Four years after litigation started regarding these devices, the FDA has released an advisory to reconfigure how hospitals use duodenoscopes in order to prevent pathogen transmission via reuse.

A duodenoscope is a medical device (in this case a type of endoscope) with a little camera designed specifically to insert through a person’s mouth and navigate a patient’s digestive tract. The scope is used primarily for Endoscopic Retrogade Cholangio-Pancreatogtraphy (ERCP). That is, to investigate the bile duct and pancreatic duct. The devices are used in over 500,000 procedures per year in the United States.

In 2014-2015, several dozen patients fell ill following ERCP procedures; two eventually died from carbapenem-resistant enterobacteriae (CRE), an exceedingly difficult to kill “superbug.” The bacteria had been riding on the same scope from procedure to procedure; no cleaning regimen had completely eliminated the bacteria from the scopes. So it seems that the FDA tumbled to the conclusion that no design that included reuse of these devices could actually eradicate patient exposure to these dangerous pathogens.

Part of the problem was the design of the device, with its tiny, side facing camera, and attachment points for devices. You can find pictures of these hard-to-clean pieces [here](https://www.google.com/search?q=duodenoscope&rlz=1C9BKJA_enUS848US848&hl=en-US&prmd=nisv&source=lnms&tbm=isch&sa=X&ved=2ahUKEwjD9uqvmavkAhXTrJ4KHUEYAd8Q_AUoAnoECA8QAg&biw=1366&bih=911#imgrc=NwforAjeAX3XCM). The small notches and tight spaces have proven exceedingly difficult to clean and are prone to passing infection from one patient to another. The cleaning system used has been akin to scrubbing with a strong disinfectant solution, running the devices through a dishwasher-like device, and steam disinfecting. Then the scopes would be left to dry completely before they are used on another patient.

The scopes were subject to further troubles by way of manufacturers currying favors with providers by, in effect, bribing them to use their devices.

This advisory will make no difference to the dozens of people who fell ill, the families of those who died, nor the hundreds exposed to dangerous bugs from the device. The devices are undoubtedly useful for ERCPs, but they have always been fraught with risk by virtue of designing difficult-to-clean corners and attachment points. Anyone who has tried to clean a coffee maker can appreciate the difficulty of really getting into those nooks and crannies; now imagine doing that on a tiny scale.

What will disposable devices or attachments look like? We will find out. Will these changes dramatically increase the costs of these procedures? We expect yes. Will there be pushback from insurance carriers? No doubt. Will the device manufacturers be able to design disposable attachments, scopes, or work arounds to prevent transmission of these types of bugs? That is to be determined. What we can discern, though, is that a major impetus to this change was plaintiff litigation that exposed the faulty designs of these medical devices.

Read the FDA’s release here: [FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection](https://www.fda.gov/news-events/press-announcements/fda-recommends-health-care-facilities-and-manufacturers-begin-transitioning-duodenoscopes-disposable)

Read previous coverage of duodenoscope litigation [here](http://cmglaw.com/Search?q=Duodenoscope).