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Augmenting Medical Device Evaluation Using a Reusable Unique Device Identifier Interoperability Solution Based on the

Guoqian Jiang1, Yue Yu1, Paul R Kingsbury1

  • 1Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

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|August 24, 2019
PubMed
Summary

This study introduces a reusable unique device identifier (UDI) solution to improve medical device safety and effectiveness evaluations. A UDI research database framework using the OHDSI common data model was developed, addressing data standardization challenges.

Keywords:
Controlled VocabularyElectronic Health RecordsEquipment SafetyReference Standards

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Area of Science:

  • Medical device evaluation
  • Health informatics
  • Data standardization

Background:

  • Evaluating medical device safety and effectiveness is crucial.
  • Current data systems often present challenges in data integration and standardization.
  • Unique Device Identifiers (UDIs) offer a potential solution for device traceability.

Purpose of the Study:

  • To develop a reusable unique device identifier (UDI) interoperability solution.
  • To augment the safety and effectiveness evaluation of medical devices.
  • To establish a UDI research database framework using the OHDSI common data model (CDM).

Main Methods:

  • Proposed a framework for a UDI research database.
  • Utilized the OHDSI common data model (CDM) for data standardization.
  • Designed, developed, and evaluated a UDI vocabulary as a pilot study.

Main Results:

  • Developed a UDI vocabulary to address data islands.
  • Enabled better standardization for medical device evaluation.
  • Demonstrated a framework for a UDI research database.

Conclusions:

  • The proposed UDI interoperability solution enhances medical device evaluation.
  • The OHDSI CDM framework supports the creation of a UDI research database.
  • A standardized UDI vocabulary is essential for overcoming data challenges in device evaluation.