The manufacturer of the specialized endoscope at the center of the deadly drug-resistant bacteria outbreak at UCLA never obtained approval from drug and medical device regulators to sell the surgical tool in the United States, CNN has learned.
Olympus began selling its TJF-Q180V duodenoscope in 2010. The Food and Drug Administration (FDA), didn’t realize until late 2013 or early 2014 that Olympus had never filed for FDA approval on the device.
Duodenoscopes are a type of flexible endoscope fitted with a camera that is put down throats of patients to treat a variety of gastrointestinal conditions. A half million duodenoscope procedures are performed each year.
Between October and January, seven patients at Ronald Reagan UCLA Medical Center were infected with CRE, or carbapenem-resistant Enterobacteriaceae, a bacteria that kills as many as 50 percent of the patients it infects. The patients had all recently undergone duodenoscope procedures. Since the UCLA outbreak was reported, the agency has learned of similar outbreaks in Tampa, Chicago, Pittsburgh and Seattle.
Last month the FDA issued a Safety Alert notifying health care professionals that bacteria can harbor in the small crevasses of the duodenoscopes and remain even after the devices are disinfected following manufacturer-recommended instructions.
Two other duodenoscope manufacturers – Pentax and Fujufilm – have applied for and were granted FDA approval to market their duodenoscopes, which are similar in design to Olympus’ TJF-Q180V.
Last year, the FDA ordered Olympus to file for approval. That application is pending. Meantime, Olympus’ duodenoscopes remain on the market. The FDA says the devices are life-saving tools and it doesn’t want to remove them from the market.
Olympus was named in the first lawsuit to be filed in the superbug outbreak. That case involved an otherwise healthy 18-year-old boy who became infected with CRE after undergoing a a duodenoscope procedure at the UCLA hospital.