Redesigned scope by Japan's Olympus cleared by FDA

Japan's Olympus, which has been the target of lawsuits in the United States and investigations in Europe, caught a break from the U.S. Food and Drug Administration last week when the federal regulator approved the company's duodenoscope with changes to its design and labeling.

The new design and label changes are meant to help cut infections that can occur when the scopes are not cleaned sufficiently. The company said it was voluntarily recalling the original model to implement the changes, according to a Reuters report.

The FDA had earlier warned healthcare facilities using Olympus scopes to ensure they were cleaned thoroughly following the detailed instructions to prevent the spread of superbugs. The scopes, which are used to investigate the gastrointestinal tract, are among the most popular on the market.

Olympus was criticized in early 2015 after it became public that the company had worked to water down the requirements for the language used in the cleaning instructions for the scopes.

The company was also cited this past week in a U.S. Senate report that showed Olympus knew as early as 2013 that its devices could be the source of deadly infections that claimed several lives, but did not report that to FDA officials until 2015.

- here's the report from Reuters

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