Formal verification of software-based medical devices considering medical guidelines.

OBJECTIVE: Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices. MATERIALS AND METHODS: Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented. RESULTS: A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL. CONCLUSIONS: The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one UML diagram. Additionally, the system design can be formally verified automatically.

Validation of a new non-invasive blood pressure measurement method on mice via pulse wave propagation time measurement on a cuff.

In the present article, we describe the validation of a new non-invasive method for measuring blood pressure (BP) which also enables to determine the three BP values: systolic, diastolic and mean value. Our method is based on the pulse transit time (PTT) measurement along an artery directly at the BP cuff. The accuracy of this method was evaluated by comparison with the direct simultaneous measurement of blood pressure from 40 anesthetized female mice. Close correlation between the gained data from these two methods was observed.