Demonstrating that Medical Devices Satisfy User Related Safety Requirements

One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.FEDER - Federación Española de Enfermedades Raras(000062)This work has been funded by the EPSRC research grant EP/G059063/1: CHI+MED (Computer–Human Interaction for Medical Devices). J. C. Campos was funded by project NORTE-07-0124-FEDER-00006

Liquid and vapour phase of lavandin (Lavandula × intermedia) essential oil: chemical composition and antimicrobial activity

Essential oils from Lavandula genus and the obtained hybrids are widely used for different purposes such as perfume production in the cosmetic field and for its biological properties. This is the first study on the liquid and vapour phase of Lavandula × intermedia “Grosso” essential oil grown in the Lazio Region, Italy, investigated using headspace coupled to gas chromatography and mass spectrometry (HS-GC/MS). The results showed the most abundant components were linalool and linalyl acetate, followed by 1,8-cineole and terpinen-4-ol, while lavandulyl acetate and borneol were identified as minor compounds, maintaining the same proportion in both the liquid and vapour phase. Furthermore, we tested lavandin liquid and vapour phase essential oil on gram-negative bacteria (Escherichia coli, Acinetobacter bohemicus, and Pseudomonas fluorescens) and gram-positive bacteria (Bacillus cereus and Kocuria marina)

Issues in number entry user interface styles: Recommendations for mitigation

Interacting with numbers is a core part of using many interactive computer systems from the remote controls of electronic media appliances to user interfaces of high-integrity systems such as medical devices. Number entry systems are widely used on mobile devices. A wide variety of different user interface designs exist for interacting with numbers. The intricacies of the different styles are not well understood by designers and developers, especially for handling use error. This paper reviews these issues and provides recommendations for mitigating them

The INGV tectonomagnetic network: 2004?2005 preliminary dataset analysis

International audienceIt is well established that earthquakes and volcanic eruption can produce small variations in the local geomagnetic field. The Italian Istituto Nazionale di Geofisica e Vulcanologia (INGV) tectonomagnetic network was installed in Central Italy since 1989 to investigate possible effects on the local geomagnetic field related to earthquakes occurrences. At the present time, total geomagnetic field intensity data are collected in four stations using proton precession magnetometers. We report the complete dataset for the period of years 2004?2005. The data of each station are differentiated respect to the data of the other stations in order to detect local field anomalies removing the contributions from the other sources, external and internal to the Earth. Unfortunately, no correlation between geomagnetic anomalies and the local seismic activity, recorded in Central Italy by the INGV Italian Seismic National Network, was found in this period. Some deceptive structures present in the differentiated data are pointed out

The MAL Interactors Animator: Supporting model validation through animation

The IVY workbench is a model checking based tool for the analysis of interactive system designs. Experience shows that there is a need to complement the analytic power of model checking with support for model validation and analysis of verification results. Animation of the model provides this support by allowing iterative exploration of its behaviour. This paper introduces a new model animation plugin for the IVY workbench. The plugin (AniMAL) complements the modelling and verification capabilities of IVY by providing users with the possibility to interact directly with the model.The authors wish to thank Michael D. Harrison for comments on an earlier version of this paper. Jose C. Campos acknowledges support from project NanoSTIMA (reference NORTE-01-0145-FEDER-000016) financed by the North Portugal Regional Operational Programme (NORTE 2020), under the PORTUGAL 2020 Partnership Agreement, and through the European Regional Development Fund (ERDF)

Templates as heuristics for proving properties of medical devices

This paper briefly describes how property templates have been used to analyse and explore the interactive behaviour of a specific medical device (an IV infusion pump). It is proposed that interactive devices that satisfy properties based on the templates are easier and safer to use. The property templates act as heuristics for the development of suitable properties tailored to the details of the particular device. A mathematically based approach is used to prove that a specification of the device satisfies the properties

Using PVS to support the analysis of distributed cognition systems

The rigorous analysis of socio-technical systems is challenging, because people are inherent parts of the system, together with devices and artefacts. In this paper, we report on the use of PVS as a way of analysing such systems in terms of distributed cognition. Distributed cognition is a conceptual framework that allows us to derive insights about plausible user trajectories in socio-technical systems by exploring what information in the environment provides resources for user action, but its application has traditionally required substantial craft skill. DiCoT adds structure and method to the analysis of socio-technical systems from a distributed cognition perspective. In this work, we demonstrate how PVS can be used with DiCoT to conduct a systematic analysis. We illustrate how a relatively simple use of PVS can help a field researcher to (i) externalise assumptions and facts, (ii) verify the consistency of the logical argument framed in the descriptions, (iii) help uncover latent situations that may warrant further investigation, and (iv) verify conjectures about potential hazards linked to the observed use of information resources. Evidence is also provided that formal methods and empirical studies are not alternative approaches for studying a socio-technical system, but that they can complement and refine each other. The combined use of PVS and DiCoT is illustrated through a case study concerning a real-world emergency medical dispatch system

Verification of User Interface Software: The Example of Use-Related Safety Requirements and Programmable Medical Devices

One part of demonstrating that a device is acceptably safe, often required by regulatory standards, is to show that it satisfies a set of requirements known to mitigate hazards. This paper is concerned with how to demonstrate that a user interface software design is compliant with use-related safety requirements. A methodology is presented based on the use of formal methods technologies to provide guidance to developers about addressing three key verification challenges: 1) how to validate a model, and show that it is a faithful representation of the device; 2) how to formalize requirements given in natural language, and demonstrate the benefits of the formalization process; and 3) how to prove requirements of a model using readily available formal verification tools. A model of a commercial device is used throughout the paper to demonstrate the methodology. A representative set of requirements are considered. They are based on US Food and Drug Administration (FDA) draft documentation for programmable medical devices, and on best practice in user interface design illustrated in relevant international standards. The methodology aims to demonstrate how to achieve the FDA's agenda of using formal methods to support the approval process for medical devices.This work was supported by the EPSRC research Grant EP/G059063/1: CHI+MED (Computer-Human Interaction for Medical Devices). The work of P. Masci and J.C. Campos was supported under Project NORTE-01-0145-FEDER-000016, financed by the North Portugal Regional Operational Programme (NORTE 2020), through the PORTUGAL 2020 Partnership Agreement, and through the European Regional Development Fund (ERDF)

The INGV tectonomagnetic network

The Italian Istituto Nazionale di Geofisica e Vulcanologia (INGV) tectonomagnetic network was installed in Central Italy since the middle of 1989 to investigate possible magnetic anomalies related to earthquakes. The network is part of the INGV L'Aquila Geomagnetic Observatory and is located in an area extending approximately in latitude range [41.6°–42.8°] N and longitude range [13.0°–14.3°] E. Actually the network consists of four stations where the total magnetic field intensity data are collected using proton precession magnetometers. New stations will be added to the network starting from the end of 2007. Here we are reporting the whole data set of the network's stations for the period 2004–2006. No significant anomaly in the local geomagnetic field correlated to the seismic activity has been found. Some considerations about misleading structures present in the data sets are reported