Medical device (MD) nomenclatures are essential for market surveillance and vigilance activities. Currently, more than 25 arthroplasty Registries are established in Europe, each of them based on a different MD nomenclature. A common and shared nomenclature of orthopaedic implants is important to analyse implant performance across different national databases referring to a unique definition of its characteristics. Aim of this study is to describe an approach to compare and harmonise two different nomenclatures: a first step towards the organization of an international nomenclature of medical devices.
Harmonisation of medical devices classification systems: development of a generalised approach starting from hip prostheses. A first example of an international and standardised nomenclature to be integrated within the European Medical Device Nomenclature / Franzo', Michela; Carrani, Eugenio; Asaro, Mauro; Caton, Edward; Tucker, Keith; Armstrong, Richard; Young, Elaine; Sampaolo, Letizia; Bini, Fabiano; Marinozzi, Franco; Torre, Marina. - 7:(2020). (Intervento presentato al convegno VII National congress of bioengineering tenutosi a Trieste; Italy).
Harmonisation of medical devices classification systems: development of a generalised approach starting from hip prostheses. A first example of an international and standardised nomenclature to be integrated within the European Medical Device Nomenclature
Michela Franzo'Primo
;Fabiano Bini;Franco Marinozzi;
2020
Abstract
Medical device (MD) nomenclatures are essential for market surveillance and vigilance activities. Currently, more than 25 arthroplasty Registries are established in Europe, each of them based on a different MD nomenclature. A common and shared nomenclature of orthopaedic implants is important to analyse implant performance across different national databases referring to a unique definition of its characteristics. Aim of this study is to describe an approach to compare and harmonise two different nomenclatures: a first step towards the organization of an international nomenclature of medical devices.File | Dimensione | Formato | |
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