Duodenoscope linked to life-threatening infections

/ / Blog, Medical Expert Witness, Medical Malpractice, Negligence, Product Liability

Olympus Duodenoscope

The US Senate is currently investigating the circumstances which caused 25 patients to contract life-threatening infections linked to a device known as the duodenoscope. The duodenoscope is used in endoscopic retrograde cholangiopancreatography (ERCP), a procedure during which doctors thread the flexible scope down a patient’s throat into the digestive tract to diagnose and treat cancers, gallstones, and other conditions.

Currently, the duoenoscope manufacturers, regulators, and hospitals are under scrutiny for multiple failures leading to the spread of a drug-resistant bacteria. According to a recent report, Olympus Corp., the leading maker of the device, knew of the potential flaws in the scope but failed to alert American hospitals or regulators (LA Times, 2016). The manufacturing firm was aware that three independent investigations revealed their product design made it extremely difficult for healthcare professionals to clean properly. Still, neither Olympus or the Food and Drug Administration (FDA) released any warnings in the United States about risks associated with the duoenoscope.

The FDA currently requires manufacturers to file reports of injuries tied to their devices. However, because hospitals rarely knew to link major infections to the device, there were not formal reports linking the Olympus duodenoscope to patient harm. The FDA will not recall the scopes because there is no other device with the ability to perform ERCP. The senate recommends a “phased recall,” which would allow the devices to be repaired, modified, and properly disinfected without completely eliminating their use.