Senate Blames FDA, Device Manufacturers For Delay In Duodenoscope Warnings

“Superbugs,” bacterial infections that have become resistant to current antibiotic treatments, have ripped through medical facilities across the country. Between October 2014 and January 2015, 7 patients were infected with a virulent strain of carbapenem-resistant Enterobacteriaceae at UCLA’s Ronald Reagan Medical Center. By the time the outbreak had run its course, at least 2 patients were dead.

Blame For Superbug Outbreaks Spread Among Hospitals, Industry & FDA

A new report, published by the US Senate’s Health, Education, Labor, & Pensions Committee, suggests that the manufacturer of a little-known medical device, along with the US Food & Drug Administration, may have blood on their hands.

Government health officials have been openly tracking superbug outbreaks, and their link to the duodenoscope medical device, for more than 2 years. But the Senate report says the agency waited 17 months before warning the public of the device’s dangers. At least 25 separate medical facilities have experienced their own outbreaks, according to the published investigation.

 

Running just over 300 pages, the report presents damning evidence that a perfect storm of blunders and concealment allowed more than 200 patients world-wide to become infected with antibiotic-resistant bacteria, a number higher than earlier federal estimates. While 200 may not seem like a lot, up to half of all patients who contract a superbug infection will die.

Published on Wednesday, January 13, 2016, the Senate report bears the foreboding title, “Preventable Tragedies: Superbugs & How Ineffective Monitoring of Medical Device Safety Fails Patients.” The committee spreads responsibility equally among hospitals, device manufacturers and the FDA.

Olympus “Endangered Patients”

Olympus Corp., the world’s largest manufacturer of duodenoscopes, failed to report the device’s inherent problems to the FDA, the Senate Committee found. As early as 2012, the company was aware that cleaning the devices thoroughly would present a significant challenge to healthcare professionals. Independent reviews of the duodenoscope’s design pointed out numerous failings, and linked the device specifically to an outbreak in the Netherlands. But Olympus’ follow-up report to the FDA was “fundamentally misleading,” the Senate report says, “misstat

[ing] the number of patients impacted” and failing to disclose the independent review’s findings.

After a similar outbreak in Pittsburgh several months later, Olympus submitted a fuller report to the FDA, but it was never entered into the agency’s system.

Duodenoscopes, used to diagnose and treat pancreatic and bile duct conditions, are meant to be reusable. But even after vigorous cleaning, the device’s numerous nooks and crannies can still hide deadly bacteria.

A spokesman for the company, Mark Miller, told the Washington Post that “although [Olympus does] 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.”

Olympus has been trying to develop new sterilization procedures, but those efforts have largely failed. Pentax and Fujifilm, who manufacture a little less than 15% of all the duodenoscope’s used in the US, are also implicated in the report. Pentax even altered its device’s design without notifying the FDA.

Hospitals “Slow To Report Infections”

Hospitals, for their part, didn’t warn the FDA of superbug outbreaks within their own facilities, even after linking the infections to duodenoscope use, something the agency could conceivably regulate.

Rather than forwarding their concerns to the FDA, at least 8 “domestic hospitals, primarily large, sophisticated health systems” failed to report outbreaks properly. That remained true even after the hospitals had discovered evidence that duodenoscopes were spreading the bacteria. When the facilities did voice their doubts, they sent informal reports (usually phone calls) to device manufacturers, rarely notifying the FDA.

FDA “Failed To Recognize […] And Respond Quickly”

In its discussion of the FDA, the report depicts an under-staffed, over-burdened agency with insufficient tools to protect public safety. At every turn, the agency was one, two or even three steps behind real-world developments, scrambling to piece together incomplete information.

The FDA relies on a “passive” surveillance system when it comes to medical devices, which means the agency’s reviewers have “no way to identify [a risk] trend until the issue [is] directly brought to their attention.” That requires prompt notifications from medical professionals and device manufacturers, but as we’ve seen, both hospitals and duodenoscope manufacturers failed to notify the FDA of the device’s link to superbugs.

Even with an adequate monitoring program, it’s unclear whether or not the FDA would have caught on in time. The agency actually lost crucial data, including an entire file on the first domestic outbreak linked to a duodenoscope, which hit Pittsburgh’s UPMC Presbyterian Hospital in November 2012. Still, the Senate report lays most of the blame not on FDA reviewers, but on the agency’s lack of an adequate surveillance system.

Update January 21, 2016 – Olympus Recalls More Than 4,000 Duodenoscopes

In the wake of Congress’ damning report, the manufacturer behind most duodenoscopes in the US has recalled 4,400 of the devices. Olympus will contact every health care facility with a TJF-Q180V scope and provide further instructions on turning the devices over, according to Medscape.

At issue is the scope’s “elevator,” a sliding mechanism that allows doctors to adjust the position of the device’s tip. On current models, the elevator door can leak, allowing fluids from one patient inside nooks in the device. From here, bacterial contaminants can be spread to other patients, even after the device is cleaned according to manufacturer specifications.

Olympus intends to improve each individual duodenoscope, making the elevator mechanism tighter. The company has also announced a yearly inspection scheme, in which individual scopes would be examined for wear and tear.

By |2017-08-17T10:24:12+00:00January 14th, 2016|Legal News|

About the Author:

Laurence P. Banville is the managing partner of Banville Law. As an experienced personal injury attorney, Mr. Banville helps clients recover compensation from those responsible for his clients' injuries. Our firm is located in New York City, serving clients from the five boroughs: Manhattan, Brooklyn, Queens, The Bronx, and Staten Island.

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