DISPOSABLE DISTAL CAP Pentax's new duodenoscope features a disposable distal cap that will improve access for cleaning and reprocessing.

The FDA has approved a newly designed duodenoscope from Pentax Medical called the ED34-i10T which features a single-use, disposable distal cap — a feature the agency says will improve access for cleaning and reprocessing and lower the risk of future infections associated with duodenoscopes.

Duodenoscopes, which are used for endoscopic retrograde cholangiopancreatography (ECRP) procedures, have been linked to numerous deadly outbreaks in recent years, and their complex design makes them extremely challenging to sterilize.

This new distal cap, however, addresses a glaring issue in old Pentax designs. This past January, the FDA issued a warning that the Pentax ED-3490TK uses an adhesive to seal its distal cap that's prone to cracking and therefore letting fluid and tissue leak inside. With a disposable cap, the new model is said to be better suited for decontamination.

Joe Madsen