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 report is the result of a yearlong investigation, initiated by Murray in January 2015, into the cause of and response to outbreaks of antibiotic resistant infections linked to medical devices called duodenoscopes at Virginia Mason Medical Center in Seattle and other hospitals nationwide.
The report found that duodenoscopes spread life-threatening, antibiotic-resistant infections, including superbug infections, among patients in a number of hospitals throughout the United States and Europe in 2013 and 2014.
It documents a “systemic and unacceptably slow response” to growing evidence that duodenoscopes could not be reliably decontaminated between patient use, and makes clear that Food and Drug Administration’s (FDA) current system to monitor medical device safety is unable to effectively identify device problems when they occur, which poses an unacceptable risk to patients.
“Following the tragic impacts outbreaks have had on patients and families in my home state and across the nation, I made it my priority to ensure we fully understood how this could have happened in the first place, and what could be done to protect patients going forward,” Senator Murray said. “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. This report lays out steps to address these failures and ensure FDA can appropriately respond to device safety issues, and I am going to continue fighting to protect patients.”
The report also recommends a series of legislative and regulatory changes to ensure the FDA is able to effectively monitor and evaluate the postmarketing safety of medical devices.
The report calls on FDA to evaluate whether repairs to closed-channel duodenoscopes are necessary to prevent the spread of infections, and if so, requiring manufacturers to implement those repairs through a phased recall.
It calls on the federal government to require that unique device identifiers (UDI) be included in medical data to allow FDA to more quickly identify risks associated with a given device.
And it calls for a strengthening of FDA guidance regarding clearance of modified medical devices by manufacturers.
In September 2013, staff at Virginia Mason Hospital and Medical Center in Seattle, Washington, traced a cluster of antibiotic-resistant infections in patients to a medical device called a closed channel duodenoscope, which is used to identify and treat conditions of the pancreas and bile duct.
Around the same time, staff at Advocate Lutheran General Hospital outside of Chicago, with the help of the Centers for Disease Control and Prevention, similarly linked an outbreak of superbug infections to closed-channel duodenoscopes.
Both hospitals concluded that closed-channel duodenoscopes remained contaminated even after proper cleaning, spreading bacteria between patients, but it took 17 more months for duodenoscope manufacturers and the FDA to alert hospitals, doctors, and the public to the risk posed by the devices.
In January 2015, after several outbreaks of serious infections, including in Seattle, became public, Senator Murray initiated an investigation to determine the extent of duodenoscope-linked infections, understand the slow response, and determine if legislative
changes were needed to prevent similar problems in the future.
Senator Murray’s staff investigation has demonstrated that the clusters of infections at Virginia Mason and Advocate Lutheran were not isolated incidents.
Between 2012 and spring 2015, closed-channel duodenoscopes were linked to at least 25 different incidents of antibiotic-resistant infections that sickened at least 250 patients worldwide.
The investigation found that by early 2013, Olympus, the manufacturer of 85 percent of the duodenoscopes used in the United States, knew of two independent lab reports finding that the closed-channel model duodenoscope could harbor and spread bacteria even after cleaning according to the manufacturer’s instructions.
The report found that Olympus never brought this information to FDA, and did not alert hospitals, physicians or patients in the U.S. to the risk of infection until February 2015.
The investigation also found that Olympus, as well as the other two manufacturers of duodenoscopes used in the United States, Pentax and Fujifilm, and Custom Ultrasonics, the manufacturer of the automated cleaning machine in use at many of the hospitals that experienced infections, failed to meet the obligations placed upon them by the current regulatory system.
Two of the manufacturers failed to seek FDA clearance before selling the “closed-channel” duodenoscopes, all failed to adequately test whether the scopes could be cleaned reliably in real-world settings, and fully comply with adverse events reporting requirements.
Additionally, although at least 16 separate U.S. hospitals traced antibiotic-resistant infections directly to duodenoscopes, the hospitals generally did not raise alarms about these infections with federal regulators.
The report found that not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers.
When hospitals did take required action to report adverse events to device manufacturers it was often late, notification was made informally by phone or email, and reports were not inclusive of all the information necessary for the manufacturers to themselves submit accurate and complete information to FDA.
While FDA started investigating how closed-channel duodenoscopes cleaned according to manufacturers’ instructions spread infection in September of 2013, the agency took no action to alert hospitals, doctors and the public to the risk posed by closed-channel duodenoscopes for 17 months.
At least 68 patients in seven different hospitals in the United States were infected with antibiotic-resistant bacteria linked to duodenoscopes during this period.
The report found that problems with FDA’s outmoded adverse event device database, as well as slow and incomplete reporting by manufacturers and hospitals, appear to have left FDA staff unable to develop an accurate sense of the frequency and severity of the infection outbreaks.
The FDA was also unaware that by early 2013, two independent labs in Europe had documented the Olympus closed channel duodenoscope remaining contaminated after repeated cleaning, or that a Dutch Health Ministry report in 2013 had already concluded that Olympus did not have the data to show their cleaning instructions worked consistently and effectively.
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 the responsible for the infections,” the report found.
Unlike FDA’s surveillance of drugs, where the agency is increasingly able to use the “sentinel” system to develop fast and accurate information about adverse events, FDA had no way to seek independent information about adverse events linked to medical devices.
The failure of FDA’s current device safety reporting system to rapidly identify duodenoscope-related, antibiotic-resistant infections, including superbug infections, should serve as warning that without a comprehensive postmarket device surveillance system that supplements self-reporting from hospitals and manufacturers, future device issues are likely to go undetected for far too long and with life-threatening consequences, the report found.