FDA Safety Communication – ERCP Duodenoscopes Design May Impede Effective Cleaning

The FDA recently issued an FDA Safety Communication alerting medical care providers that ERCP duodenoscopes may be the exposing their patients to dangerous, hard to treat infections, due to difficulty cleaning the duodenoscopes between procedures. The Communication states that “the complex design of the ERCP endoscopes (also called duodenoscopes) may impede effective reprocesseing.” “Reprocessing” refers to the process under which the duodenoscopes are prepared to be used for the next procedure. The Communication cautions that even when medical care providers fully comply with the reprocessing instructions, there patients may be exposed to harmful multidrug-resistant bacterial infections.

Since many patients suffering from injuries caused during laparoscopic cholecystectomy undergo ERCP procedures, this is of particular concern to Trief & Olk and our clients. If you plan to undergo an ERCP, the FDA recommends (1) discussing the benefits and risks of procedures using duodenoscopes with your physician, and (2) asking your doctor what to expect following the procedure and when to seek medical attention. The FDA cautions that for most patients, the benefits of ERCP outweigh the risks of infection.