FMECA Design Analysis: Risk Management for the Manufacture of a CBCT Scanner

Abstract

The identification and classification of the risks associated with the use of electromedical equipment is a critical part of its design, requiring the application of precise methods to analyse such risks. The result of this analysis leads to the preparation of documents assessing all possible risks associated with the manufacture of electromedical devices, from design to production and final use, including installation and maintenance activities, and after-sales surveillance. This process translates into a guarantee of device reliability. The more that is done to make the device design safe, the greater its reliability will be and the lower the frequency of failures. Failure Mode, Effects, and Criticality Analysis (FMECA) is one of the many risk analysis techniques proposed by the ISO 14971 standard. This method makes it possible to identify and evaluate the consequences of the failure of each component in a complex system and to quantify the extent of each failure using numerical indices. This paper describes the application of this methodology to a small Computer Tomography (CT) prototype device designed to investigate the extremities of the human body. This prototype uses Cone Beam CT (CBCT) technology, employing a divergent, cone shaped X-ray beam rather than the classic fan-shaped beam. A special bed is used in conjunction with the CT scanner to support the patient. This bed is not merely an added accessory but is part of a complex system.

Keywords

• FMECA
• medical equipment
• clinical engineering
• risk management
• risk assessment