Scores of patients were needlessly infected with potentially deadly bacteria after medical scope procedures because of repeated failures by the device manufacturers, regulators and hospitals to report outbreaks, according to a U.S. Senate investigation released Wednesday.
The investigators said they had found 25 outbreaks linked to a device known as a duodenoscope, far more than previously reported.
And they said numerous flaws in the federal government’s oversight of medical devices are continuing to put patients at risk “with life-threatening consequences.”
“Patients should be able to trust that the devices they need for treatment are safe and effective,” said Sen. Patty Murray (D-Wash.), who initiated the probe after dozens of patients were sickened at a Seattle hospital.
“Unfortunately, this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”
The report details how Olympus Corp., the leading maker of the device, knew of the potential flaws in the scope in spring 2012 because of an independent investigation of an outbreak in the Netherlands.
But Olympus — and the federal Food and Drug Administration — did not warn American hospitals about the potentially lethal problem with the device until February 2015, after the Los Angeles Times reported about a superbug outbreak at UCLA’s Ronald Reagan Medical Center where dozens of patients were potentially exposed and three died.
The investigators said that at least 141 patients in a myriad of cities were infected during that three-year delay.
The FDA began to investigate the scopes in September 2013, but “wasted valuable time” in seeking data from Olympus and two other manufacturers on whether they could show their devices could be properly cleaned, according to the report.
They also faulted hospitals where the outbreaks occurred for not filing required injury reports, which could have helped stop the infections.
The FDA requires manufacturers to file reports of injuries tied to their devices. The system — known as Maude — was designed to help give an early warning about defective devices.
Olympus filed some reports months late. And in most of the reports, the company suggested that something other than its scope, including poor cleaning procedures by hospitals, were to blame.
The FDA also strips all hospital names and locations from the reports, making it difficult for the public to track the outbreaks.
Deborah Kotz, an FDA spokeswoman, said Wednesday that stopping the risk of device-related infections “is a top priority” for the agency.
“The FDA has taken several actions to address the issue of duodenoscope-related infections and will continue to work to protect patients while ensuring access to these important devices for those who may benefit from minimally invasive procedures,” Kotz said.
Mark Miller, an Olympus spokesman, said Wednesday that the company had been cooperating with the investigators for several months.
“Although we do not agree with all of the report’s conclusions,” Miller said, “we are closely reviewing the recommendations in the report as part of Olympus’s ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes.”
Olympus, which is headquartered in Japan, sells 85 percent of the duodenoscopes used in American hospitals.
The duodenoscope is used in a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. Doctors thread the flexible scope down a patient’s throat, into the digestive tract to diagnose and treat cancers, gallstones and other conditions.
Other manufacturers of the scope are Pentax and Fujifilm.
A spokeswoman for Pentax said Wednesday that the company was working with Congress and regulators to reduce the risk of infection from scopes.
And Fujifilm spokeswoman Diane Rainey said: “The protection of the health and safety of all patients remains the No. 1 priority of Fujifilm, and we are committed to working together with all stakeholders, including patients, hospitals, regulators and lawmakers, to ensure the long-term sustainable use of duodenoscopes.”
The FDA has said it decided not to recall the scopes because there is no other device to perform ERCP — a procedure that can avoid dangerous surgeries.
The investigators said at least three independent investigations had questioned the new design of recent models of the duodenoscope. In those devices, a tiny internal channel was sealed with the intention of keeping blood and other infectious material out so that it did not have to be cleaned.
The Senate investigators called for the FDA to quickly evaluate the scope’s sealed design, saying it “is now evident” that such models can “trap and transmit bacteria” even after cleaning.
The agency should consider “a phased recall” of the devices, the investigators said, so that they can be repaired or modified and properly disinfected.
They also called for the FDA to stop relying on manufacturers and hospitals to report injuries caused by devices. Instead, the system should be strengthened, they said, so the devices have unique identifying numbers that can be tracked in pharmacy insurance claims and electronic health records.
And because most hospitals had failed to report the outbreaks to regulators, the investigators called for those injury reports to be required as a condition of participating in Medicare.