FDA orders scope manufacturers to study how scopes are reprocessed in healthcare facilities: 4 things to know

The FDA has ordered Fujifilm Medical Systems, Hoya PENTAX and Olympus to begin postmarket surveillance studies focused on how duodenoscopes are reprocessed in real-world healthcare settings.

Here are four things to know about the FDA mandate.

1. Fujifilm, PENTAX and Olympus are the three major manufacturers of duodenoscopes sold in the United States.

2. The device manufacturers have 30 days to submit postmarket surveillance study plans to the FDA.

3. "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, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, according to an FDA news release.

4. Studies conducted by the manufacturers will be required to address three questions including:

•    Are user materials sufficient to ensure adherence to manufacturers' reprocessing instructions?
•    After manufacturers' reprocessing steps are followed, what percentage of duodenoscopes remains contaminated?
•    Of the devices that remain contaminated, what contributed to microbial contamination, and what additional steps are needed to achieve decontamination?

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