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

摘要

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.