UDI Conference: “Yes, you have to do this.”

by Craig Hodgson, on April 25, 2016

UDI ConferenceAt last week’s UDI conference in Baltimore, the FDA’s Terrie Reed summed up the reaction of many companies dealing with unique device identification (UDI) compliance with the question “Do we have to do this?” Sounding almost like parents encouraging their frustrated kids, the FDA recognizes that some organizations are struggling with the regulation. But through a carefully laid out process, helpful resources, and events like this, the expectation is that compliance will happen and on time.  

Part of the problem is that some of the granular details still need to be figured out. Like what constitutes a “unit of use” when devices are smaller and packaged with similar devices in a single package. Does each swab and syringe in a 10-item package count as a unit or is it the whole package? This was discussed for 20 minutes during an open forum on building a UDI community. And this was at the conclusion of the event.

As painful as UDI compliance may be for medical device manufacturers, especially with another deadline looming for Class II devices in September, it seemed most everyone in attendance is onboard with the overall intent of UDI. That is, being able to better document, identify and track devices (and related products) across the health science ecosystem will bring extensive, long-term benefits to everyone involved. But when you consider this was the 8th annual UDI conference, it’s also clear that this is a huge endeavor with no easy shortcuts.

Couple of other takeaways from the event…

Whole lotta data going on – As mentioned, manufacturers of Class II devices are required to submit their data to the GUDID database by Sept. 24. This is the largest class of medical devices, representing 43% of all devices in use today—everything from diabetes testing kits to condoms. You can imagine the sheer volume of data that needs to be gathered and processed, and the strain it’s putting on both manufacturers and the FDA to ensure accurate and consistent submissions. Little wonder that a good portion of the conference focused on the “how to” with a dedicated workshop on the GUDID process. There are already 570,000 records in the GUDID, but you can expect that figure to jump significantly in the next few months.

Whose label is it, anyway? – More confusion exists when it comes to products that require private medical device labels. Does the brand manufacturer label the product or is that up to the co-packer? And what are the templates for managing the labeling, regardless of who’s doing it? It gets complicated quickly, which begs the need for an integrated, automated labeling solution that draws from sources of record to improve accuracy at every stage of the supply chain. The right solution also allows variable data, images, etc. to be updated within the same template, and these templates can be shared securely with partners—whether it’s from the manufacturing side or the distributor—to save valuable time and expense.

Communicate, communicate, communicate… – You would think that most industry people are actually tired of hearing about UDI (particularly the constant reminders about upcoming compliance dates), but it depends who you talk to. We spoke with an attorney for one of the larger grocery chains in the country, and he commented that their in-store pharmacy knew nothing about UDI requirements until two weeks ago when they were asked by a manufacturer to provide numbering to register products for private labels. Scary to think that at this stage, there’s not industry-wide awareness, but evidently there are pockets where the word is still not getting out.

Expert help at your disposal – Complying with UDI is no small task. Depending on the size of your organization, you need to include people from regulatory, manufacturing, supply chain, and IT. And that’s not including your extended network of participants such as distributors, providers and the FDA itself. Fortunately, you don’t have to go it alone. When you work with consultants like USDM Life Sciences or GHX, you can quickly gain guidance (and confidence) to keep your UDI readiness program on track. And when it comes to UDI label software for your medical devices, you can turn to Loftware for an enterprise-wide approach that improves labeling accuracy and scales to meet growing demands. I encourage you to learn more about the Loftware Validation Accelerator Pack recently announced in partnership with USDM that will help reduce validation time and costs of your enterprise labeling solution by up to 50%.

Deep breath, it will all be ok – The spirit behind UDI is what we need to keep in mind because it provides that extra level of traceability and accountability that in the end improves health care service across the board. And there are documented business rewards as well. During the show, Michael Schiller from the AHRMM talked about the Cost, Quality and Outcomes of UDI and the estimated savings that will be realized in several areas of the supply chain. Device recall handling costs alone could be reduced $1B annually. Terrie Reed used a car analogy where auto makers rely on a unique VIN number on each vehicle and that number is tied to the specific owner. If and when there’s a safety recall, you’re quickly informed and can take proper action. That’s how it will be with UDI as manufacturers, distributors and providers create a robust, unified tracking system that further improves patient care. The ultimate end goal.

What was your take on the UDI conference? Where are you with compliance and how are you getting there? In cooperation with USDM Life Sciences, we invite you to take our brief survey. You can share your experiences with UDI barcode software as well as other aspects of your UDI readiness program. We’d love to hear from you—plus, you’ll receive a $5 Starbucks eGiftcard!

Take the UDI Survey

 
Topics:Regulatory

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