With the FDA’s UDI program moving along, it is important that medical device manufacturers come up with plans to get into compliance.
A lot of the information we’ve provided so far on UDI has been built around the GS1 system, but HIBCC (Health Industry Business Communication Council – yes, I did get it wrong in the presentation!) is already well established in the medical industry and seems to have some nice advantages over GS1.
This presentation looks at a way to produce HIBCC 2D barcodes, encoded to the ISO 15434 standard using BarTender label software. The first video gives a little background info and shows how to format the barcode. In the second video, I show how I add the human readable text to the label, in the format required by HIBCC.
One of the things I like with the HIBCC standard is that there is plenty of choice, allowing packers of medical equipment to use what works best for their particular application.
As I mentioned in the first video, I could choose between Datamatrix, QR Code, Aztec Code and Micro PDF code for the 2D barcode.
I chose to use Datamatrix because it is robust and easy to read with any 2D scanner. Because HIBCC calls for the ECC200 level of built-in error correction, the barcode can still be successfully read if it gets somewhat damaged. We can also perform a quality verification using our Microscan UID verifier.
Regardless of whether you choose to use the GS1 or the HIBCC (GS1 is certainly easier to say!)
Our team at Winco ID is able to help you with all your medical device labeling. From labels, to printers, to software, to training, just let us know and we can get you up and running.
If you’d like a copy of my HIBCC label as a starting point – or a GS1 version – just let me know.
There is also a good source of FDA UDI info available on the HIBCC website.
Attending BIOMEDevice in Boston in April? Come and see us at booth 247. We’ll have live labeling demos showing both the HIBCC and GS1 barcodes in action.