Evaluation and improvement of the safety of 3D-printed template assisted intracavitary/interstitial brachytherapy for cervical cancer using repeat FMEA
3D-printed templates are used in intracavitary/interstitial brachytherapy (3DP-IC/IS) for locally advanced cervical cancer (LACC). We applied failure mode and effects analysis (FMEA) twice in one year to improve 3DP-IC/IS safety. A risk assessment group was established. We created a process map for 3DP-IC/IS procedures, identifying potential failure modes (FMs) and evaluating occurrence (O), detectability (D), severity (S), and risk priority number (RPN = O*D*S). High RPN values identified high-risk FMs, and quality control (QC) methods were determined by root cause analysis. A second FMEA was performed a year later. The 3DP-IC/IS process included 10 main steps, 48 subprocesses, and 54 FMs. Initial RPN values ranged from 4.50 to 171.00 (median 50.50; average 52.18). Ten high-risk FMs were identified: (1) unreasonable needle track design (171.00/85.50), (2) noncoplanar needle label identification failure (126.00/64.00), (3) template model reconstruction failure (121.50/62.50), (4) improper gauze filling (112.00/60.25), (5) poor needle position (112.00/52.50). QC interventions lowered all high-risk RPN values during the second assessment. A feasible 3DP-IC/IS process was proposed. Staff training, automatic needle path planning, insertion guidance diagrams, template checking, system commissioning, and template design improvements effectively enhanced process safety.