Due to the high infection rate associated with reusable duodenoscopes, the U.S. Food and Drug Administration (FDA) has been putting pressure on duodenoscope manufacturers to change their designs, and the U.S. Centers for Medicare and Medicaid Services (CMS) has been working to speed up Medicare beneficiaries’ access to single-use devices.
Chloe Kent, medical writer at GlobalData, says: “Resusable duodenoscopes are exceptionally difficult to sterilize and are known to spread potentially deadly infections between patients even when they look clean.”
Rapidly growing medical device manufacturer Ambu’s aScope Duodeno disposable duodenoscope has now received 501(k) clearance from the FDA, but it faces stiff competition from other devices on the market.
Ambu will be initiating a 500-patient post-market study at multiple centers in the U.S., which it plans to make public during the first quarter of 2021, when data from at least 60 procedures is available. Ambu has stated that its disposable duodenoscopes will sell at $1,400 to $1,600 per device.
However, Ambu’s aScope Duodeno has competition from other medical device companies such as Boston Scientific, Pentax and Olympus, which are also developing disposable or semi-disposable scopes.
“There’s a case to be made that a duodenoscope with a disposable endcap may be the most cost-effective option, as indicated by a modelling study presented at the Digestive Disease Week 2020 online meeting in May 2020,” Kent says.
“Semi-disposable devices like the Pentax’s DEC HD and Olympus’ TJF-Q190V may be a better option than the aScope or Boston Scientific’s disposable EXALT for hospitals that want to move away from reusable duodenoscopes, as they should be more cost-effective in the long run than fully disposable devices,” she says. “That’s to say nothing of the eco-friendly credentials associated with having reusable elements at a time when humanity is facing a serious medical waste problem, which could be exacerbated by fully disposable devices.”