Superbug warnings about medical scopes delayed
Despite rules, FDA didn’t get word until long after outbreaks
Reports alerting federal officials that contaminated medical scopes appeared to be spreading deadly superbugs among hospital patients sometimes arrived months late — or not at all, according to federal records and interviews.
Medical device makers are required to file reports to the Food and Drug Administration within 30 days of learning a product may pose safety risks. But as duodenoscopes were tied to the transmission of drug-resistant bacteria among patients in at least eight U.S. hospitals from 2012-2014, the agency wasn’t notified of some outbreaks until long after they occurred, an ongoing USA TODAY investigation finds. In some cases, the disclosures never were filed.
The FDA is examining the role of duodenoscopes in scores of patient infections, most involving a bacteria called CRE, which resists virtually all antibiotics and has mortality rates of 40% or more. Investigators have found the bacteria trapped in the scopes’ crevices, even after cleaning and disinfection, and the agency has warned that infections can be passed from patient to patient as a result.
The required disclosures from manufacturers, known as Medical Device Reports, or MDRs, are meant to help the FDA identify such problems quickly. The agency relies on them to help determine whether recalls, health advisories or other actions are needed to address safety issues in any of the thousands of medical tools and appliances it regulates — from pacemakers to instrument sterilizers.
“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,” says William Maisel, deputy director for the FDA’s Center for Devices and Radiological Health.
The reports “are an important early warning system,” Maisel says. “We certainly believe manufacturers should be reporting them to us,” so the agency can spot patterns of concern. ANONYMOUS REPORTING
Duodenoscopes are used about 500,000 times a year, often to treat problems in the bile and pancreatic ducts, such as gallstones and tumors. Determining which manufacturers have failed to notify the FDA of the devices’ contamination problems is challenging.
USA TODAY reviewed the FDA’s public database for MDRs on duodenoscope-related infections and did not find enough reports to account for all the CRE outbreaks linked to the devices. The reports are redacted by the FDA to remove identifying information, including the name of the hospital, city and state where infections occurred, so the newspaper could not pinpoint which specific outbreaks had no corresponding reports — or which manufacturers failed to file them.
Though the FDA confirmed that MDRs were missing for some scope-related outbreaks, it declined to identify those cases or the manufacturers involved, citing its ongoing investigation.
At least six of the CRE outbreaks linked to duodenoscopes occurred at hospitals that used models made by Olympus, according to information gathered by USA TODAY. The company, which dominates the duodenoscope market, declined repeated requests for comment on its MDR filings, citing pending lawsuits filed by patients claiming harm from the infections.
Pentax, which also makes duodenoscopes, declined to discuss specifics about its reporting. “It is Pentax Medical’s practice to submit medical device reports when we become aware of a device-associated safety issue,” the company said in a statement.
A third manufacturer, FUJIFILM, has acknowledged its duodenoscopes were linked to CRE-related infections in three patients at one hospital, and USA TODAY determined through public records and interviews that the outbreak occurred in April 2014 in Illinois. In a statement to the newspaper, the company said it learned of the infections in May 2014 and filed a medical device report to the FDA “within the (30-day) period required.”
The company provided a copy of the MDR, and USA TODAY confirmed it was received by the FDA in June. THE OUTBREAK IN SEATTLE
When officials from Olympus arrived at Virginia Mason Hospital in November 2013, there was little doubt the CRE infections spreading among patients were tied to the company’s duodenoscopes.
By then, more than a half dozen people at the Seattle facility had been infected after treatment with the scopes. Investigators from the hospital and the health department matched the CRE bacteria sickening patients to bacteria found on the scopes.
The visitors from Olympus were given access to the scopes, and those scopes were sent to the company for more detailed examination, according to reports from county health officials, hospital investigators and epidemiologists from the Centers for Disease Control and Prevention. The Olympus representatives observed how the hospital’s technicians washed and disinfected the devices between uses, a procedure known as “reprocessing,” and validated that the work was free of errors that might explain the bacteria found on the scopes, according to those same official accounts.
It wasn’t until nine months after that visit — August 2014 — that the FDA received an “initial” medical device report from Olympus to disclose that the company’s scopes had been implicated in the Seattle outbreak.
The MDR from Olympus differed from the official accounts in key respects.
The Olympus report says the company was informed by the hospital in 2013 of “alleged infections” in patients treated with its duodenoscopes. It never mentions that Olympus representatives had visited Virginia Mason in the midst of the outbreak and reviewed evidence that the scopes transmitted CRE.
The MDR from Olympus says the company never got a chance to examine the scopes, and it reports that the hospital declined an offer from Olympus to have the company’s staff assess the hospital’s reprocessing operation.
Ultimately, more than 30 patients at Virginia Mason contracted CRE in the episode; 11 died, though most had other illnesses that may have contributed to their deaths.
Hospital spokesman Gale Robinette declined to speculate on why Olypmus’ MDR differed so sharply from the reports of physicians and government epidemiologists who investigated the outbreak.
He called the company’s narrative “surprising.” FLAWED TRACKING SYSTEM
In 2013 and 2014, the FDA received medical device reports documenting possible infections from duodenoscopes in 135 patients. The agency acknowledges it does not know the true number of cases because it doesn’t know how many reports are missing.
The reporting problems highlight an Achilles’ heel in the FDA’s oversight of medical de- vices: The responsibility for identifying potential safety problems falls primarily on manufacturers themselves. If a flaw in a surgical instrument or some other device goes unreported, the product can remain in use for months or years.
Patient safety advocates say the problems are compounded by the FDA’s redactions in the MDRs it releases publicly, which can make it tough for consumers to spot patterns of concern.
“This system … 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.”
There’s virtually no way for the FDA to know when manufacturers don’t file MDRs. If a company fails to disclose problems with its device, they’re likely to remain hidden unless they happen to come to the FDA’s attention through agency inspections of the company’s operation or some other route, such as news stories, whistle-blower tips or reports from hospitals.
A 2008 audit by the Inspector General for the Department of Health and Human Services found that device manufacturers filed upward of 140,000 MDRs a year. Only a third were reviewed by FDA analysts within 30 days, the audit said.
The audit noted that the FDA has no way to know when — or how often — manufacturers fail to file MDRs, and it found that the agency “rarely” takes action when the reports are late.
In a statement to USA TODAY, the FDA said it does “routine surveillance” to ensure that device manufacturers file MDRs when warranted.
In 2013 and 2014, the FDA issued more than 100 warning letters to companies for failing to abide by medical device reporting requirements, according to figures provided by the agency.
The FDA said it did not have data on how often it takes enforcement action after such letters
Since USA TODAY first reported on the duodenoscope-related infections in January, the FDA has not sought to recall the devices, insisting that they remain the safest, least-invasive option for lifesaving procedures, and infection risks remain relatively low.
Instead, they are determining whether manufacturers should redesign the scopes or develop better cleaning protocols.