A breakthrough in device evaluation

May 15, 2017 – Researchers from the DCRI and Mercy Health make vital contributions toward the adoption and use of Unique Device Identifiers (UDIs), to transform and streamline medical device evaluation and surveillance.

A study recently published in the Journal of the American Medical Informatics Association by the DCRI’s James Tcheng, MD, (pictured) and Mercy Health’s Joseph P. Drozda, MD, highlights the informatics aspects of the U.S. Food and Drug Administration (FDA)-funded Mercy Demonstration Project. The project was primarily conducted in the Mercy Health System in St. Louis, where prototype UDIs were incorporated into the enterprise’s electronic information systems.

Safety surveillance of medical devices has been a top priority of the FDA but there has been no universal mechanism of identifying these devices across healthcare. This lack of standardization has been a barrier to efficient business processes and device safety surveillance in the past. Therefore, the FDA, along with the European Commission and other regulators devised the UDI system as a framework for identifying medical devices using an alpha-numerical barcode system that can be applied globally. The demonstration project goes a step further by testing the implementation of UDIs in electronic health data, which according to Tcheng, is a key priority for the FDA.

“The FDA has been working tirelessly for a number of years to modernize the approaches they are taking to device surveillance to evaluate and improve both unapproved devices under development and those already on the market,” Tcheng said. “Via the Demonstration Project, we set out to build and implement prototype UDIs for coronary stents across all electronic health information systems, using Mercy Health’s information systems as the test bed,” he added.

The demonstration project involved multiple stakeholders including the FDA, the American College of Cardiology’s National Cardiovascular Data Registry, various departments across Mercy Health, manufacturers, health system partners, professional societies and information system vendors.

During the course of the project, the researchers created both a UDI reference database containing device characteristics and a UDI Research and Surveillance Database containing the connected clinical and device data, facilitating longitudinal assessment of device performance. The UDI prototype database has since evolved into a product that is now available from the FDA – the Global Unique Device Identifier Database (GUDID), which will serve as a reference catalog for every device with a UDI.

“[This work] not only represents a major milestone in developing a device evaluation system, serving as the framework for what’s going to be put in place nationally for device surveillance,” Tcheng said. “UDI implementation will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.”

The findings are generalizable for everything from pacemakers and pacemaker leads, to intraocular lens implants, to hip prostheses or any other implantable medical device. It also provides the framework for the DCRI’s Medical Device Epidemiology Network’s Registry Assessment of Peripheral Interventional Devices project that seeks to improve quality and efficiency of peripheral interventional device evaluation.

The information and knowledge that the researchers gained through the demonstration project is now being applied to the GUDID through the Learning UDI Community (LUC). Both Tcheng and Drozda serve as chairs of several subgroups within the LUC to assist the FDA in improving the GUDID system.

“Ultimately, what we hope to do is have the American College of Cardiology’s National Cardiovascular Data Registry serve as a data aggregation point that enables improvement of devices across the total product lifecycle of devices,” said Tcheng.

In addition to Tcheng and Drozda, other researchers included James Roach, Thomas Forsyth, Paul Helmering and Benjamin Dummitt.