Duodenoscopes are Commonly Used —Yet Difficult to Sterilize

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What are Duodenoscopes?

Duodenoscopes are tools used by hospitals hundreds of thousands of times each year to aid in the diagnosis and treatment of diseases in the pancreas and bile ducts. Although these tools are deemed necessary, duodenoscopes have a large issue. Duodenoscopes are not sterilized by usual methods and are leaving hundreds of patients sick in hospital outbreaks of infections.

Duodenoscopes are thin, tube-like tools that are inserted through the mouth through to the small intestine. These scopes are often reused even though their sterilization methods can leave them with bacteria. Unlike other devices, these tools are hand scrubbed and put through a machine to sterilize after use. However, hundreds of patients in the US have been infected due to these scopes. In worst case scenarios, these scopes have transferred antibiotic-resistant infections.

FDA Study on Risk for Infection

A recent test performed by the Food and Drug Administration (FDA) found that one in 20 duodenoscopes still had bacteria including E. coli after they were cleaned. These scopes were cleaned using the manufacturers suggested cleaning process. The director of the FDA’s Center for Devices and Radiological Health commented that, “improvements are necessary.” However, there have been no repercussions from the study thus far.

The FDA has recently been under-fire for allowing medical devices on to the market without rigorous safety testing if the model is “substantially equivalent” to others on the market. In recent models of duodenoscopes, there have been additional features that add to the flexibility of the tool and its purposes, however, these features allow for more microscopic areas open to bacteria. Despite the study done by the FDA, manufacturers claim patients should be safe if hospitals follow protocol.

Although these scopes are a risk for infection, it is most likely that their need outweighs their dangers. Duodenoscopes have the ability to save lives and are much less risky than other procedures currently available. However, antibiotic resistant bacteria is a rising danger. If manufacturers are held accountable for the designs of their scopes and explore other scope designs, such as single-use scopes, the risk for infections could decrease, making everyone safer.