Reports alerting health officials about contaminated medical scopes suspected of passing the CRE superbug during several recent outbreaks were received late or not at all, delaying medical treatment and eliminating any possibility of an early response.
What’s the Problem?
Medical device manufacturers are required to file reports with the U.S. Food and Drug Administration (FDA) within 30 days of learning that a product may pose safety risks. However, in at least 8 recent outbreaks of drug-resistant bacteria linked to duodenoscopes, FDA wasn’t aware of the problem until long after it was over, and in some cases disclosures were never made.
Health officials are trying to determine how the duodenoscopes spread carbapenem-resistant enterobacteriaceae, or CRE. Investigators believe the bacteria gets trapped in the device’s “elevator channel”, even after cleaning and disinfection, and is passed from patient to patient.
Device Reports Not Received
The disclosures manufacturers are required to submit are called Medical Device Reports (MDRs), and are meant to help the FDA identify outbreaks and other problems quickly. The agency relies on MDRs to help decide whether recalls, warnings or other actions are needed to address safety issues with the medical devices and appliances it regulates.
“We are aware that there are reported duodenoscope-associated infections that have occurred for which we have not received MDRs, and we are looking into whether some of those reports should have been submitted,” said William Maisel, deputy director for the FDA’s Center for Devices and Radiological Health. “Individual MDRs often don’t contain sufficient information for the agency to make a definitive determination (of problems with a device), but we certainly believe manufacturers should be reporting them to us.”
Duodenoscopes are used in about 500,000 routine medical procedures each year, and determining which manufacturers have failed to submit MDRs when problems occur is troubling. An article published in USA Today looked at the FDA’s database for reports on duodenoscope-related infections, and failed to uncover enough reports to account for all the superbug outbreaks linked to the devices. Also, since MDRs are heavily redacted by the FDA to remove identifying information, it was impossible to tell which outbreaks were never reported on, or which manufacturers failed to disclose the reports.
Olympus Duodenoscope Linked to CRE Outbreaks
At least 6 recent CRE superbug outbreaks have been linked to duodenoscopes made by Olympus. The company has declined repeated requests for comment on its reporting system, citing lawsuits currently pending in courthouses around the country.
Another manufacturer, FUJIFILM, has acknowledged that its duodenoscopes were linked to 3 CRE infections at an Illinois hospital in April 2014. The company learned about the infections a month later and filed a report with the FDA within the 30 day requirement, according to USA TODAY.
Virginia Mason CRE Outbreak
When representatives from Olympus arrived at Virginia Mason Hospital in Nov. 2013, it was clear the CRE outbreak at the facility was linked to the company’s duodenoscopes. More than a half dozen infections were reported in patients treated with the devices; however, it wasn’t until 9 months later — August 2014 — that the FDA received a report from Olympus about the event. More than 30 patients at Virginia Mason were ultimately diagnosed with CRE in the outbreak, 11 of whom died.
Unreliable Tracking System
From 2013 to 2014, the FDA received 75 MDRs involving potential superbug infections associated with duodenoscopes. However, many of the reports were duplicates. Manufacturers often submit multiple versions for the same event, so the number of reports doesn’t necessarily reflect the true number of infections that occurred.
This highlights how the responsibility for identifying potential safety problems ultimately lies with the manufacturers, not the FDA. And if a flaw in a medical device goes unreported, that product can remain in use indefinitely, resulting in profound public health consequences.
What’s more, there’s almost no way for the FDA to know when manufacturers don’t file reports. If a company fails to submit an MDR, problems with a device are likely to remain hidden, and when they do file reports, they may not get much scrutiny.
“This system of filing these (MDR) reports is the only thing in place that can tell us that devices are having problems, (and) … it often puts the interests of (device) manufacturers and the hospitals ahead of the public,” says Lisa McGiffert, who heads the Safe Patient Project at Consumers Union, the publisher of Consumer Reports. “It’s a pretty weak system.”