Real-world health data informs FDA’s new guidance on duodenoscopes

Written by Ilana Landau, Editor

Following the results of real-world, post-market surveillance studies, the FDA has issued new guidance concerning the preferable use of partly disposable duodenoscope devices.

Duodenoscopes are utilized in more than 500,000 endoscopic retrograde cholangiopancreatography procedures a year; potentially life-saving interventions for patients with pancreatic and bile duct abnormalities. Duodenoscopes are often reprocessed — cleaned and sterilized — for use in other patients. Now, the FDA has issued recommendations that duodenoscopes which are, at least in part, disposable, be preferentially employed over conventional, fully re-processable devices, based on real-world health care infection transmission data.

The FDA guidance follows the release of results of post-market human factors studies commissioned by the FDA from each of the duodenoscope manufacturing companies in the USA: Fujifilm, Olympus and Pentax (all Tokyo, Japan). The reports detail the success with which healthcare staff could follow the manufacturer’s guidance concerning correct use and reprocessing of duodenoscopes.

Frequently asked questions:

Whilst the FDA works with manufacturers to improve the readability and translatability of manufacturer instructions, the most effective means of reducing infection rates and protecting patients involves duodenoscope design innovation such that the reprocessing procedure itself is made easier, more efficient or unnecessary.

Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA, explained that “…to advance continued efforts to help assure the safety of patients undergoing procedures with duodenoscopes…” the FDA has ordered “…new post-market surveillance studies on duodenoscopes with disposable endcaps, requesting the inclusion of real-world contamination rates in duodenoscope labeling and issuing letters to manufacturers of certain test strips used to assess duodenoscope cleanliness that have not been through proper FDA premarket review.”


What is a duodenoscope?

Duodenoscopes are hollow, flexible tubes that can be inserted into the upper area of the small intestine, via the mouth, throat and stomach. 

Whar are duodenoscopes used for?

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography procedures; they allow doctors to diagnose and treat often life-threatening diseases such as pancreatic and bile duct disorders.