Oct
21
Written by:
Karen Conway
10/21/2009 4:28 AM
I just finished attending the UDI Conference 2009 in Orlando, Florida. UDI stands for Unique Device Identification, which was mandated by Congress in 2007 as part of the FDA Amendments Act. The purpose of this part of the legislation is to require medical device manufacturers (and medical devices is broadly defined) to include an identifier on their product labels (again a broadly defined term) that enables a product to be uniquely identified through distribution and use. (The proposed rule is coming out “soon” according to Jay Crowley, the individual at the FDA in charge of this initiative.) A primary benefit of the UDI is better recall management, but there are many other areas of value, including taking the first step toward documenting which devices are used in patient care in electronic medical records (but that’s a topic for another day...stay tuned).
The conference, as I said, is about the UDI, but many of the discussions on the dais and in the hallways have been about standards in general, and in particular, GS1 standards to uniquely identify locations and products in the healthcare supply chain. They are the Global Location Number (GLN) and Global Trade Item Number (GTIN), respectively. GS1 is a global standards body, HIBCC another, although from our vantage point, a preference for GS1 standards has been gaining momentum among industry players over the past few years. A key driver has been calls from major group purchasing organizations (GPOs) and healthcare systems for suppliers to use GLNs in business transactions beginning in December 2010. The onus would appear to be on the suppliers, but in reality, the responsibility is on hospitals and healthcare systems.
One of the key benefits of GLNs is that they will significantly reduce the myriad account numbers that hospitals must manage for their ship-to and bill-to locations. One healthcare system executive told me her organization currently manages more than 450,000 different account numbers for just 100 locations. That’s because each supplier assigns different account numbers for the same customer locations, e.g., receiving docks, warehouses, etc. With GLNs, a hospital, at least theoretically, would only have to manage one GLN for each of those locations, and all its suppliers would have to use that GLN when referring to that location. But herein lies the rub. Hospitals must assign and maintain GLNs for each of those locations, and the switch is not as easy as you might think.
GHX hosts an industry standards users group, with well over 100 members (including suppliers, providers, GPOs and technology companies). As they have studied what it takes to use GLNs in order-to-cash transactions, they’ve uncovered some challenges. For example, often a single supplier will use multiple account numbers for the same customer location. Sometimes there are good reasons for this; other times, not. You can read more about the multiple account number issue in the first of a series of educational papers on standards adoption posted at: http://www.ghx.com/65boutGHX/IndustryStandards/tabid/827/language/en-US/Default.aspx. But the bottom line is it’s not simply a matter of swapping out account numbers from multiple suppliers with a single GLN.
Hospitals will have to work with their suppliers to resolve many of these issues, but the overall responsibility now and going forward will be on hospitals to assign, maintain and communicate those identifiers. As one of my colleagues in attendance at the UDI conference said yesterday, this is going to require a major paradigm shift. I’d like to hear about whether this is an issue at your organization and how you are addressing it and/or if there are other related topics you would like suggest for future educational papers. Standards can and will be great for the healthcare industry, but it will take some effort. Perhaps one of the speakers said it best yesterday, “If you have to eat a frog, don’t stare at it too long. And if you have to eat two frogs, eat the big one first.” GLNs can certainly be considered a big frog.
5 comment(s) so far...
I enjoyed the GHX presentation at the recent UDI conference in Orlando. I am interested in the UDID pilot report when it becomes publically available. Will a copy be posted to the GHX website?
I noticed that the GHX pilot UDID project, sponsored by the FDA, allowed for use of both the GS1 standards (ie GTIN & GLN codes) and HIBCC standards (ie HIBC and HIN codes). I believe you also mentioned that your study found that both codes were successfully utilized in this pilot study. I am interested because I am in the 3M Dental Division and although 3M uses GS1 codes for many products, our dental division uses the HIBC codes.
Did you work with any dental manufacturers that used HIBCC codes in your pilot? Are there any other pilot studies being conducted using HIBC codes or additional studies planned ?
Please let me know if you can provide any additional insight about UDI and the dental industry and where I can read about the study results. Thanks so much.
By Shari Myszka on
11/12/2009 4:23 PM
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Excellent post. You got most of the relevant issues. As a distributor in the middle of the supply chain we anticipate supporting both sets of standards and a fair amount of cross referencing as we always have. I do think the industry may be underestimating the resistance to moving to a single (GS1) standard as HIBCC is well established on the supplier side, both for labeling and the HIN customer identifier. Either would be costly and difficult conversions. I also don't believe a single standard is necessary with today's technology.
I agree though that the defining move is up to the hospitals and providers and I am keen to see whether an issue they have ignored for the better part of twenty years will suddenly become a priority because they are getting some pressure from the GPOs. You point out most accurately that there will be cost and work involved. We'll see.
By Ted Almon on
11/2/2009 4:38 PM
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Suppliers gain many benefits from the Global Location Number because the reporting they can get from GPO membership and market intelligence data. Though these suppliers need the major hospital systems to have an accurate GLN numbers to reflect the correct location before they can implement a change. In the end, both supplier and hospital will see efficiencies from this standard.
By Jon Ocel on
11/2/2009 4:38 PM
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I’m currently project managing a GLN pilot at the Leeds Teaching Hospitals in the UK. The GLN pilot involves GS1, GHX, Covidien, JnJ and our major distributors including NHS Supply Chain, Bunzl and Squadron medical. The initial results are encouraging and support the points raised by Jon Ocel . We hope to publish a paper through GS1 early in 2010 and will keep you informed.
The adoption of GS1 coding is incoporated in the Trust’s financial strategy and was adopted by the Department of Health within its 'Coding for Success' paper.
For more details of our work on data standards through GS1 and GHX please see our website:
www.leedsth.nhs.uk/sites/supplies/
By Graham Medwell on
11/24/2009 9:50 AM
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For thos who have expressed interest, the FDA has posted the report on the UDI pilot. You can access the report at this url.
www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers/UCM191772.pdf
By Karen Conway on
12/1/2009 9:31 AM
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