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Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products

Department of Environmental Sciences, Informatics and Statistics, University Ca’ Foscari of Venice, Via Torino 155, 30172 Venice, Italy
Department of Biology and CESAM, University of Aveiro, 3810-193 Aveiro, Portugal
Institute of Science and Technology for Ceramics, National Research Council of Italy (CNR-ISTEC), Via Granarolo 64, 48018 Faenza, Italy
Institut National de l’Environnement industriel et des Risques, Parc Technologique ALATA, 60550 Verneuil-en-Halatte, France
Division of Toxicology, Wageningen University, 6708 WE Wageningen, The Netherlands
Division of Molecular Toxicology, Institute of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden
Institute of Life and Earth Sciences, School of Energy, Geoscience, Infrastructure and Society, Heriot-Watt University, Edinburgh EH14 4AS, UK
Instituto Tecnologico del Embalaje, Transporte y Logistica, 46980 Paterna-Valencia, Spain
Empa, Swiss Federal Laboratories for Materials Science and Technology, Lerchenfeldstrasse 5, 9014 St. Gallen, Switzerland
GreenDecision Srl, Via delle Industrie, 21/8, 30175 Venice, Italy
Institute of Biological Chemistry, Biophysics and Bioengineering, School of Engineering and Physical Sciences, Heriot-Watt University, Edinburgh EH14 4AS, UK
Trinity Translational Medicine Institute, Trinity College, The University of Dublin, Dublin 8, Ireland
School of Chemical Engineering, National Technical University of Athens, 15780 Athens, Greece
Department of Bioscience, Aarhus University, 8600 Silkeborg, Denmark
Institut für Energie und Umwelttechnik e.V., 47229 Duisburg, Germany
Nanomanufacturing Institute, School of Chemical and Process Engineering, University of Leeds, Leeds LS2 9JT, UK
Institute of Occupational Medicine, Research Avenue North, Riccarton, Edinburgh EH14 4AP, UK
Author to whom correspondence should be addressed.
Materials 2020, 13(20), 4532;
Received: 21 August 2020 / Revised: 25 September 2020 / Accepted: 27 September 2020 / Published: 13 October 2020
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. View Full-Text
Keywords: risk management; nano-biomaterials; nanomedicine; medical device; life cycle; safe-by-design risk management; nano-biomaterials; nanomedicine; medical device; life cycle; safe-by-design
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MDPI and ACS Style

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. Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products. Materials 2020, 13, 4532.

AMA Style

Giubilato E, Cazzagon V, Amorim MJB, Blosi M, Bouillard J, Bouwmeester H, Costa AL, Fadeel B, Fernandes TF, Fito C, Hauser M, Marcomini A, Nowack B, Pizzol L, Powell L, Prina-Mello A, Sarimveis H, Scott-Fordsmand JJ, Semenzin E, Stahlmecke B, Stone V, Vignes A, Wilkins T, Zabeo A, Tran L, Hristozov D. Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products. Materials. 2020; 13(20):4532.

Chicago/Turabian Style

Giubilato, Elisa, Virginia Cazzagon, Mónica J.B. Amorim, Magda Blosi, Jacques Bouillard, Hans Bouwmeester, Anna L. Costa, Bengt Fadeel, Teresa F. Fernandes, Carlos Fito, Marina Hauser, Antonio Marcomini, Bernd Nowack, Lisa Pizzol, Leagh Powell, Adriele Prina-Mello, Haralambos Sarimveis, Janeck J. Scott-Fordsmand, Elena Semenzin, Burkhard Stahlmecke, Vicki Stone, Alexis Vignes, Terry Wilkins, Alex Zabeo, Lang Tran, and Danail Hristozov. 2020. "Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products" Materials 13, no. 20: 4532.

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