Maintaining endoscopes in proper working condition is a must for any busy endoscopy suite. This effort includes thorough and correct cleaning and disinfection practices, as well as timely and efficient repairs as needed. These things may sound deceptively simple, but doing them in a manner that emphasizes patient safety while retaining cost effectiveness can be challenging on many levels.
Failure to properly clean endoscopes has considerable consequences for both the patient and the healthcare provider, according to Bradley Catalone, PhD, senior manager of infection control at Olympus America Inc. “First and foremost, inadequate endoscope cleaning jeopardizes patient safety,” he says. “Although pathogen transmission in endoscopy is rare, documented cases of pathogen transmission have been invariably linked to breaches in reprocessing, with the majority being associated with a failure to properly clean the endoscope according to manufacturer’s instructions.”
Catalone also notes that healthcare facilities must expend considerable resources to investigate cases of both patient infection and pseudo-infection related to inadequate endoscope cleaning. “In addition, the identification of improper endoscope cleaning as part of an infection control investigation may lead to patient notification and testing, a consequence of which may be multiple lawsuits and immeasurable damage to the healthcare provider’s reputation. Finally, improper reprocessing may result in endoscope damage and higher repair costs for the facility. Overall, failure to properly clean endoscopes produces a myriad of avoidable consequences that drain resources from effective healthcare delivery and improving patient outcomes.”
Victoria Fraser, MD, professor of medicine and co-director of the infectious disease division at Washington University School of Medicine in St. Louis notes that endoscope cleaning and disinfection are complex, multi-stage procedures that are error-prone and very dependent on human behavior and a high level of repetition and discipline. “It’s easy for very busy healthcare workers to accidentally do the wrong thing,” she says. “Most of the time when outbreaks or breaches in technique have been identified, they have been in response to either new people on the job, increased work volume, or shortages in staff where people can’t take the time to do all the necessary steps.”
“The critical thing with cleaning endoscopes is to follow the eight-step process that is outlined by SGNA,” says Pat Holland, RN, BSN, CGRN, a former president of the Society of Gastroenterology Nurses and Associates (SGNA), and a staff nurse at Lakewood Endoscopy Center in Denver. Holland also provides consulting services via Holland Consulting. She recommends following that process to the letter and avoiding short cuts. “All infections that have been identified have resulted from some breach in the cleaning process.”
Holland emphasizes the importance of accessing all of the scope channels during the cleaning step. This begins with becoming familiar with the internal structure of the scope. “When you’re learning how to clean them, you need to understand that most gastroscopes and colonoscopes in particular have three channels: the air channel, the water channel, and the suction channel. You can only access the suction channel with a cleaning brush, and the other channels need to be accessed with a flushing or purging technique.
“It’s important to use the chemicals correctly, so when you’re using the enzymatic cleaner, you must dilute it according to the directions and allow the scope to soak both on the outside and the inside with the enzymatic product,” Holland continues. “This will loosen the debris on the inside so it can be flushed out of the scope, especially with the air and water channels, which can only be accessed by a flushing or purging technique. Those are the things I see people missing the most.”
Some of the challenges have to do with the fact that endoscopes in effect are difficult to disinfect and clean, Fraser points out. “They have complicated, multimodality materials that are sensitive to corrosion and disruption, and can retain biofilms, blood, tissue, body fluids easily, so they require rigorous, meticulous cleaning just to remove the gross bioburden and then the disinfection process,” she explains. “People can either do manual or automated disinfection, but with either approach, there are still multiple steps that need to be followed in order to feel confident that the scope was fully and thoroughly cleaned, fully and thoroughly disinfected, and then fully and thoroughly dried and rinsed, then it is completely functional.”
In addition to potentially compromising patient safety, inadequate reprocessing can negatively affect the functionality of the endoscope and/or its components, according to Keith Nelson, director of technical services for PENTAX Medical Company. “Improper cleaning can lead to organic residues that can literally clog or block various internal channels, especially the smaller air, water, and/or forward water jet channels,” he says. “As a result, these functions can fail — the endoscopist may be unable to insufflate the anatomy, the distal objective lens may be difficult to clean causing a blurry endoscopic image, and/or irrigation may not be possible through the dedicated water jet channel.
“Whether all internal channels are clinically used or not during any given procedure each accessible channel should be brushed and all channels then flushed with enzymatic detergent and the enzymes should be allowed sufficient time to break down retained patient soil before an air purge and rinse followed by a subsequent high-level disinfection process,” Nelson adds. In terms of education, Holland suggests that healthcare workers responsible for cleaning and disinfecting scopes must have initial instruction when they start in the position, and then there should be a competency validation annually at a minimum.
From an infection control perspective, proper leak testing is one of the most important reprocessing steps, Holland says. “It’s the second step after pre-cleaning, and leak testing is something that people can take short cuts around, or they might not take enough time when they’re leak testing. It’s critical to leak test the scope correctly so that you don’t have any fluid invasion in the scope, which of course would increase the risk of cross-infection with a scope, and also increases the risk of damage to the scope.”
Nelson further emphasizes that failure to detect a leak can result in extensive fluid damage and a very expensive repair, not to mention the concerns for potential infection from a compromised scope. “If instruments are not thoroughly cleaned, retained organic soil can inactivate certain germicides or it can prevent contact of the germicide with potentially contaminated surfaces, either of which creates an infection risk.”
“The problem is if you don’t detect and fix these small leaks right away, but you go ahead with the cleaning and disinfection procedure, in effect what you’re doing is ramming the cleaning brushes or the cleaning fluid or the disinfection fluid under pressure down into the leak area,” Fraser says. “So fluid now is going where it’s not supposed to go, usually increasing the tear or leak, but also damaging the very critical internal bio-works and materials that are essential for effective function of the endoscope. There’s very clear data that if you pick up these leaks early and repair them, it’s much cheaper than if you have a big, disastrous break.
“These scopes are very expensive, very complicated technical instruments that have a certain amount of breakage kind of built in to their life span,” Fraser continues. “Many endoscope users have come to the sad reality that they have not only acquisition costs, but they have very high maintenance costs as well. I think some of the excess maintenance cost is because we’re not doing a great job of identifying leaks early and fixing them before they’re horrendous breaks.”
Terry Bader, CEO of Verimetrix, also cites the difficult circumstances that often exist in reprocessing rooms. “There’s a lot of pressure on these technicians to handle the scopes very carefully,” he says. “The distal end is very delicate; there are many expensive components there. When the scopes get thrown in metal sinks, they can crack very easily. Also, because of the speed of the reprocessing room, many instruments are often cleaned together, but cleaning the scopes separately is critically important.
“That room is very hectic; there’s a lot of activity and things move very fast,” Bader continues. “There are many hard surfaces and sharp objects, and that’s a bad combination for handling an extremely delicate instrument. The doctors are also moving fast, and if they’re not very careful with these instruments, damage can be caused during procedures. The incidence of leak damage per procedure is pretty high.”
Holland estimates that scope handling is probably responsible for 90 percent of the damage issues in the scope. “There may be some things that are normal wear and tear, but handling is critical from a repair perspective,” she states. “Again, I think people need to be educated on a regular basis on proper handling. One of the simplest things you can do when handling an endoscope is either hold the distal tip in your hand or have it placed in some kind of a container where it can’t swing loose and bump something. Likewise in the storage area — you always want to be careful not to have the distal tip of the scope under the rest of the scope when you’re reprocessing it, there shouldn’t be any pressure on it; you’re just always protecting that part.”
Even when great care is taken when handling scopes, there’s no such thing as avoiding damage completely, Bader contends. “When you take that type of instrument and use it how it needs to be used, damage will occur. Given that the damage is there, how do you detect it and avoid fluid invasion?”
The traditional methods of leak testing are not fool-proof; in fact, even the most seasoned technicians can miss leaks when these processes are used, according to Bader. With the dry test, he notes, “A very large leak will cause an obvious needle movement, but most leaks aren’t that large, and cause very small needle movements. You have this analog device that moves in an almost imperceptible way, and you have someone there who can miss it or be dismissive of it; it’s very easy to ascribe these barely perceptible moves as just ‘noise.’”
The wet test presents similar problems. “You have to pay very careful attention for the right amount of time if you’re going to detect the leaks,” Bader continues. “What we’ve seen is that sometimes technicians use an enzymatic solution for cleaning, and they’ll combine the cleaning with the leak test and dunk the scope in a tub of enzymatic solution, so you’re looking for bubbles within bubbles.”
The VeriscanTM product from Verimetrix was designed to automate the leak-testing process. “We are far more accurate than the wet test or dry test,” Bader says. “All the research we did indicated that technicians were going to miss about one-third of the leaks. Those all result in fluid getting inside the scope and very expensive repairs. We’re going to catch 97 percent-plus of leaks and fluid, so the accuracy goes up dramatically and the consistency of the process is guaranteed. We have a microprocessor and the data of the leak tests in captured — at the end of the day the nurses can push a button on the screen to verify all of the testing, allowing for the ability to confirm that best practices are being followed.”
The data that’s captured by Veriscan isn’t just for confirmation and bringing accountability. “If there’s damage, they can print out the result of the leak test and send it out for repair,” Bader notes. “With many hospitals, they really want to manage the data from these procedures; they want to know how many scopes were tested and which scopes are failing, and a lot of them are very focused on scope utilization. What we often find is that certain scopes are being over-used, and that really speeds up the damage that occurs to that scope. If there’s a problem with the scope, they can go through the data and find the exact scope and time it was used. That’s also great if there’s any sort of infection — instead of having to shut down every scope because you don’t know which one could be carrying a pathogen, you can drill down right to the scope and the time and pull it out to be further disinfected.”
“By virtue of detecting leaks better, I think you actually reduce the infection transmission risk, because if you have a leak, you have fluid and biologic materials and biofilm in areas that cannot be adequately cleaned and disinfected,” Fraser offers. “Therefore you’re increasing the risk of having scopes that are colonized with bacteria and viruses, and can then get put into another patient, so you have an increased risk of cross-transmission of infection.”
Checks for functionality and visual inspections of the endoscope should be performed before every procedure, according to Alec Weiss, product manager for endoscopy service at Olympus America Inc. “An inspection of the functional aspects of the scope prior to each procedure will help to ensure that the scope is ready to be safely used,” he explains. “Additionally, proactive inspection of the condition of the instrument may significantly reduce the frequency and extent of repairs.”
Weiss adds indications that a scope may be in need of repair include signs of physical damage or poor functioning like sharp edges on the distal tip, cracks or peeling on the insertion tube, poor air/water flow, change in image quality, and reduced angulation.
“PENTAX endoscope instruction manuals recommend that end users should inspect their instruments prior to each procedure to ensure proper functionality of their equipment,” says Nelson. “Basic scope functions such as air, water, suction, and image quality should always be checked before the start of an examination. And, before reprocessing, all scopes should be leak tested.”
Nelson explains that some obvious signs indicating that the endoscope should be returned for evaluation/service include:
- Failed leak test
- Angulation control knobs rotate without corresponding distal tip deflection
- No image when endoscope is properly connected to video processor
- No air, water, or suction (after confirming all valves and peripheral devices work properly)
- Endoscopic accessory instruments such as biopsy forceps cannot pass through the scope’s instrument channel
“Scopes should be checked often by the nurses and technicians for minor deviations in their performance,” says Robert Purtell, product manager, flexible endoscope repair division, Mobile Instrument Service & Repair. “Even the smallest deviation in angulation deflection, light output, forceps channel structure, etc., can have an impact on the way the scope performs during the procedure. Overall, a facility should have its repair company perform thorough preventive maintenance inspects at least once or twice per year. These inspections will help pinpoint current damage that should be addressed immediately, as well as forecast other repairs that may be required in the coming months.”
Once detected, flaws should be addressed promptly. “Depending upon the specific problem, corrective repairs should be performed as soon as possible from the standpoints of device functionality, cost, and often to ensure patient safety,” Nelson states. “For example, one of the most frequent repairs is that of a ‘leak’ in the bending rubber at the distal end of a scope. If caught right way and returned for service, the repair is minor and cost is minimal. However, should the leak remain undetected, fluid can invade the instrument and cause extensive damage to internal components and require a costly overhaul.”
Certain flaws such as scratches on plastic control body parts can be minor, and not require immediate attention, while flaws such as blistering or cracking of the insertion tube will require repairs immediately, Purtell says. “It’s best to have a repair company address the overall condition of the scope, to help determine which flaws are passable and which will compromise patient safety and overall scope performance.”
Nelson lists some of the most common repairs performed at PENTAX Super Service Centers:
- Bending rubber replacement due to a leak (pinhole) in the sheath at the distal bending section
- Channel replacement due to a kinked, crimped or punctured instrument channel
- Maintenance to unclog a blocked air or water channel (or nozzle) associated with improper cleaning techniques
- CCD chip and other critical component replacement associated with fluid invasion
“The most common repairs are various leaks and/or trauma to the outer housings of the scopes,” Purtell states. “Bending sheath and insertion-tube punctures are common as well as ‘crush-like’ trauma to the insertion tube and light guide umbilical. Fluid invasion is also a common form of damage we see, and the effects of this can be devastating to the scope.”
How devastating? The costs related to improper cleaning and disinfection can range from less than $200, to more than $8000, according to Purtell.
Weiss notes that the majority of the repairs that his company sees are preventable, however. In addition to leak testing after every procedure, the condition of the water-resistant cap must be checked with every use, he says. “Immediate bedside cleaning reduces the possibility of damage such as clogged nozzles.” Weiss also reiterates the importance of proper endoscope handling. “In general, be conscious of any surface with which a scope comes in contact, as it can be a potential source of insertion tube punctures and damage.”