Olympus knew scopes could cause 'superbug' infections, report says
Hospitals should have been quicker to report findings to federal authorities, accordign to a Senate report.
Photo by Virginia Mason Hospital
Two days after a Senate committee released a report stating the manufacturer of 85 percent of endoscopes used in the United States knew the hard-to-clean reusable devices caused superbug infections, scope-maker Olympus issued a recall of the medical equipment.
The duodenoscopes made by Olympus, Pentax and Fujifilm Medical Systems were linked to at least 25 incidents of antibiotic-resistant infections that sickened an estimated 250 patients worldwide, according to the Jan. 13 report by the Senate Committee on Health, Education, Labor and Pensions.
At least 32 patients at Virginia Mason Hospital and Medical Center in Seattle were infected and 11 later died, though whether the deaths were a direct result of the infections remains unclear, according to a published report.
In a Jan. 15 letter to healthcare professionals, Olympus America said it was conducting a voluntary removal/corrective action on all of the closed-channel duodenoscopes.
The Senate report found that Olympus knew by May 2012 that the duodenoscope model used at Virginia Mason could harbor and spread bacteria even after proper cleaning.
"By the fall of 2012, Olympus was aware that its duodenoscopes had been linked to antibiotic-resistant infections, including superbug infections, caused by life-threatening multidrug-resistant organisms at hospitals in both the United States and Europe," ranking member Patty Murray, D-Washington, said in the report. "By early 2013, independent laboratory tests of at least two different closed-channel duodenoscopes showed the devices remained contaminated after careful repeated cleaning and reprocessing. Despite this, Olympus issued no safety alerts or guidance to hospitals and physicians in the United States until February 2015 – almost three years after first realizing the problem in April 2012."
The "superbug" kills almost half of those infected, Murray said.
"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," said Mark A. Miller, vice president of Corporate and Medical Communications for Olympus Corporation of the Americas.
Olympus cooperated with the committee, and the report demonstrates a shared responsibility with duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the Food and Drug Administration, he said.
The report found that an estimated 20 U.S. hospitals traced antibiotic-resistant infections directly to the devices, but did not proactively communicate information to federal agencies.
The hospitals reporting the greatest number of incidents include New York-Presbyterian/Weill Cornell Medical Center in New York City, with 15 patients infected; UMass Memorial Medical Center in Worcester, Mass., with 20 patients infected; Advocate Lutheran General Hospital in Park Ridge, Illinois, with 32 patients infected; Virginia Mason Hospital and Medical Center in Seattle, Washington, with 32 patients infected; and Carolinas Medical Center in Charlotte, North Carolina, with 18 patients infected.
"Overall, hospitals' slow approach left the FDA with an inaccurate picture of the frequency and severity of these events," the report states. "… Hospitals as a whole appear to have believed they had an obligation to report only what they could demonstrate beyond any doubt. Such narrow reasoning reveals a misunderstanding about hospital reporting requirements, which are triggered by information that reasonably suggests a device may have caused or contributed to a death or serious injury."
The FDA was also not spared in the report, which said the agency failed to recognize the prevalence of duodenoscope-linked infections and to respond quickly.
The report's recommendations included: having Congress require and promote that unique device identifiers be included in insurance claims, electronic health records and device registries; that the FDA should evaluate whether modifications to the design of the closed-channel duodenoscopes are necessary; and that the FDA should move faster to provide information to healthcare providers.
