Risk assessment of a self-tracking EM-integrated fetoscope

Embedding an electromagnetic (EM) sensing at the tip of a fetoscope is appealing as it would allow to record the position and orientation of the tip of the fetoscope in real time. This tracking information may be useful for advanced guidance schemes that may help the surgeon during the intervention. However, adding such an EM-sensor should be done with great care as it may lead to additional risks for the patients (mother and fetus), the surgeon or the fetoscope itself. This work proposes the use of a failure mode and effects analysis (FMEA). By means of such an FMEA one can systematically identify the risks and hazards of EM-integration via selective risk assessment. Through this FMEA it is possible to acquire a deeper understanding of the procedure. Together with new guidance schemes that rely on such EM technology, one could ultimately improve patient safety, occupational health safety and ergonomics for the surgeon.

Publication year:2020

Accessibility:Open