Duodenoscopes Infection Lawsuit Filed By Over Contamination at Washington Hospital

Olympus Corp. faces yet another product liability lawsuit over infections from duodenoscopes used during ERCP procedures, due to difficulty cleaning the devices, even when manufacturer instructions are followed.

The manufacturer has been under scrutiny since an outbreak of CRE infections in California earlier this year, among patients exposed to the “superbug” at UCLA Ronald Reagan Medical Center. However, this latest duodenoscope infection lawsuit comes from contaminated devices used at a hospital in Seattle, Washington.

The wrongful death lawsuit was filed by the family of Richard Bigler, who died in 2013 after being exposed to a drug-resistant strain of E. coli, which was allegedly caused by the Olympus duodenoscope. Bigler’s death was part of an outbreak at Virginia Mason Medical Center from 2012 to 2013, which affected 31 patients.

Both the Virginia Mason and UCLA outbreaks have been blamed on difficulties cleaning duodenoscopes, even when the manufacturer instructions are followed. In both instances, duodenoscopes manufactured by Olympus were reportedly used during endoscopic retrograde cholangiopancreatography (ERCP) procedures.

Olympus faces at least two other ERCP duodenoscope infection lawsuits stemming from the UCLA outbreak, in which at least 179 patients treated between October 2014 and January 2015 may have been exposed to a risk of carbapenem-resistant enterobacteriaceae (CRE) infections, which carry a high risk of death. At least seven infections have been identified, including two deaths.

Duodenoscopes are flexible, lit tubes that are inserted down the throat to the top of the small intestines for gastrointestinal procedures. They allow contrast dye to be injected and can be used with other medical instruments to retrieve biopsy samples. The FDA estimates that more than 500,000 ERCP duodenoscope procedures occur each year in the U.S.

According to an FDA safety communication issued last month, infections from duodenoscopes may occur because they are difficult to clean properly, potentially allowing bacteria to become trapped even when doctors and health care professionals follow the recommended cleaning steps.

Olympus duodenoscopes and many other similar devices include a movable “elevator” at the tip, which may trap pathogens and blood even when recommended cleaning techniques are used.

Last week, media reports surfaced that suggested at least two of the duodenoscopes linked to the infection outbreaks were sold without FDA approval.

Olympus began selling the endoscope, TJF-Q180V, in 2010 without FDA approval. However, the FDA did not notice until late 2013 or early 2014.

According to FDA regulations, manufacturers must receive clearance for a new model if it includes changes that, “could significantly affect the safety or effectiveness of the device.”

The new ERCP endoscope model included a modification for the exact part that is implicated in the outbreaks, the elevator channel. This piece was sealed up in attempt to make it more resistant to infection, however the changes do not seem to have worked.

Olympus said they did not think they needed to get the FDA’s approval to sell the device. Olympus initially applied for permission at the request of the FDA in 2014. The application is still pending.

A new report indicates that the manufacturers of duodenoscopes not only knew there was a problem, but quietly tried to fix it to make the devices easier to clean, without warning medical professionals that there was a problem that needed fixing.

An ABC News investigation found that all three duodenoscope manufacturers, including FujiFilm, Olympus and Pentax, made design changes to the endoscopes in recent years, which tried to enclose exposed elevator wire channels at the tips of the devices which helps make them hard to clean.

Olympus was the most recent to request clearance for design changes last year, and Fujifilm made changes in 2004, followed by Pentax in 2009.