Failure mode and effects analysis (FMEA) to enhance the safety and efficiency of Gamma Knife radiosurgery.

This risk analysis describes our Failure Mode and Effects Analysis (FMEA) for Gamma Knife stereotactic radiosurgery at our community hospital. During bi-monthly meetings over 5 months, our FMEA team mapped a detailed Gamma Knife process tree and identified potential failure modes, each were scored a Risk Priority Number (RPN) for severity, occurrence, detectability. In our process tree of 14 subprocesses and 177 steps, we identified 31 potential failure modes: 7 high scoring (RPN o150) and 3 modes (<150) selected by clinicians for mitigation strategies. Eighteen months later, rescoring of high-risk failure modes showed significant reduction in RPN scores, thus confirming the benefit of our FMEA mitigation strategies. Our study provides a roadmap to achieve high-quality Gamma Knife radiosurgery that can be utilized by new centers as a starting point for their quality management program. Five quality control documents were developed that can be customized by any Gamma Knife center.