Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers

FDA Mandates Safety Studies from Scope Manufacturers

FDA Mandates Safety Studies from Scope Manufacturers


The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The makers of the specialized gastrointestinal scopes, which are all based in Japan and have affiliates in the United States, are Olympus American, Fuji Medical Systems and Hoya Corp., LA Times reports.

The scope makers must submit plans to study how well hospital staff are complying to instructions for cleaning and disinfecting the devices in between uses. The FDA’s goal is for these studies to shed light on the superbug outbreaks. This year, there were two outbreaks linked to duodenoscopes at Los Angeles hospitals. Officials from both hospitals say the scopes were cleaned according to manufacturers’ instructions.

The devices are specialized scopes that are snaked down the throat and into the digestive tract to diagnose and treat gallstones, tumors and blockages of the pancreas and bile ducts. They contain a mechanized tip with movable instruments. The devices can spread infection when bodily fluids and other substances get trapped in small crevices and are not cleaned effectively.

In February, the FDA warned that the complex design of duodenoscopes may impede effective cleaning. Government figures show that there have been at least eight superbug outbreaks linked to medical devices in the United States since 2013, LA Times reports. All three scope brands have been linked to the spread of antibiotic-resistant bacteria. The FDA decided to keep the devices on the market despite the infections because they fill an important medical need. More than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed with duodenoscopes each year.

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