Recently, the FDA published an electronic advisory on duodenoscopes. It recommends that organizations transition to disposable duodenoscope components.
Why Disposable Duodenoscope Components?
Here’s the reason for the FDA recommendation. They find that these newer scopes with disposable components are easier to clean.
In fact, higher than expected levels of contamination occur with the fixed endcap scopes. What’s more, the FDA recommends monitoring through sampling and culturing surveillance to track this issue in your facility.
Further, the FDA introduced a new acronym for everyone to learn called RIFU. This is a new flavor of instructions for use (IFU). But, this one means reprocessing instructions for use (RIFU). You can find the complete FDA advisory here.
Lastly, we encourage readers to download this FDA notice. In addition, share it with Gastrointestinal Lab staff and infection prevention for analysis and discussion.
Patton Healthcare Consulting
Patton Healthcare Consulting provides Joint Commission Compliance Assistance and a full range of pre-survey and post survey services.