March 23, 2015 — Olympus has been hit with a lawsuit by a woman who was infected with an antibiotic-resistant “superbug” after undergoing a procedure with a duodenoscope that was not sterile.
The woman, Debbie Newton of Kirkland, Washington, was diagnosed with gallstones in January 2013. The next month, she underwent an ERCP procedure at Harborview Medical Center in Seattle with an Olympus duodenoscope.
Almost immediately after the procedure, she was admitted to the hospital and placed on life support due to heart failure, respiratory failure, renal failure, pancreatitis, septic shock and bacteremia. She also developed severe infections in her pancreas, colon, and kidneys.
Olympus is accused of negligence, recklessness, and “conscious disregard of the extreme risks to public health” by selling the scope without proper clearance from the FDA since 2010. The approval application is still pending.
The lawsuit (PDF) claims a design change on Olympus’ TJF-Q180V duodenoscope made it difficult to properly clean.
“The “sealed elevator wire channel” and the associated moving parts and the design of the forceps elevator mechanism of the Q180V Scope are collectively defective … rendered it extremely difficult — if not impossible — to consistently and safely reprocess the scope.”
Harborview joins a growing list of hospitals that have reported CRE outbreaks in association with the Olympus scopes. Other scopes that were cleaned using the same procedures have not been linked to infections. Even the FDA has warned that the complex design of some scopes may impede effective cleaning.
Earlier this year, Virginia Mason Medical Center in Seattle reported an outbreak of CRE. Between 2012 and 2014, at least 35 patients were infected with CRE, including 11 who died. Hospital staff found no breach in infection-control practices, but they have implemented more rigorous sterilization. Each scope is held for 48 hours to make sure it is clean before it can be used on another patient.