FDAnews Device Daily Bulletin

FDA Draft Guidance Would Tighten Enteral Tube Connector Safety Rules

Aug. 3, 2012
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Color-coding or labeling tubes to reduce risks associated with enteral tube misconnections will no longer be considered enough of a precaution under a new FDA draft guidance. The main risk, the draft explains, is small-bore luer connectors — universal devices that can be used to connect tubing between many kinds of medical devices. Problems arise when a tube serving one purpose is connected to a device serving a completely different purpose, the FDA said.
Devices & Diagnostics Letter