After widespread cleaning problems with duodenoscopes led to superbug infections, companies, such as Olympus, worked with the FDA to come up with better sterilization protocols.

Now, two days after a U.S. Senate report linked dirty scopes to outbreaks, the firm is voluntarily recalling the complex medical device for a design overhaul, according to an FDA release.

Reports in the Los Angeles Times found that the company was aware of possible design problems in mid-2012, but did not reveal them to either government officials or U.S. hospitals.



“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” said Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, are intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.”

In fact, there were more infections from the use of improperly cleaned devices than previously thought, according to the Senate report. It determined that, "between 2012 and spring 2015, closed-channel duodenoscopes were linked to at least 25 different instances of antibiotic-resistant infections that sickened at least 250 patients worldwide."

The devices are invaluable and widely used — more than 500,000 procedures with them happen per year. They offer a much less invasive way to "drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions," according to the FDA.

The crux of the cleaning woes had to do with a modification in 2010 to the scope's design. Olympus changed the internal channel seals to keep out foreign substances, such as blood. This made it easier to clean between uses — except that it didn't work all the time and led to contamination and the outbreaks of infection. Other makers of the scopes, Pentax and Fuji, also made similar modifications.

Scope makers “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues,” stated the Senate's 300-page report, noting that, "this disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world."

The report was launched by Sen. Patty Murray (D-Wash.). “These devices exposed far too many patients and their families to unacceptable risks, and I am pleased to see that the FDA and manufacturers have taken additional actions to protect patients in the future,” she said, adding that, "important" as these actions are, "there is much more we need to do to make sure the FDA can respond quickly and appropriately when problems with medical devices occur.”

While the Olympus redesign may be an important response to correcting the flaw in its instrument, for those ravaged by the consequences of infection, it does little to soften the blow. While they were sickened and suffered, scope sales rose 19 percent to $1.8 billion for the half-year ending September 2015, according to the Times.

"It infuriates me to know they knew about this in 2012,” Steven Wilkinson-St. George, who was made very sick by a scope procedure at UCLA's Ronald Reagan Medical Center in December 2014, told the paper. “This should have been done years ago.”

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