March 25, 2015 — Congressman Ted W. Lieu (D-California) has sent a letter to Olympus Corp. seeking answers to questions that will help lawmakers respond to the outbreaks of drug-resistant “superbugs” and get reassurance that Olympus is also doing its part.
The Olympus duodenoscope has been linked to multiple outbreaks of antibiotic-resistant “superbug” bacteria nationwide, including in California. Even when hospitals follow Olympus’ cleaning instructions, Carbapenem-resistant Enterobacteriaceae (CRE) can remain on the scopes.
The FDA has stated that the scope was re-designed in 2010, but was not approved. Olympus has failed twice to submit adequate data showing that their scopes could be cleaned reliably, according to the Los Angeles Times.
Hospitals bought the scopes with the understanding that they could be used multiple times per day and could be cleaned reliable. According to Congressman Lieu, “Neither seems to be true. Olympus thus sold a product that failed to perform to its specifications.”
In an ironic twist, many hospitals are now forced to purchase more duodenoscopes because the new cleaning protocols render the scopes inaccessible for 24-48 hours, or more. Congressman Lieu said it seems “fundamentally unfair” that Olympus should be profiting off design problems that were created by Olympus in the first place.
He wrote in a Letter to Olympus (PDF):
“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.”