Medical device interoperability a standards-based testing approach

Abstract We present a black-box messaging test approach employed to achieve a level of rigor which improves-if not assures, given no optionality-correct data exchange. In particular, we verify that physiological information derived and communicated via messaging from a source medical device (e.g., an infusion pump) or healthcare information system, to another medical device (e.g., a patient monitor) or healthcare information system, which consumes or makes use of the data, is syntactically and semantically correct. In other words, the structure of information exchanged within the healthcare system is compliant to a defined specification(s) and the information meaning conveyed and interpreted by the consumer is exactly the same and as intended by the source. Our approach for developing a test system to validate messages is based on constraining identified and recognized specifications. The test system validation performed uses codified assertions derived from the specifications and constraints placed upon those specifications. To first show conformance-which subsequently enables interoperability-these assertions, which are atomic requirements traceable by clause to the base specifications, are employed by our medical device test tools to rigorously enforce standards to facilitate safe and effective plug-and-play information exchange.