The increased use of endoscopic procedures means increased potential for malfunctions, as does the growing sophistication of these devices. Manufacturers and BMETs talk to us about the latest advances in endoscopy and some strategies for keeping them up and running.

Thanks to a 25% annual growth rate in endoscopic procedures nationwide, the typical hospital nowadays utilizes each of its working endoscopes approximately three times per day, up from an average of one time daily just 5 years ago, reports Precision Endoscopy of America Inc.

“The demand for endoscopy procedures has increased,” says Ted Honeywell, president and chief operating officer of the Baltimore-based equipment service company. “The demand will continue to increase over time as the general population ages. As that happens, endoscopy utilization will continue to climb.”

As a consequence, with increased utilization comes increased servicing requirements, Honeywell adds.

“First of all, the more often a scope is used, the more often it undergoes reprocessing,” he warns. “The more it is reprocessed, the more opportunities are created for fluid invasion. Fluid invasion, which causes extreme internal damage, is an endoscope’s number one enemy.”

In the beginning, endoscopes often were reprocessed by immersion in a bath of Betadine solution followed by a quick rinse with isopropyl alcohol. Today, the high-level disinfectant of choice is glutaraldehyde, which is relatively gentle on equipment, says Honeywell. Many institutions prefer sterilization to high-level disinfecting, and for that purpose there are specially designed endoscope sterilization systems.

“All of the disinfecting agents and sterilizing processes claim to meet the current reprocessing standards, but not all are approved for use by the OEMs [original equipment manufacturers] on their individual products because of concerns about harshness and the impact on equipment longevity,” says Honeywell. “Yet, even those agents and processes designed to go easy on the equipment can take a toll on the materials used in endoscopes if they are not used according to label. Equipment has gone to lighter-weight construction, which permits their outer diameters to be smaller. That’s been advantageous because it allows more versatility, more types of procedures. But, in our experience and based on increased frequency of repair, it has also made the instruments more delicate.”

By the same token, rough handling by the personnel performing the reprocessing or by the physicians and nurses using the instrument in the operating room also contributes to the tendency of endoscopes to more often end up in the shop for repairs. It doesn’t help matters that the newer models also tend to be feature rich—a characteristic known to increase the need for periodic adjustment to keep the instruments within spec.

No surprise, then, to hear Honeywell insist that endoscope servicing is serious business.

“Neglect proper care and you’re going to have an instrument that’s either down more frequently than it should be or that doesn’t perform properly when it’s used,” he cautions.

“Either way, throughput will decline, as will revenue. Then, the only things you’ll see going up are patient dissatisfaction and management anger.”

Fluid Situation
Industry insiders suggest biomed intervention can go a long way toward helping minimize work flow disruptions for the practitioners and departments depending on endoscopes. As Honeywell recommends, this can best be accomplished by implementing a program of preventive maintenance in which the instruments are inspected at least once every 3 or 4 months.

“Since the endoscope is a sophisticated medical instrument, a great deal of care needs to be placed in the selection of a service provider to preserve the integrity of the original investment while keeping the cost of repairs under control. To this end, we have experienced significant success in partnering with hospital biomedical personnel in the prevention and reduction of endoscope repairs. I believe that the best repair is no repair, and, prevention and proper service is the key,” says Eddie Garcés, executive director of Endoscopy Service for Olympus America Inc, headquartered in San Jose, Calif.

Preventive maintenance inspections should start with scrutiny of the endoscope’s insertion tube, which typically is subject to the most wear and tear, advises Dan Scalzo, Olympus’ director of Production Operations.

Next, look for signs of impact damage, which could be an indication that the fluid-tight integrity of the instrument has been compromised. “If you actually find any fluid, evacuate it right away,” says Scalzo. “The longer the fluid is present, the more damage it causes.”

The best way to check for fluid invasion is by means of a leak test. One option here is to introduce positive air pressure to the scope’s internal workings and measure it with a pressure gauge; a leak will be indicated if the pressure reading drops, says Honeywell. Alternatively, the scope can be immersed in water and visually assessed for a telltale stream of tiny bubbles emanating from the instrument.

Leak testing actually should be made a chore routinely performed by reprocessor personnel after every utilization of an endoscope, Honeywell suggests. Another recommendation: Obtain professional training in endoscope servicing.

“With appropriate training, biomeds can know how to troubleshoot the systems and resolve problems that normally would require shipment to an OEM or ISO [independent service organization] service center,” says Honeywell. “They also can learn to track repair trends so as to be able to identify service issues and arrange for early interventions geared to keeping equipment operable longer than might be possible otherwise. And they can help make sure that what is transpiring throughout their facility among equipment users and reprocessors is in line with industry standards.”

Chips ‘N’ Dips
Endoscope technology in the years ahead will likely advance in ways guaranteed to make the instruments even more useful and, by extension, more in demand by physicians, hospitals, and their patients. They also should prove easier to service—or, at least, easier to know what is wrong when they stop functioning correctly.

“The evolution that’s occurring combines the therapeutic accessories with the endoscope,” says Eric Halvorson, vice president and general manager of Olympus’ EndoTherapy group, headquartered in Melville, NY. “Traditionally, the endoscope and the therapeutic accessory worked independently as two separate and very different technologies. Coming soon to the marketplace are combination devices that feature the endoscope and the therapeutic accessory integrated as a single working system.”

John Cifarelli, vice president and general manager of Surgical Products for Olympus contends that the biggest current advance in surgical endoscopes revolves around distal-end–video-chip technology.

“Rigid endoscopes usually employ a rod lens, which transfers the image through to the proximal end where the eyepiece is,” Cifarelli explains. “Attempts have been made to improve the resulting image by using cameras. However, the only thing the camera can deliver is what the scope delivers. Yet, the rigid scope hasn’t changed much since its introduction in the 1960s. Its capabilities to deliver an image are essentially the same today as 30 or 40 years ago. So no matter what you put on the proximal end, you’re limited by the limitations of the scope.

“Now, with distal-end–video-chip technology, you’re inserting the image-capture component directly into the patient’s body. That—along with new, deflectable tips allowing never-before-possible angle manipulations—is opening up the arena to some incredible endoscopic capabilities. New procedures, yes. But also improved outcomes for existing ones.”

Already available from Olympus is an endoscopy-integrated video system with onboard self-diagnostics, which apprise biomeds of problems it may be encountering. This makes servicing a more efficient process, company representatives claim. Olympus plans to extend that capability to include a remote uplink that would funnel the diagnostic output into the company’s technical assistance center so that factory service specialists can better help biomeds resolve problems on-site and thereby reduce the likelihood that the instrument will need to be sent off-site for servicing (or for the company to dispatch a field service engineer).

The downside is that these new technologies will likely be more proprietary than in the past. That will mean greater reliance on OEM servicing and perhaps less on work provided by ISOs. Customers might not be delighted by that prospect, since ISOs historically discount their charges by as much as 70% below OEM costs for the same set of repairs. On the other hand, OEM quality of service will remain largely unmatched.

A reason that ISOs have trouble outdoing OEMs when it comes to repair quality is that OEMs are in control of access to replacement parts. That leaves many ISOs to affect repairs with generic, reverse-engineered goods. Challenging enough. But more daunting, says Chris Ciatto, president of clinical technology services at Philadelphia-based Aramark Healthcare Management Services, the practice sometimes drives smaller ISOs to cannibalize trashed equipment in order to procure needed parts. Having then to rely on parts in less than pristine condition means the repairs they make may not hold out as well or as long as would be the case for a service job performed by a vendor with access to brand-new parts.

Trend Lines
Not coincidentally, Ciatto thinks the increased need to rely on OEM support for repairs of next-generation endoscopes could eventually lead to a shakeout among smaller ISOs. Ciatto foresees some of those hardest hit banding together to form service alliances that will give them larger geographic reach and greater combined service capabilities—capabilities sufficient to allow them to remain in the game and thrive.

Another factor that could promote a shakeout might be the trend toward the forming of partnerships between asset managers and large ISOs. Aramark, itself a major asset manager, has done just that with its recent selection of MedServ International, Beltsville, Md, as its preferred provider for endoscope repairs.

“Asset managers will probably be working less often with local service providers,” says Ciatto. “In the days when they did routinely work with those smaller companies, the asset managers took the risk on the quality of repairs. Now and in the future, by working with large ISOs as preferred providers, asset managers will lower their risk. We partnered with MedServ because scopes are a category of equipment with sufficient complexity that getting high-quality, cost-effective, prompt service can be a real challenge. And, frankly, many of our customers were frustrated by that.”

Frustrating too has been the way that some manufacturers have discontinued certain models of endoscopes. “Many hospitals will want to hang on as long as possible to those scopes because superior durability has allowed the facilities to realize a strong return on their investment,” says Precision’s Honeywell. “But they will soon enough discover that the OEMs no longer support those particular products. That will create a number of concerns for hospitals that have depended on OEMs for servicing.

“Meanwhile, the newer models are packing more and more bells and whistles, which introduces the need for more and more servicing requirements.”

Honeywell expects some hospitals will seek to avoid the higher costs of the newest scopes by buying refurbished scopes.

“These previously owned scopes will save money and, if the scopes are adequately refurbished, they will be reliable and represent a real value,” he says. “However, because they are previously owned, they will be more prone to needing repairs, more so than might be the case were they new.”

Still, in the final analysis, whether new, old, refurbished, or over-the-hill, endoscopes are poised to do nothing so much as grow in importance in the years ahead. As will the importance of keeping them on line and ready for use.

Last year, BMET Larry E. Rochowicz, CBET, fielded 109 endoscope service requests from throughout his enterprise, 650-bed Reading Hospital in Reading, Pa. He was able to handle 68% of those orders in-house. The remainder involved repairs of sufficient complexity to require servicing by outside specialists.

Of those he sent out, approximately two thirds were performed by the OEM; the remainder by an independent service organization. There was a reason for this particular division—a good one, insists Rochowicz.

“The strategy I use is to make the ISO the first place a scope is sent if I can’t fix it in-house,” he explains. “What the ISO can do is just about everything the OEM can do, with the main exception being replacement of video-processor chip sets. So when a scope needs major overhaul, I let the ISO do as much with it as possible before forwarding the unit to the OEM for the really big stuff that only the manufacturer is capable of handling. It’s less expensive to have the majority of the overhaul performed by the ISO and then leave just what’s left for the OEM, rather than having the OEM perform the overhaul from beginning to end.

“And, fortunately, between what I can do and what the ISO can do, I can keep a scope running for a couple of years before it needs to go back to the OEM.”

Rochowicz, a senior member of the hospital’s eight-man biomed tech team under the leadership of Michael Kauffman, CBET, was for a number of years a service generalist before he developed a specialization in endoscopes.

“Disassembly and reassembly of scopes isn’t rocket science, but there are tricks of the trade you have to learn first,” Rochowicz says.

Typical problems he encounters include holes in the bending rubber and slipped angulation stoppers (which adversely affects knob chain-drive control operation).

An issue for Rochowicz is turnaround time on farmed out repairs: It takes an average of 18.8 days to get a downed scope back in operation if it must be serviced by the OEM. “The fastest I’ve ever gotten a scope back from OEM servicing was 7 days,” he says.

That compares with an average of 4 days to turn around an endoscope serviced in-house. Rochowicz says he would be able to get them back on line sooner, but can’t since he’s not exclusively dedicated to performing work on endoscopes. Consequently, “if some other piece of equipment of a more critical nature breaks, I have to drop what I’m doing with the scopes—it can be a while before I’m able to pick up where I left off,” he reveals.

To minimize the potential of major malfunctions, Rochowicz has taken the step of training key personnel in the various departments to inspect and leak-test their equipment each time before loading the instruments into the disinfectant or sterilizer system.

“They’re now alert for even the smallest signs of problems,” he says. “If they spot something that doesn’t look quite right, they know to put the scope away and give me a call to come up for a closer examination.”

In this way, trouble gets headed off before it can grow into a serious—and potentially costly—problem.

“It’s definitely cut down on the amount of big repairs we end up having to do,” Rochowicz says.

Once a year, Rochowicz visits each scope-using department to conduct a thorough PM inspection.

“I’ve got an OEM-supplied checklist that I use for this purpose,” he says. “Some of the inspection points the OEM specifies aren’t germane, so I’ve been able to narrow it down to about 15 things I have to look at.”

Among the things he checks are angulation, insertion tube shape, image quality, knob locks, and the fluid-tightness of video-capture controls and mechanisms.

A top concern for Rochowicz is access to replacement parts.

“One of the first scopes I repaired myself had a stretched out electrical connector O-ring that no longer formed a good seal,” he recounts. “I tried to obtain the replacement part from the OEM, but they wouldn’t sell it to me. Generic O-rings were unacceptable substitutes because none were the right size. It was frustrating how difficult it was to get this simple part.” He eventually found what he needed after numerous inquiries to various ISOs.

Occasionally, a new ISO will approach Rochowicz with a bid for some of his repair business. If the prospector seems capable of meeting a need that his customary ISO can’t fulfill, Rochowicz is willing to give the new guy a tumble, but he’s learned to be leery. The last untried ISO returned one scope in good working order, but a second came back with “all kinds of weird problems.” Needless to say, that particular ISO won’t be hearing from Rochowicz any time soon.

—RS

Rich Smith is a contributing writer for 24×7.

Photos courtesy of Precision Endoscopy of America Inc.