Reports to Feds on deadly bacteria outbreaks arrived late

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 that 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. And 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 if 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," adds Maisel. "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" 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. And 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. But 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.

While 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.

Listen to USA TODAY investigative reporter Peter Eisler discuss the details in his 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, adding that it is committed to filing MDRs for "any safety-related incidents that are reported to us by healthcare institutions or providers."

A third manufacturer, FUJIFILM, has acknowledged that 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 that 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 had 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 later 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 also 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.

Yet 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.

And 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. But it never mentions that Olympus representatives had visited Virginia Mason in the midst of the outbreak and reviewed evidence that the scopes were transmitting CRE. The MDR from Olympus also 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 of them died, though most had other serious illnesses that also may have contributed to their deaths. When asked about the apparent discrepancies in Olympus' MDR, a spokesman for the hospital declined to speculate on why the company's account differed so sharply from the reports submitted by the 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 75 medical device reports documenting possible infections from duodenoscopes in 135 patients. But dozens of those reports are duplicates – when manufacturers do file MDRs, they often submit multiple versions for the same event – so the number of reports doesn't necessarily reflect the true number of infection cases that have occurred.

The reporting problems highlight an Achilles' heel in the FDA's oversight of medical devices: the responsibility for identifying potential safety problems falls primarily on manufacturers themselves. And if a flaw in a medical implant, a surgical instrument or some other device goes unreported, the product can remain in use for months or years, raising profound public health risks.

Federal auditors have raised concerns repeatedly about the system's reliability. And many patient safety advocates say the problems are compounded by the system's lack of transparency, arguing that the FDA's redactions in publicly released MDRs make it tough for consumers to spot patterns of concern.

"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."

One of the most vexing problems is that 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.

And when manufacturers do file MDRs, they may not get much scrutiny.

ENFORCEMENT CHALLENGES

A 2008 audit by the Inspector General for the Department of Health and Human Services found that device manufacturers were filing upwards of 140,000 MDRs a year — more than double the number in 2003. But only a third of those reports were reviewed by FDA analysts within 30 days, the audit said, and less than half within 60 days.

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.

"The inability to obtain complete and usable information in (MDRs) hinders analysts' review," the audit concluded. It recommended that the FDA consider tougher enforcement measures to "identify and target manufacturers … with a history of noncompliance with (MDR) submission requirements."

In a statement to USA TODAY, the FDA said it does "routine surveillance" to ensure that device manufacturers file MDRs when their products are tied to possible safety risks.

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. Those letters typically advise manufacturers of regulatory violations and warn of possible legal penalties if the problems aren't corrected.

The FDA said it did not have data on how often it takes enforcement action following such letters, but it did cite several recent cases. For example, the agency filed suit last year to halt a New Jersey company's production of a medical gel linked to 16 infections reported by a Michigan hospital. The suit includes charges that the company did not file a timely MDR after learning the gel was contaminated. The company denies the allegations and the case is pending.

QUESTIONING MANUFACTURERS

Since USA TODAY first reported on the duodenoscope-related infections in January, the FDA has issued safety alerts and guidance on ways to reduce contamination risks with more robust cleaning and disinfection.

Officials have not sought to recall the devices, insisting that they remain the safest, least-invasive option for life-saving procedures, and infection risks remain relatively low. Instead, they are determining whether manufacturers should redesign the scopes or develop better cleaning protocols.

Last month, the FDA and Olympus announced that the company had validated new cleaning guidelines for a duodenoscope model that was in use at several hospitals that had CRE outbreaks. But no similar guidelines have been issued for other brands and models of duodenoscopes that remain on the market.

Meanwhile, concern about the devices is mounting.

Ten members of Congress recently wrote the FDA seeking details on its progress in addressing the contamination problems. Rep. Ted Lieu, D-Calif., followed up with scope manufacturers to pose specific questions about whether they responded appropriately when those problems surfaced.

"When did Olympus first learn that its duodenoscope was causing CRE infections and outbreaks?" Lieu asked in a letter to the company. And, "what did Olympus do with that information?"

Follow Investigative Reporter Peter Eisler on Twitter: @byPeterEisler