Risk Assessment of ZAP-X→ Radiosurgery System in a Quaternary Care Hospital Using FMEA Approach

Background and Aims: The overarching goal of this study is to conduct a robust risk assessment using the Failure Modes and Effects Analysis (FMEA) approach. By identifying potential failure modes and their potential impacts on patient care and hospital operations, this research seeks to provide actionable insights and mitigation strategies for the safe and effective implementation of the ZAP-X Radiosurgery System. The swift integration of advanced medical technologies, exemplified by the ZAP-X→ Gyroscopic Stereotactic Radiosurgery System, a computer-controlled machine that delivers radiation to an intended target in the brain, necessitates a comprehensive proactive risk assessment before the launch of the system to ensure the safety of patients, staff and operational processes. Method: Applying the FMEA methodology, we meticulously mapped all processes and sub-processes associated with the ZAP-X Radiosurgery System implementation. Our multidisciplinary team, through a discussion on ‘what can go wrong’, identified failure modes. Risks were prioritised based on severity, likelihood and detectability giving them a Risk Priority Number (RPN). The team proposed mitigation strategies, deploying controls to enhance safety and reliability.