期刊名称：Advances in Science and Technology Research Journal
印刷版ISSN：2080-4075
电子版ISSN：2299-8624
出版年度：2022
卷号：16
期号：4
页码：189-200
DOI：10.12913/22998624/152735
语种：English
出版社：Society of Polish Mechanical Engineers and Technicians
摘要：Risk analysis of personalized medical devices, such as prostheses, is a challenging task due to the complexity of technological and geometrical issues. The paper undertakes a process of risk analysis for upper limb prostheses for adult patients, individualized by 3D scanning and produced by additive manufacturing. The analysis was performed to systematize the process and its steps, as well as diagnose certain problems, in order to achieve future devices with correct fit and function, produced in as few iterations as possible. The Failure Mode and Effect Analysis of Process (PFMEA) method was used. In the results, main process risks were identified: the problems are mostly caused in stages, where operator’s decision or activity is to be performed, regarding socket length, offset and suitable lining. The main prevention activities were determined – human involvement in the decision process should be minimal and the intelligent models should be adjustable to as many patient cases as possible. In consequence, future steps for process optimization were determined – larger base of patient cases is necessary to acquire and study, to gather data for model and process improvement.
