HTG forms R&D team to accelerate UDI implementation

The Healthcare Transformation Group (HTG) announced on April 25 the formation of a research and development (R&D) team to advance the adoption of GS1® Standards and accelerate HTG’s work to implement a Unique Device Identification (UDI) system.

The announcement follows the FDA’s Center for Devices and Radiological Health report bringing to light agency plans to develop a national medical device postmarket surveillance system, which would incorporate UDI in routinely collected EHR information.

The R&D team will work jointly to develop a standard language and network of data sets within their systems. The effort is an expansion of FDA’s UDI demonstration project currently underway and “will eventually provide a pathway to implement UDI into each HTG healthcare system’s clinical processes, tracking devices end-to-end from manufacturer to research database,” according to the announcement.

Members of the team include representatives of the five HTG health systems: Geisinger, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy. Members include:

• Joseph Drozda, Jr., MD, director of outcomes research, Mercy
• Jove Graham, PhD., director of clinical research project development, Geisinger Center for Health Research, Geisinger Heath System
• J. Brent Muhlestein, MD, cardiology, Intermountain Healthcare
• Liz Paxton, MA, director of surgical outcomes, Kaiser Permanente
• Robert F. Rea, MD, cardiovascular diseases, Mayo Clinic

“We fully support the work of the HTG to adopt standards and implement UDI in our healthcare systems,” said Graham in the press announcement. “The ability to manage devices through the supply chain, and create data sets for research and safety surveillance is critical.”