New FDA Warning about Reprocessed Duodenoscopes
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
The FDA has recently issued a safety warning on duodenoscopes. Duodenoscopes are used during a potentially life-saving procedure known as Endoscopic Retrograde Cholangiopancreatography (ERCP). ERCP is a technique that combines the use of endoscopy and fluoroscopy to diagnose and treat certain problems of the biliary or pancreatic ductal systems. Unfortunately, due to its complex design, duodenoscopes are difficult to effectively clean. Even though the sterilization process is extensive, bacteria can remain on the scope through this process and transfer from one patient to another.
This new FDA warning follows reports of an association between patients with multi-drug resistant bacterial infections and the duodenoscope. This is a complex and rapidly-evolving issue and has prompted a number of additional questions from the public about what FDA is doing to address this problem. We hope to post updates as they come in.