WP 402 Use Case - Safety risk management of an interventional X-ray system

Use Case Application:
  • The use cases of Philips Healthcare concern the control part of an interventional X-ray system. These imaging systems are especially important for minimally invasive surgery, e.g. improving the throughput of a blood vessel by placing a stent via a catheter where the surgeon is guided by X-ray images. These techniques avoid open heart surgery and have many benefits in the healthcare domain such as improved productivity, more effective treatments, better success rate, and increased quality of the life of patients. It is important to be able to incorporate medical innovations fast in such systems. This is challenging, because high quality standards have to be met and a trade-off has to be made between usability and safety. To meet these goals, Philips investigates in a migration towards a component-based architecture and an improved model-based iterative development process, supported by interoperable tooling. The three use cases concern different layers of control of an interventional X-ray system. WP4.2 concerns the overall risk management process which deals with safety aspects such as collision detection and prevention.
Main Methods and Tools:
  • Safety risk management: Trackwise, QlikView, MAUDE database extractor, DOORS NG
Expected results:
  • Model for safety risk management including field surveillance for quantitative pro-active risk analysis integrated with with system development tooling 
Figure 1: Safety incident search tool
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