The FDA has again updated its warnings about Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes this week.
The FDA wants to raise awareness among health care professionals that the complex design of ERCP endoscopes (also called duodenoscopes) may hinder effective reprocessing, which is a detailed process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.
On March 4th, the FDA announced that it has received inquiries from healthcare providers about whether they should cancel ERCP procedures based on the fact that one specific model duodenoscope manufactured by Olympus does not currently have a 510(k) clearance. The FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them.
Although Olympus has a pending 510(k) application for this device, the company continues to market the product while the application is under review. The FDA is not taking action against Olympus because they believe that the removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.