Archive April 2019 XX, No. 4

Thinking of Buying... Single-Use Urology Scopes

Are one-and-done cystoscopes and ureteroscopes right for you?

Joe Paone

BIO

There aren't many versions available in the U.S. right now, but single-use, disposable cystoscopes and ureteroscopes are beginning to make an impact in outpatient surgery.

You'll need to perform your own cost-benefit analysis to determine if one-and-done urology scopes are right for your facility. Consider this when you're doing the math, however: Single-use scopes don't need to be repaired, maintained or reprocessed, and by their very nature, it's impossible for their performance to degrade over time. And from an infection control perspective, you completely eliminate the risk of using a reprocessed scope you might think is sterile or disinfected, but actually isn't. Another factor to consider in a cost-benefit analysis: Because reprocessing is entirely removed from the equation, the ease of simply opening a new package for each procedure can make the exam process more efficient and presents the possibility that you can schedule more cases on a given day.

The American Urological Association's Journal of Urology published a Mayo Clinic study in March 2017, "The Economic Implications of a Reusable Flexible Digital Ureteroscope: A Cost-Benefit Analysis" (osmag.net/FqvCC3), that compared real-world use of single-use and reusable flexible ureteroscopes over a 12-month trial. The authors concluded that "a disposable ureteroscope may be cost beneficial at centers with a lower case volume per year. However, institutions with a high volume of cases may find reusable ureteroscopes cost beneficial."

A cost-benefit analysis published in May 2018 by the BJU International journal, "Single-use disposable digital flexible ureteroscopes: an ex vivo assessment and cost analysis" (osmag.net/5YQzzH), added that the "urologist may consider using the [single-use] scope in cases in which reusable scope damage is anticipated."

Picking up on that point, a June 2018 Thomas Jefferson University study, "Bad Out of the Box: A Report on Pre-operative Failure Rates of Reusable Flexible Ureteroscopes at a Single Institution" (osmag.net/jM8RPp), said that when evaluating single-use versus reusables, often overlooked is how often urologists encounter an unsuitable reusable flexible ureteroscope at the beginning of a case. The subsequent 3-month trial found that single-use scopes could fill "an essential and immediate role" because roughly 1 in 8 initially opened reusable flexible ureteroscopes weren't fit for use.

As far as how well single-use models perform compared to reusables, there doesn't appear to be a notable variation in effectiveness between single-use and reusable. For example, a November 2018 Urolithiasis journal paper, "Clinical outcomes and costs of reusable and single-use flexible ureterorenoscopes: a prospective cohort study" (osmag.net/eTGu5U), found "no significant difference" for overall success rates, stone-free rates, operation time, radiation exposure time and complication rates. It amplified the other studies' findings on the ambiguity of cost benefit: "Partially overlapping ranges of costs for single-use and reusable scopes stress the importance to precisely know the expenses and caseload when negotiating purchase prices, repair prices and warranty conditions."

But what about the environmental impact of thousands of single-use scopes being thrown out on a daily basis? One vendor of single-use scopes responds to this ugly truth with the counterpoints that employing single-use scopes also lowers waste from disinfecting brushes, towels and test strips; reduces water and energy costs; and eliminates staff exposure to toxic chemicals and disinfecting consumables used in reprocessing scopes. A March 2018 Journal of Endourology study, "Carbon Footprint in Flexible Ureteroscopy: A Comparative Study on the Environmental Impact of Reusable and Single-Use Ureteroscopes" (osmag.net/9YTeaA), concluded that the environmental impacts between the two are "comparable." So pick your poison, as it were.

Here's a look at 5 of the single-use devices available to your center today. Expect more options in the years to come. OSM

Boston Scientific

Boston Scientific

LithoVue

bostonscientific.com
800-876-9960

Price: not provided

FYI: The LithoVue Single-Use Digital Flexible Ureteroscope has a built-in LED light source and camera head. It provides 270-degree deflection in both directions, offering standard and reverse options to suit the urologist's preference. The company touts its image quality as "comparable to the leading digital reusable scopes and superior to fiber-optic technology." Its accompanying workstation, which features integrated image processing software, is an all-in-one touchscreen PC, monitor and controller mounted on a mobile cart. You also can connect the scope to your OR's existing DVI monitors and recording systems. Fully compatible with laser lithotripsy using existing technologies, it features a 7.7F tip diameter, 9.5F outer diameter, 3.6F ID working channel, and a Digital CMOS imager with a working distance of 2mm—50mm.

NeoScope

NeoScope

NeoFlex

neoscope2020.com
408-483-5474

Price: not provided

FYI: This Silicon Valley company currently has the largest product selection of single-use urology scopes on the U.S. market, spanning rigid and flexible cystoscopes, and flexible and semi-rigid ureteroscopes. Pictured is the NeoFlex Flexible Digital Video Cystoscope System. The scope, which features a built-in LED light source and video processing module, has a USB 2.0 interface and can connect to up to 2 commercially available HD-compatible video monitors. It has a 12.0 Fr outer diameter with suction/irrigation, a 5.0 Fr working channel and an articulating tip with 280-degree deflection in both directions.

Coloplast

Coloplast

Isiris

coloplast.us
isiris-scope.com
612-337-7800

Price: not provided

FYI: This single-use digital flexible cystoscope is positioned as a product for stent removal in adults. As such, it features an integrated grasper, along with a reusable portable monitor. Because of that combination of single-use and portability, and its focus on simple stent removal procedures, the company says a dedicated endoscopy room with video stack is not needed to perform stent removal with Isiris. In fact, it advises that the system can be transferred between locations, and the surgeon doesn't even need a nurse's assistance to perform the procedure. Isiris lets urologists reserve more expensive reusable scopes for more demanding procedures, says the company.

Laborie

Laborie

PrimeSight with EndoSheath

laborie.com
800-522-6743

Price: Unity 9000 Video Processor ($22,995); CST-5000 flexible digital cystoscope ($15,950); EndoSheath ($480/box of 10)

FYI: Here's an interesting middle ground: What if you had a reusable cystoscope that you didn't need to high-level disinfect after each use? That's what Laborie proposes with the combination of its reusable PrimeSight flexible cystoscopy system and its single-use EndoSheath sterile protective barrier, formerly available from its recent acquisition Cogentix Medical. EndoSheath isn't just a bag or wrapper. Yes, it covers the scope and its controls from end to end, but it actually has its own integrated working channel for suction, irrigation and biopsy tool passage. So you don't need to deal with the difficulty of cleaning the channel, as you do with other reusable scopes. EndoSheath is available with 1.5mm and 2.1mm channels, as well as with no channel at all for quick observations.

Pusen Medical

Pusen Medical

Uscope

pusenmedical.com
0086 400 688 2023

Price: not provided

FYI: It's not entirely clear if Uscope is available in the U.S. The Chinese company's North American senior sales representative says the product has obtained FDA approval, but did not respond to a request for information about U.S. distribution. Clarion Medical Technologies carries the product in Canada, and it is available in numerous other countries. So what is it? It's a single-use flexible ureteroscope with 270-degree dual deflection that can be used with its own monitor or your existing OR monitor. It has 9.0 Fr outer diameter and a 3.6 Fr working channel.

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