Failure modes and effects analysis applied to the risk management of intraoperative radiotherapy

Abstract

Objective To analysis of the various potential risks during the implementation of intraoperative radiotherapy (IORT) using a mobile linear accelerator Mobetron.Explore to optimize the management of IORT steps to reduce the occurrence of potential risks.Methods Selected the two surgeons,two of radiation oncologists,a radiation physicist,a radiation technician and two nurses who have been working for a long term in IORT team,applied failure modes and effects analysis (FMEA) to carry out systematic risk assessment.Established process modules,detected potential failure modes together with their causes and effects,scored to occurrence rating (OR),severity rating (SR),detection rating (DR),calculated risk priority number (RPN).Results IORT process is divided into 9 modules,15 potential failure modes.The highest OR was the prol nged time of laser soft-docking (8 points),the highest SR was the Mobetron equipment failed to output beams (10 points),the highest DR was the risk in the dose calculation (8 points),the highest RPNs were recognized as the target not covered satisfyingly (198 points)and not adequately protected normal tissues (180 points).For each failure mode,the existing measures were analysis,and preventive measures were proposed.Conclusions FMEA is an effective method of the management of intraoperative radiotherapy,to help reduce the occurrence of the potential risk in the IORT. Key words: Intraoperative radiotherapy; Risk management; Failure modes and effects analysis