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Lawmaker Questions Olympus Scopes Tied to CRE Outbreak

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March 25, 2015 — A lawmaker from California is demanding answers from Olympus Corp., the manufacturer of medical scopes that have been linked to several outbreaks of drug-resistant “superbug” infections.

In a letter (PDF), Congressmen Ted W. Lieu (D-California) asked if Olympus plans to re-design the scope, issue a recall, recommend alternative cleaning methods, or provide patients with more information.

He also wanted to know when Olympus first learned the scopes were causing antibiotic-resistant Carbapenem-resistant Enterobacteriaceae (CRE) infections, and what they did with that information.

The duodenoscopes in question were re-designed in 2010, but Olympus did not seek approval from the FDA or provide hospitals with an updated cleaning protocol. The scope is not approved by the FDA and the company has failed twice to submit data showing that it can be cleaned reliably.

Ironically, Olympus might profit off their own design defect. Many hospitals have implemented a more rigorous cleaning protocol that renders them unusable for 24-48 hours. This has forced some hospitals to purchase even more Olympus scopes.

According to Congressman Lieu, this seems “fundamentally unfair.” Hospitals bought the scopes believing they could be used multiple times per day and cleaned reliably, but he said: “Neither seems to be true. Olympus thus sold a product that failed to perform to its specifications.”

Now he is calling on Olympus to do more to respond to the problem:

“I would like to ask whether Olympus — as a show of good faith that the company is trying to remedy the situation — would consider donating duodenoscopes to hospitals that resort to alternative cleaning methods, or providing the scopes at cost without a profit, until the design or cleaning problems have been resolved.”

 

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