The manufacturer of the medical scopes at the center of a deadly bacterial outbreak at UCLA Medical Center is under investigation by federal officials for possible violations of laws that ban improper payments to doctors and other customers.
Olympus Corp. of Americas, the U.S. subsidiary of the Japanese manufacturer, said earlier this month that the Justice Department had been investigating its medical business since November 2011.
Olympus manufactured the scopes that medical officials believe infected seven patients at UCLA’s Ronald Reagan Medical Center with a drug-resistant bacteria. Two of those people died.
The Food and Drug Administration warned hospitals and physicians on Thursday that the commonly used medical scopes may have fueled the superbug outbreak at UCLA. The specialized endoscope is inserted down patients' throats to treat cancers, gallstones and other ailments of the digestive system.
The hospital is notifying 179 other patients who may have been exposed to the bacteria from October 2014 to late January during a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography.
Medical experts said Olympus was the dominant maker of the medical scopes used in the procedure.
The patients were infected with a drug resistant germ known as CRE, or carbapenem-resistant Enterobacteriaceae. The infection is difficult to treat because it is resistant to most antibiotics. It can lead to death in up to 50% of patients who become infected if it infiltrates the bloodstream.
Mark Miller, a spokesman for Olympus, said Thursday that the company was closely monitoring the situation at UCLA. He said that the duodenoscopes require reprocessing and thorough cleaning after each use. The company gives physicians and hospitals instructions on how to clean the scopes, he said.
In its Feb. 6 statement, Olympus did not detail what investigators were focused on. The company said only that Department of Justice officials were looking for possible violations of federal anti-kickback laws and the False Claims Act.
In the past investigations of possible kickbacks in the medical industry have looked at whether companies improperly paid physicians or others as they promoted their products.
Olympus said in the statement that it was talking to federal officials to resolve the matter. The investigation could result in financial consequences that hurt the company's bottom line, it said.