The Food and Drug Administration is sending warning letters to makers of medical devices known as duodenoscopes for failing to report serious problems with the devices. The medical scopes are blamed for an outbreak of deadly bacteria in hospitals in Los Angeles, Seattle, and other areas.
Duodenoscopes are used in a procedure known as endoscopic retrograde cholangiopancreatography (ERCP). The devices are used in thousands of medical procedures annually in the United States.
The FDA alleges that the device makers, which include Olympus, Pentax Medical, and Fujifilm, failed to ensure the duodenoscopes could be cleaned properly and also failed to report problems with the devices. In a letter to Japanese medical device maker Olympus Medical Systems Corporation, the FDA noted that the scope maker failed to report 16 patients who contracted an infection after undergoing an endoscopic procedure using Olympus endoscopes.
An FDA warning letter to Fujifilm, another Japanese maker of endoscopes, alleges that Fujifilm failed to establish or maintain procedures to sterilize its endoscopes. The letter also alleges that Fujifilm did not submit a legally required notice to the FDA after a suction button became lodged in a Fujifilm endoscope, causing a 20 minute delay in a patient procedure. The FDA also alleges that Fujifilm lacks the requisite certifications to market the latest model of its endoscope in the U.S.
The FDA additionally holds the position that Olympus, which controls the vast majority of the American specialty endoscope market, was aware of 16 patient infections related to its endoscopes in May 2012, but did not report them until nearly three years later.
The FDA has provided Olympus, Pentax Medical, and Fujifilm until September 2 to respond to the violations alleged in the warning letters. Endoscopes have been linked to superbug outbreaks at hospitals, including three deaths at the UCLA hospital.
The FDA warning letters are dated August 12, but were not published publicly until August 17 on the regulatory agency’s website. The letters imply that the endoscope makers knew about serious problems with the medical devices long before deaths were linked to the scopes. Patients nationwide (and the families of deceased patients) are filing endoscope lawsuits against the makers of duodenoscopes after the medical devices were implicated in deaths and serious illnesses.