Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market. The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose. So far, three organizations have been FDA-accredited: HIBCC, ICCBBA and GS1.
ICCBBA has a lock on the identification of any “medical device” that has a human blood, cell, tissue, milk, and organ as a constituent part. All other devices are (or will be) identified by either a HIBCC Universal Product Number (UPN) or a GS1 Global Trade Item Number plus Application Identifiers GTIN+AIs, and for that reason, there is a kind of “competition” between these two organizations. I’ve written about this competition several times in the past. See:
- ’The State of Healthcare Logistics’
- ’Why the rush for GS1 standards?’
- WAR: GS1 Vs. HIBCC
- So a customer demands that you use GLN’s and GTIN’s. What next?
- Can HIBCC Withstand The GS1 Tide In Medical Device Identification?
This current essay is not meant to be one of those kind of essays. I just think it’s important, as a GS1 follower, to always remember that GS1 standards are used for the identification of lots of things in other healthcare supply chains besides pharmaceuticals, like for UDI for medical devices, and in fact, in lots of other industries and markets. Sometimes it is easy to think GS1 standards are only intended for the pharma supply chain and no one else.
Nothing could be farther from the truth, of course, as their use for meeting the UDI regulation in our “sister” healthcare supply chain demonstrates. The needs and applications of GS1 standards are different in that supply chain than they are in pharma. Unlike medical devices, in pharma, there really aren’t any alternatives. GS1 standards dominate.
So for that reason, companies in the pharmaceutical supply chain should be happy that GS1 has recently published version 16 of their “General Specifications”. The GS1 General Specifications is a document that contains many of GS1’s standards—particularly those related to GS1 barcodes and their contents.
Why should this update make you happy? Because it is an indication that the standards you rely upon for compliance with most global pharma serialization and tracing regulations are being aggressively maintained. That is, there is a well-established process for submitting and processing GS1 standard specification change requests (see also GS1’s Global Standards Management Process, GSMP). And that process is vital to ensuring that GS1 standards are fluid enough to allow you to meet every challenge a regulation throws at you, but not so fluid that older requirements and uses are threatened. The team of GS1 employees and industry volunteers who manage this specification and other GS1 standards documents are dedicated to keeping just the right amount of flexibility in GS1 standards to maximize their value and utility for companies who apply them.
The latest version of the General Specifications includes only one change that is aimed directly at healthcare users, although almost every change could impact some people in every industry. This time for healthcare, they have tweaked the decision tree that illustrates their recommendation for deciding how to apply human readable elements on a healthcare product label. This is a fairly minor document change, relative to the full scope of the document, but some may find it important for their needs. Last year GS1 made a much more significant and important change to their human readable interpretation (HRI) specification for healthcare, which I discovered later in the year and recommended everyone follow (see “I’ve Changed My Mind, Follow GS1’s HRI Specification”).
This regular maintenance of GS1 standards is perhaps the biggest reason governments choose GS1 standards for implementing their pharma serialization and tracing regulations. It provides companies with the confidence that these standards will morph to meet their needs, and that takes a big problem off the hands of the governments that specify GS1 standards for meeting their regulations.
If you look at China—one major country that did not choose GS1 standards for their pharma serialization and tracing requirements—they are on their own when it comes to switching to a 2D barcode in the future and expanding the data contents. Whatever they come up with will only apply to their market, which means higher costs for the drug manufacturers and other members of the supply chain who will need to develop special, “China-specific” applications, as they have for the current linear barcode used there.
But if you look at Turkey, Argentina, the U.S. and the E.U.—all of which allow or mandate GS1 standards for companies implementing their drug serialization and tracing regulations—you find a wealth of common understanding and similar applications. And you find that the governments themselves do not need to deal with the nuances and special situations that come up in a diverse supply chain because they are already dealt with by the GS1 standards maintenance processes. And if something new comes up that isn’t already addressed, it can be dealt with through GS1’s well established specification change request process. Everyone should care about that, and be happy about it. I am.