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FDA Orders Studies from Duodenoscope Makers


October 5, 2015 — The FDA has ordered manufacturers of complex medical scopes to study how they are sterilized in real-world settings.

The Japanese scope-makers Pentax, Fujifilm Medical Systems, and Olympus have 30 days to tell the FDA how they plan to study the scopes.

The study must determine whether existing instructions are adequate, what percentage of scopes remain dirty after they are cleaned according to instructions, why some scopes remain contaminated, and how to actually clean a contaminated scope.

Duodenoscopes are inserted down a patient’s throat to treat diseases like gallstones, tumors, and blocked ducts. Complex mechanisms in the tip of the scope are difficult to sterilize and can harbor antibiotic-resistant bacteria.

There have been at least eight outbreaks of infection linked to duodenoscopes since 2013. One outbreak in Los Angeles was traced to the Olympus TJF-Q180V duodenoscope, which had been on the market since 2010 without proper clearance.

In August, the FDA issued warning letters to all three manufacturers for failing to ensure the scopes could be effectively cleaned or report problems, according to Bloomberg.

According to the FDA:

“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.”


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