FDA asks duodenoscopes makers to study success of cleaning guide

[October 06, 2015] By Anjali Rao Koppala

(Reuters) - The U.S. Food and Drug Administration has ordered three Japanese manufacturers of duodenoscopes to conduct studies to evaluate how the devices are being used, as part of its effort to prevent the transmission of infections through the device.

Duodenoscopes are flexible, lighted tubes inserted down the throat to drain fluids from blocked pancreatic and biliary ducts. They are at the center of a recent superbug outbreak in the United States.

The FDA in August asked health care facilities using these and other reusable medical devices to meticulously follow the cleaning instructions to avoid the spread of superbugs.

The FDA on Monday gave Olympus Corp, Fujifilm Holdings Corp and Pentax Medical, a unit of Hoya Corp, 30 days to study the effectiveness of the instructions. (http://1.usa.gov/1LdYQcG)

The agency said the studies would help it formulate new labeling for the devices to include instructions or other actions to prevent the spread of infections.

The three Japanese companies sell duodenoscopes in the United States. Olympus is the biggest maker of the device.

The FDA gave the trio warning letters in August after finding multiple violations during inspections of their facilities in the United States and abroad.

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