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Medical Device Causes Infections


Olympus Corp. and two other medical device suppliers have been under fire recently after a rash of patients were infected by bacteria that were transmitted to them when doctors used reusable duodenoscopes (a type of gastrointestinal scope), the LA Times reports. While Americans are generally interested in stories involving outbreaks of what are referred to as super bacteria, i.e., bacteria that is resistant to the most common antibiotics, what adds to the public’s interest in this particular series of events is the Olympus’ medical device, the Olympus TJF-Q180V scope that has been for sale since 2010 and has been aggressively marketed to doctors and hospitals, despite not being cleared by the U.S. Food and Drug Administration (FDA).

The scopes have been linked to a deadly outbreak at UCLA where seven people were infected and potentially another 179 were exposed to improperly cleaned scopes, and at least one of the patients who caught an infection from the device is suing Olympus Corp. for negligence and fraud, according to a second LA Times article. The patients were exposed to the bacteria when the scopes were used in a procedure called endoscopic retrograde cholangiopancreatography or ERCP.

The Dangerous Device is Still Being Used

In light of the recent outbreaks being linked to the use of Olympus’ endoscope devices, the FDA conducted a committee meeting concerning the future of the devices. While the committee acknowledged that the devices are unsafe due to their potential to transmit infections, they also determined that the scopes should remain on the market because of their lifesaving usefulness and because no better option is available at this time and none are on their way to market in the near future. The benefits provided by using the Olympus scopes outweigh the potential costs and risk of infection.

Product Design Is Not Solely To Blame

The scopes in question are designed to be reusable. However, the scopes include small areas where bacteria can hide. Olympus provided cleaning instructions with all of the scopes that it sold, and Olympus contends that the design of the scopes is not the sole factor contributing to the transmission of the bacteria from patient to patient. Human error during the cleaning process could play a significant role in whether the scopes were properly cleaned in between patients. Some of the blame likely lies with low-paid, rushed and inexperienced workers not properly cleaning the devices.

Despite Olympus’ contentions that part of the problem, if not all, lies with improper cleaning techniques, the company issued revised cleaning instructions and provided smaller cleaning brushes for use with the device. Further, Olympus has taken steps to host dinners and other training opportunities for nurses and other medical professionals where the importance of meticulous cleaning of the scopes is emphasized.

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