FDA approves duodenoscope with disposable cap — 4 key notes

The FDA approved Pentax's ED34-i10T, a duodenoscope with a disposable, single-use distal cap, Medscape reports.

Here's what you should know:

1. The disposable cap was designed to improve device decontamination. Duodenoscopes are hard to properly disinfect because of the small parts involved. Outbreaks have occurred at several hospitals since 2012 because of this.

2. The FDA encouraged manufacturers to make scopes that would be easier to clean.

3. The FDA touted Pentax's new scope saying the cap will make the device easier to access for decontamination.

4. The scope also features improved user interface, ergonomics and image quality.

More articles on gastroenterology:
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Regulatory approval, CE marking & more — 3 GI company key notes

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