Proposta de uma sistemática de boas práticas para especificação e implementação de alarmes durante o desenvolvimento de dispositivos médicos com foco na usabilidade

Abstract

Intensive care units are highly complex environments, given the need for care and monitoring of critically ill patients. In order to ensure survival and quality of care, bedside monitoring by medical devices is crucial to provide essential life support measures. For the monitoring to be uninterrupted and signal the user/operator technical or clinical changes, there are alarms. However, what has been noticed in clinical practice and the literature is the considerable increase of these devices without clinical or technical necessity, which may lead the user/operator to be fatigued and lose perception of them. According to the literature, one of the reasons for this increase in the number of alarms is the difficulty of developers to meet the regulatory requirements of the alarm standard (IEC 60601-1-8) because this activity requires manufacturers to have much more than technical knowledge of the product given the complexity of information in the standard, the technical language, and the lack of detail on how to perform each requirement. In order to remedy this bias in the literature, this thesis sought to develop a systematic approach to assist in specifying and implementing alarms to be incorporated into the development process of medical devices, focusing on usability, aiming to minimize alarm fatigue, and maximizing the safety of users/operators and patients. Thirteen systematics were developed, which were based on the literature, the norm and the cases studied. To create and validate the developed material, exploratory multiple case studies were carried out with three companies that develop medical devices with alarms in order first to know the companies and identify their work processes in developing equipment and alarms, and later evaluate their perceptions about the constructed systems and comparing them with the organizations’ reality. Our findings enabled us to conclude that after the creation of the systematics and their evaluation by the companies, the materials created were positively evaluated and showed a potential use by the companies, serving as a visual and objective step-by-step for the development process of medical products with alarms. Lastly, it is worth mentioning that the material can also be used by laboratories that make conformity evaluations or certifiers to assist in certifying products more effectively and quickly, being a valid material to unify the understanding and compliance of the norm by companies and laboratories.