual cleaning, and the other only for rinsing. Optimally, three sinks or one sink with three separate basins should be used, with each function in a separate sink or basin.

  Yes

  No

  N/A

  Not Observed

• The sink or sinks should have faucets or manifold systems, adapters that attach to the faucet, or other accessories that facilitate the flushing of instruments with lumens.

  Yes

  No

  N/A

  Not Observed

• Sinks should have attached solid counters or adjacent work surfaces on which to place and separate soiled and clean items.

  Yes

  No

  N/A

  Not Observed

• Lighting should be placed above the sink and counter area so that personnel can adequately perform inspection activities as the endoscope is processed.

  Yes

  No

  N/A

  Not Observed

• Forced air with an upper limit of pressure as described in the endoscope manufacturer's written IFU should be provided at the sink for flushing lumened devices.

  Yes

  No

  N/A

  Not Observed

• Best practices include that the nozzle of the pressurized air source should be wiped, disinfected, and allowed to dry before placing in the opening of the channel for drying.

  Yes

  No

  N/A

  Not Observed

Temperature and relative humidity (3.3.7.1)

• The processing area should be temperature controlled for the comfort of personnel (typically between 16°C and 23°C [60°F and 73°F]).

  Yes

  No

  N/A

  Not Observed

• The temperature should be monitored. Processing or other designated personnel should be responsible for monitoring and recording the temperature to verify that the correct temperature is being maintained in each area.

  Yes

  No

  N/A

  Not Observed

• Relative humidity should not exceed 60% in all work areas; in the sterile storage area, the recommended minimum humidity level is 20%. (FGI, 2014)

  Yes

  No

  N/A

  Not Observed

• Relative humidity should be monitored. Processing or other designated personnel should be responsible for monitoring and recording the relative humidity to verify that the relative humidity is being maintained within the recommended range in each area.

  Yes

  No

  N/A

  Not Observed

Ventilation (3.3.7.2)

• It is recommended that a decontamination area be under negative pressure in relation to the adjoining rooms, whereas the clean area should be under positive pressure.

  Yes

  No

  N/A

  Not Observed

• If separate rooms are available, the decontamination area should be designed so that air flows into the area (negative pressure), with a minimum of 10 air exchanges per hour, and so that all air is exhausted to the outside atmosphere via a non-recirculating system.

  Yes

  No

  N/A

  Not Observed

• A designated clean area should be provided with positive air pressure with at least 10 air exchanges per hour.

  Yes

  No

  N/A

  Not Observed

• The ventilation system should be designed to provide at least 10 air exchanges per hour to minimize air contaminants.

  Yes

  No

  N/A

  Not Observed

• For separated room areas, air should flow from areas of positive pressure to areas of negative pressure.

  Yes

  No

  N/A

  Not Observed

• Duct covers or grids should be cleaned regularly and filters should be changed on a scheduled basis according to the<br>manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Neither fixed nor portable fans should be permitted in the processing area, with the exceptions of exhaust fans on ventilation systems and installed and operated fume control hoods.

  Yes

  No

  N/A

  Not Observed

Hand Hygiene (3.3.9) & (4.5)

• Hand hygiene facilities (i.e., sink, soap dispenser, towel dispenser, or alcohol-based hand rub dispensers) should be conveniently located and designed to allow good hand hygiene practices.

  Yes

  No

  N/A

  Not Observed

• The hand hygiene sink should be separate from the sink used to clean endoscopes.

  Yes

  No

  N/A

  Not Observed

• Hand hygiene facilities should be located in or near all areas where endoscopes and other devices are decontaminated and in the clean area where endoscopes are high-level disinfected or sterilized.

  Yes

  No

  N/A

  Not Observed

• Fingernails should be kept short and clean and should not extend beyond the fingertips.

  Yes

  No

  N/A

  Not Observed

• Artificial nails, including gels, extensions or tips, acrylic overlays, or other enhancements should not be worn (AORN, 2015c).

  Yes

  No

  N/A

  Not Observed

Emergency eyewash/shower equipment (3.3.10)

• The American National Standards Institute (ANSI) has established minimum performance criteria for eyewash units (ANSI Z358.1). ANSI Z358.1 requires that eyewash units provide a minimum of 0.4 gallons per minute continuously for at least 15 minutes, that they be designed to flush both eyes simultaneously, and that they have a "hands-free, stay open" feature once activated. Under the ANSI standard, drench hoses or eyewash bottles are not acceptable emergency eyewash units.

• Suitable eyewash units must be available for immediate emergency use in all places where chemicals are used.

  Yes

  No

  N/A

  Not Observed

• Eyewash stations should be located so that travel time is no greater than 10 seconds from the location of chemical use or storage, or immediately next to or adjoining the area of chemical use or storage, if the chemical is caustic or a strong acid.

  Yes

  No

  N/A

  Not Observed

• Eyewash stations should be located on the same level as the hazard with the path of travel free of obstructions (e.g., doors) that may inhibit immediate use of the eyewash station (ANSI Z358).

  Yes

  No

  N/A

  Not Observed

• For a strong acid or strong caustic, the eyewash unit should be immediately adjacent to the hazard.

  Yes

  No

  N/A

  Not Observed

• Plumbed eyewashes/ facewashes and showers should be activated weekly for a period long enough to verify operation and ensure that the flushing solution is available.

  Yes

  No

  N/A

  Not Observed

• When activating plumbed eyewashes, eye/facewashes, and showers, personnel should also verify that they are providing lukewarm, tepid water (between 15°C and 43°C [60°F and 100°F]). (ANSI Z358.1).

  Yes

  No

  N/A

  Not Observed

• Routine testing should be documented.

  Yes

  No

  N/A

  Not Observed

Environmental Cleaning (3.3.11)

• Environmental cleaning and disinfection procedures in areas used for any aspect of decontamination, preparation, or sterilization should ensure a high level of cleanliness at all times.

  Yes

  No

  N/A

  Not Observed

• Floors and horizontal work surfaces should be cleaned at least daily.

  Yes

  No

  N/A

  Not Observed

• Other surfaces, such as walls, storage shelves, endoscope storage cabinets, and air intake and return ducts, should be cleaned on a regularly scheduled basis and more often if needed (AORN, 2015b).

  Yes

  No

  N/A

  Not Observed

• Stained ceiling tiles should be replaced, and any leaks causing the stains should be repaired.

  Yes

  No

  N/A

  Not Observed

• Care should be taken to avoid contaminating patient-ready devices such as endoscopes or compromising the integrity of packaging during cleaning.

  Yes

  No

  N/A

  Not Observed

• Special attention should be paid to the sequence of cleaning to avoid<br>transferring contaminants from “dirty” to “clean” areas and surfaces.

  Yes

  No

  N/A

  Not Observed

Education, training, and competency verification (4.3)

• It is recommended that all personnel performing processing of endoscopes be certified as a condition of employment. At a minimum, personnel should complete a certification exam.

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties upon initial hire; annually; at designated intervals; or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

  Yes

  No

  N/A

  Not Observed

• Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include procedures for cleaning, disinfecting or sterilizing, packaging, and storing each specific endoscope make and model, including equipment connections.

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include identification of items that are single-use and discarded after use.

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include all aspects of decontamination (e.g., disassembly, manual and mechanical cleaning methods and how to monitor their effectiveness, microbiocidal processes, equipment operation, standard precautions, and engineering and work practice controls).

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include the operation of the specific manual and mechanical cleaning processes and equipment, manual and mechanical high-level disinfection processes, and, if applicable, sterilizing system(s) used by the health care facility, and the methods used to verify operation.

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include facility and processing area policies and procedures regarding sterilization and high-level disinfection, infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations.

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing, high-level disinfection, and sterilization.

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include the process of leak testing when indicated on the manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Education and training of processing personnel should include documentation of quality monitoring results.

  Yes

  No

  N/A

  Not Observed

• Competency verification activities should include monitoring processing personnel for their compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility

  Yes

  No

  N/A

  Not Observed

• Competency verification activities should include monitoring processing personnel for their level of proficiency in processing procedures.

  Yes

  No

  N/A

  Not Observed

• Education, training, and competency verification activities should be provided and documented for all processing personnel on procedures for processing of all endoscopes, and use of all AERs and sterilizers used at the facility.

  Yes

  No

  N/A

  Not Observed

Standard Precautions (4.4)

• Precautions should be taken to prevent injuries from sharp objects (e.g., needles, scalpels, broken glass).

  Yes

  No

  N/A

  Not Observed

• Sharp objects should be placed in puncture-resistant containers.

  Yes

  No

  N/A

  Not Observed

• PPE should be used to prevent exposure to blood or body fluids.

  Yes

  No

  N/A

  Not Observed

• Hands and other skin surfaces that are contaminated with potentially infectious fluids should be immediately and thoroughly washed.

  Yes

  No

  N/A

  Not Observed

• Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure to chemical or biological materials.

  Yes

  No

  N/A

  Not Observed

• Food and drink should not be kept in refrigerators, freezers, or cabinets or on shelves, countertops, or benchtops where blood or other potentially infectious materials are present.

  Yes

  No

  N/A

  Not Observed

• Employees should receive education, training, and complete competency verification activities on bloodborne pathogens.

  Yes

  No

  N/A

  Not Observed

Attire (4.6)

• All personnel entering the processing area should change into clean uniforms that are provided by and donned at the facility.

  Yes

  No

  N/A

  Not Observed

• Attire should be changed daily or more often as needed (i.e., when wet, grossly soiled, or visibly contaminated with blood or other bodily fluids).

  Yes

  No

  N/A

  Not Observed

• Reusable uniforms should be laundered by a health care-accredited laundry (ANSI/AAMI ST65, AORN, 2015d).

  Yes

  No

  N/A

  Not Observed

• All head and facial hair (except for eyebrows and eyelashes) should be completely covered with a surgical-type hair covering.

  Yes

  No

  N/A

  Not Observed

• Jewelry and wristwatches should not be worn in the processing area.

  Yes

  No

  N/A

  Not Observed

• Shoes worn in the processing area should be clean, have non-skid soles, and be sturdy enough to prevent injury if an item drops on the foot. Liquid-resistant shoe covers should be worn if there is potential for shoes becoming contaminated and/or soaked with blood or other bodily fluids (OSHA 29 CFR 1910.1030).

  Yes

  No

  N/A

  Not Observed

• The use of cover apparel when employees leave the area to travel to other areas of the health care facility should be determined by each facility and should comply with state and local regulations.

  Yes

  No

  N/A

  Not Observed

• Employees should change into street clothes when they leave the health care facility or when traveling between buildings located on separate campuses.

  Yes

  No

  N/A

  Not Observed

Personal Protective Equipment (PPE) (4.6.2)

• Personnel working in the decontamination area should wear general-purpose utility gloves and a liquid-resistant covering with sleeves (for example, a backless gown or surgical gown).

  Yes

  No

  N/A

  Not Observed

• Processing personnel should use a style of glove that prevents contact with contaminated water. Gloves that are too short, do not fit tightly at the wrist, or lack cuffs might allow water to enter when the arms move up and down. Exam gloves should not be used for decontamination. General purpose utility gloves fitted at the wrist or above should be used.

  Yes

  No

  N/A

  Not Observed

• In situations that require the highest level of protection (e.g., there is a possibility that attire can become soaked with blood or other potentially infectious material, as when items are being washed by hand), a Level 4 gown (as defined by ANSI/AAMI PB70) should be used.

  Yes

  No

  N/A

  Not Observed

• PPE should also include a fluid-resistant face mask and eye protection. PPE used to protect the eyes from splash could include goggles, full-length face shields, or other devices that prevent exposure to splash from all angles.

  Yes

  No

  N/A

  Not Observed

• Reusable gloves, glove liners, aprons, and eye-protection devices should be decontaminated, according to the manufacturer’s written IFU, at least daily and between employees. If integrity is compromised, items should be discarded. Remove torn gloves and thoroughly wash hands before donning new gloves.

  Yes

  No

  N/A

  Not Observed

• PPE worn during processing should be removed and hands should be washed.

  Yes

  No

  N/A

  Not Observed

• Before handling disinfected endoscopes, personnel should don clean PPE.

  Yes

  No

  N/A

  Not Observed

• Before leaving the cleaning area, employees should remove all protective attire, being careful not to contaminate the clothing beneath or their skin, and wash their hands. Designated areas, with the necessary containers, should be provided for donning and removing protective attire.

  Yes

  No

  N/A

  Not Observed

• Comments:

Precleaning at the point of use (5.2)

• To prevent buildup of bioburden, development of biofilms, and drying of secretions, precleaning should take place at the point of use immediately following the procedure. It is imperative that the written IFU from the endoscope, AER, and cleaning solution manufacturers are followed.

• Before the endoscope is detached from the light source and/or video processor Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor Prepare a cleaning solution according to the solution manufacturer's written IFU. Some endoscope manufacturers prescribe the use of potable water as the sole precleaning agent.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor Wipe the insertion tube with a wet, low-linting or non-linting cloth or sponge soaked in the freshly prepared cleaning solution as soon as possible after the endoscope is removed from the patient or the procedure is completed. Ensure that all endoscope controls are in the free and unlocked position. The cloth or sponge should be single use and disposed of after use.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor Suction the solution through the suction/biopsy channel as indicated in the endoscope manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor flush the air/water channels with solution using the endoscope's cleaning adapter or by IFU-instructed air/water flow.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor: if present, flush other channels (e.g., auxiliary water or elevator channels) with solution.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor: Flush with the minimally prescribed volume of solution and ensure that the channels are not blocked.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor: Place the distal end of the endoscope in the cleaning solution and suction the solution through the endoscope until clear.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor: Detach the endoscope from the light source and suction pump.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor: Attach a fluid-resistant cap over any electrical components, if applicable.

  Yes

  No

  N/A

  Not Observed

• Before the endoscope is detached from the light source and/or video processor: Visually inspect the endoscope for damage.

  Yes

  No

  N/A

  Not Observed

Transporting used endoscopes (5.3)

• The system should be marked with a biohazard label and must meet OSHA (29 CFR 1910.1030) requirements for transporting hazardous items. The system should be large enough to accommodate a single endoscope without the need to over-coil the insertion or light guide tubes.

• Isolate and immobilize a single endoscope in a container by naturally coiling it in large loops.

  Yes

  No

  N/A

  Not Observed

• Separate endoscopy accessories from the contaminated endoscope to prevent puncture and penetration damage.

  Yes

  No

  N/A

  Not Observed

Leak Testing (5.4)

• Leak testing should be performed as soon as possible after the endoscope arrives in the processing area and before immersion of the endoscope into processing solutions.

  Yes

  No

  N/A

  Not Observed

• Personnel performing the leak testing should wear PPE.

  Yes

  No

  N/A

  Not Observed

• Prior to leak testing, the fluid-resistant cap should be applied, if indicated in the manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• The largest surface counter or sink area available should be used to accommodate an open, minimally coiled endoscope for the test. (Over-coiling can mask a hole and allow it go<br>undetected.) A well-lighted work surface should also be provided.

  Yes

  No

  N/A

  Not Observed

Manual (dry) leak testing (5.4.2)

• Follow the written IFU from the endoscope and leak tester manufacturers. Generally, these steps are recommended:

• Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Remove all valves and biopsy port covers, keeping them with the scope throughout the process.

  Yes

  No

  N/A

  Not Observed

• Attach the leak tester

  Yes

  No

  N/A

  Not Observed

• Pressurize the endoscope to the indicated pressure on the leak tester gauge.

  Yes

  No

  N/A

  Not Observed

• Place the endoscope in a loose configuration.

  Yes

  No

  N/A

  Not Observed

• Gently rotate each directional knob and elevator control while watching for changes in the established pressure.

  Yes

  No

  N/A

  Not Observed

• Massage video or remote switches in a circular manner to more readily detect holes in these components.

  Yes

  No

  N/A

  Not Observed

• Maintain pressure and inspection for a minimum of 30 seconds.

  Yes

  No

  N/A

  Not Observed

• Release air pressure from the endoscope before removal of the leak testing unit.

  Yes

  No

  N/A

  Not Observed

• If the endoscope is water-tight, proceed with cleaning and disinfection processes.

  Yes

  No

  N/A

  Not Observed

• Document outcome of leak test.

  Yes

  No

  N/A

  Not Observed

Mechanical(wet) Leak Testing (5.4.3)

• Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Remove all valves and biopsy port covers, keeping them with the scope throughout the process.

  Yes

  No

  N/A

  Not Observed

• Attach the leak tester.

  Yes

  No

  N/A

  Not Observed

• Turn the air compressor on and pressurize the endoscope.

  Yes

  No

  N/A

  Not Observed

• Establish pressurization by confirming that the bending rubber has expanded.

  Yes

  No

  N/A

  Not Observed

• Place the endoscope in a loose configuration in a large sink with a sufficient volume of clean water to completely immerse it.

  Yes

  No

  N/A

  Not Observed

• Completely flush all channels with water to remove trapped air.

  Yes

  No

  N/A

  Not Observed

• Gently rotate each directional knob and elevator control, looking for bubbles at the bending rubber as well as at the knobs.

  Yes

  No

  N/A

  Not Observed

• Massage video or remote switches in a circular manner to challenge the integrity of these components while looking for bubbles.

  Yes

  No

  N/A

  Not Observed

• Manipulate the insertion tube and light guide tube, if applicable, to uncover hidden leaks due to the position of the coiled endoscope.

  Yes

  No

  N/A

  Not Observed

• Perform a complete visual inspection of the endoscope for leaks. If static bubbles are attached to the endoscope, brush them away and inspect to ensure that bubbles do not return.

  Yes

  No

  N/A

  Not Observed

• Maintain pressure and inspection for a minimum of 30 seconds.

  Yes

  No

  N/A

  Not Observed

• Remove the entire endoscope from the test water.

  Yes

  No

  N/A

  Not Observed

• Stop pressurization by turning off the air supply.

  Yes

  No

  N/A

  Not Observed

• According to the manufacturer's written IFU, remove the leak tester from the air compressor and listen for the sound of evacuated air.

  Yes

  No

  N/A

  Not Observed

• If the endoscope is water tight, proceed with cleaning and disinfection processes.

  Yes

  No

  N/A

  Not Observed

• Document outcome of leak test.

  Yes

  No

  N/A

  Not Observed

Mechanical (dry) leak testing (5.4.4)

• Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Prepare automated leakage tester and tubes.

  Yes

  No

  N/A

  Not Observed

• As applicable, power on printer.

  Yes

  No

  N/A

  Not Observed

• Power on automated leakage tester.

  Yes

  No

  N/A

  Not Observed

• Position the endoscope(s) for leakage testing as prescribed by the manufacturer.

  Yes

  No

  N/A

  Not Observed

• Ensure fluid-resistant caps are attached to the endoscope, as applicable.

  Yes

  No

  N/A

  Not Observed

• Connect leakage tester tubes to endoscope(s).

  Yes

  No

  N/A

  Not Observed

• Scan or enter user and endoscope information.

  Yes

  No

  N/A

  Not Observed

• Select start and allow automated leakage tester cycle to complete.

  Yes

  No

  N/A

  Not Observed

• If the endoscope receives a pass indication, proceed with cleaning and disinfection processes.

  Yes

  No

  N/A

  Not Observed

• If the endoscope receives a failure indication, proceed with immersion leakage testing in the manual leakage testing mode as prescribed by the manufacturer to determine the leakage area. Once the leakage area is determined, follow the manufacturer’s written IFU for processing a leaking endoscope.

  Yes

  No

  N/A

  Not Observed

• Document results upon completion of leak test or at intervals as determined by facility guidelines.

  Yes

  No

  N/A

  Not Observed

Mechanical leak testing using an AER (5.4.5)

• Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Follow the endoscope and AER manufacturers' written IFU.

  Yes

  No

  N/A

  Not Observed

• Document outcome of leak test.

  Yes

  No

  N/A

  Not Observed

Leak Test Failures (5.4.6)

• If a leak has been identified, follow the modified processing steps according to the endoscope manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Ensure pressure is maintained on the endoscope throughout the modified process.

  Yes

  No

  N/A

  Not Observed

• Re-evaluate the leak testing process if fluid invasion is a reccurring problem.

  Yes

  No

  N/A

  Not Observed

Manual Cleaning (5.5)

• Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Prepare fresh cleaning solution for each endoscope according to the solution manufacturer's written IFU for temperature, if applicable; concentration; and water quality. The temperature of the cleaning solution should be monitored and documented.

  Yes

  No

  N/A

  Not Observed

• Place the endoscope in the solution, keeping it below the fluid’s surface level at all times.

  Yes

  No

  N/A

  Not Observed

• Clean the endoscope’s exterior surfaces with a single-use lint-free cloth or sponge.

  Yes

  No

  N/A

  Not Observed

• Clean all valve cylinders, openings, and forceps elevator housings with a cleaning brush of the length, width, and material designated in the endoscope manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Endoscope valves need to be manually actuated to ensure coverage of all internal parts.

  Yes

  No

  N/A

  Not Observed

• Brush all channels according to the endoscope manufacturer’s written IFU until there is no visual debris.

  Yes

  No

  N/A

  Not Observed

• Cleaning brushes should either be single use and disposed of or reusable and receive high-level disinfection or sterilization after each use, according to their written IFU.

  Yes

  No

  N/A

  Not Observed

• Attach a model-specific cleaning adapter, flush channels, and allow for solution exposure according to the solution manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Flush all channels according to the endoscope manufacturer's written IFU and rinse exterior surfaces with potable water until all cleaning solution is visibly removed. Some cleaning solutions may require multiple rinses in fresh water.

  Yes

  No

  N/A

  Not Observed

• Purge all channels with air.

  Yes

  No

  N/A

  Not Observed

• Repeat cleaning, brushing, and rinsing steps until there is no visible debris or solution residual.

  Yes

  No

  N/A

  Not Observed

• Endoscopes that have been exposed to synthetic lipids or radiographic medium may require additional cleaning.

• Soak, scrub, brush, and rinse all reusable and removable parts (valves, buttons, port covers, tubing).

  Yes

  No

  N/A

  Not Observed

• Clean reusable endoscopy accessories (e.g., forceps, wires, baskets) according to their written IFU.

  Yes

  No

  N/A

  Not Observed

Automated Flushing System (Scope Buddy or EndoFlush)

• Personnel should follow the manufacturer’s written IFU and ensure that it is compatible with the endoscope being processed.

  Yes

  No

  N/A

  Not Observed

• Fresh solution should be used with each endoscope. All connections should be secured.

  Yes

  No

  N/A

  Not Observed

• The connection tubing and equipment should be cleaned and disinfected according to the manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Any quality assurance testing recommended by the manufacturer (e.g., daily volume verification) should be performed and documented.

  Yes

  No

  N/A

  Not Observed

Manual Rinsing (5.6)

• After cleaning the endoscope, removed components and accessories should be thoroughly rinsed with copious amounts of potable water (see AAMI TIR34) to help ensure all cleaning solutions and loosened debris are removed. Follow the endoscope manufacturer's and cleaning solution manufacturer’s written IFU for the amount of water and psi and/or pressure needed to flush through each channel and number of rinses.

• Using the cleaning adaptors provided by the manufacturer, ensure adequate flow of potable water through each lumen.

  Yes

  No

  N/A

  Not Observed

• Rinse all exterior endoscope surfaces with freely flowing potable water.

  Yes

  No

  N/A

  Not Observed

• Purge channels with air using a syringe to evacuate residual rinse water. If compressed air is used, it should be oil-free and used at a pressure not to exceed that recommended by the endoscope manufacturer.

  Yes

  No

  N/A

  Not Observed

• Rinse all valves and other removable components according to the manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Dry the exterior of the endoscope with a lint-free cloth or sponge.

  Yes

  No

  N/A

  Not Observed

• After cleaning, all detachable valves should be kept together with the same endoscope as a unique set.

  Yes

  No

  N/A

  Not Observed

High-Level Disinfection and liquid chemical sterilization (5.7)

Manual liquid chemical sterilization/high-level disinfection (5.7.4)

Disinfection (5.7.4.1)

• Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Use a closed container, labeled with a biohazard symbol or sticker that meets OSHA requirements, of sufficient capacity to completely immerse the endoscope in the LCS/HLD solution.

  Yes

  No

  N/A

  Not Observed

• Prepare LCS/HLD solution according to the manufacturer's written IFU, noting the type, date of preparation, date of use, and expiration date.

  Yes

  No

  N/A

  Not Observed

• Test the MRC before each use with the disinfectant-specific (by type and concentration) test strip. Follow the label directions for the test strip. Document results.

  Yes

  No

  N/A

  Not Observed

• Immerse the prepared endoscope and its removable components into the LCS/HLD solution, maintaining a loose coil.

  Yes

  No

  N/A

  Not Observed

• Follow the endoscope manufacturer’s written IFU for filling channels with the LCS/HLD solution.

  Yes

  No

  N/A

  Not Observed

• Follow the LCS/HLD solution manufacturer's written IFU for contact time, and temperature. Monitor process with a timer and thermometer and document.

  Yes

  No

  N/A

  Not Observed

• Document operator, date, time, make, and model of endoscope placed in solution.

  Yes

  No

  N/A

  Not Observed

• Document operator, date, and time endoscope is removed from solution.

  Yes

  No

  N/A

  Not Observed

Manual Rinsing (5.7.4.2)

• Don fresh PPE, including gloves and skin and eye protection.

  Yes

  No

  N/A

  Not Observed

• Thoroughly rinse all surfaces and channels of the endoscope and its removed components according to the endoscope and LCS/HLD solution manufacturers' written IFU in order to remove all traces of the disinfectant.

  Yes

  No

  N/A

  Not Observed

• Use fresh water for each rinse (do not reuse the rinse water if multiple rinses are specified in the IFU). Follow the device manufacturer's written IFU for the specified rinse water quality.

  Yes

  No

  N/A

  Not Observed

Manual drying (5.7.4.3)

• Drying can be achieved by flowing air through all endoscopes channels for a specified period of time.

  Yes

  No

  N/A

  Not Observed

• Drying should be facilitated by using 70–80% ethyl or isopropyl alcohol. When using alcohol, personnel should follow the<br>manufacturer’s written IFU on the volume of alcohol and method to be used for each endoscope lumen and ensure any remaining alcohol is removed with medical-grade forced air until no visual signs of moisture remain (or as otherwise recommended by the endoscope manufacturer).

  Yes

  No

  N/A

  Not Observed

Automated Endoscope Reprocessor Considerations

• Machine should ensure that recommended pressure of fluids and air is achieved through channel sensors.

  Yes

  No

  N/A

  Not Observed

• Rinse cycles should follow the cleaning and liquid chemical sterilization/high-level disinfection cycles and then be followed by an automatic air purge to remove any fluids.

  Yes

  No

  N/A

  Not Observed

• Machine should have a self-disinfection cycle.

  Yes

  No

  N/A

  Not Observed

• Drying and/or alcohol flush cycle capabilities.

  Yes

  No

  N/A

  Not Observed

• Machine should have a clogged or dirty filter alarm.

  Yes

  No

  N/A

  Not Observed

• Whether compatible adaptors have been validated with specific endoscopes and are indicated in the AER manufacturer's written IFU.

  Yes

  No

  N/A

  Not Observed

• Data verification of each cycle performed, such as a print record, should be available.

  Yes

  No

  N/A

  Not Observed

Storage of reprocessed endoscopes (10.0)

• The endoscope should be hung vertically with the distal tip hanging freely in a well-ventilated, clean area, following, the endoscope manufacturer’s written IFU for storage.

  Yes

  No

  N/A

  Not Observed

• The insertion tube hangs<br>vertically and is as straight as possible (no bends).

  Yes

  No

  N/A

  Not Observed

• If the scope has an angulation lock, it should be in the open position while in storage.

  Yes

  No

  N/A

  Not Observed

• There should be sufficient space between and around scopes to prevent them hitting into one another, which can cause damage to the scopes.

  Yes

  No

  N/A

  Not Observed

• All removable parts (e.g., valves and caps) should be detached from the endoscope.

  Yes

  No

  N/A

  Not Observed

• AORN (2015e) recommends that flexible and semi-rigid endoscopes should be stored in a closed cabinet with venting that allows air circulation around the endoscopes, internal surfaces composed of cleanable material, adequate height to allow endoscopes to hang without touching the bottom of the cabinet, and sufficient space for storage of multiple endoscopes without touching.

  Yes

  No

  N/A

  Not Observed

• A tag or label is affixed to the endoscope after it has been processed and before it is placed in the storage cabinet.

  Yes

  No

  N/A

  Not Observed

• The tag should be labeled with the following information:<br>a) Date of processing<br>b) Name(s) of person(s) who performed the processing<br>c) Date of high-level disinfection

  Yes

  No

  N/A

  Not Observed

Storage of high-level disinfected endoscopes (10.2)

• Before storage, the channel of the high-level disinfected endoscope should be dry to help prevent bacterial growth and the formation of biofilm.

  Yes

  No

  N/A

  Not Observed

• The endoscope should hang in a way to prevent damage to the scope and prevent the formation of moisture.

  Yes

  No

  N/A

  Not Observed

• Special care should be taken to avoid coiling of any part of the endoscope to reduce chances of any droplets forming within the channels.

  Yes

  No

  N/A

  Not Observed

• Endoscopes should be stored suspended vertically in a way to allow circulation of air.

  Yes

  No

  N/A

  Not Observed

• Endoscopes should hang freely.

  Yes

  No

  N/A

  Not Observed

• Caps, valves and other detachable components should not be installed on the endoscope during storage.

  Yes

  No

  N/A

  Not Observed

• Detachable parts that are to be reused (e.g., air/water and suction valves/pistons) should be processed together and stored with the specific endoscope as a unique set in order to allow traceability.

  Yes

  No

  N/A

  Not Observed

• Valves should be dried and lubricated according to the manufacturer’s written IFU.

  Yes

  No

  N/A

  Not Observed

• Each scope should be identified with a tag or other means so that when it is pulled from storage, the user is able to verify that the scope has been processed and is ready for use.

  Yes

  No

  N/A

  Not Observed

Storage of sterilized endoscopes (10.3)

• Sterilized endoscopes should be stored in the container or packaging in which they were sterilized.

  Yes

  No

  N/A

  Not Observed

• Agreement should be made between the user and the sterile processing area on a maximum shelf life for the sterilized endoscope.

  Yes

  No

  N/A

  Not Observed

• Endoscopes must be reprocessed not less than every 14 days.

  Yes

  No

  N/A

  Not Observed

• Comments: