Medical device and MedTech insights, news, tips and more

Scandal Over Tainted Olympus Scopes Renews Call For Tougher Requirements on Medical Device Warnings

August 1, 2016

medical device warnings

medical device warnings

A U.S. lawmaker is renewing his push for Congress to toughen requirements on medical device warnings, calling Olympus Corp.’s 2013 decision against issuing a broad alert to U.S. hospitals about scope-related superbug outbreaks


Rep. Ted Lieu, a Democrat from California, says internal Olympus emails about that decision, detailed for the first time in a Los Angeles Times/Kaiser Health News article on Sunday, were “incredibly disturbing” and the company officials involved should face questions at a Congressional hearing. At least 35 patients in American hospitals have died since 2013 after developing infections tied to tainted duodenoscopes.

In company emails from February 2013, a senior executive at Olympus’ Tokyo headquarters told its U.S. managers not to issue a broad warning to American hospitals despite reports of scope-related infections in Dutch, French and U.S. hospitals. The executive added that they could respond to questions from a customer.

The company had issued an alert to European customers a month earlier but chose not to do so in the U.S. until last year. The emails were filed in a Pennsylvania court this month as part of a patient lawsuit and obtained by Kaiser Health News working in collaboration with the Los Angeles Times.

“Olympus’ actions in this case were despicable,” Lieu says. “They knowingly failed to warn hospitals and patients of their defective scopes.”

After the company opted against a U.S. alert in early 2013, Virginia Mason Medical Center in Seattle discovered an outbreak involving contaminated gastrointestinal scopes manufactured by Olympus. The hospital said 39 patients eventually became infected and at least 18 of them died. The hospital acknowledged that the patients who died had other underlying illnesses.

Hospital patients in Los Angeles, Charlotte, Denver, and other cities were also sickened by antibiotic-resistant bacteria, known as superbugs, after being treated with Olympus duodenoscopes.

“We are very troubled by the now very clear facts that Olympus in Japan knew of the infection problems with their duodenoscopes long before the outbreaks we saw in America, and chose not to warn physicians,” says Dr. Andrew Ross, section chief of gastroenterology at Virginia Mason Medical Center.

“If they had done so, physicians could then determine what is best in how to treat and advise their patients,” Ross says.

Virginia Mason is suing Olympus for fraud and misrepresentation in Washington state court. In court documents, Olympus denies the allegations and contends that the hospital failed to follow the instructions for cleaning the scopes.

Lieu filed a bill in April, known as the Device Act, which would make it mandatory for device makers to share safety alerts more widely, including those issued abroad.

Under the proposed legislation, companies would have to notify the Food and Drug Administration when they issue safety warnings in other countries related to the design and cleaning of their devices. The legislation also would require manufacturers to notify the FDA when they change the design or cleaning instructions of their devices, regardless of whether those changes warrant new government approval.

Lieu says he will press lawmakers to take up the bill in September when Congress reconvenes.

Read Full Article – Source: Scandal Over Tainted Scopes Stirs Renewed Call For Tougher Medical Device Regulations

by Chad Terhune, Kaiser Health News

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.