Olympus redesigned its duodenoscopes following a series of superbug outbreaks and deaths linked to the devices, but the new scopes have also been tied to a deadly infection outbreak at a foreign facility, according to a new report.
At least one of the five infected patients died, according to a report filed to the Food and Drug Administration (FDA) but said the patient's death was due to her pre-existing condition. The report didn't specify where the outbreak occurred, but noted that five patients had tested positive for a strain of Klebsiella pneumoniae that is resistant to all but last-resort antibiotics.
Mark Miller, an Olympus spokesman, told the Los Angeles Times that it had notified the FDA of the infection outbreak. “In the interest of patient safety, it is premature to reach a conclusion regarding the cause,” Miller said.
An FDA spokeswoman told the newspaper that the agency was aware of the report and that it would investigate concerns with duodenoscopes “as appropriate.”
Japan-based Olympus has been under the microscope for more than year because of a series of infections linked to its scopes:
- Three patients at UCLA Medical Center died after being infected with carbapenem-resistant Enterobacteriaceae (CRE), a superbug the World Health Organization named as one of the deadliest
- An outbreak at Huntington Hospital in Pasadena hospital sicked 16 people, 11 of whom later died, the LA Times reported
- CRE infections linked to the scopes later cropped up at hospitals in North Carolina, Pittsburgh, Seattle and Chicago
- Olympus came under fire after lawsuits filed in the wake of the infections unearthed evidence that the company failed to notify U.S. officials about the infection risk and instead suggested hospitals had not properly cleaned the scopes
- Between learning of the outbreaks and notifying federal agencies, Olympus increased the prices of the scopes to maximize profits
- Reports also found that the FDA failed to act on the threat in a timely manner
Olympus controls about 85% of the U.S. market for duodenoscopes. The company voluntarily recalled the original scopes in January 2016 and also offered new guidelines on cleaning the products to reduce infection risk.
Patients with a history of bile duct cancer or who are hospitalized may face a greater risk of infection from tainted scopes, and the risk of contaminated scopes may be much greater than previously thought.