How to Launch the Country’s First-Ever Medical Device Tracking System

In a landmark step toward improving patient safety, the U.S. Food and Drug Administration (FDA) is establishing a national database to tag and track medical devices for the tens of millions of Americans that require pacemakers, artificial joints, heart defibrillators and the like. A new report from the Engelberg Center for Health Care Reform titled, Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation, outlines how this system should be designed and implemented. It includes several recommendations and action steps for providers, payers, medical device manufacturers, regulators and patients.

With UDIs operating as the standard for communicating information about each device across major health care sectors, they can unlock important opportunities to improve and ensure patient safety, enhance patient-provider communication and offer insights on the performance and effectiveness of certain devices.

The system relies significantly on the adoption of Unique Device Identifiers (UDIs), a new coding system that assigns a unique number to each medical device, much like vehicle identification numbers (VINs) for automobile. Just like VINs, UDIs will be used to ensure proper surveillance, track safety and recall information, and even evaluate the performance of specific devices over time. Perhaps most importantly, for the first time, providers and manufacturers will have a universal system to communicate critical, and often life-saving information, to patients and caregivers.

Recommendations for Moving Forward
The report provides over a dozen recommendations for adopting UDIs across three major intersections of the health care system. In order to spread the use of UDIs immediately, two efforts can begin right away with little to no regulation or oversight: doctors can begin capturing UDIs and patients can begin asking for their UDI. The report also recommends that:

  • UDIs should be captured in provider systems, such as electronic health records (EHRs), hospital inventory management and billing systems and even required in meaningful use criteria.
  • UDIs should be captured in administrative transactions, including claims data and payment information.
  • Finally, UDIs can be used across a variety of patient-directed tools, such as personal health records (PHRs), mobile applications, public awareness campaigns and through federal databases.

The report is available for download here.