FDA approves Ambu single-use duodenoscope

The FDA approved Ambu's single-use duodenoscope July 17 as device companies continue creating scopes to decrease cross-contamination issues.

What you should know:

1. The Denmark-based device manufacturer created a two-piece system. There's the Ambu aScope Duodeno and an accompanying reusable processor unit, the aBox Duodeno.

2. Ambu will now initiate a 500-patient postmarket study at multiple U.S.-based centers, with the goal of making early data available during the 2020-21 fiscal year.

3. The FDA recommended manufacturers and healthcare facilities begin using partial or completely single-use scopes in August 2019. Duodenoscopes have multiple small parts that make the scope difficult to disinfect.