By Dalia Deak
In the United States, though many millions of individuals live with implanted devices, it may shock you to know that it is easier to recall tainted dog food than it is to recall a faulty pacemaker. This is due in large part to the lag of the medical device world behind most other industries in the implementation of a standardized system that can uniquely identify and track medical devices as they move through the supply chain to a patient. Such an identification system has existed for most products since stores implemented the UPC and Congress mandated that drugs be labeled with the National Drug Code, both of which were introduced in the early 1970s.
To remedy this lag, Congress, in FDAAA of 2007, tasked the FDA with the creation of a unique device identification (UDI) system. In 2013, FDA published a Final Rule regarding manufacturer labeling of UDIs, to be rolled out by class in the coming years. While the establishment of such a system would certainly constitute an important step forward, another number on a label will do little to enhance patient safety on its own. Rather, the value of UDIs is in the uptake of the identifier at each point in a medical device’s life—from manufacturer to distributor to provider to patient to payer (see this report I co-authored on this very issue).
The premise is simple: if we want to access the value that UDIs can provide—be it in facilitating a national database to identify issues with medical devices or improving a hospital’s ability to manage its own inventory—it will require broad stakeholder adoption. However, this broad adoption will not occur unless we pick up where legislation left off and incentivize uptake in our patchwork of health care data systems, most of which have not been designed with device identification in mind.
Perhaps the two systems upon which the success of UDI most strongly depends are electronic health records (EHRs) and claims. EHRs have the potential to both capture, at the time of implantation for example, and provide information regarding a medical device to providers. If a patient presents in an acute care setting such as the ER, the patient’s health care providers may want to know if they have an implant or if the make/model of their implant has been associated with a particular adverse event. There is an added layer of complexity in that even if patients in a less acute setting were to be tasked with tracking down their surgeon in hopes that their device information was documented, given the rate of failure in some of these devices (which can be upwards of 7 years) providers may not have retained those records for that long. In each of these situations, without readily available information regarding the device, providers may be required to make decisions without complete information. Given the importance of incorporating UDIs into EHRs, there are calls for the Office of the National Coordinator for Health Information Technology and the Centers for Medicaid & Medicare to include UDI capture in their EHR Certification Criteria, which has made it into the Proposed Rule, and eventually as part of Stage 3 Meaningful Use.
Payer claims are another important dataset that could benefit from UDI incorporation. In an era of big data helping to shed light on cost and utilization within the health care system, UDIs are uniquely positioned to provide unprecedented insight into the costs and use of medical devices. Moreover, as claims data continue to be an important source of information for national drug safety efforts, such as Sentinel, incorporation of UDIs into claims would help medical devices fall into step with drugs as our nation’s ability to identify, assess, and quickly act on safety signals grows. As a result, calls have emerged to incorporate UDIs into claims, a request that is currently under review by standards organizations.
It is clear that though UDI has the potential to enhance patient safety, it cannot without a concerted effort on the part of stakeholders across the health care system to incorporate UDIs into their data systems, particularly EHRs and claims. While important progress is underway to that end, there is still much to be done. Stay tuned, as I plan to continue to follow the progress of UDI in the coming months as the system continues to develop.