Tags:Endoscopy, Flexible Systems and Gastroenterology
Abstract:
Endoscopic Retrograde Cholangeopancreatography (ERCP) is the gold standard treatment for a variety of disorders of the pancreaticobiliary system. An FDA review in 2019 found that many post-ERCP deaths and infections over the past few years have been due to multi-drug-resistant bacteria transferred between patients undergoing ERCP. The root cause was determined to be the reusable duodenoscopes that are used to perform ERCP. These realizations led to the August 2019 call-to-action by the FDA, which recognized that a paradigm shift in duodenoscope technology was needed. The FDA call-to-action emphasizes the urgent need to develop "innovative device designs, such as those with disposable components." To answer this call, we are developing a fully disposable ERCP system that enables physicians to perform ERCP using standard, forward-viewing upper-GI endoscopes, which are inherently much easier to clean due to their simpler construction, and are far less likely to transmit infections to patients.
Answering the FDA’S Call to Action: Using Steerable Sheaths and Mirrors to Prevent ERCP Infections