SIMONA PASCUCCI

Dottoressa di ricerca

ciclo: XXXVI



Titolo della tesi: Taxonomies of medical devices as a tool to support their monitoring and traceability in the Italian and international context: design and application to the Italian Implantable Prostheses Registry

In 2012, the European Commission highly encouraged a revision of medical device (MD) legislation in order not only to reinforce the post-market surveillance, but also to increase the vigilance, the functioning of notified bodies and the support to development useful tools, such as nomenclatures and registries, that might ensure patient safety, traceability and post-market surveillance of MDs. Thus, to ensure this action, the European Regulation 2017/745 (MDR) on medical devices was defined. The MDR stated the implementation of a European central MD database named EUDAMED to collect data on all MDs marketed in Europe in order to enhance transparency and better access to information for healthcare professionals. Following the MDR provisions, the adoption of an internationally recognised and free available MD nomenclature, the European Medical Device Nomenclature (EMDN), was required. On 4th March 2019, the EU Commission adopted the Italian National Classification of Medical Devices (CND) as a model. The CND nomenclature was introduced in Italy in 2007 by the Ministry of Health. MDs nomenclatures are also necessary to develop other systems having the need to classify MDs such as MDs registries. Article 108 of the MDR asks Member States to take measures to establish registries and databanks for specific types of medical devices to collect their information necessary for the evaluation of performance, traceability and long-term safety. To effectively monitor MDs, a registry should refer to a MD library, a database including all implantable devices collected by the registry and based on a MD taxonomy, classification or nomenclature. Each MD registered in the library is defined by a specific set of technical attributes. In Italy, the National Implantable Prostheses Registry (Registro nazionale delle protesi impiantabili, RIPI) was established to assess the effectiveness and safety of MDs belonging to the highest risk class. The aim of this Thesis is to describe the methodology used to design a taxonomy complementary to the existing nomenclature, as a tool to support monitoring and traceability of the devices included in RIPI (joint prostheses, spinal implants, cardiac implantable electronic devices, and hearing implantable devices).

Produzione scientifica

11573/1678020 - 2023 - Hybrid system mixed reality and marker-less motion tracking for sports rehabilitation of martial arts athletes
Franzo, M; Pica, A; Pascucci, S; Marinozzi, F; Bini, F - 01a Articolo in rivista
rivista: APPLIED SCIENCES (Basel: MDPI AG, 2011-) pp. - - issn: 2076-3417 - wos: WOS:000938185800001 (8) - scopus: 2-s2.0-85149342785 (11)

11573/1678022 - 2023 - A proof of concept combined using mixed reality for personalized neurorehabilitation of cerebellar ataxic patients
Franzò, Michela; Pica, Andrada; Pascucci, Simona; Serrao, Mariano; Marinozzi, Franco; Bini, Fabiano - 01a Articolo in rivista
rivista: SENSORS (Basel : Molecular Diversity Preservation International (MDPI), 2001-) pp. - - issn: 1424-8220 - wos: WOS:000930308100001 (3) - scopus: 2-s2.0-85147848348 (8)

11573/1678202 - 2023 - Augmented virtual reality in vestibular assessment: a dynamic gait application
Margani, Valerio; Pascucci, Simona; Talamonti, Rita; Serani, Emilio; Bini, Fabiano; Marinozzi, Franco; Volpini, Luigi; Elfarargy, Haitham H.; Covelli, Edoardo; Barbara, Maurizio - 01a Articolo in rivista
rivista: AUDIOLOGY & NEURO-OTOLOGY (Basel Switzerland: S Karger AG) pp. - - issn: 1420-3030 - wos: WOS:000972842600001 (1) - scopus: 2-s2.0-85160268299 (1)

11573/1695599 - 2023 - Key points to design the MDs Library of a National implant Registry: lesson learned from the Italian experience
Pascucci, S.; Franzo, M.; Mari, V.; Biondi, A.; Ceccarelli, S.; Bini, F.; Marinozzi, F.; Ciminello, E.; Ciccarelli, P.; Laricchiuta, P.; Carrani, E.; Torre, M. - 04b Atto di convegno in volume
congresso: 8th National Congress of Bioengineering, GNB 2023 (Padova)
libro: Convegno Nazionale di Bioingegneria - ()

11573/1715633 - 2023 - National spine surgery registries’ characteristics and aims. Globally accepted standards have yet to be met. Results of a scoping review and a complementary survey
Pascucci, S.; Langella, F.; Franzo', M.; Tesse, M. G.; Ciminello, E.; Biondi, A.; Carrani, E.; Sampaolo, L.; Zanoli, G.; Berjano, P.; Torre, M. - 01a Articolo in rivista
rivista: JOURNAL OF ORTHOPAEDICS AND TRAUMATOLOGY (Editore Springer-Verlag Italia Luogo pubbl. Milano) pp. - - issn: 1590-9921 - wos: WOS:001067804500002 (1) - scopus: 2-s2.0-85171399503 (2)

11573/1695600 - 2023 - Assessment of balance disorder and vestibular dysfunction using mixed reality
Pascucci, S.; Margani, V.; Franzo, M.; Curcio, M.; Polsinelli, A.; Talamonti, R.; Barbara, M.; Marinozzi, F.; Bini, F. - 04b Atto di convegno in volume
congresso: 8th National Congress of Bioengineering, GNB 2023 (Padova)
libro: Convegno Nazionale di Bioingegneria - (9788855580113)

11573/1659638 - 2022 - Exergaming in mixed reality for the rehabilitation of ataxic patients
Franzo', M; Pascucci, S; Serrao, M; Marinozzi, F; Bini, F - 04b Atto di convegno in volume
congresso: 17th IEEE international symposium on medical measurements and applications, MeMeA 2022 (Messina, italy)
libro: 2022 IEEE international symposium on medical measurements and applications, MeMeA 2022 - Conference Proceedings - (978-1-6654-8299-8)

11573/1655557 - 2022 - Inside the Michelangelo effect: The role of art and aesthetic attractiveness on perceived fatigue and hand kinematics in virtual painting
Iosa, Marco; Bini, Fabiano; Marinozzi, Franco; Antonucci, Gabriella; Pascucci, Simona; Baghini, Giulia; Guarino, Valeria; Paolucci, Stefano; Morone, Giovanni; Tieri, Gaetano - 01a Articolo in rivista
rivista: PSYCH JOURNAL ([Oxford?] : Wiley Publishing Asia Pty Ltd ; [Beijing] : Institute of Psychology, Chinese Academy of Sciences) pp. 748-754 - issn: 2046-0260 - wos: WOS:000860465000001 (2) - scopus: 2-s2.0-85138680377 (5)

11573/1623576 - 2021 - CAPITOLO 1 – RIAP, aggiornamento e attività 2020
Franzo', Michela; Bacocco, Duilio Luca; Biondi, Alessia; Galati, Fabio; Carrani, Eugenio; Pascucci, Simona; Ceccarelli, Stefania; Ciminello, Enrico; Torre, Marina - 02a Capitolo o Articolo
libro: Registro Italiano ArtroProtesi. Report annuale 2020 - (978-88-490-0714-5)

11573/1556585 - 2021 - Kinect-based wearable prototype system for ataxic patients neurorehabilitation. Software update for exergaming and rehabilitation
Franzo', Michela; Pascucci, Simona; Serrao, Mariano; Marinozzi, Franco; Bini, Fabiano - 04b Atto di convegno in volume
congresso: 16th IEEE International Symposium on Medical Measurements and Applications, MeMeA 2021 (Neuchatel; Switzerland)
libro: IEEE Medical Measurements and Applications, MeMeA 2021 - Conference Proceedings - (978-1-6654-1914-7)

11573/1619126 - 2021 - Il Registro Italiano delle Protesi Impiantabili: una nuova realtà per la sicurezza del paziente
Torre, M; Carrani, E; Franzo', M; Ciminello, E; Urakcheeva, I; Bacocco, Dl; Valentini, R; Pascucci, S; Madi, S; Ferrara, C; Toccaceli, V; Sampaolo, L; Ceccarelli, S; Biondi, A; Laricchiuta, P. - 01a Articolo in rivista
rivista: BOLLETTINO EPIDEMIOLOGICO NAZIONALE (Roma: Istituto Superiore di Sanità) pp. 16-23 - issn: 2724-3559 - wos: (0) - scopus: (0)

11573/1623583 - 2021 - Analisi dei dati RIAP 2019
Torre, Marina; Franzo', Michela; Valentini, Riccardo; Bacocco, Duilio Luca; Pascucci, Simona; Lepore, Stefano; Boniforti, Filippo; Tornago, Stefano; Zanoli, Gustavo; Romanini, Emilio; Ciminello, Enrico; Cornacchia, Attanasio; Carrani, Eugenio - 02a Capitolo o Articolo
libro: Report annuale 2020 - (978-88-490-0714-5)

11573/1471079 - 2020 - Kinect-based wearable prototype system for ataxic patients neurorehabilitation: Control group preliminary results
Franzo', M.; Pascucci, S.; Serrao, M.; Marinozzi, F.; Bini, F. - 04b Atto di convegno in volume
congresso: 15th IEEE International Symposium on Medical Measurements and Applications, MeMeA 2020 (Bari; Italy)
libro: IEEE Medical Measurements and Applications, MeMeA 2020 - Conference Proceedings - (978-1-7281-5386-5)

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