Formal Methods Based Development of a PCA Infusion Pump Reference Model: Generic Infusion Pump (GIP) Project

Arney, David; Jetley, Raoul; Jones, Paul; Lee, Insup; Sokolsky, Oleg

doi:10.1109/hcmdss-mdpnp.2007.36

Cited by 64 publications

(39 citation statements)

References 12 publications

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“…This is due to the fact that at the moment there is no widely accepted method for verification of software in medical devices (Arney et al, 2007).…”

Section: Discussionmentioning

confidence: 99%

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Plug-and-play design and distributed logic control of medical devices using IEC 61499 function blocks

Sorouri

Vyatkin

Xie

et al. 2013

IJBBR

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Plug-and-play control design and interoperability of medical devices has now become a decisive mission of technological research. One of the reasons for these requirements is the ever increasing attention that the medical sector is paying these days to specific treatments each individual patient requires which mandates having medical devices that are customisable and, more importantly, are able to interact with each other to handle more complex tasks and, as well, avoid more risks. Currently, vendor-specific devices and proprietary communication systems have hindered clinical environments from thoroughly reaching these goals. Thus, this paper concentrates on the software development aspect of medical devices and proposes a novel approach for the development of distributed control logic for them using modular, reusable and interoperable software components based on the IEC 61499 function blocks (FB). This technology enables the control design of the entire application to be in one software tool and consequently, alleviates design complexity and development time. Following that, it presents a simplified case study to exhibit the viability of this methodology to be exploited for control software design of medical and rehabilitation devices.Keywords: medical robotics; plug-and-play software components; medical devices; distributed control design; IEC 61499; function blocks; upper-limb rehabilitation device; biomechatronics; biomedical robotics.Reference to this paper should be made as follows: Sorouri, M., Vyatkin, V., Xie, S. and Salcic, Z. (2013) Zoran Salcic is a Professor of Computer Systems Engineering at the University of Auckland. His main research interests include digital systems design, custom-computing machines, reconfigurable computing, processor and computer systems architectures, embedded systems and their implementation, design automation tools for embedded systems, hardware-software co-design, new computing architectures and models of computation and languages for heterogeneous systems and wireless sensor and actuator networks. He has published more than 250 peer-reviewed journal and conference papers, several books and numerous technical reports. He is a Fellow of the Royal Society New Zealand (Academy of Science) and recipient of Alexander von Humboldt Research Award. This paper is a revised and expanded version of a paper entitled 'Distributed control design of medical devices using plug-and-play IEC 61499 function blocks' presented at

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“…This is due to the fact that at the moment there is no widely accepted method for verification of software in medical devices (Arney et al, 2007).…”

Section: Discussionmentioning

confidence: 99%

“…There exist some challenges regarding the software characteristics of medical devices manufactured by almost fifteen thousand companies (Arney et al, 2007). These are influenced by the nature of conventional software development approaches that are mainly centralised, on a case-by-case basis and demand a high amount of programming effort.…”

Section: Introductionmentioning

confidence: 99%

Plug-and-play design and distributed logic control of medical devices using IEC 61499 function blocks

Sorouri

Vyatkin

Xie

et al. 2013

IJBBR

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“…We also think that there are good reasons why we should be examining whether or not we should be developing not just domain specific software certification methods, but even product specific, product-focused software certification methods. Interestingly, the FDA is also considering similar ideas [41], which would be a major change in direction for their certification regime.…”

Section: Discussionmentioning

confidence: 99%

On Software Certification: We Need Product-Focused Approaches

Wassyng

Maibaum

Lawford

2010

Lecture Notes in Computer Science

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Abstract. In this paper we begin by examining the "certification" of a consumer product, a baby walker, that is product-focused, i.e., the certification process requires the performance of precisely defined tests on the product with measurable outcomes. We then review current practices in software certification and contrast the software regime's process-oriented approach to certification with the product-oriented approach typically used in other engineering disciplines. We make the case that productfocused certification is required to produce reliable software intensive systems. These techniques will have to be domain and even product specific to succeed.

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“…This pump will autonomously disable itself under a number of conditions in order to mitigate several hazards associated with infusion pumps [4]. For example, if the pump detects air bubbles in the infusion line, it will halt infusion and raise an alarm in order to prevent an air-embolism.…”

Section: Motivating Examplementioning

confidence: 99%

A Modal Specification Approach for On-Demand Medical Systems

King

Sokolsky

et al. 2014

Foundations of Health Information Engineering and Systems

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The on-demand approach, where systems are assembled from components by lay users, has seen success in the consumer electronics industry. Currently, there is growing demand for on-demand capabilities in medical systems so caregivers can create larger medical systems from smaller medical devices. Unlike consumer electronics, medical systems pose challenges for the on-demand approach due to attributes such as device complexity, device variability and safety requirements. In this paper, we propose a formal specification language for on-demand (medical) systems. Our approach is based on the formalism of Modal I/O Automata, which allows system designers to express complex device requirements and can be used to reason about safety and liveness properties of on-demand medical systems directly from their specifications. We illustrate the applicability of our approach through a case study of a closed-loop patient controlled analgesia system. we propose a formal speci cation language for on-demand (medical) systems. Our approach is based on the formalism of Modal I/O Automata, which allows system designers to express complex device requirements and can be used to reason about safety and liveness properties of ondemand medical systems directly from their speci cations. We illustrate the applicability of our approach through a case study of a closed-loop patient controlled analgesia system.

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Formal Methods Based Development of a PCA Infusion Pump Reference Model: Generic Infusion Pump (GIP) Project

Cited by 64 publications

References 12 publications

Plug-and-play design and distributed logic control of medical devices using IEC 61499 function blocks

Plug-and-play design and distributed logic control of medical devices using IEC 61499 function blocks

On Software Certification: We Need Product-Focused Approaches

A Modal Specification Approach for On-Demand Medical Systems

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