Abstract
In recent years, there has been an emerging interest in the use of claims and electronic health record (EHR) data for evaluation of medical device safety and effectiveness. In Korea, national insurance electronic data interchange (EDI) code has been used as a medical device data source for common data model (CDM). This study performed a preliminary feasibility assessment of CDM-based vigilance. A cross-sectional study of target medical device data in EHR and CDM was conducted. A total of 155 medical devices were finally enrolled, with 58.7% of them having EDI codes. Femoral head prosthesis was selected as a focus group. It was registered in our institute with 11 EDI codes. However, only three EDI codes were converted to systematized nomenclature of medicine clinical terms concept. EDI code was matched in one-to-many (up to 104) with unique device identifier (UDI), including devices classified as different global medical device nomenclature. The use of UDI rather than EDI code as a medical device data source is recommended. We hope that this study will share the current state of medical device data recorded in the EHR and contribute to the introduction of CDM-based medical device vigilance by selecting appropriate medical device data sources.
Highlights
In recent years, there has been an emerging interest in the use of claims and electronic health record (EHR) data for evaluation of medical device safety and effectiveness
Pharmacovigilance uses common data model (CDM) to analyze adverse events associated with the use of a drug while medical device vigilance analyzes adverse events associated with the use of a medical device
According to the user manual provided by FEEDER-NET15, institutional unique prescription codes were used as medical device data sources and converted into electronic data interchange (EDI) codes used by national insurance claims in Korea
Summary
There has been an emerging interest in the use of claims and electronic health record (EHR) data for evaluation of medical device safety and effectiveness. We hope that this study will share the current state of medical device data recorded in the EHR and contribute to the introduction of CDM-based medical device vigilance by selecting appropriate medical device data sources. Passive surveillance is limited by the voluntary nature of reporting, the strong inherent bias associated with spontaneous reports, underreporting, and the lack of denominator data on comprehensive exposure[4,5,6,7] To overcome these limitations, an active surveillance system via common data model (CDM) could be helpful. Attempts have been made to implement MDV active surveillance through a webbased platform for sharing the experiences on medical device incidents[11] and through a multicenter, prospective, observational research s tudy[12] Both studies used a centralized method with patient data entered into the database as a common language agreed between network organizations. This study was conducted to identify the current situation and derive improvements, assuming that medical device information deficiencies in EHR or CDM could become a hurdle for CDM-based MDVs
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