The benefits of formalising design guidelines: a case study on the predictability of drug infusion pumps

Masci, Paolo; Rukšėnas, Rimvydas; Oladimeji, Patrick; Cauchi, Abigail; Gimblett, Andy; Li, Yunqiu; Curzon, Paul; Thimbleby, Harold

doi:10.1007/s11334-013-0200-4

Cited by 31 publications

(29 citation statements)

References 23 publications

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“…The typed higher-order logic of the Prototype Verification System (PVS) [8] has been used for the formal specification of many kinds of systems, including medical devices [3,7,6]. In the PVS, a system is modeled by a theory, i.e., a set of statements in the PVS logic language describing the system by means of variable, constant, and function definitions, and of axioms and theorems about them.…”

Section: Formalizationmentioning

confidence: 99%

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Towards a Formalization of System Requirements for an Integrated Clinical Environment

Bernardeschi¹,

Domenici²,

Masci³

2015

Proceedings of the 5th EAI International Conference on Wireless Mobile Communication and Healthcare - "Transforming Healthcare

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Interoperability of medical devices, and their interface to clinicians and patients, are critical issues for the safety and effectiveness of patient care. Ongoing efforts strive at establishing standards for integrated clinical environments, which may connect and co-ordinate several medical devices and interface them to patients, clinicians, and hospital information systems. In this paper, an approach to the formalization of system requirements for an integrated clinical environment is presented. The formalization relies on the higher-order logic language of the Prototype Verification System.

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Section: Formalizationmentioning

confidence: 99%

“…The latter have many causes, including ill-designed interfaces [6] and incorrect information about the patient. The issue with interfaces is aggravated by the fact that devices with the same purpose may have different interfaces, depending on vendor or model.…”

Section: Introductionmentioning

confidence: 99%

Towards a Formalization of System Requirements for an Integrated Clinical Environment

Bernardeschi¹,

Domenici²,

Masci³

2015

Proceedings of the 5th EAI International Conference on Wireless Mobile Communication and Healthcare - "Transforming Healthcare

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“…For example, Rushby [24] used model checkers Murφ and SAL to verify mode confusion in a cockpit; Rukšėnas et al [21] used SAL to identify post-completion errors in infusion pumps; Campos and Harrison used IVY/NuSMV to analyze infusion pumps against properties such as consistency, visibility, and feedback [4,11]; and in our own work, we used SAL and Event-B/Rodin to analyze the data entry system of infusion pumps for their predictability [15,16] and other safety properties identified by FDA [22].…”

Section: Related Workmentioning

confidence: 99%

“…The present work builds on our previous research on the verification of medical device user interfaces [11,[14][15][16]22] and on user interface prototyping [19]. These previous efforts have demonstrated that formal methods can be used to identify human factors issues in reverse-engineered models of medical devices.…”

Section: Introductionmentioning

confidence: 99%

Formal Verification of Medical Device User Interfaces Using PVS

Masci

Zhang

Jones

et al. 2014

Fundamental Approaches to Software Engineering

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Abstract. We present a formal verification approach for detecting design issues related to user interaction, with a focus on user interface of medical devices. The approach makes a novel use of configuration diagrams proposed by Rushby to formally verify important human factors properties of user interface implementation. In particular, it first translates the software implementation of user interface into an equivalent formal specification, from which a behavioral model is constructed using theorem proving; human factors properties are then verified against the behavioral model; lastly, a comprehensive set of test inputs are produced by exploring the behavioral model, which can be used to challenge the real interface implementation and to ensure that the issues detected in the behavior model do apply to the implementation. We have prototyped the approach based on the PVS proof system, and applied it to analyze the user interface of a real medical device. The analysis detected several interaction design issues in the device, which may potentially lead to severe consequences.

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“…However, hardly any concrete examples of model-based development of user interfaces have been explored that take account of human factors or human factors engineering. In our previous work, we illustrated how verification tools could be used to verify the design of commercial infusion pump user interfaces against properties that capture human factors concerns [4,6,13,14] and safety requirements [12]: potential issues were identified precisely, and verified design solutions that could fix the identified issues were presented. This work builds on our previous work, and extends it by introducing a model-based development approach for rapid prototyping of medical device user interfaces that are verified against given safety requirements.…”

Section: Introductionmentioning

confidence: 99%

Model-Based Development of the Generic PCA Infusion Pump User Interface Prototype in PVS

Masci

Ayoub

Curzon

et al. 2013

Lecture Notes in Computer Science

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A realistic user interface is rigorously developed for the US Food and Drug Administration (FDA) Generic Patient Controlled Analgesia (GPCA) pump prototype. The GPCA pump prototype is intended as a realistic workbench for trialling development methods and techniques for improving the safety of such devices. A model-based approach based on the use of formal methods is illustrated and implemented within the Prototype Verification System (PVS) verification system. The user interface behaviour is formally specified as an executable PVS model. The specification is verified with the PVS theorem prover against relevant safety requirements provided by the FDA for the GPCA pump. The same specification is automatically translated into executable code through the PVS code generator, and hence a high fidelity prototype is then developed that incorporates the generated executable code. Abstract. A realistic user interface is rigorously developed for the US Food and Drug Administration (FDA) Generic Patient Controlled Analgesia (GPCA) pump prototype. The GPCA pump prototype is intended as a realistic workbench for trialling development methods and techniques for improving the safety of such devices. A model-based approach based on the use of formal methods is illustrated and implemented within the Prototype Verification System (PVS) verification system. The user interface behaviour is formally specified as an executable PVS model. The specification is verified with the PVS theorem prover against relevant safety requirements provided by the FDA for the GPCA pump. The same specification is automatically translated into executable code through the PVS code generator, and hence a high fidelity prototype is then developed that incorporates the generated executable code.

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The benefits of formalising design guidelines: a case study on the predictability of drug infusion pumps

Cited by 31 publications

References 23 publications

Towards a Formalization of System Requirements for an Integrated Clinical Environment

Towards a Formalization of System Requirements for an Integrated Clinical Environment

Formal Verification of Medical Device User Interfaces Using PVS

Model-Based Development of the Generic PCA Infusion Pump User Interface Prototype in PVS

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