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.INDEX TERMS FMECA, medical equipment, clinical engineering, risk management, risk assessment.
The Failure Mode, Effects, and Criticality Analysis (FMECA) is one of the risk analysis techniques proposed by the ISO 14971 Standard. This analysis allows to identify and assess the consequences of faults that affect each component of a complex system. The FMECA is a forward-type technique used for highlighting critical points and classifying them by priority. It also makes it possible to evaluate the extent of failures by means of numerical indices. It can be applied to a product or to a work process. In the latter case we talk about Process-FMECA. The application of the Process-FMECA to bioengineering is of particular interest because this procedure provides an analysis related to risk management during all the different phases of the medical device life cycle. However, practical applications of this method have revealed some shortcomings that can lead to inaccuracies and inconsistencies regarding the risk analysis and consequent risk prioritization. This paper presents an example of application of a Fuzzy Process-FMECA, an improved Process-FMECA based on fuzzy logic, to a small computerized tomography (CT) device prototype designed for studying the extremities of the human body. This prototype is a CT device that uses the Cone Beam CT (CBCT) technology. The Fuzzy Process-FMECA analysis has made it possible to produce a table of risks, that are quantified according to the specifications of the method. The analysis has shown that each phase or activity is fundamental to guarantee a correct functioning of the device. The methodology applied to this specific device can be paradigmatic for analyzing the process risks for any other medical device.
Regulations are binding acts which are obligatory in the European Union. All members of the European Union must apply Regulations. On the other hand, there are Directives, legislative acts which represent the base setting the goal which has to be achieved by EU countries for a specific area. Each EU country has individual national laws in order to achieve that goal. Directives which regulate harmonized products in the EU are known as New Approach Directives. One of the Directives which belong to the group of the New Approach is Directive 93/42/EEC on medical devices. The integral part of a Directive is Harmonised Standard which serves Manufacturers, other economic operators, or conformity assessment bodies to demonstrate that products, services, or processes comply with relevant EU legislation. Conformity assessment is a process that is performed by the manufacturer in order to demonstrate if all specific requirements related to the product have been met. Conformity assessment is provided by a competent body (notified bodies) and differs for different classification of medical devices. There are different approaches in conformity assessment of medical devices in the EU and USA which are described in this chapter. Many European countries have recognised the importance of metrology and its influence in providing services which will ensure accurate and precise measurements of medical devices that have a measurement function.
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