The endoscope can be very deceiving—small and sturdy looking, it is actually quite delicate. The rigid endoscope has parts inside it that are composed of materials, such as glass, that are easily broken. Encased in steel, however, the instrument looks unbreakable. At least, that is what one employee in a New York hospital thought. He had been tossing them onto steel tables as he collected them.
“On the inside, his scopes looked like kaleidoscopes. Essentially, it was as if he were tossing china, because that is what the glass inside these scopes is like,” says Gregg Agoston, sales manager for Karl Storz Protection 1 Services of Karl Storz Endoscopy America Inc (KSEA of Culver City, Calif).
The repair bill was a bit more expensive than the cost of replacing a dish, even a very fine china dish. Agoston estimates that a rigid endoscope can cost anywhere from $3,000 to $6,500. “If you put it into the hands of someone who doesn’t know how to use it or care for it properly, you can spend hundreds or thousands of dollars on a repair or exchange,” Agoston says.
Flexible endoscopes fare no better. “We had a resident at a university hospital who broke three flexible scopes in one procedure. That was an expense close to $15,000,” Agoston says, adding, “One person can do a lot of damage.”
Endoscope damage is expensive, in part because the components are pricey but also because the repair is very specific and complicated. As videoscopes become more common, repairs become even more complex and, subsequently, more expensive.
Fortunately, many repairs can be avoided. Those who monitor damage note that most of it is caused by operator error. Gilles Gervais, manager of biomedical engineering for Ottawa Hospital, Civic Campus in Ottawa, Ontario, estimates that roughly 70% of damage is user related and 30% is due to wear and tear. However, he adds, “Most do not get to that stage [wear and tear], because some mishap usually happens beforehand.”
Damage can be introduced during procedures or reprocessing. Because so many hands touch the instrument, it can be difficult to determine where problems are introduced. But if no specific user can be found to educate, it helps to educate them all. “Repetition is the most important thing. There is turnover, and education needs to be ongoing,” says Chris Crowe, biomedical engineering technologist at Ottawa Hospital, Civic Campus.
Even with proper care, however, accidents and wear and tear will happen. Original equipment manufacturers (OEMs) keep a strong hold on repair-related information for reasons both commercial and quality related. “We believe that no one other than the manufacturer will be able to restore an endoscope back to its original quality. And we want to be able to test the instrument and truly ensure that everything, from the components inside to the assembly, meets specifications,” Agoston says.
However, Agoston also supports biomed departments offering user training and troubleshooting. “It’s more cost effective to teach people how to better handle and care for an endoscope than it would be to train someone to perform the repair on-site, because in most cases maintaining the necessary inventory of parts would not be economical,” he says.
For biomeds, troubleshooting alone can save the facility money. Combined with education and routine checks, an endoscope does not need to cost more over its lifetime than it did to purchase it.
Endoscopes are an investment. Agoston already noted that rigid scopes can cost up to $6,500. Gervais adds that flexible endoscopes cost even more, nearing $50,000 Canadian ($44,300 US).
“The rigid scope is very simple, just a metal shaft with a body. At one end is an ocular, which is strictly an optical device. You can see through it, but in surgical situations, they clamp a camera on the end so images can be placed on a monitor for everyone to see,” says Gervais’ colleague Chris Crowe, biomedical engineering technologist.
At one end, the flexible scope has a light guide connector with an electrical contact that, according to Crowe, lets light into the scope. This is attached to a tube connected to the control body on the other end. “This is where the physician controls the scope with a couple of knobs and switches,” Crowe says. The assembly ends in the insertion tube, which has a bending tip. There is also a biopsy port through which the physician can collect tissue samples.
“Flex scopes were originally optical, but as companies, particularly the Japanese, got into digital cameras, they decided to put cameras in the scopes. In the move from optical to digital, the only way to get an image is to attach a scope to a processor and monitor,” Crowe says.
Gervais notes that in many cases a company will manufacture a processor and a series of scopes that work with it. “Adapters allow them to fit other scopes so they can be used for two or three different series. Eventually, you will need to replace them [the processor and light source]; but for the most part, you can use them for an entire family of scopes. As long as they have the same physical connectors at the end, there is no problem mating them together,” Gervais says.
How often do these components need to be replaced? Chris Skelley, vice president of sales at Fibertech Medical (Hollis, NH), estimates that with proper care and handling, an endoscope can last 5 to 8 years. However, this varies widely. Skelley compares it to estimating how long a car will last. “How many procedures will you be doing a day? How will the scope be reprocessed? Handling can alter the life of a product dramatically,” he says. —RD
Videoscopes require a processor and a light source, which Gervais estimates can cost an additional $50,000 Canadian, making the use of a scope a $100,000 Canadian ($88,611 US) enterprise. These components can be reused with other scopes, but, “The initial cost is prohibitive for smaller facilities,” Gervais says.
There are, however, a wide range of scopes to choose from, varying in type, quality, and cost (see sidebars, below and on page 29). Categories of scopes include rigid, flexible, and semirigid; they may also be fiber-optic or video. The latter are primarily flexible. Agoston observes that the video rigid endoscope is a new category, but not a prevalent one at this time. “There are nuances with each and differences in care and handling that need to be defined,” Agoston says.
Reprocessing is key to scope performance. Not only does it keep the scope sterile, preventing the spread of infection, but it also cleans the dirty parts, such as viewing lenses, that can interfere with performance. Unfortunately, reprocessing can also introduce damage.
“When cleaning scopes, it’s important to follow the manu-facturer’s instructions provided,” Agoston says. Washing by hand versus a machine is recommended for rigid endoscopes, as machine washing can damage a rigid endoscope. The scope can be cleaned with a neutral pH enzymatic solution along with a soft cloth or sponge. If it has a working channel, it must also be brushed with the appropriate-size brush. Particular attention must be paid to the window, which can be wiped clean with alcohol. Incomplete cleaning can result in a film buildup on the windows that can interfere with the image. “I have seen people send a scope in that they think is broken but is really just dirty,” Agoston says. “A film had formed over the lens, so the user couldn’t see clearly.” If cleaning has been done properly, then it may be the water quality, and the hospital will want to investigate.
Agoston recommends checks of the light fibers. “Over time, with sterilization and use, there can be broken fibers which diminish the output. You can check it by holding the scope up to an incandescent light and viewing the light fibers to make sure they are not broken,” he says.
Mary Ross, manager of the biomedical engineering department for Regions Hospital in St Paul, Minn, notes that much of the damage seen on rigid scopes is broken glass rods. “Doctors use them as pry bars, and glass rods don’t flex,” Ross says.
Bends But Also Breaks
Broken image fibers in flexible fiber-optic endoscopes will register as black dots on corresponding images. “There can be anywhere from 4,000 to 8,000 fibers put in a matrix that runs from the distal end all the way to the housing end. If one of them breaks, it will show up as a black dot,” Agoston says.
“Following the manufacturer’s instruction for inspection and cleaning of flexible endoscopes is extremely important,” Agoston says. Cleaning is often done by hand, but a mechanical device, such as an ultrasonic cleaner, may also be used.
Working channels in the scope must be properly cleaned, which includes brushing the working channel with the proper supplies to prevent debris from remaining in the channel. However, KSEA has found that many hospitals do not have the proper brush or the right-size brush to do the job. “The wrong-size brush can damage the channel, but if you don’t use the brush at all, then the scope has not been thoroughly cleaned,” Agoston says.
The light fibers can be checked the same way on a fiber-optic flexible endoscope as they are on a rigid endoscope, according to Agoston.
Prior to decontaminating, the flexible endoscope should also be leak tested to be sure there are no leaks, which would prevent the scope from being properly sterilized.
Crowe notes that flexible endoscopes often suffer wear and tear. “Things like angulation go out and need to be corrected. Eventually, the insertion tubes wear out and must be replaced. The bending rubber at the distal tip, which the physician controls with the unit’s knobs, can wear out or get punctured. Users can knock the tip, and if they hit it hard enough, crack the lenses or damage the camera. If you coil the tube too tight, it can buckle or damage the biopsy channel,” Crowe says.
If a scope is punctured or breached, the entire instrument can be flooded during processing. “A mistake, such as not putting the cap on properly, can allow liquid to flow into the scope, flooding it. If the insides have been exposed to water, the whole internal scope can be damaged or rust and be very expensive to fix, as much as $15,000 [Canadian or $13,402 US],” Crowe says.
For a flooded scope, Ottawa’s biomed team sends the scope out, but it has worked with both the vendor and a third party to develop some in-house skills. “We do minor things, like change the bending rubbers, fix the knobs, or change the biopsy channel, but we send scopes out for big repairs, like changing the tubes, because the work is so complicated,” Crowe says.
Bringing some of the repairs in-house has saved the hospital money directly, as in the cost of repairs, and indirectly, as with instrument availability. “It can take 3 to 5 days to get an endoscope back, creating delays for patients,” Gervais says.
To get around this, the department purchased a number of “loaner units,” a strategy it has successfully applied in other areas. “We are able to supply a similar instrument to the unit within an hour, so for the user, the process is transparent. This gives us time to assess whether we can do the repair in-house or need to send it out,” Gervais says, adding, “More often than not, the repairs are minor and can be done in-house.”
Ross notes that Regions Hospital also does minor repairs in-house and sends more complex problems to a third-party vendor. With no loaner endoscopes in her inventory, Ross cites downtime as a definite disadvantage. Repairs, particularly those that are sent out, can be time-consuming. “We can’t always get a loaner when we need one,” Ross says.
Scoping Out the Body
• Amnioscopes allow examination of the fetus through the cervical canal without breaking the amniotic sac;
But she is happy with her third-party vendor. “Certainly, you take your chances on parts and maintenance with a third party. It may not be done to the same specifications as if sent to the manufacturer, and there are really no warranties, but we’ve had only good luck with our provider,” Ross says.
Luck may have only played a small part. Ross did her homework before selecting the third-party vendor, using the biomed community as a resource during her decision-making process.
Bill Skelley, principal of Fibertech Medical USA (Hollis, NH), prefers “OEM alternative” over third party, and notes there are alternative companies that do not have the qualified technicians or components that meet OEM specifications. “So you can get a cheaper repair, but at a greater cost of ownership,” Skelley says. However, he adds, there are OEM alternatives that do meet specifications and can offer repair that may be less expensive than the OEM.
Agoston has seen the damage wreaked by inexpert repairs. One third-party vendor attempted a repair without the proper-sized rod lenses; its efforts to make the available size work properly affected the quality of the image. “The effect was so significant, a physician filed a formal complaint about the repair,” Agoston says.
Agreeing with Skelley, Agoston states, “Allowing someone else to repair an endoscope to save a few hundred dollars jeopardizes the thousands of dollars spent to acquire the system.”
Putting Endoscopes Under the Scope
At the same time, facilities do not want to spend a lot of money maintaining their scopes. The first way to rein in this expense is to monitor it. Gervais shares that prior to getting involved with endoscope repair, about 4 years ago, the biomed department “had little control and did not know what it was spending its money on.” Working in collaboration with providers and repair outfits, they educated themselves.
“One of the things the hospital didn’t do well initially was look after the cost of repair. With biomed taking it over, we are able to better understand what repairs are needed and educate the users to prevent them from breaking the scopes,” Crowe says. They have found that having a biomed dedicated to the modality helps even more; Crowe fills this role. “As I do repairs, I notice the damage. When breakages are unusual, I know to talk to the staff,” Crowe says.
“Our role has expanded to lending a helping hand with education, because we have a vested interest in minimizing end-user errors,” Gervais says. Training is repeated three or four times per year, along with endoscope checks. “We try to catch problems while they are still small and less costly,” Gervais says.
The pattern seems to work. Chris Skelley, vice president of sales (and Bill’s son), notes that Fibertech will conduct education programs and instrument checks twice per year for clients. “If we go in every 6 months and retrain, and then track repairs, we find education significantly brings down the cost of ownership,” the younger Skelley says.
Agoston recommends biomed inspections of all the areas through which scopes travel, including decontamination, reprocessing, storage, use in the operating room, and transportation. “Each area has the potential for damage, but just by letting people know you will be checking, you will see better care,” he says.
With scopes poised to continue down a digital path, becoming more complex and expensive in the process, better care and maintenance will become even more important. “Facilities that are proactive around education and preventive maintenance can greatly reduce and control their repair costs. Those that don’t will end up spending a lot of money on repairs, frequently more than the cost of the product over its lifetime,” Bill Skelley says, making the repair bill even more misleading than the steel-encased yet fragile endoscope.
Renee DiIulio is a contributing writer for 24×7