By: Jeffrey Shuren, M.D., J.D.
As the FDA works with manufacturers to launch a new system of identifying medical devices using standard bar codes and numbers, we look forward to the day when the system, called the Unique Device Identifier (UDI) system, will be fully set up— with identifiers on device labels and a corresponding database of identifying information about most of the devices in the U.S. marketplace.
But why does that matter?
Much like vehicle identification numbers (VINs) for automobiles, UDIs are intended to streamline the monitoring of devices, improve safety tracking and recall efficiency, and even make it easier to evaluate device performance over time. So while there’s little doubt that UDI can improve patient safety, modernize how we evaluate devices once they are in use, and facilitate future device innovation, these benefits will only become a reality when the UDI system is adopted and integrated into the health care system—when hospitals, doctors’ offices, patient registries, heath care insurance companies, and others incorporate UDI as part of their standard electronic health information systems.
Without the practical implementation on the clinical side, UDI will be codes and a database with limited utility to improve patient care or reach its other critical goals.
The FDA is thinking about this now—not later. While going full steam ahead to fulfill our responsibility for implementing UDI regulations for medical device manufacturers, we are doing everything we can to promote the widespread adoption of UDI in the U.S. health care system.
We commissioned the Brookings Institution to create a “roadmap” for provider systems, patients, payers, supply chain personnel, and many others, to adopt and utilize UDIs. This report, released on Friday, December 5, provides 17 recommendations for adopting UDIs across three major intersections of the health care system—providers (e.g., electronic health records, hospital inventory management, billing records); administrative transactions (e.g., claims data and payment information); and patient-directed tools (e.g., mobile apps and public awareness campaigns).
We’re working hard to create and populate an efficient and useful UDI system for medical devices. But even the perfect system will fail to improve patient care if it’s not properly integrated into electronic health information systems. That process has to start now.
Today, we are co-sponsoring with Pew Charitable Trusts and the Department of Health and Human Services Office of the National Coordinator (ONC) a meeting where some 400 experts are convening to discuss changes that are needed to store and share UDI information throughout the health care system, with the ultimate goal of improving patient care.
The goal is to have the UDI system not only up and running—but actually used as the key to unlock important data that can help patients.
But how does such a system really help patients and the providers who care for them? Consider a possible scenario where the connections made via UDI could make an important difference in patient care.
A patient undergoing knee surgery—we’ll call him John—has the UDI of his knee implant scanned and electronically recorded into his clinical record.
When John is discharged, he can also register the UDI into his personal health record (PHR), available from his provider, through a variety of mobile apps that can enable two-way communication with his provider.
Having the UDI recorded will help John to know if safety alerts apply to his specific implant. It will also help him accurately report any potential adverse event to the provider, the FDA, or the manufacturer, with the confidence that the UDI ensures that all parties know what the type of device may be causing John—and possibly other patients—problems. Importantly, if John hears about knee implants being recalled, he will be able to quickly pinpoint, by using his UDI, if his particular type of implant is involved in that recall. If it’s not, John may avoid needless anxiety; if it is, he can take any necessary action, such as following up with his orthopedic surgeon.
The UDI from John’s surgery is also available to be transmitted to a total joint replacement registry, without any of his personal information. Data from the registry may then be used to support the development of innovative implants and reduce the data requirements for — or replace altogether — postmarket studies conducted by the device manufacturer to demonstrate long-term performance.
The possibilities of UDI are exciting—better and more precise information can lead to better care and better awareness of how medical devices work in the general population. The FDA is working to set up the system, but implementation and integration are critical. The question is—if we build it, will people adopt it?
Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health