AORN Comments to FDA on Medical Device Identifier Rule
Publish Date: 12/5/2012
AORN recently submitted written comments to the Food and Drug Administration (FDA) in response to its proposed rules for establishing a unique device identification system for medical devices. The proposed system would require the label of medical devices and device packages to include a unique device identifier (UDI). Each UDI would have to be provided in a plain-text version and in a form that can be read by a bar code scanner or similar technology. The UDI would also be directly marked on implantable devices, devices intended to be used more than once, and certain stand-alone software. The UDI will provide a key to obtain critical information from a new database that will be maintained by the FDA, which will include descriptive information about the device and any additional safety or recall information. AORN’s comments provide feedback to the FDA on what nurses in the OR need from a UDI system and a new national database with device information.
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