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  3. Device Advice: Comprehensive Regulatory Assistance
  4. Unique Device Identification System (UDI System)
  5. Optimizing GUDID Data Quality
  1. Device Advice: Comprehensive Regulatory Assistance

Optimizing GUDID Data Quality

Fully realizing the benefits of the unique device identification system depends on UDI being integrated into electronic data sources throughout our healthcare system, including in the supply chain, electronic health records, and registries. This requires UDI data submitted to GUDID to be of a high quality such that all stakeholders in the healthcare community have sufficient confidence in the accuracy and completeness of that data. This will enable the GUDID to be a reference source of data used in downstream systems.

The UDI program team has received feedback from stakeholders regarding the GUDID data and materials. In late Spring 2018 we plan to:

  • Update the GUDID Data Elements Reference Table (DERT) focusing on the "Top 10" GUDID fields to provide better direction to ensure consistency and quality of the data submitted to GUDID; and
  • Continue to analyze specific elements of the GUDID data and work with labelers to ensure quality data is submitted to FDA.

One or more of the following fields are being loaded into patient records, registries and other electronic health information to improve the identification of a device through distribution and use.

  • Device Identifier (DI)
     
  • Brand Name
     
  • Version/Model
     
  • Catalog Number
     
  • Description
  • Size
     
  • MRI Safety
     
  • Latex Information
     
  • DUNS Number/Company Name
     
  • GMDN/FDA Product Code

A key driver for UDI adoption is the Office of National Coordinator's 2015 Edition Certification Criteria for Electronic Health Records that includes UDI as part of a patient’s core clinical data1. Hundreds of early adopters are actively implementing and using UDI and GUDID. These early adopters are working with collaborative communities to develop implementation roadmaps and remove barriers to UDI adoption. Below is a list of some of the early adopters and collaborative communities; this is not an exhaustive list.

Early Adopters and Collaborative Communities

1 UDI is identified as a data element in the Common Clinical Data Set (CCDS), a core set of 20 data elements and associated standards that facilitates reporting for all summary of care records, care transitions, discharges, and patient access, allowing for more advanced clinical processes.