Olympus Duodenoscopes Linked to Disease, Failure to Report

Santa Clara, CA: Olympus has received a warning letter from the US Food and Drug Administration (FDA) over its failure to report infections associated with the company' duodenoscope. According to the Associated Press, for three years Olympus withheld information about infections that may have been associated with their scopes used in 16 patients in 2012.

The federal agency inspected four Olympus plants from mid-March through late April 2015, in Japan, Pennsylvania, and California. It then wrote a warning letter to Olympus regarding 16 patient infections, which the firm appeared to have known about since May 16, 2012 that may have been tied to use of its device, the duodenovideoscope Olympus TJF Type Q-180V.

A recent outbreak of carbapenem-resistant Enterobacteriaceae (CRE) bacteria at Ronald Reagan UCLA Medical Center in Los Angeles has been linked to contaminated duodenoscopes. At least two people died, and officials have said dozens of other patients may have been exposed to the potentially fatal bacteria. Additionally, Cedars-Sinai Medical Center, also in Los Angeles, reported four patients this year who became infected with the superbug following procedures involving duodenoscopes.

On the east coast, a hospital in Connecticut has reported that it has contacted nearly 300 patients who might have been exposed to a dangerous type of drug-resistant E. coli after undergoing duodenoscope procedures.

Duodenoscopes are lighted tubes inserted in a patient through the mouth to the top of the small intestine. They are used during endoscopic retrograde cholangiopancreatography (ERCP), a procedure involved in diagnosing and treating problems of the pancreas and bile ducts.

Because the devices have many small parts, tissue or fluid from one patient can remain on a duodenoscope even after it is cleaned. This can result in a patient-to-patient infection. The FDA has said that the infections have occurred even after medical professionals followed proper manufacturer cleaning instructions. The reported infections to Olympus involved Pseudomonas aeruginosa, a common strain typically found in people with weakened immune systems, like hospital patients. Serious Pseudomonas infections can lead to severe illness and death, according to the Centers for Disease Control.

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Last updated on Sep-9-15