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FDA Hears Testimony of Scope Infection Outbreak Victims

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May 15, 2015 — An advisory panel of experts to the FDA has met to discuss problems with disease-transmission on contaminated medical scopes, warning that patients continue to face health risks due to basic design flaws that make the scopes difficult to clean.

The Los Angeles Times reported that the most gripping testimony came from a widow from North Carolina who watched her husband die an excruciatingly painful, slow death after contracting an unstoppable antibiotic-resistant infection on an Olympus duodenoscope.

After hearing her tragic story, FDA official Suzanne Schwartz said:

“There’s no way I can even begin to understand and feel the pain and suffering you’ve had to endure as a result of your husband’s passing. Our FDA team is committed to getting this right.”

The manufacturer of the scope that caused his death, Olympus Corp., declined to participate in the FDA hearing.

Olympus is facing intense scrutiny for modifying the design of the scope and selling it without FDA-approval since 2010. Earlier this year, it was linked to several deadly “superbug” outbreaks in Los Angeles, Seattle, and other cities.

Virginia Mason Medical Center in Seattle says at least 39 patients have been infected on contaminated scopes, including 11 who died. The hospital has been sued by the widow of a man who died. Her attorney told the Seattle Times: “Virginia Mason was misled and misinformed by Olympus as to the safety of its devices.”

 

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