Unique Device Identification for Medical Devices- what is the business case?

Current international regulatory requirements demand that medical devices be labeled with a minimum level of primary information (Product Name, Model No. Manufacturer Address) on the device and a certain level of secondary information (Expiry Date, Serial Number).

However, the concept of Unique Device Identification for medical devices has been under intensive consideration for quire sometime now, and the Global Harmonization task force has floated a document on this topic (UDI AHWG Draft Guidance for GHTF SC). The FDA has also discussed this topic in depth (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers/ucm054169.htm)

Automatic Identification and Data Capture is not a new concept to the commercial world. We see bar codes on literally every product at every level of packaging- units, cartons containing multiple units, shipping containers etc. And then there is RFID, OCR for the more sophisticated businesses. These serve the purpose of coding in a lot of information which can be decoded using dedicated readers.

Implementing a Unique Device Identification would by no means be an inexpensive proposition.
A lot of time and effort need to be invested in selecting the method, in defining the coding, maintaining a database and making it really work when it is supposed to. Unless there is a strong business case and assured return on Investment (Tangible or intangible) UDI implementation would not be favored.

The two reasons that seem to favor UDI, based on my limited experience are:

1. The first and foremost compelling reason, to me seems to be that a well designed (complicated but well defined for decoding purposes)UDI system can overcome the distribution of duplicates in the market.
2. Tighter control over quality, more effective delivery through the supply chain

Finally it is the individual stakeholder that should decide on the need for UDI implementation. More and more clarity of UDI schemes and more visibility on the benefits will definitely drive more medical device manufacturers to embrace UDI as an integral part of their device labeling requirements.