Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

I was recently asked to help a small medical device manufacturer switch all of their medical device-related product codes from Health Industry Business Communications Council (HIBCC) Universal Product Numbers (UPN) to GS1 Global Trade Item Numbers (GTIN).  Historically, the pharmaceutical supply chain has used GS1 GTINs but the medical device supply chain has predominantly used HIBCC UPNs, so a switch like that seemed to be against the grain.  I asked them, “Why are you abandoning HIBCC codes for GS1 codes?”

The answer was a little startling.  My customer didn’t have any opinion one way or the other about the merits of HIBCC or GS1 identifiers, but two of their European distributors had recently informed them that they would no longer distribute their products after the end of 2012 unless they were labeled with GS1 identifiers.  Faced with the threat of shrinking the availability of their products in an important market, they made the decision to switch to GS1 product codes.  Those distributor demands made the choice a pretty devious wedge for this particular medical device manufacturer.

I assume that those distributors have made the same demands of other manufacturers who are currently using HIBCC codes.  J&J, perhaps the biggest medical device manufacturer in the world, has made it clear that they intend to make the same switch voluntarily (not due to anyone’s demands) and I am aware of others.  Cardinal Health, a big distributor of medical devices in the United States and a medical device manufacturer, has announced their preference for GS1 identification standards, although I don’t think they are insisting that all of their suppliers switch to them.

I’ve written before about this battle between HIBCC and GS1 for supremacy in the healthcare supply chains, but this is the first time I’ve heard of such firm demands coming from a distributor.  For more on the contest, see my essays “So a customer demands that you use GLN’s and GTIN’s. What next?, WAR: GS1 Vs. HIBCC”, “’Why the rush for GS1 standards?’” and “’The State of Healthcare Logistics’”.


The deadline stated “by the end of 2012” sounds suspiciously familiar.  That is the deadline of the GS1 US Healthcare program known as “GTIN Sunrise 2012“.  If that is what is driving the two European distributors then they are taking the GS1 US program to an extreme because that program is voluntary.

On the other hand, what is voluntary to GS1 US may be viewed as compulsory to companies who would benefit by having one less identification standard to deal with.  But it seems to me that these distributors shouldn’t expect to convert every manufacturer they deal with.


The U.S. Food and Drug Administration (FDA) put a lot of effort into ensuring that the definition of their proposed Unique Device Identification (UDI) regulation would not favor the identifiers of one standards organization over that of another, as long as they are based on a certain set of International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) standards.  Both GS1 and HIBCC standards are based on that set, so both of them are expected to be usable when the regulation goes into effect in the U.S. in the next few years (see my essay “FDA Proposed UDI: A Revolution In Number Assignment”).

The UDI regulation proposed by the U.S. FDA is a masterpiece that was borne out of the hard work of the Global Harmonization Task Force (GHTF), a consortium of regulators from countries around the world.  (Now that its work is done, that organization has since transformed itself into the International Medical Device Regulators Forum, or, IMDRF).

It is clear from the GHTF final document that they intended that both GS1 and HIBCC identification standards (at least) should be usable for compliance with national UDI regulations, and the U.S. FDA has properly followed that guidance.  But perhaps not all distributors around the world have received that word from their local regulatory body, and so some are apparently requiring their suppliers to only use GS1 GTINs, as in this case.  My client chose to follow that demand without much protest because they are small.

So my question is, if this is anything other than an isolated incident, can HIBCC survive this kind of arm-twisting?  What do you think?  Leave a comment below.


6 thoughts on “Can HIBCC Withstand The GS1 Tide In Medical Device Identification?”

  1. Payers, manufacturers and distributors would be well served to evaluate the current and potential cost differences between the two systems. Regulators and legislators could serve all healthcare
    Stakeholders well by demanding cost disclosures and controls from these not-for-profit entities.
    Thanks as always.

  2. I agree with Mr. Monroe. It would be very helpful to see a cost comparison of the leading Issuing Agencies for ISO 15459 (e.g., GS1, HIBCC, EHIBCC, DoD-DLIS, etc…) Whatever the costs are they will most likely be pasted on to the consumer.

  3. As a contract medical device assembler/packager, we guide customers through this “debate” quite frequently. We are agnostic here, as our role is label development, printing and application.

    New (new to UDI) customers are attracted to the one-and-done HIBC fee structure. They shade to GS1 once we discuss allocation rules and UDI change triggers; the abstraction of the labeled REF makes future “GTIN-rolls” appear more straightforward.

    We try to keep “FDA” out of this discussion as much as possible, telling customers to listen to and honor their supply chain partners first and foremost.

    If a customer’s supply chain partner(s) require GS1 over HIBC, our working assumtion is not a “devious” intent; rather that partner likely utilizes other GS1 tools (GLN, GDSN, etc.) as well.

    When FDA allowed several avenues to UDI compliance, the discussion immediately became an e-commerce topic, not regulatory. While HIBCC does provide some tools, such as the UPN Repository, there is no debate that GS-1 is the clear leader in the e-commerce arena.

  4. It seems to me WalMart attempted to “strong arm” their suppliers on RFID with a goal to get to item level tracking. Most suppliers complied to the pallet and case level but we have all read about or lived through the battles, difficulties and struggles.

    Even though barcoding itself was primarily implemented because big players required it, the reality was that there were clear benefits to barcode use throughout the manufacturing and supply chain.

    As we evaluate new technologies, the business case needs to be made for all key players. I doubt that any one or two major players, even huge global distributors, will be able to force a new technology adoption without satisfying the cost/benefit evaluation and providing a reasonable transition path forward.

  5. Concerning auto-ID technologies, as we saw and heard confirmed during today’s UDI webinar briefing (organized by Prisymid, which included representatives from both FDA and GS1), the FDA is not prescribing any particular auto-ID technology as the UDI data carrier.
    Following on from John Sweitzer’s posted comment, superficially this is a good move, allowing participants in the n-tier medical / surgical device supply chain to focus on their various operational (business process) needs, such then driving selection and adoption of best fit auto-ID technology (or technologies). However, there is risk in endorsing multiple auto-ID technology standards for the same application. Specifically, we heard today that both standards compliant HF and UHF passive RFID tags will be acceptable forms of UDI data carriers. As we have witnessed, the retail industry leaders drove forwards with a single RFID standard (UHF, ISO 18000-6C / EPCglobal Gen2) in order to avoid the need for multi-technology reader infrastructure at various points of data capture in stakeholders’ operations. Mixing HF and UHF RFID technologies is radically different from deploying agile bar code scanners to capture data from labels which use different symbologies. Stakeholders in the healthcare supply chain should take careful note of the direction chosen and driven in retail for “item tracking”, in order to bring clarity to their industry through unity of purpose and direction.

  6. I think GS1 will win. Most of the manufacturers send their products to international markets and don’t sell them in the US only.
    Since HIBCC is only being accepted in the US, most companies I know will use the GS1 standards. GS1 standards are accepted almost everywhere.

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