Feasibility of Life Cycle Assessment for Complex Medical Devices

Abstract: The interest in environmental issues is increasing and for this reason, assessing the potential environmental impacts of a product or system is of interest. A methodology developed for this particular purpose is the life cycle assessment, also known as LCA. It is not purely of interest these aspects are investigated though, as increasing requirements on organizations also matter. The purpose of this thesis was to investigate the feasibility to implement the methodology of LCA in the aspect of complex medical devices. To do this, the framework for the methodology has been reviewed and a case study performed. The case study comprised of conducting an LCA study on the radiosurgery device Leksell Gamma Knife® IconTM.  The outcome of the investigation showed that conducting an LCA study means a wide range of aspects need to be considered and specified to a high degree. A particular issue was the data requirements, as obtaining data meeting several objectives was challenging. The modeling was also identified as a difficulty. Tools such as software and databases with predefined processes were used, though as complex medical devices can use materials not common in other fields, a lack of appropriate predefined processes hinders the feasibility. The conducted case study was able to attain valuable insights even though the study did not comply with the standards providing the framework, the ISO 14040 series. To conduct a compliant LCA study for complex medical devices, extensive resources would be required as well as the involvement of relevant parties along the supply chain. It is seen improbable to achieve a compliant study the first time a particular type of complex medical device is investigated. However, it is believed the feasibility would increase as studies are repeated, as the data quality is likely to increase. Advancements of the tools, as well as ongoing research on the environmental impacts of more materials, are other factors thought to increase the feasibility of conducting LCA studies on complex medical devices in the future.