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Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products

Authors :
Virginia Cazzagon
Leagh G. Powell
Adriele Prina-Mello
Vicki Stone
Hans Bouwmeester
Bernd Nowack
T A Wilkins
Alex Zabeo
Antonio Marcomini
Jacques Bouillard
Elena Semenzin
Lisa Pizzol
Carlos Fito
Anna Luisa Costa
Bengt Fadeel
Alexis Vignes
Lang Tran
Teresa F. Fernandes
Elisa Giubilato
Danail Hristozov
Magda Blosi
Burkhard Stahlmecke
Janeck J. Scott-Fordsmand
Haralambos Sarimveis
Marina Hauser
Mónica J.B. Amorim
University of Ca’ Foscari [Venice, Italy]
Universidade de Aveiro
CNR Istituto di Scienza e Tecnologia dei Materiali Ceramici (CNR-ISTEC)
Consiglio Nazionale delle Ricerche [Roma] (CNR)
Institut National de l'Environnement Industriel et des Risques (INERIS)
Wageningen University and Research [Wageningen] (WUR)
Karolinska Institute
Heriot-Watt University [Edinburgh] (HWU)
Swiss Federal Laboratories for Materials Science and Technology [Dübendorf] (EMPA)
Trinity College Dublin
National Technical University of Athens [Athens] (NTUA)
Aarhus University [Aarhus]
University of Leeds
Source :
Giubilato, E, Cazzagon, V, Amorim, M J B, Blosi, M, Bouillard, J, Bouwmeester, H, Costa, A L, Fadeel, B, Fernandes, T F, Fito, C, Hauser, M, Marcomini, A, Nowack, B, Pizzol, L, Powell, L, Prina-Mello, A, Sarimveis, H, Scott-Fordsmand, J J, Semenzin, E, Stahlmecke, B, Stone, V, Vignes, A, Wilkins, T, Zabeo, A, Tran, L & Hristozov, D 2020, ' Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products ', Materials, vol. 13, no. 20, 4532 . https://doi.org/10.3390/ma13204532, Materials (Basel) 13 (2020): 1–29. doi:10.3390/ma13204532, info:cnr-pdr/source/autori:Giubilato, Elisa; Cazzagon, Virginia; Amorim, Mónica J.B.; Blosi, Magda; Bouillard, Jacques; Bouwmeester, Hans; Costa, Anna Luisa; Fadeel, Bengt; Fernandes, Teresa F.; Fito, Carlos; Hauser, Marina; Marcomini, Antonio; Nowack, Bernd; Pizzol, Lisa; Powell, Leagh; Prina-Mello, Adriele; Sarimveis, Haralambos; Scott-Fordsmand, Janeck James; Semenzin, Elena; Stahlmecke, Burkhard; Stone, Vicki; Vignes, Alexis; Wilkins, Terry; Zabeo, Alex; Tran, Lang; Hristozov, Danail/titolo:Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products/doi:10.3390%2Fma13204532/rivista:Materials (Basel)/anno:2020/pagina_da:1/pagina_a:29/intervallo_pagine:1–29/volume:13, Materials, Volume 13, Issue 20, Materials 13 (2020) 20, Materials, Vol 13, Iss 4532, p 4532 (2020), Materials, MDPI, 2020, 13 (20), pp.4532. ⟨10.3390/ma13204532⟩, Materials, 13(20)
Publication Year :
2020

Abstract

International audience; The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

Details

Language :
English
ISSN :
25248138 and 19961944
Database :
OpenAIRE
Journal :
Giubilato, E, Cazzagon, V, Amorim, M J B, Blosi, M, Bouillard, J, Bouwmeester, H, Costa, A L, Fadeel, B, Fernandes, T F, Fito, C, Hauser, M, Marcomini, A, Nowack, B, Pizzol, L, Powell, L, Prina-Mello, A, Sarimveis, H, Scott-Fordsmand, J J, Semenzin, E, Stahlmecke, B, Stone, V, Vignes, A, Wilkins, T, Zabeo, A, Tran, L & Hristozov, D 2020, ' Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products ', Materials, vol. 13, no. 20, 4532 . https://doi.org/10.3390/ma13204532, Materials (Basel) 13 (2020): 1–29. doi:10.3390/ma13204532, info:cnr-pdr/source/autori:Giubilato, Elisa; Cazzagon, Virginia; Amorim, Mónica J.B.; Blosi, Magda; Bouillard, Jacques; Bouwmeester, Hans; Costa, Anna Luisa; Fadeel, Bengt; Fernandes, Teresa F.; Fito, Carlos; Hauser, Marina; Marcomini, Antonio; Nowack, Bernd; Pizzol, Lisa; Powell, Leagh; Prina-Mello, Adriele; Sarimveis, Haralambos; Scott-Fordsmand, Janeck James; Semenzin, Elena; Stahlmecke, Burkhard; Stone, Vicki; Vignes, Alexis; Wilkins, Terry; Zabeo, Alex; Tran, Lang; Hristozov, Danail/titolo:Risk management framework for nano-biomaterials used in medical devices and advanced therapy medicinal products/doi:10.3390%2Fma13204532/rivista:Materials (Basel)/anno:2020/pagina_da:1/pagina_a:29/intervallo_pagine:1–29/volume:13, Materials, Volume 13, Issue 20, Materials 13 (2020) 20, Materials, Vol 13, Iss 4532, p 4532 (2020), Materials, MDPI, 2020, 13 (20), pp.4532. ⟨10.3390/ma13204532⟩, Materials, 13(20)
Accession number :
edsair.doi.dedup.....e4854c9a5974deaabd2844547b79f3b2
Full Text :
https://doi.org/10.3390/ma13204532