Olympus recalls medical scope linked to 'superbug' infections - updated

The tip of a duodenoscope.
The tip of a duodenoscope.
U.S. Food and Drug Administration/AP

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Days after a sharply critical Congressional report, the manufacturer of a medical scope linked to a number of "superbug" infection outbreaks is recalling the device.

Olympus America Inc. on Friday sent a letter to hospitals that use its duodenoscope informing them that it is recalling the scopes to replace their "forceps elevator mechanism" with a newly approved design. Experts say this part of the scope can trap and transmit antibiotic-resistant "superbug" bacteria even after thorough cleaning.

Olympus, which makes most of the duodenoscopes used in the U.S., said it is also updating the pre-cleaning and manual cleaning instructions in the device's manual. It directed the hospitals to "ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new reprocessing instructions."

The company said it anticipates the turnaround time to replace the elevator mechanisms to be four business days. "Olympus regrets any inconvenience," the letter said.

A Senate committee on Health issued a report on Wednesday saying that more people than necessary were sickened with "superbug" infections because Olympus, the FDA, and hospitals failed to report outbreaks. It said at least 250 people, mostly in the U.S., came down with life-threatening infections linked to contaminated scopes in the past three years - more than previously estimated by federal regulators.

Last year, the FDA reported that the medical devices from Olympus and other manufacturers were linked to 142 patient infections.

The committee linked the scope to 25 outbreaks, including one at Cedars-Sinai Medical Center and one at UCLA's Ronald Reagan Medical Center.

Officials at UCLA's Ronald Reagan Medical Center declined to comment on the recall Friday.

In a statement Cedars-Sinai says it is monitoring reports of the recall and the redesign. 
"We are working closely with our staff to make sure that Cedars-Sinai is in full compliance with all government regulations and manufacturer recommendations. As always, we are guided by our mission to provide our patients with the best possible healthcare," the statement says.

Rep. Ted Lieu (D-Los Angeles) called Olympus' recall "belated," saying it "confirms what lawmakers and regulators have been highlighting: design defects in these scopes were causing deadly infections in patients." Lieu argued that if Olympus had initiated the recall sooner, "numerous patients would not have been infected with antibiotic resistant superbugs, and less people would have died or been seriously injured."

The congressman also called for monitoring of the new forceps elevator mechanism, "since previous claims of effectiveness by Olympus have proven not to work." Lieu also called on Pentax and Fuji, the other two major scope manufacturers, "to fix their design problems and recall their duodenoscopes."

Last month Lieu called on the Securities and Exchange Commission to investigate when Olympus knew about the problem with the scope and why it did not reveal the issue sooner because it is a publicly traded company.

The scopes are used to identify and treat conditions of the pancreas and bile duct.

Sen. Patty Murray (D-Washington), the health committee's ranking minority member, commissioned the report.

She called for the review last January following the outbreak of antibiotic-resistant infections tied to the medical devices at Virginia Mason Medical Center in Seattle.

At least 32 patients at Virginia Mason contracted infections in 2013 and at least 11 later died, though it's unclear whether those deaths were a direct result of the infections, the report said.
Patients were sickened by dangerous bacteria that remained on specialized scopes even after they were cleaned according to manufacturers' directions.

Huntington Memorial Hospital in Pasadena, California, was among the other hospitals that said some of its patients contracted the antibiotic-resistant "superbug" linked to the scope.
In August it notified public health authorities after several patients who had procedures using Olympus duodenoscopes were found to have the bacteria.

"Patients should be able to trust that the devices they need for treatment are safe and effective," Murray said in a statement.

The report recommends a number of legislative and regulatory changes. It urges Congress to require that unique device identifiers be included in insurance claims, electronic health records and device registries. It says the FDA should evaluate whether design modifications are needed and if so, require manufacturers to implement repairs through a phased recall.

"We appreciate the report from Sen. Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address," FDA spokeswoman Deborah Kotz wrote in an email.

The report also found that at least 16 U.S. hospitals traced antibiotic-resistant infections directly to the devices, but the hospitals generally did not raise alarms about these infections with federal regulators.

The report said that by early 2013, Olympus, the manufacturer of 85 percent of the duodenoscopes used in the U.S., knew the scopes could harbor dangerous bacteria but didn't warn U.S. hospitals until early 2015.

Mark Miller, an Olympus spokesman, said in a statement posted on the company's website Wednesday that the firm cooperated with Murray's office and that the report recognized the need for regulators, hospitals and manufacturers to address infection risk.

"Although we do not agree with all of the report's conclusions, we are closely reviewing the recommendations in the report as part of Olympus' ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes," Miller wrote.

Murray sought records from Olympus, Pentax Medical and Fujifilm Medical Systems to understand ongoing concerns about the scopes used in about 700,000 procedures a year in the U.S., often to avoid invasive surgery.

Gale Robinette, a Virginia Mason spokesman, told the Seattle Times that hospital officials were eager to read the report.

"We will evaluate any guidance the report offers as an opportunity to further improve our processes. Patient safety and quality care are the highest priorities at Virginia Mason," he said in an email.

The report noted outbreaks at hospitals in Washington state, California, Connecticut, Florida, Illinois, Massachusetts, New York, North Carolina, Pennsylvania and Wisconsin.

This story has been updated.