UDI and Health IT: Getting Closer? | GHX

Karen Conway

Executive Director, Industry Relations
Saturday, September 14, 2013

UDI and Health IT: Getting Closer?

Monday marks the start of National Health IT Week in Washington, DC. It’s the 8th time the event has been held to “raise awareness of Health Information Technology’s power to improve the health and health care of patients…at a lower cost.” I attended some of the earlier National Health IT week activities (prior to passage of the American Recovery and Reinvestment Act, aka the stimulus bill), when the primary, and often sole, focus of the discussions on the hill was how to get funding for electronic health records (EHRs). My concern then, and my concern now, is that we often look too narrowly at health IT and what really needs to happen to get value out of our technology investments.   

I am pleased that this year’s program agenda is much broader than some of those in the early years. The 2013 agenda includes sessions focused on building health IT-enabled practices that can coordinate patient care and empowering patients to be better partners in their health. And yes, I get it, we have to start somewhere and EHRs, along with health information exchanges (HIEs) are key components. But despite the progress we have made, I still think we are still missing a key piece of the puzzle - the ability to accurately document the supplies used in patient care, especially products that are implanted in patients. After all, stage one of meaningful use required capture of the pharmaceuticals given to patients. What’s the difference between a drug ingested and a cardiac stent or replacement joint implanted? But much of that documentation is still handled in a highly manual, often error-ridden, and difficult to track manner.

This is not a new issue. I have mentioned it before, here in the Healthcare Hub and in numerous articles and speeches. And we are making progress with the GHX implantable device supply chain initiative, which automates and improves visibility around the products used in the OR and Cath Lab. But the connection (or lack thereof) to National Health IT Week is particularly noteworthy this year, with the UDI Conference led by the FDA being held at the same time just up the road in Maryland. As many of us plan to gather in Baltimore, September 19 and 20, we are hoping the FDA will be able to issue the final rule in advance of the conference. That will make the discussions far more valuable to manufacturers who will need to comply with the rule, especially those who make Class III devices, including implantables, who will have to be in compliance first. For those who may not know, the UDI rule will require manufacturers to label medical devices with unique device identifiers in both human and machine readable formats and to populate a UDI database with additional information about those products.

But it goes far beyond just labeling the products. As I have said many times, and will again, if providers do not capture the UDIs in a manner that enables them to understand which products are used in patient care and to what result (in terms of quality and cost), we will have only added regulatory burden and cost to our healthcare system. UDIs are foundational to the FDA’s plan for strengthening our national medical device post market surveillance, but they can also contribute significantly to the goals of National Health IT Week, the Affordable Care Act, and our need for a better quality and more affordable healthcare system.

Those who followed the evolution of the Affordable Care Act may recall earlier versions that included requirements to document UDIs in electronic health records. That language was later removed, but the conversations continue between the FDA and the Office of the National Coordinator for Health IT regarding the topic. In contrast, The European Commission’s April recommendation on “a common framework for a unique device identification system of medical devices” specifically calls on health institutions to store the UDI for implantable medical devices in the electronic patient record. As the document rightly indicates, “it should be possible to know exactly which medical device has been implanted to which patient.”

But in my mind, this is not a matter of whether or not providers should or should not be mandated to document the UDI. It’s a matter of what will be required for us to successfully move to a value-based healthcare system based on good population health management. Yes, we need EHRs and HIEs, interoperability and trust among the parties, and patient accountability, but we also need good data on the role that implantable devices have on the quality and cost of patient care. And that starts with good documentation at the point of use.

I look forward to seeing many of you at the UDI conference. If you are there, try to find me and say hello. If you cannot make it, watch for future issues of The Healthcare Hub for a full report. 

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