Seeing is believing: the present and future of endoscopy

February 27, 2015
by Gus Iversen, Editor in Chief
Medical percussion, the process of tapping a patient’s chest to diagnose conditions of the abdomen and thorax, was popularized by Leopold Auenbrugger in the 18th century. On the strength of that discovery, the era of modern medicine was ushered in, and medical percussion is still practiced to this day.

But compared to the latest in endoscopic advancements, this technique seems “archaic,” according to Paul Wetter, chairman of the Society of Laparoendoscopic Surgeons. He says, “It would seem like standing behind a wall and trying to figure out what’s on the other side.”

For Wetter and his colleagues, rapid advancements in endoscopic technology will soon displace such time-tested approaches. He points to the smart phone — and the notion that it contains greater computing power than the NASA spacecraft that put men on the moon — as evidence of an overarching change in mankind’s relationship with the world. And it isn’t merely a philosophical shift. New offerings from endoscope OEMs are breaking ground in computerized visualization.

That clarity, coupled with smaller scopes with bigger channels and more capable clips, are expediting better outcomes. For gastroenterologists, one of the largest endoscopic specialties, a trend toward in-house pathology is cutting costs and leading to more accurate results. All of these developments, plus improvements to screening protocols and reimbursement guidelines, are making a huge impact on a major patient base.

3-D technology is becoming an increasingly central part of the endoscopy conversation too, and breakthroughs in robotic tools and techniques are not far behind. But, say the experts, there is still a vital role for older refurbished equipment, especially for the reimbursement pressured, budget-conscious facility.

Endoscopy, as a concept, is right at home in the modern health care landscape. By utilizing the latest in computer science, it is accomplishing more — faster — by actually doing less. Those efficiency-oriented outcomes are intrinsic to not only health reform, but life itself in the 21st century.

Evolving quality measures in gastroenterology
With over 11 million colonoscopies being performed in the U.S. every year, Dr. Blair Lewis, a private practice gastroenterologist in New York, calls them the “bread and butter” of endoscopy. And while the number of practicing gastroenterologists is declining, there is no small demand for quality care.

“The challenge is that the number of gastroenterologists is not growing at the pace of the market,” says Doug Ladd, chief marketing officer at EndoChoice. Ladd attributes this, in part, to limited GI fellowship slots and sees a trend — predominately in rural areas — toward general surgeons and family practitioners taking up the slack. He says that shift raises questions about training qualifications, which is something the major medical societies have to address.

Meanwhile, pathology services are emerging that focus on gastroenterology practices. “Big lab players like Quest, Sonic Healthcare, the big national laboratories; they do everything from blood samples, urine samples, hair samples, dermatology samples, and so on,” says Ladd. “As a gastroenterologist, do you want someone evaluating your GI specimen who just reviewed a scalp sample? Or do you want that being looked at by an expert pathologist who has spent the entire day looking at gastro slides?” says Ladd. Lewis credits new quality-assurance databases and information technology advancements with establishing more thorough and effective care standards.

He says a doctor should spend at least six minutes conducting a colon exam because shorter exams are proven to yield fewer polyps and adenomas, and those detection rates are part of the data being collected. Lower polyp detection rates are shown to lead to a high interval colon cancer rate.

“In New York, the Department of Health sends out quarterly reports benchmarking where you stand,” says Lewis. They are evaluating doctors on a number of things: “Ten-year recall numbers, adenoma detection rates, examination time, completeness of exam, and quality of exam,” he says. “Screening every ten years helps wipe out 80 percent of colon cancer deaths,” says Lewis, but over-screening can lead to unnecessary expenses. It has been shown that many doctors do not follow national guidelines and that excessive screening can be a costly problem in its own right.

“The only exceptions are if you find polyps or there is high risk, or colon cancer in the family,” says Lewis, which would indicate the need for more frequent screenings. There are also new quality measures that make doctors responsible for their patient’s prep, which in previous years had not been the case. If a patient shows up for a colonscopy but they haven’t been properly prepped, (usually with a liquid diet or something to clear the bowel) then time and money are wasted.

“The cleansing of the bowel before the procedure is important because if it’s not effective then it’s hard to see lesions in the colon,” says Philip Doyle, director of marketing, gastroenterology at Olympus, who anticipates preparation becoming an increasingly important topic in coming years.

According to Lewis, this emphasis on prep has opened the door to a new kind of third-party business that helps patients along that process. “They call, text, or e-mail the patient several times leading up to the exam to make sure they’re following directions,” he says.

The more cameras the better
Quality measures aside, new tools from the major manufacturers are also contributing to better patient outcomes. Doyle says his company’s EVIS EXERA III has been shown in some studies to detect polyps at double the rate of the standard accepted threshold. It is also proven to provide faster insertion into the colon and therefore may lead to increased throughput while minimizing anesthesia requirements.

On the miniaturization front, more imagers are enabling a wider angle of view, and additional cameras are being fixed to the scopes. “It’s about seeing more,” says EndoChoice’s Ladd, “You can’t fix a problem you can’t see.”

The latest suite of equipment from EndoChoice, the second generation of their Fuse system, features a three-camera colonoscope and a two-camera gastroscope presented on a widescreen 4K Ultra HD monitor. “In three to five years, will anyone buy a single camera scope for upper or lower flexible endoscopy? I can’t comprehend that happening,” says Ladd.

Dr. Lewis echoes that sentiment, “Having three cameras will be the way of the future. All manufacturers will move to this technology because you can see more.” And while some companies are beginning to offer 3-D tools, Ladd questions the ratio of cost-to-benefit. “The challenge of today’s 3-D technology is that it requires the doctor to wear different glasses,” he says. Those glasses, coupled with the need for specific viewing angles, are principal drawbacks to 3-D.

“And being able to see in 3-D does not necessarily increase ability to find something,” says Ladd. Despite his skepticism, he did allude to some 3-D developments at EndoChoice that he was not at liberty to discuss. Wetter, of the Society of Laparoendoscopic Surgeons, looks at 3-D as one part of a much bigger picture. “It’s really an improvement in visualization— and that’s computer driven.” He expects that kind of computer assisted procedure to become more and more standard going forward.

Ladd notices another overarching trend in the next generation of scopes, “As microchip technology and lighting technology gets better, working channels will get larger, enabling clinicians to get larger tools that allow them to do more through their endoscopes.” A greater channel allows for more versatile clips. As one example, “If a doctor is looking at an aggressive upper GI bleeder, or they did a polypectomy and got a very large open defect in the mucosa as a result of it, you don’t really have a good way to close that with today’s clips,” says Ladd.

Olympus is now marketing the QuickClip Pro, which is a rotatable clip with the ability to open and close. “Basically, you’re talking about a very long shaft where the working end is down in the body and the control end is several feet away in the hands of the physician or nurse,” says Olympus’ Doyle, “So to be able to rotate from outside the body and precisely position the clip with the edges of a defect or bleed is an important and fairly unique capability.”

Robotic or computer-assisted developments
Ladd says that the overwhelming majority of endoscopic procedures are relatively straightforward and that robotics is still primarily a topic of interest reserved for the academic and research side of things.

“Making it practical for the average gastroenterologist who does eight procedures per day of moderate complexity, it’s probably not something that will become realistic and usable to them for another five to 10 years,” says Ladd.

Lewis says that while there have been attempts at robotic colonoscopy, none have been successful. The consensus, however, is that the popularization of robotics in an endoscopic setting is more a question of when than if.

“Robotics is one of the most important and misunderstood areas of surgery,” says Wetter, of the Society of Laparoendoscopic Surgeons, “99.99 percent of robotic surgery is really computer assisted surgery.” Meaning the surgeon is doing the surgery — not a robot. “The reason there has been this discussion about robotics is that we haven’t seen big changes recently,” says Wetter, who mentions the da Vinci Surgical System from Intuitive Surgical as an example, but says that system had so many patents associated with it that the competition was stifled. He thinks that will change soon. “There is no question that the idea of the computer chip and its enhancement make better surgeons, just as the way a car now has computer assist on the brakes, steering, and safety features,” says Wetter.

New life for used equipment
Not every physician or facility can afford the newest equipment, so they may explore fully refurbished alternatives. Consequently, a number of companies, including OEMs, have tapped into that growing market. Olympus, the market leader in Endoscopy, is in a particularly good position to help fulfill the demand for certified pre-owned (CPO) scopes.

“We fully refurbish all of our CPO scopes with original Olympus parts that are installed by extensively trained technicians in our National Service Center in Silicon Valley,” says Tonya Resutek, CPO product manager at Olympus.

Resutek says the original manufacturer specifications for their endoscopes are proprietary information that a third-party seller would not have access to. “All of our certified pre-owned (CPO) endoscopes get a certain list of brand new OEM parts installed on them,” says Resutek, which include new insertion tubes, angulation wires, and channels, “Then it’s packaged up and we provide a warranty just the same as we would a new product.”

Infection control
While smaller incisions are typically associated with lower infection rates, an unsanitary endoscopic procedure carries infection risks of serious consequence. Diseases like Hepatitis C, HIV, and other blood-borne pathogens are all within the realm of possibility and ensuring a clean procedure and scope is of paramount importance.

Ladd says national guidelines from the SGNA and OSHA have established standards and protocols to help limit the incidence of cross-contamination. And although infections related to endoscopy are pretty well under control, when one does happen it can result in some high profile bad press for the treating facility. Olympus provides its end-users with a manual devoted to reprocessing and also provides a large field-based team and other resources for training and technical support for reprocessing. “We put a lot of effort into making sure that protocols are clearly spelled out so people don’t have mistakes that could lead to contamination,” says Doyle.

“If you follow the process for cleaning a scope post-procedure, you’re certain to put a clean scope into the next patient,” says Ladd, “When the process fails, that’s when you don’t know.” Doyle says patients undergoing certain advanced endoscopic procedures may already have increased likelihood of acquiring an infection because they are generally already not well, so, “It’s crucial that people follow all the required steps.”

“There is a 3M Clean-Trace product that came out a year or two ago that measures a chemical compound called ATP, which is residual of bacteria,” says Lewis. “You can wipe down an instrument, put it through the machine, and it will tell you if instrument has been adequately manually cleaned.”

Lewis also says new software tracks an instrument so that if you pick it up you can see the recent history on who cleaned it and when it was cleaned, which may tie in to the overall trend toward greater accountability in endoscopy and health care.

The endoscopy of tomorrow
Despite the uncertainties faced by gastroenterologists, (a group he calls “an aging subspecialty”), Lewis describes himself as “upbeat” about the changes happening in the industry. For him, it’s the new regulations and care standards that are creating better outcomes, just as much as, if not more than, new tools. Lewis also says that there has been discussion in the industry of establishing companies where patients can go for all preparation and gastroenterological testing, such as blood work, stool testing, and sonograms. They have not materialized yet, but the increase in GI-only pathology labs may be an indication that it’s coming. Doyle, with Olympus, says that while there is still a lot of screening and diagnosis going on, “Therapeutic or interventional treatments have grown over the years.” He notices more and more formerly surgical procedures becoming outpatient endoscopic procedures, and expects that trend to continue.

Ladd, with EndoChoice, foresees a near future with full spectrum endoscopes using larger channels, better tools, and the emergence of versatile, multi-channel capabilities.

Wetter, with the Society of Laparoendoscopic Surgeons, describes a recent visit to an ear, nose and throat (ENT) doctor. “Right there in the office they had a miniature scope and looked right into my sinus, and in five minutes it was done. All new technologies start with the elite and then if it’s useful they go down, so I wouldn’t be surprised if down the road even more family doctors will be doing certain types of endoscopy.”

Meanwhile, Wetter says simulation systems are already starting to allow new surgeons to perform their first procedures on virtual patients. He sees this as a logical step in a movement toward computerization. “We’re getting very close to the point where a surgeon’s capabilities can be checked using simulation,” says Wetter, “Airline pilots do the same thing.”

And from there, as with airline pilots, the sky is the limit. Wetter foresees a future beyond incisions altogether, where what was once minimally invasive will become non-invasive, and there will be no cutting whatsoever.

DOTmed Registered Endoscopy Companies


Names in boldface are Premium Listings.
Domestic
Joe Kruizenga, Northbay Networks, CA
Sterling Silver, GI Lab Supply, IA
Chris Barnett, Medical Equipment Services Inc., IL
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Alison Fortin, Global Inventory Management, NH
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DOTmed 100
Adam Rudinger, Lex-Tech, Inc., NY
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Scott Scholl, Medical Inventory Control, OK
Manish Ingle, NOVAPROBE INC., PA
Sean McCauley, Surgical Device Repair Inc., TN
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Robert Overmars, BPI Medical, Inc., WA
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International
Juan Carlos Liga, EndoMedical Group SRL, Argentina
Rahul Shah, Emergent Technologies, India