Douglas G. Adler, MD, is an advanced endoscopist who performs up to 700 endoscopic retrograde cholangiopancreatography procedures annually.
He first heard rumors of a fully disposable duodenoscope — the device used for ERCP — more than a decade ago.
“This is a notion that has come and gone a few times, but now it’s really here in our hands,” Dr. Adler said. “It’s sort of like how I imagine when they went from propeller planes to jet aircraft.”
Dr. Adler was the first physician to use the fully disposable duodenoscope from Ambu Inc., the world’s leading single-use endoscope supplier, on a patient. Single-use duodenoscopes are brand new to the GI suite and only two models have obtained U.S. Food and Drug Administration 510(k) clearance since the agency recommended an industry switch to partially or fully disposable duodenoscopes in August 2019. These recommendations resulted from growing concern around multi- drug resistant bacteria transmission from contaminated devices.
But the rationale for transitioning to single-use endoscopy extends beyond the perhaps obvious benefit of eliminating device-related infections and outbreaks. From clinical, patient and financial perspectives, single-use endoscopes offer healthcare organizations a more comprehensive way to improve outcomes and patient experience while lowering costs and improving efficiency.
Quality performance in a portable platform
More than 75 million endoscopies are performed in the U.S. annually. Endoscopes are comprised of long, often flexible, working channels that enable clinicians to diagnose and treat ailments in hollow cavities of the body, including the lungs, digestive tract, urinary system and uterus.
While less invasive than surgery, endoscopy is not without its risks and endoscope performance is paramount to success. To illustrate this point, Dr. Adler likens using a duodenoscope for ERCP — arguably one of the most difficult endoscopic procedures — to driving a car, in that you only think about the vehicle if something is not working properly.
After a while, “we weren’t really focusing on the scope very much; we were mostly just doing the case,” Dr. Adler said of his first trials of Ambu’s duodenoscope. “It’s really impressive, there’s no other way to put it.”
Ali Tabatabai, MD, an intensivist in Baltimore, Md., said Ambu’s single-use bronchoscopes have played a central role in his work throughout the ongoing COVID-19 pandemic. The combined single-use bronchoscope and closed-loop sampling system for bronchoalveolar lavage have also helped protect his colleagues from the virus during a time of heightened healthcare worker risk, he said.
“Everything else being equal, the disposable scope gives you that added measure of safety,” Dr. Tabatabai said.
Ambu created the world’s first single-use bronchoscope in 2009 and plans to introduce the fifth generation of that bronchoscope line later this year. Frost & Sullivan recently awarded Ambu the Global New Product Innovation Award and described the company as the “most innovative single-use endoscopy player in the market.”
Many institutions, Dr. Tabatabai added, lack a video tower for reusable bronchoscopes in every ICU, so essential staff may be redirected off the floor for extended periods to track down necessary equipment. Alternatively, Ambu’s single-use bronchoscopes and compact display monitors are easily stored and are set up in a fraction of the time. Ambu’s plug-and-play model has proven invaluable in minimizing treatment delay in intensive care.
“The more pieces of equipment that you have in a setup, the greater the chances that something will be malfunctioning or not available,” Dr. Tabatabai added.
Large, cumbersome video towers and display systems make it harder to do inpatient consults as well, said Seth K. Bechis, MD, an associate clinical professor of urology at UC San Diego Health. The convenience and quality of Ambu’s platform has enabled him and the residents in his hospital practice to perform cystoscopy for inpatient consults which might otherwise have required a separate outpatient clinic visit.
“What I like is, every time you open a scope, you know it’s going to have a brand-new deflection,” Dr. Bechis said, referring to a urologist’s ability to control the tip of a cystoscope, a function in reusable endoscopes that typically deteriorates over time. “The reliability of knowing every time that it’s fresh out of the box, brand new, is very attractive.”
Easing patient concerns
Faster set-up times, and eliminating the need for complex, time-consuming disinfection between procedures, reduces patient wait times and increases procedural volume both on the hospital floor and in outpatient clinics. Dr. Bechis has reduced patient appointment intervals from one hour to 15 minutes since he switched to exclusively using Ambu’s single- use cystoscopes in one of his outpatient clinics, he said. In addition, he is able to offer cystoscopy procedures to patients in satellite clinics that do not have the capability to sterilize reusable scopes.
“As hospitals branch out and continue to expand, there’s an emphasis on providing good clinical services in the outpatient setting and satellite clinics,” he said. “Having the single-use scope system has been huge.”
Increasing available appointments will help manage the procedural backlog brought on by the ongoing COVID-19 pandemic and puts patients at ease regarding their safety, Dr. Bechis added. “In the time of COVID, I think patients really appreciate the idea of a disposable, single-use scope that has not been used on another person.”
Fears of cross-contamination, however, pre-date the COVID-19 era. While more high-profile media reports have exposed duodenoscope-associated infections and related deaths, patients have begun to question the cross-contamination risk involved in other areas of GI endoscopy, Dr. Adler said, particularly healthy colonoscopy patients in for a cancer screening.
Because all reusable endoscopes need reprocessing, the complex process of cleaning, disinfecting or sterilization equipment for use, they carry a risk for patient cross- contamination and subsequent infection. Multidrug-resistant bacterial infections have been traced back to patient-ready duodenoscopes, bronchoscopes and cystoscopes. FDA post market surveillance studies point to inconsistencies in reprocessing success, the complexity of reprocessing such delicate instruments, as well as the time pressures on technicians that may cause vital steps to be skipped or performed poorly.
“Before a few years ago, we never really thought about it. I mean, literally never thought about it,” Dr. Adler said of device- related infection in GI endoscopy.
That was before some highly-regarded institutions reported instances of duodenoscope-associated infection from multidrug-resistant bacteria.
“As clinicians, you have to have a healthy respect for these organisms,” Dr. Adler said. “It really can happen to you.”
Cost transparency in single-use
News coverage of infection outbreaks can damage an institution’s reputation. Negative attention might drive patients to other hospitals and providers, leading to a financial hit as well as other losses that are difficult to quantify.
“Everybody who knows anything about this is very, very afraid of the possibility of this happening to their patients and in their hospital system,” Dr. Adler said. “If you have an outbreak in your hospital, you will never, ever forget it.”
It is similarly challenging to put a dollar amount on the impact to a healthcare system should patients need readmission or further treatment for endoscope-associated infection, according to Russ Montgomery, director of health economics and market access at Ambu. That’s why, when reviewing cost drivers in endoscopy, Mr. Montgomery focuses on transparency.
Repair and maintenance of sterile processing equipment, the chemicals used, and the personal protective equipment worn by cleaning personnel all contribute to reprocessing expenses. Ongoing training and labor costs must also be accounted for. Mr. Montgomery said it is hard to measure the efficacy of the sterile processing unit or if institutions are getting the full value out of outside contracts associated with endoscope reprocessing and repair.
“With single-use you know what you’re spending, you know what you’re getting,” he said. “Many don’t fully appreciate all that they’re spending already for reusables because the costs are distributed across different budgets within the hospital.”
Endoscopes are delicate and can get damaged being transported to or set up for a procedure — not to mention during the examination itself. If an accident occurs mid- procedure, such as a patient biting through a scope when not fully anesthetized, valuable time is also lost as staff search for a new endoscope to complete the procedure, Dr. Tabatabai said.
Instead of damaging a piece of equipment “that is relatively irreplaceable in real time” and running into the tens of thousands of dollars, damaging a single-use bronchoscope is “less of a big deal,” he said.
When considering the depreciating capital investment of reusable endoscopes and subsequent reprocessing and repairs, single-use endoscopy for many facilities is cost neutral or even saves money, according to Mr. Montgomery. Adding the operational benefits of single-use endoscopes and the reduced risk of exogenous patient infection makes single-use a clear, cost-effective solution.
‘The ultimate disruptive technology’
Single-use endoscopy ensures quality care, reduces patient infection risk, and increases potential procedural volume. Sterile equipment that provides reliable performance in an easily portable platform helps clinicians better serve their patients.
And as hospitals recover from the impacts of the ongoing COVID-19 pandemic, single-use endoscopes also provide a cost-effective patient safety solution.
“There is some impetus behind trying to minimize, however we can, the risk of transmitting infectious diseases between patients,” he added. “A disposable product is a natural evolution of that concept.”
Today, Ambu’s complete line of single-use endoscopes includes duodenoscopes, rhinolaryngoscopes, bronchoscopes and cystoscopes. Ambu plans to quadruple its innovation pipeline and launch more than 20 new flexible endoscopy products in the next three years. More than 1 million Ambu single-use endoscopes were sold in fiscal year 2020.
“It is a big shakeup for the market,” Dr. Adler said of single-use endoscopes. “I call it the ultimate disruptive technology.
This article was sponsored by Ambu.