First Entirely Disposable Duodenoscope Authorized for Marketing

The FDA has cleared for marketing the first completely disposable duodenoscope. The Exalt Model D single-use duodenoscope removes the potential for infection that can arise when reusable models are reprocessed.

Contaminated duodenoscopes have been implicated in outbreaks of carbapenem-resistant Enterobacteriaceae in recent years. In August, the FDA advised healthcare facilities to switch to duodenoscopes with disposable endcaps — or to fully disposable systems once available.

The Exalt Model D is expected to cost roughly $3,000, the New York Times reports, and “insurance coverage is still uncertain.”

The manufacturer says it will release a limited amount to the market in early 2020.