The FDA's new Unique Device Identifier (UDI) system was established on September 24, 2013 in an effort to increase the safety of medical devices in the healthcare industry while also minimizing the costs of sharing the necessary data through a new, publically accessible Global Unique Device Identification Database (GUDID). This new system will allow the healthcare industry to share information about medical device model, manufacturer, device class, expiration date, manufacture date, production batch, production lot and even unique codes to identify human cells, tissue or cellular and tissue-based products, also known as HCT/P. With compliance dates for some requirements as early as September 24, 2014, medical device manufacturers are working hard to make sure they have the means to generate their required labels as per the appropriate specification.
The Unique Device Identifier, or UDI, is a string of numbers that represents the following:
- "+" identifier of the HIBC Supplier Data Structure
- 4 character Labeler Identification Code (LIC)
- 1 to 18 character Product or Catalog Number (PCN) that is used to identify information about the product including expiration, manufacture date, batch, lot and more.
- 1-digit Unit of Measure
- 1-digit Check Character
There are a variety of barcode symbologies that may be used to generate an HBICC, or UDI barcode such as Code 39, Code 128, Data Matrix, Aztec, QR Code and MicroPDF417. Which one your organization decides to go with will depend on a range of factors specific to your industry. IDAutomation offers a variety of products that would allow generation of these important HIBC UDI barcodes for the medical device industry in a variety of environments including Excel, Crystal Reports, Oracle, FileMaker, SSRS, Access and more.