‘Right Product, Right Time:’ FDA Clears Boston Scientific's Single-Use Duodenoscope
Amid concerns of infections from duodenoscopes that are not sufficiently re-sterilized, the US FDA has cleared Boston Scientific’s Exalt-D as a the first single-use duodenoscope. Investors expect the device will likely take a significant chunk of the market, especially considering the next competitor is at least a year away.
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ANSI/AAMI ST91:2021 offers best practices for cleansing the notoriously difficult-to-clean devices and strongly recommends health care providers transition from manual, sink-based cleaning to sterilization.
US Medicare’s designation of Boston Scientific’s single-use duodenoscope aims to reduce infections from a popular procedure to treat pancreatic and biliary conditions.
The single-use scopes should be used in lieu of reprocessed devices when a significant infection risk exists, the US agency says.