Unique Devise Identification

FDA reported Dec. 1, 2010 about the progress of the UDI project for unique devise identification. The Health Care Barcode - HIBC and GS1 bar code are the two unique data structures being prioritized for UDI under the scope of the global standard ISO/IEC 15459 Unique Identification. The UDI project is harmonized internationally in conjunction with the Global Health Care Task Force – GHTF.

National specific solutions will be considered. The legal regulation for UDI in the US is expected early 2011 but FDA is motivating the users not to wait. There is a FDA data base for medical devices in planning. Serialization is not a mandatory issue yet but wishful for users. Hospitals appreciate the efforts but would like to see even more support for in house tracking & tracing.

The UDI conference was an ideal podium to learn about the FDA efforts and to discuss implementation issues as pros and cons of straight forward coding by help of HIBC or mapping to product references with GS1 coding. UDI is a unique data concept independent of data carrier and technology.

Read the whole article in English or in German.