A federal lawmaker said it’s wrong for device-maker Olympus Corp. to profit from recent superbug outbreaks as hospitals buy more of the company’s scopes in response.
Monday, U.S. Rep. Ted Lieu (D-Los Angeles) asked the company to donate scopes to hospitals or forgo profits from the sale of additional devices.
“It seems fundamentally unfair for Olympus to be selling more duodenoscopes to these same hospitals as a result of the design problems created by Olympus in the first place,” Lieu said in a letter sent Monday to the company.
The spread of lethal bacterial infections from contaminated scopes has forced many hospitals nationwide to adopt new cleaning procedures for these reusable medical instruments to ensure patient safety.
But those extra measures, such as sending out these duodenoscopes for gas sterilization or quarantining them for 48 hours for additional testing, have prompted some hospitals to buy more scopes in order to have ample equipment.
Lieu asked Olympus to give scopes to hospitals that adopt alternative cleaning methods or provide devices at cost “as a show of good faith that the company is trying to remedy the situation.”
A spokesman for Olympus said the company is “carefully reviewing” Lieu’s letter.
“As a medical device manufacturer, Olympus continuously strives to improve our products for safe and effective use and we look forward to any engagement toward that goal,” spokesman Mark Miller said in a statement.
Olympus has about 70% of the global market for gastrointestinal endoscopes. Two other firms, Pentax Medical and Fujifilm, also make duodenoscopes.
In his letter, Lieu also sought additional information from Olympus about its plans for a scope redesign and when did it first learn that its devices were causing infections.
Last month, the Food and Drug Administration warned medical providers that the duodenoscopes may not be free of bacteria even if they follow the manufacturers’ cleaning instructions. Bacteria can become trapped in tiny crevices near the tip of the devices.
In Los Angeles, outbreaks from contaminated Olympus scopes have occurred at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai hospital involving the superbug CRE.
At UCLA, seven patients were infected, including two who died, and 179 more were exposed. Cedars reported four patients were sickened and 67 others may have been exposed.
Lieu was among 10 members of Congress -- six Democrats and four Republicans -- who sent a letter to the FDA this month with a long list of questions about the agency’s response to the outbreaks.
Likewise, U.S. Sen. Patty Murray (D-Wash.) sent a second letter to the FDA last week, seeking more information about the agency’s handling of the matter.
“As we have seen, insufficient cleaning procedures can create huge risks and cost lives,” Murray said. “We cannot afford to be complacent regarding the danger that CRE infections, or other superbugs, pose.”
Olympus has also come under criticism for selling a redesign of its TJF-Q180V duodenoscope without the necessary government approval since 2010.
Olympus has said the company didn’t believe further regulatory approval was necessary. At the FDA’s request, the company subsequently filed for approval, which is pending.