Disposable Scopes Are Likely to Play D A Larger Role at Small-Volume Centers A

Disposable Scopes Are Likely to Play A Larger Role at Small-Volume Centers

The FDA approved the first disposable colonoscope in 2016, but one-time-use scopes have yet to enter the U.S. market. A study by researchers at Johns Hopkins University suggests that the market best suited for these scopes is likely to be at smaller, lower-volume endoscopy centers.

“We found that the cost to use reusable scopes is volume dependent and also dependent on how many scopes you have,” study investigator Susan Hutfless, PhD, the director of Johns Hopkins’ Gastrointestinal Epidemiology Research Center, told Priority Report. “If, for example, an ambulatory surgical center is doing 3,000 colonoscopies per year and owns 20 colonoscopes, we estimate that it costs them just over $200 per use of that colonoscope to reprocess it. For that practice, the

break-even point on cost for a disposable would have to be around that point. In addition, if an infection is coming from mistakes that happen during the reprocessing of the scope, a disposable colonoscope in theory should decrease a practice’s infection rate.”

Dr. Hutfless and her colleagues assessed the costs (cleaning, capital and operating) associated with current reusable scopes and found that these costs ranged from $189 per procedure at centers that perform at least 3,000

colonoscopies per year to $501 per procedure at centers performing 1,000 or less (Gut 2019. pii: gutjnl-2019-319108). The cost of treating postprocedural infections added an additional $20 per procedure in centers with low infection rates to almost $47 for centers with greater infection rates.

In a 2018 study, Dr. Hutfless and her colleagues “found a direct correlation between the number of procedures performed at a particular center and the rates of infection, with highvolume centers having lower infection risks,” she said. The adjusted overall risk for infection was 0.86 for middle-volume centers and 0.77 for high-volume centers compared with low-volume centers (Gut 2018;67[9]:1626-1636).

“In fact, the infection rates observed at some low–procedure volume ASCs were over 100 times more than the rates we would expect to see had patients received procedures at an average ASC,” Dr. Hutfless said. The association between lower procedure volume and higher infectionrelated unplanned visit rates persisted even after the researchers accounted for patient and procedure complexity.

Disposables Not Practical For High-Volume Centers

So, for centers that perform a significant volume of colonoscopies, Dr. Hutfless said, the research indicates that moving to disposable scopes would not make sense, either financially or clinically. “Based on what we’re hearing in terms of cost estimates for disposables, it’s unlikely to make sense for most ambulatory surgical centers that are doing high volumes of colonoscopies to replace their entire unit with disposable scopes.”

At Austin Gastroenterology in Texas, which performs between 35,000 and 40,000 endoscopies annually (about 150 per day), there have been no infections associated with colonoscopies over the past decade, according to gastroenterologist Harish Gagneja, MD. “Infection rates on colonoscopes are extremely low; indeed, the claims data in these studies don’t make clear whether these infections are truly related to the scope disinfection,” he said. “If you follow the manufacturer’s guidelines, have well-trained and experienced reprocessing staff and do not cut corners, then there is no need for a disposable scope. And in this era of decreased reimbursement, disposable scopes are likely to cost more, not less, for most centers.”

The prospect of disposable scopes also raises storage, supply chain and environmental issues. “Where would you store them? At 150 procedures a day, we would need to have storage [for] 3,000 scopes a month,” Dr. Gagneja said. “What if the scopes are manufactured overseas and you encounter an interruption in shipping, and you can’t do procedures? And when they’re discarded, where are these scopes going to go? Into a landfill?”

Niche for Smaller Centers With Higher Infection Risk

But for small-volume centers, the inverse relationship between infection rate and procedural volume might make disposable colonoscopes a smart choice. “If you are a smaller-volume center, doing less than 100 colonoscopies a year, then you should absolutely buy disposables once they are available,” Dr. Hutfless said. “You won’t have to worry about reprocessing facilities and expertise.”

Dr. Gagneja agreed. “Yes, for a smaller-volume center that is only doing one or two colonoscopies a week—perhaps in rural centers where there is limited staff available—that’s probably the best thing you can do. But that is the only type of setting where I could see the utility of disposable colonoscopes.”

The only other circumstance in which a disposable scope might make sense is for patients who are at extremely high risk for infection, Dr. Hutfless added. “For example, if you suspect that patient may have a [Clostridioides] difficile infection, it would be advisable for any center to use a disposable scope.”

“With the potential for disposable scopes to enter the U.S. market soon, we wanted to make this data available so that centers can start considering their options,” Dr. Hutfless said. “Of course, it could be that the disposable scopes come out and no one likes the design and they don’t want to use them. But assuming that quality and comfort for the provider are the same, this research provides an idea of what the numbers look like.” —Gina Shaw