FDA approves the Pentax ED34-i10T duodenoscope for visualization and access to the upper G.I. tract with a disposable distal cap to improve access for cleaning and reprocessing.- Pentax Medical.

The FDA has cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope ( the DEC Duodenoscope) is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems

In January 2017, the FDA issued a Safety Communication alerting health care providers about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. The communication identified the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope�s distal cap onto the scope. These cracks and gaps could allow fluids and tissue to leak into the duodenoscope. The new features of the Dec Duodenoscope include a single use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved image quality, and a reduced length.

Pentax Medical obtained a CE mark for the new the DEC� Duodenoscope on 14 September 2017. The new DEC Duodenoscope will be presented for the first time during the EUS-ENDO congress, in Marseille, France, 28-29th September 2017.

Comment:The DEC Duodenoscope single-use, sterile, distal end cap is unique in the market. This innovative feature responds to the need for single-use products in endoscopy as a result of increasing incidences of carbapenem-resistant Enterobacteriaceae (CRE) infections that may be linked to improper cleaning or disinfection of the elevator mechanisms of duodenoscopes.