Dottorato in INGEGNERIA INDUSTRIALE E GESTIONALE

Titolo della tesi: Medical device nomenclatures as a basis to classify medical devices in registries: development of a methodology to compare different nomenclatures in order to interconnect registries and support the organisation of internationally shared databases

Nomenclatures of medical devices could have many purposes. The essential one is to support market surveillance and vigilance activities. Currently, considering only orthopaedics, more than 25 arthroplasty Registries are established in Europe and base their databases on different medical device (MD) nomenclatures. The Italian Arthroplasty Registry (RIAP), a project supported by Italian Ministry of Health since 2006, set up the RIAP-DM-Dictionary and classified devices using the Italian National Classification of Medical Devices (CND). CND is a free public available nomenclature developed and established by the Ministry of Health in 2007. Since 2007, the Italian Ministerial Database uses CND to support the activities related to MD governance, in order to register and homogeneously classify medical devices, considering both technical and economic points of view. The National Joint Registry (NJR) started its activities in 2003. Since then, it has progressively involved several United Kingdom regions and currently covers England, Wales, Northern Ireland, the Isle of Man and the States of Guernsey. In order to achieve a common international standard, in the last years, NJR started a collaboration with the German Registry EndoProthesenRegister (EPRD) to develop a specific common nomenclature. The NJR-EPRD nomenclature is currently used in the NJR-EPRD Component Library MD. Several Arthroplasty registries use as nomenclature of reference the Global Medical Device Nomenclature (GMDN). GMDN was first published in 2001 to provide, for the first time, an international tool to identify all medical devices in a meaningful and understandable manner. Its structure follows the requirements stated in the standard ISO 15225 Nomenclature – Medical device nomenclature data structure. In 2017, the European Regulation 745/2017 stated that a shared nomenclature of MDs should be adopted for the European Database of MD (EUDAMED) and recommended the establishment of national registries of MDs in EU States. A common and shared nomenclature is, in fact, a key tool to analyse device performance across different national databases because it allows to refer to a unique definition of the MD characteristics. Therefore, in 2019, CND was adopted by European Commission as official European Medical Device Nomenclature (EMDN) for the European Database of MD (EUDAMED). Considering the current European context, in which the importance of registries is recognised and a European unique and shared Database is established, a collaboration was started between NJR and RIAP to create a shared international database of the orthopaedic prostheses, widening to Italy the positive common experience of NJR and EPRD. This research was performed in the framework of this collaboration and, for joint prostheses, supported all the activities to update the extension of CND to the first version of EMDN. The aim of this study is to describe the results obtained by the comparison of CND with GMDN and NJR-EPRD nomenclature for joint prostheses and to propose a first scientific approach to compare and harmonise two different nomenclatures. The achieved results led to the identification of significant technical attributes useful to define and group MDs, further considered in the updating process of CND. Properties were selected on the basis of the following analyses performed on RIAP clinical and MD databases, on the Ministry national MD database and on a wide literature review: frequencies of implantation in Italy, high recurrence in RIAP-DM Dictionary and technical characteristics, criteria to be used to revise CND according to what stated on this topic by the MoH. The proposed approach represents the abstraction and generalisation of that applied to compare CND and NJR-EPRD nomenclatures for joint prosthesis and might be considered as a useful reference for further generalization of other MD categories. Thus, its application on other nomenclatures might contribute to making EMDN a single harmonised international nomenclature of medical devices, supporting a better and harmonised recording and reporting of medical devices outcomes from Registries of different countries.