Olympus Fails to Warn US Hospitals about Risk of Infection with DuodenoscopesDec 30, 2015
The duodenoscope debacle continues to grow, as an LA Times investigation reveals that scope maker Olympus failed to warn US hospitals about the risk of infection with its TJF-Q180V duodenoscope. According to LA Times, Olympus became aware of potential infections in 2012 when a technician found a film of bacteria inside a scope at a Netherlands hospital. The device was suspected to be the source of an infection that sickened 22 patients, Qmed reports. The technician also discovered that the rubber ring, intended to stop bacteria from getting in, was worn and cracked. Olympus was advised to conduct a global investigation, and issue a recall if problems persisted.
In 2013, Olympus issued “important safety advice” in Europe, and the company issued another alert over a contaminated duodenoscope in 2014. In the United States, however, Olympus never notified any hospitals about this information, LA Times reports. Since the discovery of bacteria in the Netherlands three years ago, dozens of people became sick and 21 died. Illnesses arose in Los Angeles, Pittsburgh and Seattle. Every time an outbreak occurred, Olympus treated the event as an isolated incident and blamed hospital cleaning procedures. According to LA Times, the company never said similar outbreaks had occurred elsewhere.
Duodenoscopes are snaked through the digestive tract and into the duodenum, the first portion of the small intestine. The device is used to diagnose and treat disorders of the digestive system. Earlier this year, the U.S. Food and Drug Administration (FDA) warned that the scopes were linked to antibiotic-resistant strains of bacteria. The agency said the complex design of the devices, particularly the movable “elevator” mechanism, impedes effective cleaning. The FDA said the risk of infection was present even when the scopes are cleaned according to manufacturer's instructions.
Olympus produced the TJF-Q180V in order to compete with rivals Pentax and Fujifilm. The new model, priced at $40,000, was touted as being easier to clean. But the opposite appears to be true, LA Times reports. The scope has been implicated in an outbreak of CRE at University of Pittsburgh Medical Center. CRE is dubbed the “nightmare bacteria” by many health officials due to its high resistance to antibiotics; patients with CRE infections can have a 50 percent mortality rate. Earlier this year, it also came to light that Olympus never obtained 510(k) clearance for the TJF-Q180V.