FDA Orders Studies of Duodenoscopes Following Reports of Contamination

Washington, DCThe U.S. Food and Drug Administration (FDA) has ordered the three manufacturers of duodenoscopes marketed in the US.. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

This action comes as a result of an FDA warning that duodenoscopes could be linked to the spread of deadly bacteria. This warning concerns ERCP endoscopes, also known as duodenoscopes, and comes on the heels of reports of serious multi-drug resistant bacteria in patients who had medical procedures involving the medical devices. Duodenoscope lawsuits have now been filed after patients reportedly developed infections linked to devices.

The three manufacturers ordered to perform the studies are, Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division). These studies are based on the FDA’s current understanding of factors that may be contributing to infection outbreaks following endoscopic retrograde cholangiopancreatography procedures (ERCP), as well as the information needed to help fill gaps in knowledge.

Duodenoscopes are flexible, lighted tubes that are used to treat patients undergoing ERCP. More than 500,000 ERCPs are performed each year in the United States. These procedures often are life-saving and are the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions.

However, the FDA has identified evidence that duodenoscopes have contributed to the transmission of infections, including antibiotic resistant infections, to patients. Duodenoscopes undergo a multi-step cleaning and high-level disinfection procedure called reprocessing so the medical devices can be reused between patients. The complex design of the devices makes it difficult to remove contaminants compared to other types of endoscopes. The FDA’s analysis to date also indicates that manufacturer’s reprocessing instructions are not always being followed correctly, as these instructions are labor intensive and prone to human error.

An 18-year-old who developed a CRE (carbapenem-resistant Enterobacteriaceae) infection after undergoing a procedure involving a duodenoscope has filed a lawsuit against Olympus, maker of the device. According to the Los Angeles Times, although Olympus redesigned its duodenoscope it did not provide proper cleaning guidelines for the product.