Healthcare asset tracking

UDI Basics

In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format that is consistent with international standards and international practice.

Fictitious example of what a unique device identifier (UDI) would look like on a medical device label. The label contains information about the product name, its expiration date, reference and lot numbers, manufacturer information, bar code, and details about the item.

 

Unique Device Identification – UDI

FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID).

How ItemSight Can Help:

The ItemSight Cloud is uniquely positioned  for this mandate as it was originally designed and built for the DOD with it’s roots in the stringent requirements set forth by the Department of Defense

Our EPCIS compliant database is at the core of  our relational system. It can store RFID EPC data and Barcode Data. The system feature full UDI Life Cycle management, custom reporting, and data analytics.  

 

Automate the printing and design of labels on premise for FDA-regulated Pharmaceutical, Medical Device, Biotechnology manufacturers and the Department of Defense.

Globally Manage and Transmit label data and mandated elements  to the FDA GUDID data base. Additionally the ItemSight system will manage all associated documents of multiple types.