Nine University of Colorado Hospital patients developed infections and three of them later died after undergoing surgeries with a medical device suspected of causing fatal infections nationally.
The instrument, an Olympus Medical System Corp. duodenoscope, is inserted down the throats of patients to perform difficult and sometimes life-saving surgeries. But it has proved difficult to clean and has become associated with sometimes-fatal infections.
The surgery is called an endoscopic retrograde cholangiopancreatography procedure (ERCP) and is commonly used to reach the pancreas or bile ducts.
University of Colorado Hospital released a statement Monday confirming that one Olympus scope had been linked to patient infections there this year.
“Providing the very best and safest care to our patients is our top priority at University of Colorado Hospital,” spokesman Dan Weaver said. “We thoroughly investigated this incident and determined that nine patients who underwent an ERCP using a particular endoscope developed infec -tions; three of these patients later died.”
Weaver noted that when a patient suffering from a severe disease dies of an infection after surgery, it can be hard to pinpoint the cause.
“These patients were very ill, and it is unclear what impact the infections had on their deaths,” he said.
The hospital notified infected patients, families and other patients who had undergone surgery with the suspect endoscope, he said, as well as the manufacturer, the Colorado Department of Public Health and Environment and the Food and Drug Administration.
Health department spokesman Mark Salley said the agency is preparing a report concerning the deaths and infections.
The hospital and the state confirmed the infection investigation after inquiries from Lawrence Muscarella, a Pennsylvania-based medical safety expert, and from The Denver Post.
Muscarella provided a copy of an Olympus report to the FDA that Weaver acknowledged refers to University of Colorado Hospital, although it did not match some details of the hospital’s own findings, including the numbers of infections and deaths.
According to that report, Olympus was informed Jan. 22 that six patients had been infected with E. coli and two of them had died.
The hospital took the device out of service.
On Feb. 29, the manufacturer reported, the hospital “informed Olympus of two additional patients infected by E. coli.”
The device was sent to an independent laboratory, where “sample fluid extracted from the suction channel recovered bacteria,” Olympus reported.
At Olympus, a visual examination of the scope found “the bending section adhesive was whitish in color and had open gaps at each side of the bending section cover, the glue around the nozzle had signs of cracks and gaps,” and “the insertion tube had multiple buckles throughout the entire length.”
A microscopic inspection noted “brownish stains” internally.
The device had been used 791 times, according to Olympus.
Muscarella said duodenoscopes have been linked to more than 250 infections and dozens of deaths nationwide. But the real number is “orders of magnitude higher,” he said, because “many hospitals don’t file a report.”
Duodenoscopes are supposed to be reprocessed, or disinfected and cleansed, between surgeries, and Olympus recently issued even more stringent cleaning instructions for hospitals.
But medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly.
Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, according to the FDA, but may not entirely eliminate it.
“The benefits of these devices continue to outweigh the risks in appropriately selected patients,” the FDA said in a safety alert in August.
More than 500,000 ERCP procedures using duodenoscopes are performed in the United States annually. It is the least invasive way to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions, according to the FDA.
It also carries a known infection risk.
Last year, the Los Angeles Times reported that at least two patients at UCLA’s Ronald Reagan Medical Center had died of drug-resistant bacterial infections after an ERCP surgery.
Last week, the Times reported three more deaths associated with the same device at Huntington Hospital in Pasadena.
Other Olympus duodenoscope-related outbreaks have been reported in the U.S. and abroad.
David Olinger: 303-954-1498, dolinger@denverpost.com or @dolingerdp
