When fully implemented, the Unique Device Identification System will offer a range of benefits to industry, FDA, consumers, health care providers and health care systems by:
- Allowing more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reducing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- Leading to the development of a medical device identification system that is recognized around the world.
Adoption in Health Care Systems
The final UDI rule provides the regulatory framework for implementation of a UDI system by the device industry. The benefits offered by such a system will only be fully realized with the adoption and use of UDIs by manufacturers, distributors, payers, providers, patients, healthcare systems and other stakeholders with important roles to play throughout the medical device lifecycle.
A key element for achieving these benefits requires working collaboratively with Federal partners and other external stakeholders to promote of UDI incorporation into electronic health information. FDA also is collaborating with the Engelberg Center for Health Care Reform at Brookings to develop a roadmap for the successful adoption and implementation of UDI throughout the healthcare systems, which will convey the value of UDI implementation, guide relevant stakeholders in addressing key challenges, and serve as a foundation for policies supporting UDI adoption.
In 2012 and 2013 the FDA supported an 18 month demonstration project with Mercy, a large U.S. health care system, related to the adoption of UDI in the clinical setting. This project had three aims:
- To implement a coronary artery stent UDI-based surveillance system in the electronic health record (EHR) in a multi-hospital system
- To identify obstacles to implementation of the UDI Roadmap produced by the MDEpiNet Think Tank and characterize the effectiveness of interventions to overcome them.
- To assess the validity and utility of data obtained from the EHR and incorporated UDIs for purposes of post-market surveillance.
The final report "Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance" summarizes the identified challenges and opportunities of implementing UDI in a large hospital system.
In addition, the Pew Charitable Trusts developed a video highlighting the benefits of UDI implementation in Mercy. In the video Mercy’s efforts are discussed by a cardiologist, supply chain executive and nurse and serve as a model for health care professionals and health systems looking to utilize and benefit from the UDI system.
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