examining the infection risks posed by a popular medical device ii

Last time, our blog discussed how several hospitals in the U.S., including right here in Pittsburgh, saw an outbreak of the carbapenem-resistant enterobacteriaceae — CRE — infections back in 2012, and how these infections were ultimately traced by investigators to specialized medical devices known as duodenoscopes.

According to these investigators, the spread of CRE wasn’t caused by improper sterilization of the instruments, but rather by the design of the duodenoscopes. Specifically, duodenoscopes feature what are known as “elevator” mechanisms that enable physicians to control small devices that extend from the bottom of the device.

Investigators determined that these elevator mechanisms can actually accumulate trace amounts of biological material that are not removed when the duodenoscopes are cleaned in accordance with the FDA-approved manufacturer guidelines.

For its part, the FDA has indicated that it is well aware of the infection risk posed by contaminated duodenoscopes, and is now working alongside manufacturers of the device to explore potential design changes and/or changes to the sterilization process.

Many experts, however, have been critical of what they’ve believe is the FDA’s somewhat plodding response to the issue, arguing that quicker and more definitive action is needed given the all too likely possibility that duodenoscopes are spreading not just CRE, but other less serious infections.

It is worth noting that several of the hospitals stricken by the deadly CRE outbreak back in 2012 have now instituted their own protocols for sterilizing duodenoscopes.

At the University of Pittsburgh Medical Center, duodenoscopes are now processed using EtO gas sterilization, which destroys any bacteria remaining after traditional sterilization. While the introduction of this process mandated the purchase of special equipment and building of special facilities, the infection rate associated with duodenoscopes at UPMC has now fallen to zero.

It’s encouraging to see hospitals taking proactive measures. Here’s hoping the FDA introduces the necessary guidelines to protect patients such as requiring hospitals to take periodic bacterial cultures from duodenoscopes to ensure they are properly sterilized.

Source: USA Today, “Deadly bacteria on medical scopes trigger infections,” Peter Eisler, Jan. 27, 2015

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