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Risk analysis for the design of a safe artificial pancreas control system

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Abstract

Closed-loop glucose control has the potential to improve the glycemic control in patients with diabetes mellitus type 1. Such an artificial pancreas (AP) should keep the user safe despite all disturbances and faults. The objective of this paper is to analyze those perturbations according to their effects on the glycemic status, and thereby supporting an informed design process of the control system. As suggested by the international standard ISO 14971 for risk management of medical devices, the well proven failure modes and effects analysis (FMEA) was chosen as instrument. An FMEA scheme was modified for this purpose and applied to a single-hormone system with subcutaneous and intraperitoneal routes for glucose sensing and insulin administration. Faults that imply urgent danger and thus require fast detection and diagnosis were identified and distinguished from disturbances that can be sufficiently addressed by basic control functions, e.g. by adaptive control algorithms. Requirements and testing criteria for basic control functions as well as fault detection and diagnosis functions can be derived from the provided overview.

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Acknowledgements

The study was financed by The Liaison Committee for Education, Research and Innovation in Central Norway (project no. 46075403), and partly by the Research Council of Norway (project no. 248872) and the Centre for Digital Life Norway. The authors would like to thank Sverre C. Christiansen for invaluable input.

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Authors and Affiliations

  1. Department of Engineering Cybernetics, Norwegian University of Science and Technology (NTNU), Trondheim, Norway

    Konstanze Kölle, Anders Lyngvi Fougner & Øyvind Stavdahl

  2. Department of Endocrinology, St. Olavs University Hospital, Trondheim, Norway

    Konstanze Kölle & Sven Magnus Carlsen

  3. Department of Mechanical and Industrial Engineering, Norwegian University of Science and Technology (NTNU), Trondheim, Norway

    Mary Ann Lundteigen

  4. Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway

    Sven Magnus Carlsen

  5. Department of Electronic Systems, Norwegian University of Science and Technology (NTNU), Trondheim, Norway

    Reinold Ellingsen

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  1. Konstanze Kölle
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  2. Anders Lyngvi Fougner
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  3. Mary Ann Lundteigen
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  4. Sven Magnus Carlsen
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  5. Reinold Ellingsen
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  6. Øyvind Stavdahl
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Corresponding author

Correspondence to Konstanze Kölle.

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Human and Animal Rights

This article does not contain any studies with human participants or animals performed by any of the authors.

Author disclosure statement

An abstract and a poster with preliminary results from this paper were presented at the ATTD conference in Milano, February 2016. All authors expect M. A. Lundteigen are members of the Artificial Pancreas Trondheim (APT) research group (http://www.apt-norway.com/) which focuses on the double intraperitoneal approach for an artificial pancreas. R. Ellingsen is a shareholder and board member of GlucoSet, a company in the glucose monitoring field.

Conflict of interest

The authors declare that they have no conflict of interest.

Terminology

Adverse event

Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (...) in subjects, users or other persons, whether or not related to the investigational medical device [110]

Artificial pancreas

Closed-loop control of blood glucose in diabetes, is a system combining a glucose sensor, a control algorithm, and an insulin infusion device [111]

Disturbance

An unknown (or uncontrolled) input acting on a system [112]

Error

Discrepancy between a computed, observed or measured value or condition, and the true, specified or theoretically correct value or condition [113]

Failure mode

Manner in which a failure occurs [113] (Fault modes rather than failure modes are actually analyzed in an FMEA, but the term failure modes and effects analysis is the common name of this methodology [7].)

Failure

The termination of the ability of an item to perform a required function [113]

Fault detection

Event by which the presence of a fault becomes apparent [113]

Fault diagnosis

Action to identify and characterize the fault [113]

Fault identification

Determination of the size and time-variant behaviour of a fault. Follows fault isolation [112]

Fault isolation

Determination of the kind, location and time of detection of a fault. Follows fault detection [112]

Fault tolerance

Ability of an item to perform a required function in the presence of certain given sub-item faults [113]

Fault

Inability to perform as required, due to an internal state [113]

Harm

Physical injury or damage to persons, property, and livestock [113]

Hazard

Potential source of harm [113]

Hazardous event

Event that can cause harm [113]

Hazardous situation

Circumstance in which persons, property and livestock or the environment are exposed to at least one hazard [113]

Intended use

Use of a product, process or service in accordance with the information for use provided by the supplier [113]

Perturbation

An input acting on a system, which results in a temporary departure from the current state [112]

Random hardware failure

Failure, occurring at a random time, which results from one or more of the possible degradation mechanisms in the hardware [114]

Reasonably foreseeable misuse

Use of a product, process or service in a way not intended by the supplier, but which may result from readily predictable human behaviour [113]

Reliability

Ability to perform as required, without failure, for a given time interval, under given conditions [113]

Residual

A fault indicator, based on a deviation between measurements and model-equation-based computations. [112]

Risk analysis

Systematic use of available information to identify hazards and to estimate the risk [113]

Risk

Combination of the probability of occurrence of harm and the severity of that harm [113]

Safety

Freedom from unacceptable risk to the outside from the functional and physical units considered [113]

Systematic failure

Failure that consistently occurs under particular conditions of handling, storage or use [113]

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Kölle, K., Fougner, A.L., Lundteigen, M.A. et al. Risk analysis for the design of a safe artificial pancreas control system. Health Technol. 9, 311–328 (2019). https://doi.org/10.1007/s12553-018-0269-8

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  • DOI: https://doi.org/10.1007/s12553-018-0269-8

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