Risk Assessment of Individualized 3D Printed Prostheses Using Failure Mode and Effect Analysis

Abstract

Risk analysis of personalized medical devices, such as prostheses, is challenging 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 and diagnose specific problems 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. The results identified main process risks: the problems are primarily caused in stages, where the operator's decision or activity is to be performed, regarding socket length, offset, and suitable lining. The primary 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. Consequently, future steps for process optimization were determined -a more extensive base of patient cases is necessary to acquire and study, to gather data for model and process improvement.

Development and Testing of an Individualized Sensorised 3D Printed Upper Limb Bicycle Prosthesis for Adult Patients

“…more than 40 years of his lifetime. That suggests the high level of acceptance, confirmed by another ongoing studies on a larger group of child and adult patients (some results are partially mentioned in [21]). Results of these studies will be the topic of numerous future publications).…”

“…The prosthesis has been specifically tailored to meet the requirements of an adult patient engaged in rigorous and continuous cycling. The modular mechanical prosthesis was originally made for child patients (and successfully implemented, as described in [14] and [21], and shown in Figure 1). Building upon the foundational concept of the modular prosthesis model, essential modifications were implemented to customize it for adult use.…”

Experimental Evaluation of Extended Reality Technologies in the Development of Individualized Three-Dimensionally Printed Upper Limb Prostheses

“…1. The prosthesis model is prepared in a CAD system, using available archive anatomical data as gathered in some previous studies [28]. It is exported to an appropriate filetype for visualization in a 3D engine.…”

“…The initial concept of the modular prosthesis, which is a basis of all the applications, was made as part of the project "Automation of design and rapid production of individualized orthopedic and prosthetic products based on data from anthropometric measurements", serving the development of the prototype AutoMedPrint system [28,29], continuing previous long-term studies by the authors. The prosthesis design was created and iteratively improved in a number of studies [30], resulting in successful implementations for various patients, demonstratively shown in Figure 3 (not part of this study).…”

Influence of Antibacterial Coating and Mechanical and Chemical Treatment on the Surface Properties of PA12 Parts Manufactured with SLS and MJF Techniques in the Context of Medical Applications

“…Currently, 3D printing techniques are used in many fields, including in the aviation industry [ 5 , 6 , 7 ], automotive industry [ 8 , 9 ], and in medicine [ 10 , 11 , 12 ], e.g., in the process of reconstructing and manufacturing the geometry of anatomical structures [ 13 , 14 ], surgical templates [ 15 , 16 ] and implants [ 17 , 18 ]. They are also often used in manufacturing orthoses [ 19 , 20 , 21 ] and prostheses [ 22 , 23 ].…”