Hundreds of patients have been infected with antibiotic-resistant bacteria because of the use of dirty medical devices called duodenoscopes, according to a report published Wednesday by the U.S. Senate Committee on Health, Education, Labor and Pensions.
The investigation, led by Sen. Patty Murray, found that the scopes manufactured by Olympus caused at least 25 outbreaks, leading to 250 superbug infections in different countries from 2012 to 2015 - figures that are greater than previously thought.
Duodenoscopes are used to examine the top section of the small intestine or duodenum. Apparently, the medical device posed the risk of infection because its design made it difficult to clean.
According to the report, Olympus had been made aware of two infections in the Netherlands in 2013. However, even though the company was supposed to inform the U.S. Food and Drug Administration about the health risk associated with the device, they did not do so until February 2015. As a result, the use of the device continued for years.
"It is their responsibility when the device that they have manufactured has safety defects to notify the patients, the doctors, the hospitals," said Murray, according to the New York Times. "People should know this. We should not allow manufacturers to knowingly allow the use of any device or medication that's not safe."
The senator also criticized the FDA's slow response regarding the issue. The agency received information regarding at least 11 hospital outbreaks associated with the use of the duodenoscopes in 2013.
"Some of the hospitals were late in notifying patients, and the FDA did not take action immediately when they began to get reports," said Murray.
Outbreaks from as early as 2008 and 2009, which infected 70 and killed 15 people, have been linked with the duodenoscope. A U.S. Centers for Disease Control and Prevention official sent an email to the FDA in 2009 saying "there is a real chance that these issues might be more widespread" and recommended that the agency issue "some type of educational alert" about the difficulty in cleaning the device, reported Bloomberg.
"We appreciate the report from Sen. Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address," said FDA spokeswoman Deborah Kotz, according to the New York Times. "We agree with the senator that a broader approach to understanding how well duodenoscope devices work in real-time use is critical to public health."
