Architectural specification for infusion pumps and realization towards safety technological trends

According to the Food and Drug Administration, infusion pumps are considered nowadays the most safety-critical medical device due to the nature of their operations and associated risks. The design of these devices is still an open question and several improvement initiatives are under research. However the released specifications of such systems are not yet adapted to the current state-of-art systems architectural developments. For example, in our regulatory research, we were not able to mention any project meeting the views and viewpoints patterns for specification and documentation of system and software architectures during the engineering process. This paper proposes a functional specification of an architecture for infusion pumps that can be realized through several technological trends for these products in order to improve safety. Therefore, we validate our specification by developing a prototype of an infusion pump that can be programmed through data retrieved from a webservice using a mobile application as a remote control and changing the infusion parameters according to accuracy properties as a multi-channel device. Thus, the main contribution of this paper can be presented as a distributed architecture for this sort of device, allowing early integration with Electronic Health Records and Patient Health Records for embedded systems domain implying in risk reductions during the programming activity.