At hospitals around the country, outbreaks of the deadly CRE bacteria are being linked to one medical device and ­ specifically ­ one model. Specifically, the Olympus TJF­Q180V duodenoscope.

First of all, What is a Duodenscope?

A duodenoscope is a complex and sensitive endoscopic medical device. Most commonly, they are used for a procedure known as endoscopic retrograde cholangiopancreatography (ERCP). In this procedure, a duodenscope is used to diagnose problems and preform therapies on bile ducts, the duodenum and the pancreas.

How Is CRE Bacteria Transmitted Via Duodenoscope?

CRE bacteria from one colonized patient can contaminate a duodenoscope and be transmitted to another patient during the next ERCP procedure. Because duodenoscopes are not disposable devices ­- in fact they are quite expensive and can cost as much as $40,000 each -­ they are used on many different patients, often in the same day. To combat this type of infection, all duodenoscopes are put through a rigorous, extensive, and manufacturer recommended disinfecting regime known as reprocessing after use in a procedure,. In theory, all organic matter ­ CRE bacteria included ­ should be killed during reprocessing.

However, reprocessing of the Olympus TJF­Q180V in the manner provided for by the manufacturer does not completely eradicate CRE and other bacteria.  According to the Los Angeles County Department of Public Health,

“After further investigation…it was determined that the routine cleaning of the ERCP scopes as recommended by the scope manufacturer does not completely eradicate CRE as it does for other bacteria and viruses. After discussion with local and national public health officials, it appears that the ERCP scopes will require additional cleaning techniques beyond what is recommended by the manufacturer or significant redesign of parts of the scope.”

Why is the Olympus Duodenoscope Transmitting CRE Bacteria?

An FDA warning was issued to inform hospitals and healthcare providers of how the complex design of all duodenoscopes can cause challenges for cleaning and disinfection. However, disinfecting the Olympus TJF­Q180V is more than challenging, it has been near impossible. This particular model of endoscope underwent a redesign in 2014 that added an extra channel (a channel is an opening running through the device ­ the new one allows operators to control an elevator arm at the end of the scope), giving the device more crevices for bacteria and organic matter to hide. If this new channel is not cleaned properly, the duodenoscope can transmit bacteria ­ deadly CRE bacteria included ­ from patient to patient.

After the redesign, the manufacturer failed to update the reprocessing (cleaning) protocols and hospitals were not made aware of the change. What’s more, reports have found that Olympus did not even seek FDA approval for the design change. The results have been disastrous. Because hospitals were unaware of changes to the device, the use of an outdated cleaning protocol has led to outbreaks of bacteria all over the country ­ with more being linked to the device seemingly every week. In Los Angeles alone, multiple outbreaks of CRE superbug bacteria traced to the Olympus TJF­Q180V duodenoscope have killed several patients and left hundreds more exposed.

Are There More CRE Outbreaks to Come?

Ideally, the FDA would recall all Olympus duodenoscopes to protect patients and prevent new CRE outbreaks while they are under investigation. Unfortunately, that may not be possible. The FDA and specialists who use the scopes in the procedures say that they are too vital to do without and no viable alternatives currently exist. Healthcare facilities simply must use the devices despite the risks.

To this end, hospitals have improvised solutions in attempts to completely sterilize the devices ­ including adding more duodenoscopes to their inventory as to quarantine tainted devices until they are cleared to be used again ­ using toothbrushes to better clean difficult to reach areas of the device. However, while hospitals are doing everything they can to prevent the spread of this deadly infection, the simple fact is Olympus’ actions caused hospitals to use tainted equipment in a vast, but unknown amount of complex ERCP procedures.

For all we know, many more people have been exposed to and infected with CRE bacteria through tainted duodenoscopes than have been reported thus far. Experts have known about the problems with dirty scopes since at least 2009.

What Do I Do If I Was Infected with CRE by a Tainted Duodenoscope?

If you or a loved one have undergone a procedure involving the use of a duodenoscope at any hospital in the country, you may have been exposed to CRE bacteria. You have legal options and Olympus SHOULD be held accountable. Lawsuits have been filed on behalf of infected patients around the country. Contact us for a free and confidential case evaluation if you have been infected or you have any questions.