Infection Prevention: Are Single-Use Urological Scopes Right for You?

They largely remove infection risk, but financially, it’s complicated.

Urology is at a crossroads regarding its key tools: flexible cystoscopes and ureteroscopes. Should outpatient facilities rely upon (and further invest in) tried-and-true reusable models that can be reprocessed, or flip the script and move to disposable or “single-use” scopes?

A major impetus for the spread of single-use scopes has been infection prevention. In 2021, the FDA launched an investigation of more than 450 medical device reports from the previous four years that described post-procedure patient infections — including three reported patient deaths outside of the U.S. — and other possible contamination issues associated with reusable cystoscopes, ureteroscopes and cystourethroscopes, the reprocessing of which involves both cleaning and high-level disinfection (HLD) or sterilization. Two scope manufacturers were cited in the announcement.

Two of the patient deaths involved infectious bacteria present in a scope’s forceps/irrigation plug, which controls water flow and enables access to the working channel. The same bacteria were present in the patients. The third death involved the use of a cystoscope that did not pass a leak test. The FDA noted, however, that it was unknown whether or to what degree the reported infections contributed to the three deaths, as well as the role patient comorbidities might have played.

The FDA also investigated whether the blame for the largely nonfatal patient infections rested with facilities engaging in poor reprocessing or device maintenance, issues with reprocessing instructions in the labeling, or the devices’ designs. A year later, it announced that the reprocessing instructions for certain scopes from one manufacturer were inadequate and being updated after the manufacturer identified reprocessing failures following high-level disinfection. The vendor initiated a voluntary recall and issued an urgent field safety notice instructing users to discontinue HLD methods for all affected scopes and discontinue liquid chemical sterilization for most of them. Instead, the manufacturer said its scopes should be sterilized after each use by an appropriate method recommended in the updated instructions for use. If a facility did not have access to those sterilization methods, the manufacturer accepted returns of the affected scopes.

Notably, this language was embedded in the original announcement of the investigation: “The FDA has encouraged manufacturers to transition to devices with features that eliminate the need for reprocessing.” The FDA has been quiet on the issue since, but its actions caused a splash in the specialty, as many facilities began weighing the clinical and financial pros and cons of reusables and disposables.

View from both sides

There are positives and negatives on each end. Ultimately, the choice to commit to one, the other or even both reusable and disposable scopes comes down to each individual facility’s consideration of their volume and the nature of their service lines.

Most facilities still consider reusable flexible scopes reprocessed using HLD the standard of care, with formal sterilization utilized in certain centers, says Brad D. Lerner, MD, FACS, CASC, president of Chesapeake Urology Associates in Owings Mills, Md., chief of urology at MedStar Union Memorial Hospital in Baltimore and medical director of United Urology Group, a management services organization that partners with urology groups throughout the U.S. “However, due to infection control issues with certain types of scopes and select manufacturers, the time and expense of processing with HLD and potential concerns of chemical exposure to staff, single-use disposable scopes have gained a larger share of the market,” he says. Dr. Lerner believes when HLD or sterilization are properly performed, infection rates should not be significantly higher than those of providers utilizing single-use scopes. “While some may argue that single-use disposable scopes are safer from an infection control standpoint, that has yet to be absolutely determined depending on the clinical setting,” he says.

The choice then comes down to case volume and the economics that result from it. Dr. Lerner breaks it down this way: The higher your volume, the more sense reusable scopes make — provided they are properly reprocessed and maintained. “If you have an upfront purchase of capital equipment and utilize proper processing techniques, there is a one-time expense for the equipment with an ongoing expense for the processing supplies, along with service and performance maintenance agreements,” says Dr. Lerner. “If you switch to single-use disposables, you have a recurring annual expense that can be significant depending on the volume of cases performed.”

For facilities with lower urologic volume, such as hospitals, ERs and multispecialty ASCs, single-use is a compelling option. It removes the time, personnel and expense needed to process, store, handle, maintain and repair reusable scopes. Providers simply grab a sterile packaged single-use scope, use it, and discard it, without any worry about reuse cross-contamination. Patient flow is also less likely to be disrupted by backups in reprocessing reusable scopes.

While the math may not currently favor widespread adoption of single-use scopes at high-volume urology centers, Dr. Lerner says that could change if Medicare decides to reimburse for disposable scopes at a rate that meets or even exceeds their cost. He cites CMS’ January 2023 approval of an Incremental Device Reimbursement with pass-through code C1747 for select manufacturers and ureteroscopes.

“The payment calculation is based on the hospital/ASC charge for a pass-through device and is adjusted to the cost based on the individual hospital/ASC revenue center cost-to-charge ratio,” he says. If this code expands to all single-use ureteroscopes and cystoscopes, he believes it would likely cause a paradigm shift. “If there truly is going to be reimbursement for at least the cost of these single-use scopes, one would question the need for future purchase of fiber optic or digital scopes that will require processing, storage and preventative maintenance and service,” he says.

Environmental impact is a concern for both options. Heavy use of disposable scopes will lead to an increased volume of medical waste. However, there are known environmental impacts from the chemicals and energy used in reprocessing scopes.

Gary Kirsh, MD, president of The Urology Group in Cincinnati, and president, CEO and co-founder of Solaris Health Partners, a national platform for independent urology practices, says his practice still reprocesses scopes. “I still think that is preferable economically and with respect to the quality of scope you’re using,” he says. “That’s not to say there’s never an occasion to use a disposable scope, but in general at good ASCs you have the same sterilizing technology you have at a hospital, so it’s not really an issue to run the equipment through.”

Dr. Kirsh sees a strong appeal to utilizing single-use scopes for office-based procedures, however. “The problem with office sterilization is that there are a lot of steps to ensure the working channels are sterilized using soak techniques, as opposed to hospital-level sterilization,” he says. Providers at offices also must perform leak tests on reusable scopes. “There also are some OSHA considerations in terms of staff being exposed to these soak agents,” notes Dr. Kirsh, who believes the increasing difficulty in safely reprocessing scopes at offices is a good reason to either shift to disposables or move certain office procedures into ASCs, where hospital-level reprocessing technology usually resides. OSM