In January 2008, a facility leak-tested an endoscope and identified a leak in the bending rubber of a colonoscope after a procedure. Due to time constraints, the colonoscope was not processed and was packaged for delivery to the manufacturer for repair. That’s when things went from bad to worse.
"It was (foolishly) hung in the endoscope cabinet with clean and well-functioning endoscopes that were in active circulation," relates Patricia DeSouza, RN, BSN, CGRN, a consultant for establishing GI endoscopy units. "Needless to say, no sign was even placed on this dirty scope (which of course should never have been hung there in the first place), and an unsuspecting nurse came along later and used this colonoscope for a procedure."
It is frighteningly easy for something like this to happen in any facility. "I think this underscores the importance of following careful and consistent protocol to assure that these endoscopes are immediately taken out of circulation," DeSouza offers. "I think that facilities, from my experience, are often confused as well about how to render such scopes high-level disinfected for return to the manufacturer when there is a leak, which may make this process difficult (the last thing you want to do is cause fluid invasion through the leak when trying to disinfect it). The original equipment manufacturer (OEM) should be contacted to give guidelines based upon where the leak exists, how large it is, etc."
The reason for the mix-up, she explains, was traced back to the time element. "The endoscopy staff member hung the scope up, with the intention of processing and packaging it for delivery, but apparently didn’t get back to do it before the other nurse assumed that it was patient-ready — since it was, after all, hanging in the scope closet. I would imagine that an incident report would have to be filed and steps taken to evaluate and intervene, as appropriate, on that patient’s behalf. It’s scary," she relates.
"One of the key things to consider whenever looking at the cost of a repair is what could have been done to prevent the repair in the first place," posits Eddie Garces, president of the Olympus Medical Production Repair Group. "The vast majority of repairs related to leaks can often be avoided. Damage to a scope from a leak and subsequent fluid invasion can be not only costly, but can also shorten the usable life of the equipment. The other less quantifiable cost relative to any repair is the potential down-time and scheduling delays that can occur when a scope has to be taken out of circulation for service. So I’d like to offer a few preventive steps every facility can take to minimize their occurrence."
First, Garces says, training is crucial. "When new hires begin their reprocessing positions, it is important that they are fully versed in proper reprocessing, care, and maintenance protocols following society guidelines and original equipment manufacturer instructions. One very positive note for the GI and bronchoscopy industry is that a new Certified Flexible Endoscope Reprocessor exam was introduced in the United States in February 2008 and will be offered four times per year. Until now, the role of ‘reprocessor’ has lacked uniform guidelines and standards for evaluating the knowledge and skill set necessary to competently fill this critical position."
Also, Garces points out, the proper handling of scopes is an issue that requires special attention. No matter who is handling the scope, it is essential that staff members follow proper handling techniques during transport, reprocessing, procedures and storage. "This helps avoid inadvertent damage, including tears or punctures to the scope’s exterior. The reprocessing area should be checked prior to use to ensure it remains free of sharp edges or objects that could damage the scope. Scopes should not be transported, reprocessed or stored with supplies and/or accessories at any time, and handlers should avoid stacking scopes in transport containers, on countertops and in sinks."
Patience — the unappreciated virtue — is also necessary in this setting. "The procedural schedule can often get hectic. Unfortunately, the more rushed the reprocessing technician gets, the more opportunity there is for damage to occur, such as a tear from hasty removal from the transport bin, accidentally missing a small leak during the leakage test, or forgetting to put on the water resistance cap before immersing the scope into the basin of water."
And finally, he says, there is accountability. "Encourage your staff to be accountable for the quality of the reprocessing by helping them understand the direct correlation between proper endoscope care and handling and the safety of your operation. They must comprehend that skipping and/or ineffectively performing reprocessing steps or failing to follow OEM instructions can adversely affect patient safety and increase the incidence of repair. Careful equipment handling and preventive maintenance protocols can eliminate the need for many repairs or detect minor leak damage before it escalates into something more serious."
The cost to fix a scope leak can range from a few hundred dollars to thousands. Properly identifying leaks — and properly treating them — is paramount to keeping repair costs down.
"The cost to repair a small leak that is detected while the damage is limited will likely cost between $100 and $300. An example of this would be replacing the bending rubber when there is a hole or cut identified, or resealing the control body," says Jon Fish, director of scope operations for Cardinal Health’s Onsite Services business. "Extensive damage to a scope can cost from $300 to as much as $8,000, depending on the components affected, model of scope and repair vendor used. Extensive damage occurs when fluid invasion extends into the electronics and angulation systems. Once inside the scope, fluid can corrode delicate fiberoptic, mechanical and electrical components. Repairs that might be needed include a rebuild of the ocular system, rebuild of the angulation system, replacement of electronics, replacement of image bundle, and replacement of the camera CCD chip that is very costly to replace."
Also, he explains, there are a variety of tools available to detect leaks from less expensive hand-held leak testers to more automated equipment. A scope that has a leak may be reprocessed by attaching it to an automated leak testing unit and submerging it in the appropriate high level disinfectant referenced in the manufacturer’s suggested cleaning process. "However, the most important element is the education of the staff to assure they understand proper techniques and frequency of leak testing," he says. "To repair the leaks, scopes must be professionally evaluated by a flexible endoscope repair facility, such as Cardinal Health’s OnSiteSM Services Equipment Repair Center."
"Small leaks are usually reasonable repairs ($150 - $250) if they are just a hole or cut in the bending sheath. Keep in mind that even a small leak in either the insertion tube or light guide tube can involve significant costs even though the leak appears to be small. The reason for this is the entire tube would need to be replaced, as simply patching it is not an appropriate repair," says Robert Purtell, director of business development for Mobile Instrument Service & Repair. "A large leak or a leak that has gone undiagnosed for a period of time can have significant repair costs attached to it. If fluid has been introduced to the inside of the scope because of the leak, components can rust, electronics can become damaged or corroded, and fiberoptic bundles can weaken or become brittle. The repair costs at this point can range from several hundred dollars and go all the way up to complete overhaul charges," Purtell adds.
When performing audits at endoscopy facilities, Mobile Instrument has found several factors that can lead to high repair costs. "Multiple employees being involved in the cleaning and disinfecting of scopes can be a contributing factor to higher repair costs," Purtell offers. "The more hands involved in processing this equipment, the greater the chance for something to go wrong. Facilities that can dedicate one to three people to processing scopes will usually find more contained costs."
Another way to decrease scope damages, he says, is continuing education. "Nurses and technicians need periodic inservices on the care and handling of the equipment they use, as changes in staff will inevitably occur over time. A good refresher is always helpful, just to make sure everyone is on the same page and following the same protocol. Oftentimes, changes can be made in the process that will decrease future leaks. These can range from modifying the way scopes are transported around the department, to upgrading the storage area, to simply installing a larger sink or better organizing the cleaning/disinfecting area," says Purtell.
The cost of a repair will vary based on several factors, offers Garces. "It depends on the scope model, location of the pinhole puncture, tear or leak, when it was discovered, and how much fluid (if any) invaded the interior of the scope."
For major damage, however, the bill skyrockets. "More extensive leak-related repairs also are impacted by the same questions as minor leak repairs," Garces adds. "In some cases, damage can be so extensive that it is the metaphorical equivalent of totaling your car. Did you just damage the front of the car, or does the entire car need to be rebuilt or replaced? With proper handling, reprocessing, transport and storage protocols, this type of damage should happen very rarely, if ever."
|Image provided courtesy of Cardinal Health, OnSite services. They reflect fluid invasion in an ocular eyepiece (left) and in a control body (right).|
Many of Olympus’ customers who have experienced inadvertent, extensive fluid invasion could have avoided the damage in large part, he explains. "We have had the opportunity to help a lot of these customers avoid repetitions of these repairs with training on proper handling, reprocessing and maintenance protocols," he adds. Specific training at Olympus University, site visits from company support specialists, and VIP tours of the company’s national service center can help customers to reduce their repairs.
"To help avoid fluid invasion damage, customers should follow the leakage testing instructions provided in their equipment manuals," he adds. "Olympus provides detailed instructions for returning Olympus flexible endoscopes to service centers for repair. All flexible endoscopes must be rendered safe to handle prior to being returned. Damaged endoscopes that are still watertight should be reprocessed according to instructions provided in the Olympus reprocessing manual. However, if the endoscope has developed a leak, routine reprocessing may lead to further damage. Therefore, Olympus has developed special guidelines for flexible endoscopes that have failed leakage testing. The key to preventing further damage to a leaking endoscope is to provide positive pressure to the endoscope during all phases of reprocessing by connecting the endoscope to the maintenance unit or light source. This will ensure that the endoscope is pressurized throughout the entire reprocessing cycle and help to prevent fluid from entering the endoscope. Cleaning instructions vary depending on where the leak has occurred, so customers should follow the detailed manufacturer’s instructions for cleaning leaking endoscopes."
Tools of the Trade
Several companies offer tools to assist GI suites in finding leaks.
"The Medivators Veriscan is an automated endoscope leak detection system with 98 percent accuracy," says Thomas Arcand, product manager for Medivators Reprocessing Systems (Minntech Corporation). "Veriscan detects endoscope leaks early when repairs are minor and less costly, which drives down repair costs and dramatically lowers the risk of cross-contamination due to undetected leaks. All testing is documented, and results are easily exportable to spreadsheet or database software."
The Veriscan has been designed to ensure best practices and is compatible with all flexible endoscopes. The idea is to automate the leak testing so that staff is freed to perform other tasks. It is designed to be simple to set up and to use, and can provide either exportable or hard-copy usage reports — indicating if a scope has passed the test or if there is evidence of a leak.
"There are continuous air (electric) leak testers as well as hand-held leak testers that can be used to detect leaks. As far as tools needed to repair leaks, there is a very wide variety of tooling that technicians will use to complete these repairs — from custom tools that pertain to each individual manufacturer, to common tools such as precision screwdrivers and micro pliers," says Purtell. "Once a scope has a leak in it, there really isn’t too much the hospital can do to further protect the scope. We ask that the nurse and/or technician take great precaution as the scope is processed to avoid any additional damage, but for the safety of everyone involved, the scope must be cleaned and disinfected before it is shipped in for repair."
Another tool available for scope repair is a Class VI sealant, ScopeSeal, offered by Endoscope Repair Inc. "It is easily administered and applied to leaks on scopes, sealing leaks within minutes, so the endoscope can be reprocessed and then used until repairs are performed," says Jennifer Kropp, of Endoscope Repair Inc.
Tales From the Trenches
Two nurses shared their own experiences with scope leaks and preventive efforts.
Leah Hansen, RN, BSN, ACGEN, RNP, MRCNA, clinical nurse manager of Mercy Endoscopy Suite in Western Australia, writes, "Scope leaks... ahh — there goes the budget and sufficient scopes again, not because of missed leaks in our case, but because we are very good at picking them up. I sent three gastroscopes off for repair of leaks yesterday. That leaves me down three with four gastroscopes left to manage double lists. Our colonoscopes have more leaks than the gastroscopes, followed closely by the flexicystoscopes whose A rubbers seem to deteriorate very quickly, with exposed threads often noticed. After every use, every scope is leak tested during immersion. I have both regulated and unregulated personnel in my reprocessing area who are all extremely conscientious at looking for leaks."
After manual leak testing, Hansen’s scopes are placed in an automatic endoscope reprocessor. "We use the Soluscope, which also performs a leak test. This has picked up three scopes with undetectable leaks on manual testing, and one scope with a leak that could not be found upon repair after multiple scopes had successfully gone through this machine. Over the last five years, we have only had one scope suffer internal moisture damage secondary to a missed leak. Our repair costs due to endoscope leaks over the last five years are minimal due to early detection and dedicated staff. We have now with our purchase of new scopes joined the company’s service club, which covers all repairs for the first three years. This has been terrific, as it usually means one phone call to say I’m sending a scope and a replacement is delivered within 24 hours, resulting in less stress, less wear and tear on remaining scopes, and the decreased potential of ‘We’ll just use it one more time.’"
"Our leak problems are very minimal," relates Dorie Werner, RN, BSN, CGRN, nurse manager at the Ridge View Endoscopy Center in Lone Tree, Colo. "We use the Olympus MU-1 leak tester, and every scope is leak-tested prior to cleaning, as well as when received back from repair. Our leaks are detected very early, and thus, damage due to leaking is very minimal, if any. Also, after a leak is detected, the MU-1 stays connected and activated to the scope as it goes through the automatic endoscope reprocessor (we use Custom Ultrasonics). Since we switched to using the Olympus leak tester vs. the manual ones, we have detected very small leaks much more quickly than before."
Alan Scott, CERT, has been an endoscope reprocessor in the endoscopy suite at London Health Sciences Centre, London, Ontario, Canada, for the past 11 years. He has his own story to relate about scope leaks.
"As studies have shown, operator error resulting in fluid invasion accounts for over 35 percent of scope repairs in our industry," he says. "I am proud to say that over my years of endoscope reprocessing, I personally have never flooded an endoscope. Now, I could say this is totally due to my understanding of how important leak testing is in reprocessing scopes, but I can't take the whole credit."
Scott's unit has begun using the Reliance HLD scope reprocessor from Steris. "The added feature that the Reliance has over our Steris System I is that it performs a leak test prior to and during the reprocessing of the endoscope," he relates.
"April 10, 2008, is the day the Reliance enabled me to continue to claim my perfect record. I had just finished my leak testing and manual cleaning of a endoscope and had put it in the Reliance for HLD," he continues.
"After I started the cycle, the Reliance showed a fault that the scope had failed the leak test and therefore would not run the cycle. I removed the scope and performed a manual leak test again, with flexing distal tip. Still I could not find a leak. I returned the endoscope to the Reliance and started the cycle. Again the Reliance showed a fault that the scope had failed the leak test. I did another manual leak test and found the leak. Although it is not recommended, it took my bending the insertion tube at 40 cm almost in half before the leak was recognized in the biopsy channel. After sending the scope out for repair, it showed that there was no fluid invasion. Adding the Reliance HLD in our unit saved us an expensive repair bill," he concludes.