Implementing audio and visual alarms to an intensive care cerebral function monitor: A standards compliance case study

Abstract

Product certification can be the most complex and exhausting product development task. Compliance with technical standards must be taken into account during the whole development process, aiming the product approval by national quality and metrology laboratories and registering it on to the national healthcare authority. This article presents a case study concerning visual and audio alarms implementation for a cerebral function monitor (TiEEG) to be used in intensive care units, which must be in conformity to the Brazilian National Standards Organization version of International Electrotechnical Commission standards concerning multifunction monitors, electrocardiographic monitors and general alarm system standards. This case study is part of the process of obtaining National Institute of Metrology, Quality and Technology certification, demanded by the Brazilian Healthcare Surveillance Agency for product registration. In this context, a method to study and comply with the standards is introduced, as well as the issues on adopting them, and to the equipment interface with the alarm system. Furthermore, since it is a product aiming the health industry complex, aspects related to its commercialization in the local market such as usability and acceptance by the health professionals were also considered.