In an effort to make the device safer, Olympus made a small design change to its TJF-Q180V duodenoscope back in 2010: It sealed up a part of the device, known as the elevator channel, hoping to make the side-viewing scope more impervious to infection. But the modified elevator channel, which has crevices that are difficult to access with a cleaning brush, has been implicated in the outbreak of a drug-resistant superbug that killed 2 patients and sickened 7 others at a Los Angeles hospital last month. And yesterday the FDA confirmed a report that Olympus didn't seek 510(k) clearance for the modifications it made to its FDA-cleared device.

CNN first reported that Olympus never obtained permission to sell the modified device (see "Deadly superbug-related scopes sold without FDA approval").

The FDA informed Olympus last March that it must submit a 510(k), which the agency says the company did in October. "That submission is pending because the FDA requested more data from the company," says FDA spokesperson Leslie Wooldridge. The FDA requires manufacturers to seek permission to put new models on the market if the updated versions include "labeling changes, technology or performance specifications changes, and materials changes." In explaining the 4-year delay in seeking approval, Olympus determined that its modified TJF-Q180V did not require a new 510(k) application according to the FDA policy on modifications to 510(k)-cleared devices, but adds that Olympus "continues to cooperate with the agency," says company spokesperson Mark Miller."

Owing to their complex design, all duodenoscopes are difficult to properly clean — even if the manufacturer's reprocessing instructions are followed correctly, says Ms. Wooldridge. "We have received reports of infections associated with the duodenoscopes manufactured by all 3 (Olympus, Pentax and Fujifilm) device companies," she says. The FDA issued a safety communication last month intended to raise awareness among healthcare professionals.

In a safety memo of its own, Olympus gives an idea of the complexity of duodenoscope reprocessing. Techs must raise and lower the forceps elevator of its scope multiple times in the detergent solution during manual cleaning. "While the TJF-Q180V's forceps elevator wire is sealed, the area around and under the actual moving parts, such as the elevators, needs to be meticulously manually cleaned," says Olympus.

Health officials in February identified 7 patients at Ronald Reagan UCLA Medical Center in Los Angeles who had contracted carbapenem-resistant Enterobacteriaceae, a dangerous superbug that causes severe diarrhea and kills an estimated 29,000 people in the U.S. every year.

Despite the emergence of drug-resistant microorganisms like CRE, the FDA does not plan to pull the devices. "Of the more than 500,000 procedures performed in the United States each year using duodenoscopes, only a small fraction have been associated with transmission of antibiotic-resistant organisms, including CRE, from inadequately reprocessed duodenoscopes," says Ms. Wooldridge. She adds that there are no alternative devices for Endoscopic Retrograde Cholangiopancreatography (ERCP), which she calls "the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancer, gallstones and other conditions."

"Pulling these devices from the market would prevent hundreds of thousands of patients from access to this beneficial and often life-saving procedure," says Ms. Wooldridge. "The FDA believes at this time that the continued availability of these devices is in the best interest of the public health."

Dan O'Connor