Reprocessing Flexible GI Endoscopes

Publication Date: February 1, 2017
Last Updated: March 14, 2022

Recommendations

All healthcare personnel in the endoscopy suite should be trained in and comply with standard infection prevention and control recommendations (eg, standard precautions), including those to protect both patients and healthcare workers. (IA)
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Precleaning should be performed at the point of use, before bioburden has an opportunity to dry, and before comprehensive decontamination. Point of use precleaning should remove visible debris by wiping the exterior of the endoscope with appropriate detergent solution and aspiration of a large volume of detergent solution through the air/water and biopsy channels. (IB)
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After point-of-use precleaning, transport the soiled endoscope to the reprocessing area for subsequent steps in high-level decontamination before remaining soil has an opportunity to dry. During transportation, soiled endoscopes should be contained in a manner to prevent exposure of staff, patients, or the environment to potentially infectious organisms. An open container can suffice for transport to immediately adjacent reprocessing rooms, but fully enclosed and labeled containers or bags should be used for transportation through corridors used for other patients, staff, or visitors to reprocessing areas. AORN provides additional guidance on this issue. (II)
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Perform pressure/leak testing after each use and before formal reprocessing, according to manufacturer guidelines. (IB)
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Before manual or automated HLD, meticulously clean the entire endoscope, including valves, channels, connectors, and all detachable parts using only model-specific cleaning devices (such as brushes) designed for the endoscope model being cleaned. Manual cleaning should occur within the manufacturer’s recommended time frame. When cleaning is delayed beyond this interval, the manufacturer’s directions for delayed processing should be followed. Strict compliance with manufacturer’s guidance must be maintained, particularly for endoscopes with movable mechanisms such as the distal tip elevator present on duodenoscopes and linear US endoscopes. Disconnect and disassemble endoscope components (eg, air/water and suction valves) and completely immerse the endoscope and components in an appropriate detergent that is compatible with the endoscope, according to the manufacturer’s instructions. Flush and brush all accessible channels to remove all organic (eg, blood or tissue) and other residues. Repeatedly actuate the valves during cleaning to facilitate access to all surfaces. Clean the external surfaces and components of the endoscope using a soft cloth, a sponge, or brushes. (IB)
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Use brushes appropriate for the size of the endoscope channel, parts, connectors, and orifices (eg, bristles should contact all surfaces) for cleaning. All brushes should be appropriately sized for the part of the endoscope being brushed and should be approved for this use by the endoscope manufacturer. Cleaning items should be disposable or thoroughly cleaned and disinfected between uses. (II)
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Discard enzymatic detergents after each use, because these products are not microbicidal and will not retard microbial growth. (IB)
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Reusable endoscopic accessories (eg, biopsy forceps or other cutting instruments) that break the mucosal barrier should be mechanically cleaned as described above and then sterilized between each patient use (HLD is not appropriate). Reprocessing of single-use items should not be performed except according to FDA guidance. (IA)
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Ultrasonic cleaning of reusable endoscopic accessories and endoscope components may be used to remove soil and organic material from hard-to-clean areas. (II)
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Endoscopes (and accessories) that come in contact with mucous membranes are classified as semicritical items and should receive at least HLD after each patient use. (IA)
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There are new high-level disinfectants and agent-specific machines in the marketplace. Information regarding these technologies should be obtained from the FDA website and independent peer-reviewed publications. Use a high-level disinfectant and compatible reprocessing machine cleared by the FDA for their respective HLD claims (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/ucm437347.htm). (IA)
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The exposure time and temperature for disinfecting semicritical patient care equipment varies among the FDA-cleared high-level disinfectants. Follow the FDA-cleared label claims for HLD. (IA)
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Select a liquid disinfectant or sterilization technology that is compatible with the endoscope. The use of specific high-level disinfectants or sterilization technologies on an endoscope should be avoided if the endoscope manufacturer warns against use because of functional damage (with or without cosmetic damage). (IB)
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The selection and use of disinfectants in the healthcare field is dynamic, and products may become available that were not in existence when this guideline was written. As newer disinfectants become available, persons or committees responsible for selecting disinfectants for GI endoscope reprocessing should be guided by FDA clearance of these products and by information in the scientific literature. (II)
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Completely immerse the endoscope and its components in the HLD solution and ensure that all channels are perfused. Nonimmersible GI endoscopes should not be used. (IB)
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HLD can be performed in an automated endoscope reprocessor (AER) or using manual processes. Use of an AER is advisable and should be adopted when feasible. When an AER is used, ensure that the endoscope and endoscope components can be effectively reprocessed in the AER (eg, the elevator wire channel of duodenoscopes is not effectively disinfected by most AERs, and this step should be performed manually). Users should obtain and review FDA-cleared model-specific reprocessing protocols from both the endoscope and the AER manufacturers and check for compatibility. (IB)
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If an AER is used, place the endoscope and endoscope components in the reprocessor and attach all channel connectors according to the AER and endoscope manufacturers’ instructions to ensure exposure of all internal surfaces with the high-level disinfectant solution. Only approved connectors should be used. (IB)
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If an AER cycle is interrupted, HLD or sterilization cannot be ensured. Therefore, the cycle should be repeated. (II)
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Because design flaws have compromised the effectiveness of AERs and can also involve endoscopes, the infection prevention staff should routinely review and document their attention to FDA advisories, manufacturer alerts, and the scientific literature for reports of endoscope and AER deficiencies that may lead to infection. (II)
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After HLD, rinse the endoscope and flush the channels with sterile or filtered water to remove the disinfectant solution. Discard the rinse water after each use/cycle. Flush the channels with 70% to 90% ethyl or isopropyl alcohol and dry using filtered forced air. The final drying steps greatly reduce the risk of remaining pathogens and the possibility of recontamination of the endoscope by waterborne microorganisms. Some organizations stipulate use of “instrument air,” which is further characterized relative to humidity, vapors, and so on. (IA)
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Visually inspect both endoscopes and reusable accessories frequently in the course of their use and reprocessing, including before, during, and after use as well as during and after cleaning and before HLD. Manual cleaning of complex endoscope components, such as elevators, requires optimal lighting and may be facilitated by magnification. Damaged endoscopes and accessories should be removed from use for repair or disposal. (II)
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When storing the endoscope, hang it in a vertical position to facilitate drying (with caps, valves, and other detachable components removed as per manufacturer instructions). (II)
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Endoscopes should be stored in a manner that will protect them from contamination. In the absence of data linking infection outbreaks to transport or storage and given the limited data on this issue, equipment and practices for storage and equipment for transport should be addressed at the facility level in conjunction with the infection prevention department or consultants. (II)
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Beyond the reprocessing steps discussed in these recommendations, no validated methods for additional duodenoscope reprocessing currently exist. However, units should review and consider the feasibility and appropriateness for their practice of using 1 or more of the additional modalities suggested by the FDA for duodenoscopes: intermittent or per procedure culture surveillance of reprocessing outcomes, sterilization with ethylene oxide gas, repeat application of standard HLD, or use of a liquid chemical germicide. (II)
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Although reuse of endoscopes within 21 days of HLD appears to be safe, the data are insufficient to proffer a maximal outer duration for use of appropriately cleaned, reprocessed, dried, and stored flexible endoscopes. This interval remains poorly defined and warrants further study. As noted in the discussion above, some organizations advise shorter intervals. (NR)
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Use HLD or sterilize the water bottle (used for cleaning the lens and irrigation during the procedure) and its connecting tube at least daily. Sterile water should be used to fill the water bottle. (IB)
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Maintain a log for each procedure indicating the patient’s name and medical record number (if available), the procedure and serial number or other identifier of the endoscope (and AER, if used), the date and type of the procedure, along with the name of the person performing the cleaning and HLD/sterilization process to assist in an outbreak investigation. Logs for transmission identification and reporting should include identifiers and use of specific loaner endoscopes that may be added to local inventories on a temporary basis. (II)
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Perform routine testing of the liquid HLD to ensure at least the minimum effective concentration of the active ingredient. Check the solution at the beginning of each day of use (or more frequently in accordance with manufacturer’s guidelines) and document the results. If the chemical indicator shows that the concentration is less than the minimal effective concentration, the solution should be discarded. (IA)
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Discard the liquid HLD at the end of its reuse life (which may be single use), regardless of the minimal effective concentration. If additional liquid HLD is added to an AER (or basin, if manually disinfected), the reuse life should be determined by the first use/activation of the original solution (ie, the practice of “topping off” of a liquid HLD pool does not extend its reuse life). (IB)
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Facilities where endoscopes are used and disinfected should be designed to provide a safe environment for healthcare workers and patients. Eyewash stations should be available to reprocessing staff using caustic chemicals. Eyewash stations should not be placed on sinks used for washing or soaking soiled endoscopes. Air exchange equipment (eg, ventilation system and exhaust hoods) should be used to minimize the exposure of all persons to potentially toxic vapors (eg, glutaraldehyde). The vapor concentration of the chemical disinfectant used should not exceed allowable limits (eg, those of the American Conference of Governmental Industrial Hygienists and the Occupational Safety and Health Administration). Although organic vapor respirators appropriate for chemical exposures can provide respiratory protection (eg, in the event of spills), they are not intended for routine use and are not a substitute for adequate ventilation, vapor recovery systems, and work practice controls. ()
(Category IB and IC)
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Reprocessing facilities should be designed with attention to the optimal flow of personnel, endoscopes, and devices to avoid contamination between entering dirty instruments and reprocessed clean instruments. Reprocessing of endoscopes (other than immediate precleaning) should not be performed in patient care areas because of risk of patient exposure to contaminated surfaces and devices. ()
(Category IC and II)
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Personnel assigned to reprocess endoscopes should receive device-specific reprocessing instructions (ie, endoscope and/or AER manufacturer, as needed) to ensure proper cleaning and HLD or sterilization. Competency testing of personnel that reprocess endoscopes should be performed and documented on a regular basis (eg, commencement of use, at least annually, any time a breach is identified, when a major technique or new endoscope or reprocessing equipment is introduced, and in the context of local quality control efforts). Training and competency testing should include recognition of excessive wear or damage to instruments. Temporary personnel should not be allowed to reprocess endoscopes until competency has been established. (IA)
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Personnel assigned to reprocess endoscopes should receive device-specific reprocessing instructions (ie, endoscope and/or AER manufacturer, as needed) to ensure proper cleaning and HLD or sterilization. Competency testing of personnel that reprocess endoscopes should be performed and documented on a regular basis (eg, commencement of use, at least annually, any time a breach is identified, when a major technique or new endoscope or reprocessing equipment is introduced, and in the context of local quality control efforts). Training and competency testing should include recognition of excessive wear or damage to instruments. Temporary personnel should not be allowed to reprocess endoscopes until competency has been established. (IC)
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Personal protective equipment (eg, gloves, gowns, eyewear, and respiratory protection devices) should be readily available and should be used, as appropriate, to protect workers from exposure to chemicals, blood, or other potentially infectious material. (IC)
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Healthcare facilities should ensure that users can readily identify whether and when an endoscope has been reprocessed. (II)
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The use of routine environmental microbiologic testing of endoscopes for quality assurance has not been established but warrants further study. (NR)
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If environmental microbiologic testing is performed, standard microbiologic techniques per CDC guidance should be used. (II)
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Reprocessing of nonendoscopic devices, accessories, and attachments should adhere to manufacturers’ recommendations. ()
(Category IC and II)
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Standard infection prevention practices for aseptic administration of medications, including injectable agents and sedation and analgesia, should be used. (IC)
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In the event of an outbreak caused by a suspected infectious or chemical etiology, environmental sampling should be performed according to standard outbreak investigation protocols. (IA)
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Endoscopy-related infections should be reported to all of the following:
a.Persons responsible for infection control at the institution, with notification of the referring physician and potentially affected patients as appropriate.
b.The appropriate public health agency (state or local health department as required by state law or regulation).
c.The FDA (www.fda.gov/medwatch). Medical Device Reports submitted through “Medwatch” can be reviewed on the FDA’s MAUDE database.
d.The manufacturer(s) of the endoscope, disinfectant/sterilant, and AER (if used). Category IB and IC.
(IC)
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Recommendation Grading

Overview

Title

Reprocessing Flexible GI Endoscopes

Authoring Organization

Publication Month/Year

February 1, 2017

Last Updated Month/Year

August 2, 2023

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Inclusion Criteria

Female, Male, Adult, Older adult

Health Care Settings

Ambulatory, Emergency care, Hospital, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Diagnosis, Prevention, Treatment

Diseases/Conditions (MeSH)

D020776 - Endoscopes, Gastrointestinal

Keywords

GI endoscopes

Source Citation

Petersen, B. T., Cohen, J., Hambrick, R. D., Buttar, N., Greenwald, D. A., Buscaglia, J. M., … Eisen, G. (2017). Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointestinal Endoscopy, 85(2), 282–294.e1. doi:10.1016/j.gie.2016.10.002