FDA orders three duodenoscope manufacturers in the U.S. to conduct postmarket surveillance studies

The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

"This is a significant step in the effort to combat infections spread through duodenoscopes. The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used," said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. "These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA's actions to protect the public health and help reduce the risk of infections."

The three manufacturers – Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division) – that market duodenoscopes sold in the U.S will have 30 days to submit postmarket surveillance plans to the FDA. These proposals must detail their plans to conduct studies to evaluate, among other things, how well health care personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes. 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.

The goal of these studies is to collect useful data about the effectiveness of current reprocessing instructions and practices that can provide the FDA with information necessary to protect the public health, including taking action to help reduce the risk of duodenoscope infections. Specifically, the manufacturers' studies are required to answer three important surveillance questions:

• Are user materials, such as user manuals, brochures and quick reference guides included in the manufacturers' duodenoscope labeling and instructions for use, sufficient to ensure user adherence to the manufacturers' reprocessing instructions?
• After use of the manufacturer's validated reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms?
• For devices that remain contaminated after use of the manufacturers' labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?

As there are no alternative devices for ERCP, the FDA believes at this time that the continued availability of duodenoscopes is in the best interest of the public health. However, the results of the postmarket surveillance studies could help inform the FDA's next steps and future risk mitigation strategies, such as informing new labeling for the devices to include different reprocessing instructions or other administrative or regulatory actions necessary to protect the public health.