Especificação formal do gerenciamento de risco de equipamentos médicos baseado na ISO 14971:2009 utilizando Redes de Petri Coloridas

Abstract

The advance of medicine and Information Technology (IT) has allowed the emergence of new techniques and medical device to provide direct or indirect improvements to the people's health, such as the minimally invasive surgical techniques and new devices for diagnosis and patient monitoring (HOLSBACH; NETO; HOLSBACH, 2013). The use of such devices provides a better diagnosis procedure and better diseases treatment, shorter hospital stay, convenience and privacy, as well as the possibility of the patient to proceed with home treatment. However, the growth of the number of devices is not always based on quality. The poor quality of such device is a problem that may compromise people's health. Therefore, in order to mitigate the risks of failures during the development of these medical devices, the manufacturers must follow safety standards specifications, such as the International Organization for Standardization (ISO) 14971 (ABNT - ASSOCIAÇÃO BRASILEIRA DE NORMAS TÉCNICAS, 2009) and the technique Failure Mode, Effects and Criticality Analysis (FMECA). The ISO 14971 was specified to guide the controls and basic care to be observed by the manufacturer throughout the development of all stages during the medical device's life cycle. According to this standard, security is freedom from unacceptable risk, and the discovery and verification if the risk is unacceptable or not happen during the risk management process. However the ISO 14971 was described in natural language, which is an error-prone description, ambiguous and is susceptible to problems such as misunderstanding of the stages of the risk management process, creating too complex process which will be difficult to be applied or too simplistic that does not address all risk management. Within this context, we use the ISO 14971 standard with the FMECA technique to provide a case study that performs the security specification of the Electrogastrography (EGG) device. This case study was performed at the Federal University of Alagoas Hospital, with the support of an expert in the development of biomedical signal acquisition systems. This case study was the basis to develop a Colored Petri Net that describes the risk management process, reducing the problems on natural language descriptions. In addition, this model helps in the verification and the validation steps of medical devices manufacturing and allows the use of modeling as a tool for teaching and training the risk management process.