Augmenting Medical Device Evaluation Using a Reusable Unique Device Identifier Interoperability Solution Based on the OHDSI Common Data Model.

The objective of the study is to augment safety and effectiveness evaluation of medical devices through building a reusable unique device identifier (UDI) interoperability solution. We propose a framework for building a UDI research database for medical device evaluation using the OHDSI common data model (CDM). As a pilot study, we design, develop and evaluate a UDI vocabulary, which would enable tackling challenges of data islands and standardization for medical device evaluation.