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
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.
Materials (Basel). 2020 Oct 13;13(20):4532. doi: 10.3390/ma13204532.
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.
纳米技术与生物技术的融合推动了用于医疗设备（MD）和先进治疗药品（ATMP）的纳米生物材料（NBM）取得了重大进展。然而，人们担心，由于目前对NBM安全性的了解尚不完整，将其应用于医学诊断、治疗和再生医学可能也会带来健康和/或环境风险。因此，需要一种科学策略来评估这些产品生命周期中出现的所有风险。为满足这一需求，本文提出了一个用于MD和ATMP中使用的NBM的总体风险管理框架（RMF），这是欧盟项目BIORIMA内的一个专家团队与外部利益相关者的相关投入共同努力的结果。该框架符合当前的监管要求，是根据纳米材料和生物材料风险评估与管理的最新方法设计的。NBM安全性评估数据的收集/生成基于创新的综合测试与评估方法（IATA）。该框架可以支持利益相关者（如制造商、监管机构、顾问）系统地评估MD和ATMP生命周期中的患者安全，以及职业（包括医护人员）和环境风险。该框架的输出使用户能够识别合适的设计更安全替代方案和/或风险管理措施，并根据疗效、质量和成本标准比较NBM的风险与其（临床）益处，以便为稳健的风险管理决策提供依据。
