May 31, 2016 — San Diego, CA. The manufacturer of a reusable medical device linked to “superbug” outbreaks in the United States and abroad is being pulled from the market.
Olympus America Inc. announced in January that it would voluntarily recall its duodenoscopes from the market in order to redesign a certain part of the device that can trap body fluids and spread infections. The announcement came two days after a US Senate report linked the device made by Olympus and two other manufacturers to at least 25 outbreaks of drug-resistant bacteria.
Roughly 250 patients in more than a dozen US cities were infected between 2012 and 2015 with potentially deadly bacteria that are resistant to antibiotics, according to the Senate report. An especially virulent superbug, called carbapenem-resistant Enterobacteriaceae, or CRE, was identified in many of these outbreaks. The bacteria, which health officials call “nightmare bacteria,” kill as many as 40 to 50 percent of infected patients. At a Seattle hospital, 18 patients died after becoming infected with CRE in 2013; in Los Angeles, three patients died from CRE infections in late 2014 and early 2015.
The Senate report, as well as investigations led by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), linked the infectious outbreaks to a medical device used in a specialized procedure called an endoscopic retrograde cholangiopancreatography (ERCP). ERCPs are used to diagnose and treat problems in the pancreas and bile ducts.
The devices used during these procedures: duodenoscopes.
Duodenoscopes are flexible, lighted tubes threaded through a patient’s mouth and throat into the top of the small intestine (called the duodenum). They are used in about 700,000 procedures every year. The FDA said the instruments are “complex” with “many small working parts” that if not cleaned properly could lead to patient-to patient infection.
Duodenoscopes have been in use for nearly four decades. Olympus helped pioneer the first devices, but two other players eventually entered the game: Fujifilm and Pentax. Still, Olympus sells about 85 percent of duodenoscopes in the US.
In 2010, Olympus’ competitors rolled out a newly redesigned duodenoscope they said was easier to clean because a portion of the device was sealed to keep out bacteria. Olympus soon put out its own revamped version of the device, also marketing the $40,000 scope as easy-to-clean.
What the makers would eventually find out is the sealed portion of the device could actually trap bacteria and make it nearly impossible to clean.
One of the first major outbreaks of superbug infections occurred at a Dutch hospital in 2012, when 22 patients were sickened. The hospital linked the outbreak to duodenoscopes, after which Olympus issued an alert in Europe, but not the United States.
Several months later, an outbreak occurred at University of Pittsburgh Medical Center Presbyterian Hospital, where at least 13 patients were infected.
Less than a year later, 32 patients were infected at Virginia Mason Hospital and Medical Center in Seattle; 18 patients eventually died.
Between the two outbreaks in Pittsburgh and Seattle, an additional 81 patients at six different hospitals across the country were infected with superbugs after undergoing an ERCP with a duodenoscope, according to the Senate report. All of those outbreaks involved Olympus devices except one.
It appeared none of the hospitals knew of the other outbreaks. Olympus did not file a detailed report on the outbreak in the Netherlands until 2015 – three years after it occurred – according to an article published by the Los Angeles Times in December 2015.
By that time, the FDA had got involved. It issued the first of several safety communications regarding the use of duodenoscopes and their potential for superbug outbreaks in February 2015 – shortly after an outbreak at the University of California Los Angeles Medical Center claimed the lives of three patients and sickened 12 others.
In the safety communication, the agency called duodenoscopes “inherently difficult” to clean and recommended additional steps – beyond the manufacturers’ instructions – to sterilize the devices between uses.
On Aug. 4, 2015, the FDA issued another safety communication outlining a “detailed list of supplemental measures” to clean duodenoscopes. These measures were the result of a two-day expert panel meeting held a few months earlier and include quarantining the devices after they are used, testing the devices for bacteria and reusing them only after it is clear there is no contamination. This time-consuming process, which can take the scopes out of service for 48 hours, required some hospitals to purchase additional devices to ensure there was one available for every procedure, according to the LA Times article.
Just eight days after the FDA issued the Aug. 4 communication, it sent Warning Letters to all three duodenoscope manufacturers, saying the companies failed to report problems associated with the devices and, in some cases, failed to ensure the devices could be cleaned properly between uses.
Less than a year later, Olympus announced it would pull its duodenoscopes from the market. The company said it would replace the portion of the device that couldn’t be cleaned, called the elevator mechanism, in all 4,400 devices currently in use in the US. The company estimates it can replace all devices by August 2016.
But Olympus’ announcement came too late for hundreds of patients, nearly two dozen of whom lost their lives in the outbreaks.
Many of those patients and their family members have filed lawsuits against Olympus, saying the company knew of the product’s potential to spread infections but failed to warn patients and doctors of the risk.
If you or a loved one were infected by a superbug after undergoing an ERCP, you may be entitled to compensation. The lawyers at Hood National Law Group are currently accepting cases involving the Olympus TJF-Q180V model and its potential to cause drug-resistant bacterial infections. Call us today at 1-800-214-1010 for a free case evaluation, or use the form on the right-hand side of your screen.