Scope linked to “superbug” outbreak not cleared by FDA

In an incident that could be of interest to Tennessee residents, the U.S. Food and Drug Administration reports that the manufacturer of a medical instrument linked to an infectious “superbug” outbreak in California did not have clearance from the federal agency to sell the device. The instrument, a redesigned version of a specialized endoscope made by Olympus Corp., has been on the market since 2010.

The flexible fiber-optic device, called a duodenoscope, is inserted down the throat to treat medical issues in the stomach and small intestine. However, the instrument has proven difficult to disinfect even when following the manufacturer’s instructions. An “embedded” antibiotic-resistant strain of bacteria which was found on the devices has been linked to the infections of seven people at Ronald Reagan UCLA Medical Center in Los Angeles between October and January. Two of the victims died. On March 4, Cedars-Sinai Medical Center also reported that four of its patients may have been infected by the devices.

The “superbug” bacterial strain, known as carbapenem-resistant Enterobacteriaceae, has been found on identical Olympus endoscopes in other hospitals across the country. According to the FDA, Olympus updated the device in 2010 and did not obtain the federal clearance required for all substantially redesigned medical instruments marketed in the U.S. However, the agency said doctors could continue to use the endoscope because a review may not have prevented the infections. They said the instrument’s complex, flexible design, which traps body fluids and particles, makes it extremely difficult to disinfect. It is used in approximately 500,000 procedures each year.

Anyone who has been harmed by dangerous pharmaceutical and medical products may wish to meet with a legal representative. An attorney could review details of the case and advise a client on the available legal options, including the possibility of filing a civil lawsuit for damages.

Source: The Houston Chronicle, Maker of device in ‘superbug’ outbreak lacked FDA clearance,” Matthew Perrone, March 5, 2015