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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.
Elisa Giubilato; Virginia Cazzagon; Mónica J. B. Amorim; Magda Blosi; Jacques Bouillard; Hans Bouwmeester; Anna Luisa Costa; Bengt Fadeel; Teresa F. Fernandes; Carlos Fito; Marina Hauser; Antonio Marcomini; Bernd Nowack; Lisa Pizzol; Leagh Powell; Adriele Prina-Mello; Haralambos Sarimveis; Janeck James Scott-Fordsmand; Elena Semenzin; Burkhard Stahlmecke; Vicki Stone; Alexis Vignes; Terry Wilkins; Alex Zabeo; Lang Tran; Danail Hristozov. Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products. Materials 2020, 13, 4532 .
AMA StyleElisa Giubilato, Virginia Cazzagon, Mónica J. B. Amorim, Magda Blosi, Jacques Bouillard, Hans Bouwmeester, Anna Luisa Costa, Bengt Fadeel, Teresa F. Fernandes, Carlos Fito, Marina Hauser, Antonio Marcomini, Bernd Nowack, Lisa Pizzol, Leagh Powell, Adriele Prina-Mello, Haralambos Sarimveis, Janeck James Scott-Fordsmand, Elena Semenzin, Burkhard Stahlmecke, Vicki Stone, Alexis Vignes, Terry Wilkins, Alex Zabeo, Lang Tran, Danail Hristozov. Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products. Materials. 2020; 13 (20):4532.
Chicago/Turabian StyleElisa Giubilato; Virginia Cazzagon; Mónica J. B. Amorim; Magda Blosi; Jacques Bouillard; Hans Bouwmeester; Anna Luisa Costa; Bengt Fadeel; Teresa F. Fernandes; Carlos Fito; Marina Hauser; Antonio Marcomini; Bernd Nowack; Lisa Pizzol; Leagh Powell; Adriele Prina-Mello; Haralambos Sarimveis; Janeck James Scott-Fordsmand; Elena Semenzin; Burkhard Stahlmecke; Vicki Stone; Alexis Vignes; Terry Wilkins; Alex Zabeo; Lang Tran; Danail Hristozov. 2020. "Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products." Materials 13, no. 20: 4532.
Nanotechnologies have been increasingly used in industrial applications and consumer products across several sectors, including construction, transportation, energy, and healthcare. The widespread application of these technologies has raised concerns regarding their environmental, health, societal, and economic impacts. This has led to the investment of enormous resources in Europe and beyond into the development of tools to facilitate the risk assessment and management of nanomaterials, and to inform more robust risk governance process. In this context, several risk governance frameworks have been developed. In our study, we present and review those, and identify a set of criteria and tools for risk evaluation, mitigation, and communication, the implementation of which can inform better risk management decision-making by various stakeholders from e.g., industry, regulators, and the civil society. Based on our analysis, we recommend specific methods from decision science and information technologies that can improve the existing risk governance tools so that they can communicate, evaluate, and mitigate risks more transparently, taking stakeholder perspectives and expert opinion into account, and considering all relevant criteria in establishing the risk-benefit balance of these emerging technologies to enable more robust decisions about the governance of their risks.
Panagiotis Isigonis; Danail Hristozov; Christina Benighaus; Elisa Giubilato; Khara Grieger; Lisa Pizzol; Elena Semenzin; Igor Linkov; Alex Zabeo; Antonio Marcomini. Risk Governance of Nanomaterials: Review of Criteria and Tools for Risk Communication, Evaluation, and Mitigation. Nanomaterials 2019, 9, 696 .
AMA StylePanagiotis Isigonis, Danail Hristozov, Christina Benighaus, Elisa Giubilato, Khara Grieger, Lisa Pizzol, Elena Semenzin, Igor Linkov, Alex Zabeo, Antonio Marcomini. Risk Governance of Nanomaterials: Review of Criteria and Tools for Risk Communication, Evaluation, and Mitigation. Nanomaterials. 2019; 9 (5):696.
Chicago/Turabian StylePanagiotis Isigonis; Danail Hristozov; Christina Benighaus; Elisa Giubilato; Khara Grieger; Lisa Pizzol; Elena Semenzin; Igor Linkov; Alex Zabeo; Antonio Marcomini. 2019. "Risk Governance of Nanomaterials: Review of Criteria and Tools for Risk Communication, Evaluation, and Mitigation." Nanomaterials 9, no. 5: 696.