Abstract
Background: Nationwide medical device registries have the potential to provide real world data for regulatory purposes. The objective of this article is to assess how to develop and manage Nationwide Registries Associated with Cardiovascular Medical Devices (NRACMD). Methods: A questionnaire comprising of 43 items was designed to clarify the quality, characteristics, utility and sustainability of existing NRACMD in Japan. It was then sent to various organizing bodies. Findings: Eight organizations responded to the questionnaire. Three NRACMD were device-specific registries in which the patient was registered when a device was used. The others were procedure-specific registries. Six registries covered more than 95% of target population and two covered 80-95%. Five registries were associated with specialty board certification systems or with physician qualification for using priority devices. No NRACMD was linked to medical re-imbursement. All NRACMD were used for academic purposes related to scientific papers. Two registries were currently in use for all case surveillance under the provision of the Japanese PMD-ACT. One registry provided a historical control group for a device in clinical trial for pre-market application. The analytical output was provided to participating institutions in all registries and to manufacturers in five registries. In terms of registry management sustainability, different funding sources including public funding, funding from institutions or from physicians and manufacturers were used for NRACMD. Accuracy of registered data was verified by institutional site visit and collation of extracted sample data. Interpretation: Japan currently has eight NRACMD are in operation. Although mainly used for academic purposes, there are several examples where data have been used for regulatory purposes and shared with the manufacturers. Cooperation between the academic sector, industry and regulatory bodies is essential for efficient use of NRACMD data.
Highlights
The accumulation of real world data associated with medical devices, or a “Medical Device Registry”, plays an important role in promoting the development of medical devices [1,2]
We focus on the eight existing Nationwide Registries Associated with Cardiovascular Medical Devices (NRACMD) in Japan and discuss their characteristics including data quality, data utilization and financial sustainability
Six NRACMDs cover more than 95% of the target population and two covered 80-95% (Table 2)
Summary
The accumulation of real world data associated with medical devices, or a “Medical Device Registry”, plays an important role in promoting the development of medical devices [1,2]. It is desirable to utilize registry data for pre-approval review as well as post-marketing safety measures. The registry may not include all data elements required for demonstrating the effectiveness and safety of medical devices. As such, it may not meet the regulatory requirements for pre-market review. It may not meet the regulatory requirements for pre-market review Despite these limitations, there are many national registries, such as orthopaedic total hip joint registries in multiple countries, that have successfully detected the increased revision rate of metal on metal hip implant [3,4]. Nationwide medical device registries have the potential to provide real world data for regulatory purposes. The objective of this article is to assess how to develop and manage Nationwide Registries Associated with Cardiovascular Medical Devices (NRACMD)
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