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# FDA, Others Issue Duodenoscope Sampling Protocols
- URL: https://www.fdaweb.com/fda-others-issue-duodenoscope-sampling-protocols/
- Published: 2018-02-26T12:00:00.000Z
- Updated: 2026-09-14T23:25:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140843

FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology have announced the availability of voluntary, standardized duodenoscope surveillance sampling and culturing [protocols](https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/UCM597949.pdf?utm%5Fcampaign=FDA%2C%20CDC%20and%20ASM%20are%20providing%20recommendations&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=CBE0C2BE22760D25991275C61F74EEA7&elq=0fd75243f7eb467dbc16331c190c9a16&elqaid=2561&elqat=1&elqCampaignId=1850) to help reduce the risk of infection and increase the safety of the medical devices. The protocols are an update to an interim duodenoscope surveillance protocol released by CDC 3/2015\. FDA says microbiological sampling and culturing of duodenoscopes involves sampling their channels and distal ends, then culturing those samples to bacterial contamination that may be present after reprocessing.

Duodenoscopes undergo a multi-step cleaning and high-level disinfection procedure (reprocessing) so that they can be reused with patients. However, their design makes it difficult to remove contaminants compared to other types of endoscopes. “If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient,” an FDA [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=55285&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=0fd75243f7eb467dbc16331c190c9a16&elqaid=2561&elqat=1&ref=fdaweb.com) says.

The groups have scheduled a 3/22 Webinar to review the sampling and culturing protocols.