Vakharia, VN;
Rodionov, R;
McEvoy, AW;
Miserocchi, A;
Sparks, R;
O'Keeffe, AG;
Ourselin, S;
(2018)
Improving patient safety during introduction of novel medical devices through cumulative summation analysis.
Journal of Neurosurgery
10.3171/2017.8.JNS17936.
(In press).
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Abstract
Objective: To implement cumulative summation analysis (CUSUM) as an early warning detection and quality assurance system for the pre-clinical testing of the iSYS1 novel robotic trajectory guidance system. Methods: Anatomically accurate 3D printed skull phantoms were created for three patients that had previously undergone implantation of 21 stereoelectroencephalography (SEEG) electrodes using the current standard of care (frameless technique). Implantation schema were recreated using the iSYS1 system and paired accuracy measures were compared with the previous frameless implantations. Entry point, target point and implantation angle accuracy were measured from post-implantation CT scans. CUSUM analysis was undertaken prospectively. Results: The iSYS1 trajectory guidance system significantly improved electrode entry point accuracies from 1.90+/-0.96 mm (Mean+/-SD) to 0.76+/-0.57 mm (Mean+/-SD) without increasing implantation risk. CUSUM analysis was successful as a continuous measure of surgical performance and acted as an early warning detection system. The surgical learning curve, although minimal, showed improvement after insertion of the 8th electrode. Conclusions: The iSYS1 trajectory guidance system did not show any increased risk during phantom preclinical testing when performed by neurosurgeons who had no previous experience of its use. CUSUM analysis is a simple technique that can be applied to all stages of the IDEAL framework as an extra patient safety mechanism. Further clinical trials are required to prove the efficacy of the device.
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