Manufacturers failed to report infections from duodenoscopes, US investigation findsBMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i240 (Published 14 January 2016) Cite this as: BMJ 2016;352:i240
Manufacturers of hard to clean duodenoscopes that spread potentially life threatening, antibiotic resistant bacterial infections to hundreds of patients in the United States and Europe failed to meet their legal obligations to report serious infections and deaths to federal regulators, says a US Senate committee report released on 13 January.1
The report, the result of a year long investigation by the Senate Health, Education, Labor, and Pensions Committee, also found that almost all the US hospitals where the infections occurred failed to properly inform health officials of the outbreaks. The investigators estimated that the outbreaks, which occurred in 2013 and 2014, were responsible for at least 250 deaths, considerably more than previous estimates.
“These outbreaks occurred despite the fact that the manufacturer of 85% of the duodenoscopes used in the United States, Olympus, was aware by early 2012 that its closed-channel duodenoscope could harbor dangerous bacteria even after repeated and careful cleaning according to instructions,” the report said.
“Multiple hospitals were also aware that duodenoscopes were linked to superbug and other antibiotic-resistant infections in ERCP [endoscopic retrograde cholangio-pancreatography] patients,” the report said. “Yet none of the three manufacturers of duodenoscopes sold in the United States—Olympus, Fujifilm, and Pentax—and only one hospital, ever alerted CDC [the Centers for Disease Control and Prevention] to the infections.”
Outbreaks of carbapenem resistant enterobacteriaceae infections were first traced to the duodenoscopes by the staff of two US hospitals in 2013. Investigations by both hospitals had determined that the devices remained contaminated after proper cleaning, yet it took 17 more months before the manufacturers of the duodenoscopes and the FDA alerted hospitals, doctors, and the public to the hazard, the report said.
The investigators identified 25 outbreaks, including several in Europe, which occurred at the Erasmus Medical Centre, Rotterdam; Universitair Medisch Centrum, Utrecht; Clinique De Bercy, Charenton-Le-Pont, France; Charite-Universitatsmedizin, Berlin; and Evangelisches Waldkrankenhaus, Spandau, Berlin.
Senator Patty Murray, a Democrat from Washington state who led the investigation, called the response to the outbreaks unacceptably slow. “Patients should be able to trust that the devices they need for treatment are safe and effective. 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,” Murray said.
The closed channel duodenoscopes are typically used in endoscopic retrograde cholangio-pancreatography to relieve blockage of the bile or pancreatic ducts caused by tumors, gallstones, and other conditions. Because this procedure requires insertion of a guide wire and catheter into the ducts, these devices have more complex and difficult to clean mechanisms than standard endoscopes. Patients undergoing the procedure are often quite ill and vulnerable to infections.
The report found that, once it had been alerted to the outbreaks, the FDA’s investigation was hampered by slow and incomplete reporting by manufacturers and hospitals, as well as the agency’s outmoded system for reporting adverse events involving medical devices. “As a result, the FDA wasted valuable time seeking cleaning data from manufacturers and trying to conclusively determine that cleaning mistakes by hospital staff in cleaning were not responsible for the infections,” the report said.
Among its recommendations, the report called for the FDA to quickly evaluate the design of closed channel duodenoscopes and implement a phased recall to fix and modify the devices as necessary. It also called for the FDA to implement new guidance to disseminate information to healthcare providers more quickly when the agency became aware that patient safety might be compromised by a medical device. Finally, it said that it should be made a condition of participation in Medicare for hospitals to report adverse events related to medical devices.
In a statement issued in response to the report, Olympus said, “We appreciate that the staff report noted Olympus’ cooperation and that the report demonstrates the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the Food and Drug Administration, each of which can contribute to increasing patient safety. Although we do not agree with all of the report’s conclusions, we are closely reviewing the recommendations in the report as part of Olympus’ ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes.”
Cite this as: BMJ 2016;352:i240