Today's SurgiCenter - The Pulse of Endoscopy

The Pulse of Endoscopy

By John Roark

Not only are hospitals experiencing a nursing shortage in the wake of an aging baby boomer generation, a paucity of healthcare providers, rising costs, and decreasing government reimbursements also factor into the big picture. These challenges have touched gastroenterological medicine as well — there is a growing concern about the numbers of GI manpower in general.

“It’s a significant problem,” says Stan Branch, MD, director of the endoscopy unit at Duke University. “Back in the early 1990s we were told that we needed to cut our training programs in half. Everybody thought that managed care was going to reduce the need for GI. A workforce study was done in the early ‘90s, and quotes were coming out saying gastroenterologists were going to be standing on corners with tin cups. We, like most big programs in the country, cut our training programs in half. Now there’s a crying demand for gastroenterologists, because we can’t do all these screening procedures. We’ve got a waiting list that’s just ridiculous. How do we provide the healthcare providers to do all of this? Are we eventually going to be training mid-level people to do colonoscopy?

“There certainly are people doing endoscopy out there that you worry about. If a hospital grants you privileges, you can do whatever they grant you privileges for. There are people doing endoscopy who haven’t been trained as gastroenterologists — that’s a very political issue. My worry is this: if more people get screened, more people are going to need colonoscopies who have got polyps that need to be removed. How do we put the manpower out there? There’s potentially going to be a doctor shortage in this country. There’s certainly a nursing shortage now.”

The big struggle for teaching hospitals, says Branch, is the lack of money and resources to train more people. “We’re not getting money from Medicare to help pay for fellowships to help train people. We’re in the struggle of being told we need to compete and be efficient like private practice, generate income for the teaching center, and do all of our academic missions. Manpower is a big issue. And for me, recruiting people who may want to go into gastroenterology in academics, it’s difficult. There are not that many people there, and the academic center just can’t pay what’s paid in private practice.”

Branch recognizes a corollary between medical malpractice and the low number of new docs entering the workforce. “I think people are more nervous. The cost is one thing, but the terror of going through being sued is a horrible thing,” he says. “Fortunately, I’ve not experienced it, but I’ve seen it. That certainly is driving up the cost. We cover the malpractice for all of our trainees — and that adds $100,000 a year to our budget. Where do we get that? Whose pocket does that come out of?”

Proper cleaning and processing of endoscopes is paramount in preventing nosocomial infection caused by both patient-borne and environmental pathogens, says Lawrence Muscarella, PhD, chief, infection control at Custom Ultrasonics, Inc. In February 2003, the Association of periOperative Registered Nurses (AORN) published its Recommended Practices for Cleaning and Processing Endoscopes and Endoscope Accessories.¹

These guidelines are inconsistent with guidelines published by other organizations, and have led to confusion, says Muscarella. “It’s important that healthcare staff have guidelines that are consistent, that send the same message and recommend the same practices. There was a multi-society guideline published in July 2003 that AORN endorsed. Nevertheless, it contains recommendations that are different from AORN’s recommended practices for reprocessing endoscopes. There’s really no need for the confusion, and as a result you can get variations in the standard of care and increases in the risk of patient injury.

“If nothing else, the professional organizations need to send consistent messages. One thing that would be important is when writing a guideline, first review other organizations’ guidelines, and use them as a template. Deviations from a guideline may be acceptable, but only if compelling evidence-based rationale is provided. I see deviations and inconsistencies in recommendations that have no rationale for going off in their own direction — I’m not really clear on why this happens.”

Concern, says Muscarella, lies in AORN’s recommendation that endoscopes should be dried only before storage and after high-level disinfection (or after a tap water rinse) using a 70 percent to 90 percent ethyl or isopropyl alcohol rinse followed by forced air. “This recommended practice is arguably incomplete and may fall short of AORN’s laudable goal to establish an ‘optimal level of practice’ and to achieve ‘optimal outcomes for patients undergoing operative and other invasive procedures.’ ²

“AORN does not recommend drying the endoscope between patient procedures after either high-level disinfection or liquid sterilization,” continues Muscarella. “Nor does AORN recommend drying the endoscope before storage and after liquid sterilization or a sterile water rinse. Instead, to minimize the risk of nosocomial infection due to bacterial colonization in the endoscope’s internal channels during overnight storage or idle ‘down-time,’ AORN recommends reprocessing every endoscope immediately before its first use of the day (and immediately before each subsequent use throughout the day.)”

But this early morning practice can be time-consuming and prohibitively expensive, making it impractical for many endoscopy centers.

“This is an issue that needs to be resolved, particularly in the OR setting. What is the position: do endoscopes need to be dried or not? There’s inconsistency in published guidelines,” says Muscarella. There is no reason to reinvent the wheel, he says. “Just follow SGNA’s (Society of Gastroenterology Nurses and Associates) all-inclusive recommendation, which is evidence-based and recommends drying the endoscope after every reprocessing cycle, whether between patient procedures or before storage, and irrespective of the water quality or label claim of the endoscope reprocessor. If this is done, bacterial infections linked to contaminated endoscopes are unlikely to be reported.”

Another hot spot, says Muscarella, is reprocessing errors. It is essential that the staff is adequately funded, sufficiently educated and that a quality control program is in place to make sure that all of the necessary endoscope reprocessing steps are being done and that a disinfectant of the appropriate concentration is used.

“When there are different endoscope models coming in to be reprocessed, maybe the technician has been trained on the bronchoscope, which has only one channel. But that doesn’t help the technician to know how to process an ERCP endoscope, which has four internal channels. Different endoscope models require different training.”

Muscarella cites another recurring issue that has many implications to the standard of care: “Hospitals typically will monitor the disinfectant only once in the morning before the first patient. They usually don’t monitor it after every patient throughout the day, which they probably should be doing. Let’s say they’re doing 15 procedures a day. It can be argued that they then should be monitoring the disinfectant 15 times, but hospitals generally do it only once. The problem is, if they do it first thing in the morning on a Monday and it’s fine, and then they check it on a Tuesday and it fails, that means that the results are only as good as the previous passing test, which was Monday morning.

“Let’s assume worst-case scenario: Monday’s first patient was OK, because you tested the disinfectant before the first patient. But it could have failed just prior to the second patient. You have to assume that. So the second through the 15th patients could have been exposed to potentially pathogenic microorganisms. What does the hospital do? Does it let this go under the radar and not do anything about it? Or does it notify each patient? This happens a lot more than people think. It’s an example of a quality control that probably should be in place.”

What do the guidelines say? “They kind of skirt the issue,” says Muscarella. “They say to monitor the reusable disinfectant just once a day or more if needed depending on the volume and workload and the number of scopes being reprocessed. But that’s vague — not everyone knows what that means.

“I get a lot of calls from hospitals that say they didn’t monitor the disinfectant. Or they switched from one disinfectant to another and thought that the soaking times and temperatures were the same. Then they found out later they weren’t the same. There’s an example of some kind of quality control that goofed. People tend to think that in endoscopy you have a lot of room to work with. I disagree. Patient safety must come first.”

“The care and cleaning of the scopes are a big, big deal,” says Linda Hylind, BS, RN, an endoscopy clinical nurse and research clinical nurse at Johns Hopkins University, and regional president-elect of the Chesapeake Society of Gastroenterology Nurses & Associates (CSGNA). “A vital part of infection control is having a company come in and do competencies once a year on their equipment, going through everything with the staff and making sure everything is being cleaned properly. Inservices are key. If you get a new scope with a new attachment, does everyone know how it works and how to clean it? Education and infection control go hand in hand.”

Still, Hylind is optimistic that things are headed in the right direction. “You see a lot more being published on infection control in endoscopy. I think it’s coming up to the forefront. I think everybody is trying to be on the same wavelength.”

There is no denying that there is an increased awareness of colon cancer, a subject that used to be cloaked in silence. “People feel a lot more comfortable talking about it,” says Hylind. “Colon cancer and colonoscopy used to be things you would never talk about. Some people say that the rates haven’t gone down, but what’s important to note is that they’re finding things sooner. There’s so much more awareness out there now. There are guidelines for people who have hereditary or family history of colon cancer. I think awareness is the key thing. People are more aware and not afraid to talk about it.”

Hylind credits the “The Katie Couric Effect” as a major force in raising consciousness about colon cancer. After Couric had an on-air colonoscopy in 2000, the number of people having colonoscopies increased by 20 percent nationally. “Katie’s effort really put things to the forefront. She’s made an enormous impact,” says Hylind.

Branch agrees that a once “not-ready-forprime- time” subject has gained a more prominent awareness. “Most primary care physicians are in tune with it and talk to their patients about appropriate screening. I think people are much more informed about screening, with all of the press information that’s out there,” he says. “Patients are very savvy. We did a survey of our patients coming through our clinic. About 70 percent had gone to the web and looked up some sort of information. Patients are very informationhungry, but unfortunately can get mixed information.” To that end, Branch’s clinic has posted a list of Web sites deemed to have quality information for patient inquiry. “The chat rooms are the cans of worms,” he says. “That’s where it gets dangerous.”

More and more procedures, especially in the realm of general surgery, are becoming minimally invasive. Vascular surgeons are turning to endoscopic procedures, using stents instead of bypass grafts when possible. In orthopedics, smaller incisions are used in joint replacement.

“As technology keeps progressing, we’re doing more and more through areas of access that are less and less,” says Annette Wasielewski, RN, BSN, CNOR, manager of minimally invasive surgery at Hackensack University Medical Center. “The images we first had when they first started doing gallbladders were minimal at best. There was always an issue with light, and you couldn’t see as clearly. Today we’re using digital cameras and getting tremendous vision, and for many procedures we actually can see better doing it laparoscopically than the surgeon can do in doing an open procedure. We can get right up there. You have a magnified image.”

The new frontier in therapeutic endoscopy is minimally invasive surgeries, says Branch.

“Taking things that have been and are presently in the surgical realm, can we do some of those things in a less invasive way with endoscopy? I think those things are coming down the pike. Some of the fundoplication therapies are already approved, though the data to support those is not as good as everyone would like. I think that’s still in evolution.

“Other areas of endoscopy are potentially improving our abilities to make diagnosis of malignancies, or pre-malignant lesions. Barrett’s esophagus is a good example — are there ways endoscopically to screen Barrett’s more efficiently or effectively and try to find areas that are pre-malignant or have a high chance of malignancy? If we can pick those things up earlier, we can provide better treatment.

“Endoscopy is a diagnostic tool that will evolve into a therapeutic tool,” continues Branch, who cites endoscopic ultrasound as a prime example. “EUS is primarily a diagnostic tool now, but we’re beginning to do more with it — therapies we can do using EUS, at least as a guide. And whether eventually we can use high frequency ultrasound (HIFU) as a therapy.”

Branch notes that there have been advances in new imaging techniques using different wavelengths of light to help screen for malignancies or pre-malignant lesions.

“In the past we’ve sprayed dyes on things to see if we could separate where the tissue is pre-malignant or not,” he says. “There are newer ways of looking at how light reflects back. As the endoscope and the processor are emerging with the computer world, you’re starting to be able to look at what information you can get back from a chip, and how you can process that information. When this all started out, you’d look through a fiberoptic bundle, and what you saw with your eyes is what you saw. It’s evolved, and now it’s all predominantly video chip-driven.

Now, can we get higher definition with these video chips and maybe subtract a wavelength out, or pick up a wavelength that we normally don’t see with our eye? And does that tell us more about the lining, and is this lining developing changes that could be pre-malignant? Can we do something about it at an earlier point?”

Bard Interventional Products has developed an incisionless therapeutic option for the treatment of GERD called the EndoCinch™ suturing system. Endoluminal gastroplication works by creating plications, or pleats, at the lower esophageal sphincter (LES). Performing the procedure has been shown to significantly improve symptoms and regurgitation while reducing or eliminating patients’ dependence on acid controlling medications.

It works like this: the EndoCinch device, like a tiny sewing machine, is attached to the end of a standard, flexible endoscope. The suturing system allows the physician to place a suture near the LES. Two stitches can be placed and tied together to create a pleat near the LES and treat symptomatic reflux.³

Although standard endoscopes provide some magnification, the resolving power is insufficient for observing subtle mucosal details. Magnification endoscopy, with or without dye spraying, has been developed for this purpose, allowing fine topographical details to be seen. Magnification has been primarily studied in the colon using dye spraying to clarify abnormalities already seen by conventional endoscopy. Using dye spraying, experts can differentiate adenomatous versus hyperplastic polyps.

CT colonography is performed using rapid helical CT scanning and software to view the colon, which is inflated with room air or carbon dioxide. Its use has been controversial since the concept was first described in 1994. “We’re trying to avoid using the term ‘virtual colonoscopy’ because it really isn’t anything like that,” says Christopher J. Gostout, MD, president of the American Society for Gastrointestinal Endoscopy (ASGE), and professor of medicine at the Mayo Clinic College of Medicine.

Is colonography a valid approach to screening for colorectal cancer? “It has a role,” says Gostout. “We have an obligation to effectively screen our population for colorectal cancer. All possibilities for screening should be looked at, and should be supported. I don’t think we should have a negative view toward CT colonography. There are some shortcomings to it right now; we need a lot more experience with it. More refinement needs to go into the technique, to the software.”

In December 2003, a study published in the New England Journal of Medicine (NEJM) demonstrated that CT colonography with a three-dimensional approach was an accurate means of screening for colorectal neoplasia in asymptomatic average-risk patients.

“The article in the NEJM represents one of the latest developments in using this method, especially software and fly-through capability, but not everyone has that,” Gostout observes. “There are issues such as still needing to give a patient a full bowel prep. It’s not necessarily a comfortable procedure; one’s colon is filled up with air like a balloon. I think gastroenterologists should embrace CT colography and determine when to use it appropriately. But right now, the issues of cost, the technology itself and the time involved for interpretation are keeping it from being a widespread screening technique.

“It’s an exciting technology, and it’s still in the process of evolution or development,” Gostout says. “Since we are attempting to in effect do a colonoscopy-like examination using CT scanning, who’s going to interpret CT colography? Maybe it’s best off being interpreted by gastroenterologists as opposed to radiologists. There are going to be some very interesting developments occurring as this technology moves along and gains experience.”

A multi-center study by Cotton et al. published in the Journal of the American Medical Association comparing standard colonoscopy with CT colonography for the detection of colorectal cancer revealed that this technology, in the form used most often in the United States, while of significant interest, is not presently a viable option for routine colorectal cancer screening.

The study found that the sensitivity of CT colonography for detecting patients with one or more lesions sized at least 6 mm was 39 percent, and for lesions sized at least 10 mm it was 55 percent; this compared with 99 percent and 100 percent respectively when examined using conventional, or complete colonoscopy. Only marginal improvements occurred when the 3-dimensional results were evaluated. These findings contrast sharply with findings by Pickhardt et al. published in the New England Journal of Medicine in December 2003.

One of the new study’s co-authors, Douglas K. Rex, M.D., FACG, current president of the American College of Gastroenterology and director of endoscopy at Indiana University Hospital in Indianapolis, comments, “This is the third largest study in the literature. Other studies using 2-D imaging had equally poor results. Given these disparate results, we need to see verification of the results obtained in the Pickhardt study using new methods before CT colonography can be considered as appropriate for colorectal cancer screening.”⁶