Authors: Jorge Humberto Rodríguez-Quintero, MD and David M Pechman, MD
Ambu® received FDA approval for aScopeTM Duodeno on July 17th, 2020.
The Ambu® aScopeTM Duodeno is a single-use duodenoscope for endoscopic retrograde cholangiopancreatography (ERCP) procedures. It was approved by the FDA along with its reusable processor video unit, the Ambu® aBoxTM Duodeno. The device was created to address the ongoing concern regarding cross-contamination with reusable endoscopes and it is one of two devices approved by the FDA as a fully disposable duodenoscope. This is in contrast to other similar FDA-approved products which offer disposable endcap only.
The aScopeTM Duodeno is lightweight and is ergonomically designed with a rippled-surface handle for improved comfort during prolonged procedures. The design is similar to conventional duodenoscopes to ensure seamless transition for users. The device features controls for lens washing, insufflation, and sunction and standard remote switches for image freezing and capture. The aScopeTM Duodeno offers high definition imagery, flexible bending angles, and precise elevator functionality to allow for successful navigation of the GI tract and access to the biliary system. The device has an outer diameter of 13.7mm and a working channel of 4.2mm.
In 2015, the FDA started to conduct post-market surveillance studies to evaluate the percentage of duodenoscopes that remained contaminated after following standard reprocessing instructions. Preliminary results showed higher than expected levels of contamination with 3.6% of positive cultures for low to moderate risk organisms and up to 5.4% for higher risk organisms such as E.coli and Pseudomonas aeruginosa. FDA analysis of 205 medical device reports revealed 45 reports of patient infection, one report of patient exposure, and 159 reports of device contamination. Three deaths were at least partially attributed to the use of contaminated duodenoscopes. The center for Medicare & Medicaid Services recently announced a new transitional pass-through payment category for single-use endoscopes, recognizing how these devices are important for improving patient safety.
The aScopeTM Duodeno has been determined to be substantially equivalent and perform as well as or better to predicate devices such as the Olympus TJF-Q180V (K143153) – EVIS EXERA II Video system. (K100584).
The aScopeTM Duodeno is indicated for use with the aBoxTM Duodeno Video System, endoscopic accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
