May 15, 2015 — Contaminated medical scopes continue to pose serious health risks due to basic design flaws and complex mechanisms that are difficult to clean, an expert panel to the FDA has warned at a hearing yesterday.

The hearing included tearful testimony by a woman from North Carolina who lost her husband from an infection transmitted on a contaminated duodenoscope made by Olympus Corp.

She said she watched her husband suffer for nine months, fighting through intense pain before his death in November 2013, according to the Los Angeles Times.

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.”

Olympus declined to participate in the FDA hearing.

The company is facing a barrage of criticism for selling a modified scope without approval since 2010. That scope was linked to a “superbug” outbreak in Los Angeles that exposed over 150 people, resulting in seven confirmed infections and two deaths.

In a similar outbreak in Seattle, at least 39 patients at Virginia Mason Medical Center were infected on contaminated duodenoscopes. Eighteen patients died, although it is not clear that the deaths were caused by the infections.

The Seattle Times reports that Virginia Mason has been sued by the widow of a man who died from an unstoppable antibiotic-resistant infection after undergoing a procedure involving an Olympus duodenoscope. Her attorney said, “Virginia Mason was misled and misinformed by Olympus as to the safety of its devices.”


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