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Safety-oriented design of in-house software for new techniques: A case study using a model-based 4DCT protocol.

Dylan O'Connell1, David H Thomas2, John H Lewis1

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This study adapted TG-100 risk analysis for in-house software in a novel four-dimensional computed tomography (4DCT) protocol. Additional methods enhanced software safety, ensuring reliable implementation of new imaging techniques.

Keywords:
4DCTFMEATG-100software

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Area of Science:

  • Medical Imaging
  • Software Engineering
  • Quality Management

Background:

  • In-house software is crucial for implementing novel imaging and therapy techniques before commercial availability.
  • Existing risk analysis methods like TG-100 offer process guidance but limited software design insights.
  • Model-based four-dimensional computed tomography (4DCT) requires specialized in-house software for complex tasks.

Purpose of the Study:

  • To examine a novel model-based 4DCT protocol using the TG-100 risk analysis framework.
  • To describe supplementary methods for ensuring the safety of associated in-house software.
  • To integrate quality management and software safety into the development of new clinical imaging techniques.

Main Methods:

  • A model-based 4DCT protocol was implemented using in-house software for signal synchronization, deformable image registration (DIR), and treatment planning system integration.
  • A process map and Failure Modes and Effects Analysis (FMEA) were used to identify critical workflow steps and guide quality interventions.
  • Software safety was enhanced by developing use cases and codifying safety requirements using the easy approach to requirements syntax (EARS).

Main Results:

  • FMEA identified 61 failure modes, leading to interventions such as integrated reporting/logging systems and mandatory quality assurance procedures.
  • Use cases and EARS-based requirements directly informed the design and testing of the in-house software.
  • Quality management interventions included daily/monthly equipment QA and an image acquisition checklist.

Conclusions:

  • TG-100 methods successfully established a process-level quality management program for the 4DCT protocol.
  • Requirements engineering tools (use cases, EARS) effectively elicited and codified software safety requirements.
  • These methods provide a generalizable approach to promoting safety in in-house software for novel clinical techniques.