Ganzheitliche Risiko- und Nachhaltigkeitsbewertung von Nanotechnologie für medizinische Anwendungen

Sustainable industrial production is one of seventeen goals of the United Nations for a sustainable development. According to this goal, optimization of product- and processes can bring improvements i.e. in the reduction of environmental emissions or resource consumption. In this context, nanotechnology has been defined as one of six key enabling technologies. However, many new nanotechnology-based products raised the public question of possible risks for humans and the environment. Several concepts and methods for risk- and sustainability assessment are discussed, whereas only a few case studies in the use of the concepts are known. Therefore, the present work focused on the application of the concept according to DIN CEN / TS 16937 in a case study on thirteen iron oxide nanoparticles as potential contrast agents in magnetic resonance imaging (MRI). The presented holistic evaluation approach was constructed in two stages, which first examined the suitability and possible risks of using the nanoparticles as a contrast agent, e.g. in the magnetic properties for MRI or hemocompatibility. In an interim summary of the results, it was possible to limit the number of nanoparticles, which reduced the evaluation effort in the followed sustainability assessment. Throughout the product life cycle, the potential environmental impacts were identified. Also, potential benefits in the resource availability of iron for nanoparticle synthesis over gadolinium as a critical resource for gadolinium chelate complexes as conventional contrast agents were analyzed. In a multi-criteria analysis, the different obtained results on the nanoparticles were summarized for decision-making of the most suitable formulations. Overall, the developed evaluation approach provides a basis to integrate sustainability aspects besides risks in preclinical development of new medical products.