March 18, 2015 — Olympus Medical Systems has been hit with at least five lawsuits after a deadly outbreak of antibiotic-resistant infections at UCLA was traced to an unapproved duodenoscope that is very difficult to clean between uses.
Reuters reports that the latest lawsuit was filed in Los Angeles Superior Court on behalf of Domingo Gomez, a 76 year-old man who was diagnosed with the “superbug” carbapenem-resistant enterobacteria, or CRE.
Officials at UCLA Ronald Reagan Medical Center said 179 people were exposed to CRE after undergoing medical procedures involving the Olympus duodenoscope.
Olympus is accused of negligence for selling a scope that is unreasonably difficult to clean. The lawsuits were not filed against UCLA.
According to another lawsuit involving an 18 year-old student who was hospitalized, Olympus modified the design of the scope in mid-2014 but failed to update the cleaning protocol.
The protocol provided to hospitals was allegedly for an older scope with a “significantly different design. … As a result, end-users were not able to effectively sanitize and clean the new redesigned scope.”
The FDA also reported that the duodenoscope in question was sold without clearance for years, and its approval application is still pending. However, the agency is reluctant to pull it off the market because the risk of disease-transmission is low and the scope is often used in life-saving procedures, such as cancer biopsies.