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’”.
GS1’S SUNRISE 2012
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.
WITH UDI, FDA WALKS THE LINE
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.