On January 15, 2016, medical device manufacturer Olympus America announced a voluntary recall of its TJF-Q180V duodenoscope so it can be modified to reduce the risk of spreading bacterial infections.
Duodenoscopes are flexible, lighted tubes passed through the mouth and stomach into the top of the small intestine, which are used as a less invasive way than traditional surgery for various gastrointestinal conditions. While these devices play an important role in the treatment of patients, there is evidence that some have been associated with the transmission of infectious agents, including antibiotic-resistant infections.
Outbreaks of antibiotic resistant infections linked to dirty duodenoscopes prompted Senator Patty Murray, ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, to launch an investigation in January 2015. That investigation was concluded with a 301-page report, issued January 13, 2016, which confirms that Olympus, the leading maker of the device, knew of the potential flaws in the scope but failed to alert American hospitals or regulators. Most prominently, the report charges that Olympus knew for 2 years about a design flaw that made the scope harder to clean before disclosing it to hospitals, physicians, and patients in February 2015 – after the investigation had begun. By early 2013, Olympus, the manufacturer of 85 percent of the duodenoscopes used in the United States, knew of two independent lab reports finding that the closed-channel model duodenoscope could harbor and spread bacteria even after cleaning according to the manufacturer’s instructions.
The committee report also faults hospitals for being slow to report infections, some fatal, caused by dirty duodenoscopes, and the FDA for a slow response. It calls for the FDA to develop a more robust system to monitor medical device safety in general.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” Sen. Murray said in a press release. “Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented”, Murray said. And the FDA, in part hamstrung by an ineffective surveillance system, failed to spot the deadly infections linked to contaminated scopes quickly or to alert the public. “It appears that not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers”, Murray’s aides wrote.
If you have a question about an injury from a medical device, such as the Olympus duodenosope, call the defective product lawyers at Tittle & Perlmuter for a free consultation.