By Kathy Dix
Reprocessing earlier models of endoscopes has always beenchallenging; however, new technologies have introduced even greater burdens oncleaning and decontamination staff.
Shekhar Challa, MD, a board certified gastroenterologist andauthor of Spurn the Burn; Treat the Heat: Everything You Need to Know to Beat AcidReflux Disease, is medical director of the Endoscopyand Surgery Center of Topeka, Kan., and medical director of Midwest HeartburnClinic. In his practice, he utilizes video-based equipment, endoscopes,colonoscopy scopes and scopes for endoscopic retrograde cholangiopancreatography(ERCP) and notes that each has several channels for taking biopsies,washing, etc.
He cautions, Most of what I know about cleaning scopes isfrom talking to the nurses or reading about it, as opposed to hands-on. Having said that, it is very clear that every documented caseof patient infection linked to a contaminated scope is because of a breach ofsome of the reprocessing protocol. If you look back on the history, that is what it is improper disinfection, you dont dry the scope, inadequate cleaning, orsomebody forgot to clean the biopsy channel. It has been more human error thananything else.
Many infection control and endoscopy societies offerrecommendations for decontamination, cleaning and reprocessing of endoscopes,and, Challa says, The protocols out there are more than adequate, whetherthey be manual or automatic endoscope reprocessors. He references an outbreak in Pittsburgh related to anauxiliary water channel that was not being cleaned. That is not uncommon,because some scopes have it and some dont. Rules No. 1, 2 and 3 are to educate the people who arecleaning the scopes how and what should be done. If I had it my way, I wouldhave them take a test before letting them do the cleaning.
Challa then references an article featured in TheLos Angeles Times; They made a big deal ofinfection risk being high, and I think they were doing it a disservice; the riskof infection is not very high. Some of the literature says [the risk is] 1 in1.8 million. Its blown out of proportion. One outbreak of hepatitis C inNew York affected eight or nine patients; this, they ascertained, was mostlikely due to poor endoscope cleaning. But the reports we hear are so sporadicthat it is not common, Challa emphasizes.
Instruments that can be problematic include some of the newcolonoscopes and ERCP equipment, he says. The new thing I believe is eventhough I dont do endoscopic ultrasound I understand they have one extrachannel that people can forget (to clean). That one channel needs to be cleanedseparately. Some of the colonoscopes have an auxiliary water channel, which isthe primary thing. One other issue is bronchoscopes; even though I dont do bronchoscopies, bronchoscopes Iunderstand have a much higher incidence compared to colonoscopes, because thecolon is not sterile. Most people undergoing bronchoscopies are inpatients, andtheir chances of [being exposed to and becoming ill from] bacteria, especiallyPseudomonas, is much higher, if the bronchoscopes are not cleaned.
Challa highlights one point: There has been a lot of talkabout which is better, manual cleaning or automatic endoscope reprocessingmachines. Either one of them is as good as the person doing the cleaning, hesays. Even with the automatic reprocessor, the processing requires the personto clean the endoscope with enzyme first, then put it in the STERISÂ® equipment,whereas the manual processing involves Endozyme, water, Cidex, alcohol anddrying. With both of them, theoretically, this may not be done correctly sothe human error is what the problem is, not the cleaning. They make a big dealabout air drying after the processing. If they dont air dry, especially thenight before they put it out to use the next day, that may cause somePseudomonas transmission. There have been some anecdotal reports about that.
Cleaning video-related equipment requires its own special setof tasks. Lee Ann Purtell, product manager of the Rigid Scope Repair Division atMobile Instrument Service & Repair, Inc. explains these steps for thedecontamination, cleaning and reprocessing of video cameras and couplers.
Camera heads and endocouplers are used in conjunction withrigid endoscopes and a camera control unit/console (CCU) to capture video andphotographic images during endoscopic surgical procedures, Purtell explains. Because these systems are both optical-mechanical andelectronic in nature, certain precautions are necessary when cleaning andhandling these devices to avoid damage and to ensure patient and staff safety.
She adds, The camera head, cable and endocoupler should becleaned and sterilized prior every use. There are two major styles of cameraconnector ends that plug into the camera control unit. The first is a pin-styleconnector. This type of connector end will also have a soak cap unit. It is veryimportant that the soak cap and o-rings are functioning properly and installedprior to cleaning or sterilization. The pins inside the connector are nothermetically sealed, and fluid invasion can travel through the pins into thecamera cable if the connector end is exposed to any moisture. This can causeshorts, video noise, discoloration or intermittent video image.
Not only that, but the soak cap and soak cap o-rings shouldbe inspected frequently. Ensure that the o-rings are present and are intact. The soakcap should be placed over the connector and turned clockwise until it is secure.The second type of connector is a paddle connector. Although the paddle styleconnector is hermetically sealed and no soak cap is required, be advised thatthe connector has to be completely dry before plugging in to the CCU to avoidimage problems and electrical shortages.
Instructions for cleaning the equipment are similar to otherendoscopic instruments and accessories. Purtell says, Immediately after use,unplug the camera from the CCU and securely install the soak cap (ifapplicable). Rinse the camera head with tap water. Using an enzymaticdetergent and soft brush, clean to remove any gross debris or bioburden from thesurfaces. Always follow manufacturers directions for mixing enzymaticdetergent and do not leave items to soak in enzymatic for longer than therecommended soak times. Severe chemical damage can result (as can discoloration,deterioration of components, chemical etching of the glass components.) Rinsethoroughly with water. Clean all glass surfaces with alcohol. Dry the camera,endocoupler and cable thoroughly.
For disinfecting the equipment, most cameras can bedisinfected in a glutaraldehyde solution, following the manufacturersguidelines for compatibility and soak times, she points out. Separate thecamera head, coupler and scope. Keep the camera separate from sharps andinstruments of dissimilar materials to avoid damage. Verify that the soak cap isinstalled. Inspect the camera headshell and cable for cuts tears, or otherdamage. If damaged, do not soak the camera. Fluid invasion into the camera head and cable will result. Donot allow to the unit to remain in disinfecting solution for longer than therecommended soak times. (Soak times average 10 - 20 minutes.) Following thesoak, rinse thoroughly in sterile water. Dry all parts with sterile towel,says Purtell.
Sterilization can be accomplished with ethylene oxide (ETO)gas, STERIS and SterradÂ®. However, consult the users manual for specificsterilization compatibility guidelines, since not all brands of cameras can besterilized in this manner. Verify the soak cap is securely installed before sterilization (if applicable), Purtell emphasizes. Some of the newest cameras on themarket are autoclave compatible but not most. Do not autoclave cameras that arenot marked autoclave. Severe damage to the camera cable and imaging system canresult. If a camera has been autoclaved, do not rinse or immerse in water orsaline to cool.
Additional considerations, she continues, include somemanufacturers recommendations to attach the coupler to the camera head beforesterilization to avoid moisture and subsequent fogging between the coupler andcamera head. If this process is followed, do not detach the coupler from thecamera head while in use, as the sterility of the products will be compromised,she says. If detaching the camera head and coupler when reprocessing, you canavoid moisture and fogging between the camera head and coupler by making surethe pieces are completely dry before re-attaching. You can also blow dry bothpieces (particularly the threads) with compressed air, then wipe with a sterile4-by-4 before attaching the coupler to the camera head.
Finally, she says, To remove buildup of chemicals or waterstains on the camera and coupler windows, you can clean using a soft eraser,then follow with an alcohol wipe to clean the buildup off of the lens prior todisinfection and sterilization. Commercial pastes and liquid cleaners are alsoavailable.
In response to the advent of more complex equipment, theSociety of Gastroenterology Nurses and Associates (SGNA) released a positionstatement on the reprocessing of endoscopic accessories and valves in 2002. TheSGNAs position statement declares:
A. All accessories labeled as reusable are reprocessedaccording to manufacturers instructions. Accessories that are classified ascritical medical devices require sterilization. Critical items labeled for single-use should not bereprocessed and/or reused.
B. Following each use of the endoscope, valves must beremoved, manually cleaned and high-level disinfected or sterilized according tothe manufacturers instruction. This must occur as part of the cleaning anddisinfecting process for the endoscope. When using an automated endoscopereprocessor (AER), follow the AER instructions regarding reprocessing of valves in the AER.1
The position statement was developed to ensure the safe andsuccessful treatment of patients, and the SGNA vigorously maintains theimportance of devices that can be easily disassembled, cleaned, high-leveldisinfected and/or sterilized.
In its Standards of Infection Controlin Reprocessing of Flexible Gastrointestinal Endoscopes,the SGNA asserts that only personnel educated in the proper reprocessing ofendoscopes should be allowed to do so; these individuals must meet yearlycompetency standards.
Additionally, no temporary staff members should be allowed toclean or disinfect any of these instruments.
Education, training and knowledge of infection control iscritical, including an awareness of universal precautions, OSHA regulations,disease transmission, safe work environment and safe handling of high-leveldisinfectants, sterilants, and waste management, says the association.
Quality assurance is another area of special importance;well-educated supervisors are crucial to this. One facet of the reprocessingprotocol may sometimes be overlooked reusable high-level disinfectants andsterilants must be monitored at least daily to ensure that they meet the minimumeffective concentration and also fall within the manufacturers recommendedshelf life. Failure in either area necessitates immediate replacement of thedisinfectants or sterilants.
Endoscopic accessories are a particular area of concern; ifthey are classified as critical devices, they must be sterilized rather thandisinfected. For reprocessing the main body of the endoscope, special attentionshould be paid to the biopsy/suction channel. Also, the SGNA notes, Alternate suctioning of fluid and airis more effective than suctioning fluid alone in the removal of debris frominternal lumens.
Before disinfection, the endoscope must be cleaned; allaccessible channels should be cleaned with a non-abrasive brush, and themanufacturers instructions for special endoscope channels should be observed these may include an elevator channel, a forward water jet, or adouble-channel scope. Ensuring that cleaning fluid extends to all lumens, it may benecessary to incorporate adaptors or channel restrictors recommended by themanufacturer.
Of special note, duodenoscopes have an elevator channel thatis a particularly small lumen and must be reprocessed manually for all steps,because an automatic reprocessor cannot generate sufficient force to push fluidthrough the channel.
When manually disinfecting a scope, it is necessary to ensurethat disinfectant is injected into all the channels until it egresses out theopposite end; air pockets are a particular concern. Because it is impossible to view internal contact for theentire scope, the disinfecting personnel must watch for a steady flow ofsolution to ensure complete contact.
Automatic reprocessing presents its own challenges; it mustcirculate fluids through all channels without trapping air, and it isrecommended that cycles for both alcohol flushing and forced air are included.
The Association of periOperative Registered Nurses (AORN) hasits own recommended practices for endoscope cleaning and reprocessing; they emphasize the importance of proper cleaning andprocessing according to the manufacturers instructions, as morehealthcare-associated infection outbreaks have been associated with contaminatedendoscopes than with any other medical device.3
AORN emphasizes that endoscopes, their accessories and relatedequipment be disassembled and cleaned manually, observing that Flexibleendoscopes that have crevices, joints and internal channels may be moredifficult to clean and sterilize or disinfect than rigid instruments that haveflat surfaces. Removing gross soil from narrow internal channels and lumens maybe difficult.
AORN also offers a sample cleaning protocol, highlighting theimportance of opening all ports during the cleaning process, and utilizingirrigation of internal suction/biopsy channels with large amounts of enzymaticdetergent and tap water in order to remove blood, feces, respiratory secretions,etc. Cleaning brushes either reusable or disposable should be used tobrush accessible channels.
For high-level disinfection, it is necessary to immerse theendoscope, accessories and related equipment completely in the disinfectant, andto flush all channels with the solution. If using an automatic reprocessor, itis necessary to clean the scopes manually before inserting them in thereprocessor.
Endoscopes and related equipment are considered medicaldevices and surgical instruments. They represent a risk to patients if they arenot processed correctly, AORN states. Failed or improperly performedcleaning procedures may result in disinfection failure with outbreaks ofinfection. Numerous infections have been transmitted via gastrointestinalendoscopy and bronchoscopy. Clinical manifestations range from symptomatic colonization todeath. One multi-state investigation found that 23.9 percent of bacterialcultures from the internal channels of 71 gastrointestinal endoscopes grew morethan 100,000 bacterial colonies after all disinfection/sterilization proceduresand before use on the subsequent patient.