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Duodenoscopes Linked to Illness and Deaths

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Los Angeles, CAA recent outbreak of carbapenem-resistant Enterobacteriaceae (CRE) bacteria at Ronald Reagan UCLA Medical Center in Los Angeles has been linked to contaminated duodenoscope. At least two people are dead, 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, has 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.

The problem is so serious it has warranted intervention by the Food and Drug Administration (FDA). Further to warning letters sent to manufacturers of the scopes earlier this year, the FDA sent warning letters out last week to three major duodenoscope manufacturers, namely Olympus, Pentax and Fujifilm. The letters reportedly cited Pentax and Olympus for failing to inform the FDA that their scopes might have “caused or contributed to a death or serious injury” with 30 days of learning about the incidents. The agency also cited Pentax and Fujifilm for failing to validate their detailed instructions for cleaning the scopes.

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.

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