Reprocessing earlier models of endoscopes has always been challenging; however, new technologies have introduced even greater burdens on cleaning and decontamination staff.
Shekhar Challa, MD, a board certified gastroenterologist and author of Spurn the Burn; Treat the Heat: Everything You Need to Know to Beat Acid Reflux Disease, is medical director of the Endoscopy and Surgery Center of Topeka, Kan., and medical director of Midwest Heartburn Clinic. 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 is from talking to the nurses or reading about it, as opposed to hands-on. Having said that, it is very clear that every documented case of patient infection linked to a contaminated scope is because of a breach of some of the reprocessing protocol. If you look back on the history, that is what it is — improper disinfection, you don’t dry the scope, inadequate cleaning, or somebody forgot to clean the biopsy channel. It has been more human error than anything else.”
Many infection control and endoscopy societies offer recommendations for decontamination, cleaning and reprocessing of endoscopes, and, Challa says, “The protocols out there are more than adequate, whether they be manual or automatic endoscope reprocessors.” He references an outbreak in Pittsburgh related to an auxiliary water channel that was not being cleaned. “That is not uncommon, because some scopes have it and some don’t. Rules No. 1, 2 and 3 are to educate the people who are cleaning the scopes — how and what should be done. If I had it my way, I would have them take a test before letting them do the cleaning.”
Challa then references an article featured in The Los Angeles Times; “They made a big deal of infection risk being high, and I think they were doing it a disservice; the risk of infection is not very high. Some of the literature says [the risk is] 1 in 1.8 million. It’s blown out of proportion.” One outbreak of hepatitis C in New York affected eight or nine patients; this, they ascertained, was most likely due to poor endoscope cleaning. “But the reports we hear are so sporadic that it is not common,” Challa emphasizes.
Instruments that can be problematic include some of the new colonoscopes and ERCP equipment, he says. “The new thing I believe is — even though I don’t do endoscopic ultrasound — I understand they have one extra channel that people can forget (to clean). That one channel needs to be cleaned separately. Some of the colonoscopes have an auxiliary water channel, which is the primary thing. One other issue is bronchoscopes; even though I don’t do bronchoscopies, bronchoscopes I understand have a much higher incidence compared to colonoscopes, because the colon is not sterile. Most people undergoing bronchoscopies are inpatients, and their chances of [being exposed to and becoming ill from] bacteria, especially Pseudomonas, is much higher, if the bronchoscopes are not cleaned.”
Challa highlights one point: “There has been a lot of talk about which is better, manual cleaning or automatic endoscope reprocessing machines. Either one of them is as good as the person doing the cleaning,” he says. “Even with the automatic reprocessor, the processing requires the person to clean the endoscope with enzyme first, then put it in the STERIS® equipment, whereas the manual processing involves Endozyme, water, Cidex, alcohol and drying. With both of them, theoretically, this may not be done correctly — so the human error is what the problem is, not the cleaning. They make a big deal about air drying after the processing. If they don’t air dry, especially the night before they put it out to use the next day, that may cause some Pseudomonas transmission. There have been some anecdotal reports about that.”
Cleaning video-related equipment requires its own special set of tasks. Lee Ann Purtell, product manager of the Rigid Scope Repair Division at Mobile Instrument Service & Repair, Inc., explains these steps for the decontamination, cleaning and reprocessing of video cameras and couplers.
“Camera heads and endocouplers are used in conjunction with rigid endoscopes and a camera control unit/console (CCU) to capture video and photographic images during endoscopic surgical procedures,” Purtell explains. “Because these systems are both optical-mechanical and electronic in nature, certain precautions are necessary when cleaning and handling these devices to avoid damage and to ensure patient and staff safety.”
She adds, “The camera head, cable and endocoupler should be cleaned and sterilized prior to every use. There are two major styles of camera connector ends that plug into the camera control unit. The first is a pin-style connector. This type of connector end will also have a soak cap unit. It is very important that the soak cap and o-rings are functioning properly and installed prior to cleaning or sterilization. The pins inside the connector are not hermetically sealed, and fluid invasion can travel through the pins into the camera cable if the connector end is exposed to any moisture. This can cause shorts, video noise, discoloration or intermittent video image.”
Not only that, but “the soak cap and soak cap o-rings should be inspected frequently. Ensure that the o-rings are present and are intact. The soak cap 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 style connector is hermetically sealed and no soak cap is required, be advised that the connector has to be completely dry before plugging in to the CCU to avoid image problems and electrical shortages.”
Instructions for cleaning the equipment are similar to other endoscopic instruments and accessories. Purtell says, “Immediately after use, unplug the camera from the CCU and securely install the soak cap (if applicable). Rinse the camera head with tap water. Using an enzymatic detergent and soft brush, clean to remove any gross debris or bioburden from the surfaces. Always follow manufacturers’ directions for mixing enzymatic detergent and do not leave items to soak in enzymatic for longer than the recommended soak times. Severe chemical damage can result (as can discoloration, deterioration of components, chemical etching of the glass components.) Rinse thoroughly with water. Clean all glass surfaces with alcohol. Dry the camera, endocoupler and cable thoroughly.”
For disinfecting the equipment, most cameras can be disinfected in a glutaraldehyde solution, following the manufacturer’s guidelines for compatibility and soak times, she points out. “Separate the camera head, coupler and scope. Keep the camera separate from sharps and instruments of dissimilar materials to avoid damage. Verify that the soak cap is installed. Inspect the camera headshell and cable for cuts tears, or other damage. If damaged, do not soak the camera. Fluid invasion into the camera head and cable will result. Do not allow to the unit to remain in disinfecting solution for longer than the recommended soak times. (Soak times average 10 - 20 minutes.) Following the soak, rinse thoroughly in sterile water. Dry all parts with sterile towel,” says Purtell.
Sterilization can be accomplished with ethylene oxide (ETO) gas, STERIS and Sterrad®. However, consult the user’s manual for specific sterilization compatibility guidelines, since not all brands of cameras can be sterilized in this manner. “Verify the soak cap is securely installed before sterilization (if applicable),” Purtell emphasizes. “Some of the newest cameras on the market are autoclave compatible but not most. Do not autoclave cameras that are not marked autoclave. Severe damage to the camera cable and imaging system can result. If a camera has been autoclaved, do not rinse or immerse in water or saline to cool.”
Additional considerations, she continues, include some manufacturers’ recommendations to attach the coupler to the camera head before sterilization to avoid moisture and subsequent fogging between the coupler and camera head. “If this process is followed, do not detach the coupler from the camera 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 can avoid moisture and fogging between the camera head and coupler by making sure the pieces are completely dry before reattaching. You can also blow dry both pieces (particularly the threads) with compressed air, then wipe with a sterile 4-by-4 before attaching the coupler to the camera head.”
Finally, she says, “To remove buildup of chemicals or water stains 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 to disinfection and sterilization. Commercial pastes and liquid cleaners are also available.”
In response to the advent of more complex equipment, the Society of Gastroenterology Nurses and Associates (SGNA) released a position statement on the reprocessing of endoscopic accessories and valves in 2002. The SGNA’s position statement declares:
A. All accessories labeled as reusable are reprocessed according to manufacturer’s instructions. Accessories that are classified as critical medical devices require sterilization. Critical items labeled for single-use should not be reprocessed and/or reused.
B. Following each use of the endoscope, valves must be removed, manually cleaned and high-level disinfected or sterilized according to the manufacturer’s instruction. This must occur as part of the cleaning and disinfecting process for the endoscope. When using an automated endoscope reprocessor (AER), follow the AER instructions regarding reprocessing of valves in the AER.1
The position statement was developed to ensure the “safe and successful treatment of patients,” and the SGNA vigorously maintains the importance of devices “that can be easily disassembled, cleaned, high-level disinfected and/or sterilized.”
In its Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, the SGNA asserts that only personnel educated in the proper reprocessing of endoscopes should be allowed to do so; these individuals must meet yearly competency standards. Additionally, no temporary staff members should be allowed to clean or disinfect any of these instruments.
Education, training and knowledge of infection control is critical, including an awareness of universal precautions, OSHA regulations, disease transmission, safe work environment and safe handling of high-level disinfectants, 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 reprocessing protocol may sometimes be overlooked — reusable high-level disinfectants and sterilants must be monitored at least daily to ensure that they meet the minimum effective concentration and also fall within the manufacturer’s recommended shelf life. Failure in either area necessitates immediate replacement of the disinfectants or sterilants.
Endoscopic accessories are a particular area of concern; if they are classified as critical devices, they must be sterilized rather than disinfected. For reprocessing the main body of the endoscope, special attention should be paid to the biopsy/suction channel. Also, the SGNA notes, “Alternate suctioning of fluid and air is more effective than suctioning fluid alone in the removal of debris from internal lumens.”
Of special note, duodenoscopes have an elevator channel that is a particularly small lumen and must be reprocessed manually for all steps, because an automatic reprocessor cannot generate sufficient force to push fluid through the channel.
When manually disinfecting a scope, it is necessary to ensure that disinfectant is injected into all the channels until it egresses out the opposite end; air pockets are a particular concern. Because it is impossible to view internal contact for the entire scope, the disinfecting personnel must watch for a steady flow of solution to ensure complete contact.
Automatic reprocessing presents its own challenges; it must circulate fluids through all channels without trapping air, and it is recommended that cycles for both alcohol flushing and forced air are included.
The Association of periOperative Registered Nurses (AORN) has its own recommended practices for endoscope cleaning and reprocessing; they emphasize the importance of proper cleaning and processing according to the manufacturer’s instructions, as “more healthcare-associated infection outbreaks have been associated with contaminated endoscopes than with any other medical device.3
“Endoscopes and related equipment are considered medical devices and surgical instruments. They represent a risk to patients if they are not processed correctly,” AORN states. “Failed or improperly performed cleaning procedures may result in disinfection failure with outbreaks of infection. Numerous infections have been transmitted via gastrointestinal endoscopy and bronchoscopy. Clinical manifestations range from symptomatic colonization to death. One multi-state investigation found that 23.9 percent of bacterial cultures from the internal channels of 71 gastrointestinal endoscopes grew more than 100,000 bacterial colonies after all disinfection/sterilization procedures and before use on the subsequent patient.”