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Outrage of the Month: Failures by Device Manufacturer, FDA Exposed Patients to Life-Threatening Infections
Health Letter, February 2016
Michael Carome, M.D.
In January, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a detailed report of a yearlong investigation into recent outbreaks of serious, often fatal, infections. The infections were linked to procedures with contaminated medical instruments known as duodenoscopes. The damning report reveals critical failures by both the leading manufacturer of these devices and the Food and Drug Administration (FDA) that likely contributed to avoidable patient illnesses and deaths.
Duodenoscopes are flexible, hollow, lighted tubes that can be passed through the mouth, throat and stomach and into the small intestine. According to the FDA, each year more than half a million people undergo procedures with these scopes for treatment of gallstones or other conditions.
The Seattle Times first broke the news of these outbreaks on Jan. 21, 2015, when it reported that from 2012 to 2014 at least 32 patients at Virginia Mason Medical Center in Seattle had developed serious antibiotic-resistant bacterial infections following duodenoscope procedures. Eleven of those patients died. The infections spread even though the scopes that caused the outbreak purportedly had been cleaned and disinfected according to the device manufacturers’ instructions.
In the several weeks following the Seattle Times story, a flurry of news reports documented similar outbreaks that had occurred at other medical facilities across the country, including at hospitals in Los Angeles, North Carolina and Wisconsin. Most of these reported outbreaks were linked to duodenoscopes sold by medical device manufacturer Olympus, which makes 85 percent of such scopes used in the U.S. News about the outbreaks grew even more troubling in March 2015 when the media reported that Olympus had not obtained the required clearance from the FDA before it began selling the scope model linked to the infections in 2010.
Soon after the Seattle Times exposé, Sen. Patty Murray, the leading Democrat on the HELP Committee, launched an investigation. Committee investigators discovered that infections linked to use of the duodenoscopes were more widespread than was reported by the media: From 2012 to 2015, these devices had been linked to at least 25 different outbreaks of antibiotic-resistant infections in 10 states and three other countries, sickening approximately 250 patients.
Two findings uncovered by committee investigators are particularly troubling. First, by early 2013, Olympus was aware of two independent lab reports finding that its duodenoscope model could harbor and spread bacteria even after cleaning according to the manufacturer’s instructions. But Olympus never communicated this information to the FDA and did not alert hospitals, physicians or patients in the U.S. to the risk of infection until February 2015. The Senate report found that Olympus’ failure to take action and alert the FDA likely contributed to at least 141 infections in the U.S.
Second, by late 2013, the FDA was aware of serious infections linked to duodenoscopes made by Olympus and at least one other manufacturer after receiving an alert about such infections from the Centers for Disease Control and Prevention. The FDA had started investigating how the scopes spread infections. However, it took no action to alert hospitals, doctors or the public to the dangers posed by these medical devices for 17 months. Senate investigators found that during this period, at least 68 patients in seven hospitals in the U.S. became infected with antibiotic-resistant “superbugs” linked to duodenoscope procedures.
The HELP Committee report offers useful recommendations for improving the reporting and monitoring of adverse events related to medical devices. However, the report falls short by not recommending that individuals at Olympus and the FDA be held accountable for the egregious failures that likely contributed to avoidable patient illnesses and deaths.
Senior leaders at both Olympus and the FDA almost certainly knew of the dangers posed by the duodenoscopes many months before the media alerted the public. These leaders must be replaced. If these individuals are not held accountable for their unacceptable failures to protect patient and public health, similar preventable tragedies will be more likely to occur in the future.