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The Food and Drug Administration oversees manufacturers’ postmark surveillance studies on new and significant health concerns in order to understand a device’s risks and to update policies on such risks.
“The FDA is reporting new information from postmarket surveillance studies on rates of contamination after the cleaning and reprocessing of certain duodenoscopes; these flexible lighted scopes are vital for minimally invasive procedures to diagnose and treat conditions of the pancreas and bile duct,” Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement.
For years, the FDA has painstakingly worked to prevent patient infections from contaminated duodenoscopes by evaluating current instructions and releasing better protocols for sampling and culturing. Since 2015, the three main manufacturers (Olympus, Fujifilm and Pentax) have worked with the FDA on two postmarket surveillance studies. Preliminary findings from these studies were released in December with a 3 percent contamination rate for “high concern” organisms but a new update finds that the rate is 5.4 percent of all samples were contaminated with “high concern” organisms. Low to moderate risk organisms were found in 3.6 percent of the tested samples.
“When the sampling studies were designed, the FDA expected to see a total contamination rate for any type of organism of less than 1% or as close to zero as possible for duodenoscopes,” said Shuren. “The percent of contaminated samples based on these interim results shows that improvements are necessary, and we are committed to taking additional steps to reduce infections and contamination even further.”
In order to further reduce the risk, the FDA is working with the Centers for Disease Control and Prevention on the issue. It will also be a topic at the Healthcare Infection Control Practices Advisory Committee next month.
