[Editor's note: I have a view which differs from Sterling's even-handed one and certainly from the bias of the two gentlemen quoted below. I think HIBCC was adopted because there was no clear solution as an alternative in the mid-90s. That is not true today and the handful of people remaining at that organization -- I've only heard of these two, compared to dozens of folks I've worked with at GS1 -- show the battle is done. Too many countries have mandated GS1. The only vestige of hope HIBCC clings to is "the alphanumeric argument" but it is irrelevant; it's not going to matter. Uniqueness matters. The GTIN->GDSN is what makes GS1 the clear solution.
Now, I don't think the FDA would ever actually designate a one-standard-only but, in reality, GS1 is it. The "many already use HIBCC" argument is a non-starter. The world has adopted GS1; you go to market with HIBCC, you're still going to have to do it with GS1. These sorts of arguments below are really just debating the alphanumeric lettering on the tombstone for this standard. But, as Sterling says below, Comments? Agree? Disagree? ]
Two senior HIBCC officials have just written and published a piece entitled, Why UPNs Make Sense for Medical Devices. The authors are Kirk Kikirekov, president of HIBCC AU (New South Wales, Australia), and Robert A. Hankin, PhD, who is president and CEO of HIBCC (Phoenix). Their long defense of alphanumeric HIBCC standards, versus numerical-only GS1 barcodes appears in Medical Device Link. Below, in an effort to spark discussion, I have attempted to capture the essence of their main arguments in favor of their standard versus GS1 by excerpting directly from their viewpoint piece. However, in fairness, the full essence of their position probably warrants a complete read. In short form, here’s what they are saying:
The use of product identification as a resource in medical practice, as opposed to just a tool to manage inventory and warehouse logistics, is creating an entirely new paradigm. A UDI system based on universal product numbers (UPNs) would be a safe and efficient way to accommodate both hospital and warehouse needs… HIBC standards were also designed to coexist with generic retail and pharmaceutical standards known as GS1 codes. The codes work well in cash-register and warehouse environments, but are less suitable for medical applications in which safety and error minimization are crucial… It is logical for FDA to adopt the UPN standards for UDI because they are based on existing, internationally recognized standards and leverage the significant progress that has already been made by the medical device industry in product identification… a deviation by FDA from existing labeling standards and practices would burden manufacturers with significant costs at a time when reducing healthcare inflation is a critical national priority. Manufacturers that currently use HIBC formats would be required to redesign their labeling systems and implement changes to software in their warehouse and distribution centers.
Agree? Disagree?
Filed under: GS1 Tagged: | C-Level Issues, Global Standards, GS1, GS1 Adoption
I agree with the article. GS1 is expending a lot of resources on selling their standard to Healthcare, but I wonder if similar resources are being allocated to keeping their standard dynamic to meet market needs, and adding functionality to make it better suited to Healthcare. When I spoke to one executive from GS1about the HIBCC standard, he seemed unaware that the HIBC had features useful to healthcare that do not exist in the GS1 bar codes. I encouraged him to update their standard with expanded features such as longer item numbers (preferably alphanumeric) so a single license would suffice, structure linkers, packaging level field, and true 2D code like datamatrix. If those were in the GS1 code, there would only be the license price structuring to consider when chosing between the two. Several large manufacturers are currently faced with having to label with both standards to meet varying contractual (not regulatory) requirements.
While your loyalty to HIBCC is admirable, I need to correct a couple of statements in your comment. The GS1 standard includes a packaging level indicator as a component of the GTIN and GS1 does support 2D barcodes such as Datamatrix. It does not need the structure linkers as the data standard is consolidated into a single code with function characters separating the application identifiers (HIBC required a primary and secondary code).
Not to single you out, but when I read comments like this I ask myself why any company in the medical device world would resist adopting the GS1 standard. Is it really just the work required to data map existing item numbers to GS1-conforming product numbers? There are companies (yes, Loftware, but certainly others) who are very well trained and can provide the assistance to ease this transition.
Love GS1 or hate them, it is the data standard required to do business in Healthcare throughout most of the world. The energies spent fighting to keep HIBCC alive would be much better spent converting to GS1 as this battle was lost long ago. The bottom line is I have yet to see a public document from any GPO or IDN demanding HIBCC. I have numerous examples demanding GS1.
To your point regarding manufacturers having to consider labeling using both standards due to contractual obligations, I would strongly suggest they contact the HIBCC user and inquire about their GS1 adoption plans. I would not be surprised if they would gladly accept a GS1 coded package. (As an aside, I regularly speak with major medical device manufactures and GPO executives. No one has mentioned this to be a concern for them.)
Finally, and as an aside to explain my passion on this topic, previous to my immersion in the wonderful world of medical device packaging I spent numerous years working on hospital information systems and have extensive hospital experience. I can honestly tell you that having two competing data standards is confusing to the caregivers and ultimately at odds with our ultimate goal of patient safety. The reality today is most hospitals over-label our medical products as soon as they arrive on their loading docks, covering up our heavily-debated GS1 and HIBCC labels. This causes extra work and investment for the hospital (money better spent on nurses, trust me!) and creating hurdles for recalls and adverse event recording.
Having a single, globally acceptable, data standard that hospital information systems vendors can develop systems around and caregivers can be educated on will save patients lives by reducing errors, provide a foundation for evidence-based medicine, and support recalls and adverse event recording. The majority of the world healthcare industry has spoke in favor of GS1.
Christopher, It is not loyalty. It is working in one capacity or another in healthcare since I was 17. As you know, you end up looking at safety a bit differently. I am also responding to the request for discussion of the points brought up in the article, not a fight. A standard should grow with the needs of the users. GS1 has been slower than HIBCC to respond, but is doing so. GS1 clung desperately to PDF417 as their 2D bar code standard for years. It was really just a stacked linear, lacking the error protection built into the true 2D standards like Aztec and Datamatrix. Recently GS1 made DataMatrix usable for IUID. It took the US DoD and its suppliers, primarily aerospace, to get them to make that concession, not healthcare, as far as I can tell. HIBCC bar codes can be concatenated just like GS1 structures. The problem comes when, for space and package shape limitations, the various fields need to be in separate bar codes. The GS1 standard does not have linkers. If the serial number bar code is not concatenated with the item number bar code, there is no way to validate that they go together. The operator could have scanned the item code for a part, been distracted, then scanned the serial number for a different product. Now you have an item in inventory that does not exist and the two items that should have been entered, have not been. The HIBC linker allows checking that the bar codes go together. However, the best solution to this problem is to concatenate and use DataMatrix, but hospitals have been using linear scanners. I recommend they invest in imagers. Converting from HIBC to GS1 AIs is not difficult. I expect to be doing a lot of it. The GS1 structures are quite simple. The next issue is in the maintenance of the lookup tables. Oracle finally added a filed for GTIN to their latest version, but many Oracle users have not migrated yet as they have to validate the new version and foot the upgrade cost. Other ERP systems have had fields for GTIN and HIBC for a long time, making this a bit easier.
[...] out the opinion of the “Editor” in his/her remarks at the top of this Loftware Blog post from last year. Yow, that’s [...]
I was a champion of HIBCC for many years and commend them for taking the leap of faith in healthcare when many others were not. I still think its product ID/ UPN system is as valid and useful as the GS1 GTIN. However, its check-digit flaws and numerous secondary barcode configurations let it down and proved to be too difficult and costly to develop and maintain for data capture and data processing. Having lived through a major global IT/ ERP overhaul recently… moving to GS1 was the right choice. I really don’t understand the HIBCC vs. GS1 war nonsense though, plenty of room for the two standards to exist.