Failure mode and effects analysis of skin electronic brachytherapy using Esteya® unit

PURPOSE A failure mode and effect analysis (FMEA) of skin lesions treatment process using Esteya™ device (Elekta Brachyterapy, Veenendaal, The Netherlands) was performed, with the aim of increasing the quality of the treatment and reducing the likelihood of unwanted events. METHODS A multidisciplinary team with experience in the treatment process met to establish the process map, which outlines the flow of various stages for such patients undergoing skin treatment. Potential failure modes (FM) were identified and the value of severity (S), frequency of occurrence (O), and lack of detectability (D) of the proposed FM were scored individually, each on a scale of 1 to 10 following TG-100 guidelines of the AAPM. These failure modes were ranked according to our risk priority number (RPN) and S scores. The efficiency of existing quality management tools was analyzed through a reassessment of the O and D made by consensus. RESULTS 149 FM were identified, 43 of which had RPN ≥ 100 and 30 had S ≥ 7. After introduction of the tools of quality management, only 3 FM had RPN ≥ 100 and 22 FM had RPN ≥ 50. These 22 FM were thoroughly analyzed and new tools for quality management were proposed. The most common cause of highest RPN FM was associated with the heavy patient workload and the continuous and accurate applicator-patient skin contact during the treatment. To overcome this second item, a regular quality control and setup review by a second individual before each treatment session was proposed. CONCLUSION FMEA revealed some of the FM potentials that were not predicted during the initial implementation of the quality management tools. This exercise was useful in identifying the need of periodic update of the FMEA process as new potential failures can be identified.