Unique Device Identification (UDI) System for Medical Devices
Title:
Unique Device Identification (UDI) System for Medical Devices
Origin/Publisher:
GHTF
Document Type:
Guideline
Content:
A UDI unambiguously identifies a manufacturer’s specific medical device. A standardized UDI applied to the device or its label, documented in the UDI Database, and used consistently throughout distribution and use should facilitate a number of patient safety benefits, including:
•
traceability of devices,
•
the identification of devices in adverse events reports and other postmarket safety surveillance activities,
•
recalls and other field safety correction, and
•
reducing medical errors.