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Duodenoscope Makers Must Perform Safety Studies, FDA Says

Oct 7, 2015

Olympus American, Fuji Medical Systems and Hoya Corp. must perform safety studies to assess whether or not their duodenoscopes are being cleaned according to manufacturers' instructions, the U.S. Food and Drug Administration (FDA) announced. The agency ordered the safety studies following a series of superbug outbreaks linked to contaminated scopes, which are inserted down the throat and through the digestive tract to diagnose and treat gallstones, tumors and blockages of the pancreas and bile ducts. The scope makers are all based in Japan but have affiliates in the United States, LA Times reports.

There were two superbug outbreaks linked to contaminated duodenoscopes at Los Angeles hospitals this year. Officials from both hospitals say the scopes were cleaned according to manufacturers' instructions. The FDA warned in February that the complex design of duodenoscopes may impede effective cleaning. The devices, which contain a mechanized tip with movable instruments, can spread infection when bodily fluids and other substances get trapped in small crevices and are not cleaned effectively.

According to the FDA press announcement, scope makers must submit plans to study how well hospital staff are complying with instructions for cleaning and disinfecting the devices in between uses. The agency hopes that the studies will give better insight into how contamination is spread.

"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, according to the FDA release. "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."

LA Times reports that there have been at least eight superbug outbreaks linked to medical devices since 2013, based on government figures. All three scope brands have been linked to the spread of antibiotic-resistant bacteria. The FDA did not remove the devices from the market because they fill a medical need, and are involved in over 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year.

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