Pre-clinical validation and risk management of autonomous tumor prosthesis using FMEA approach

Abstract

Since prostheses are biomedical devices implanted directly on the patient's body, they carry a higher risk compared to other engineering products. In the development process, it is a critical issue to identify potential errors and malfunctions that may arise during the clinical use of prostheses and to take precautions against them. Autonomous tumor prostheses have a higher risk than any other prosthesis due to its extension capacity of approximately 100 mm, having a large battery in its structure and performing non-clinical extension without physician control. In this study, the risk analysis of the autonomous tumor prosthesis previously developed by the authors was performed using the failure mode and effects analysis (FMEA) method. In order to determine potential failure risks, a literature review was performed on clinical errors of tumor prostheses. In addition, malfunctions caused by each component of the prosthesis have been identified. Risk Priority Number (RPN) values are calculated for each risk determined. The design of the prosthesis was changed by taking the necessary precautions for the risks with high RPN values.  After taking the necessary precautions, the RPN values of the risks that the prosthesis still carries have been recalculated and discussed. As a result of the measures taken, the RPN values of all risks were reduced to below the threshold value that was generally accepted.