FMEA-guided transition from microSelectron to Flexitron for HDR brachytherapy

Abstract

Purpose: To utilize failure mode and effects analysis (FMEA) to effectively direct the transition from the Elekta microSelectron to the Flexitron high dose-rate afterloader system.

Materials and methods: Our FMEA was performed in two stages. In the first stage, the lead brachytherapy physicists used FMEA to guide the brainstorming sessions and to identify vulnerabilities during this transition. The second stage of FMEA was carried out 2 months after the clinical release of the Flexitron system. The process map was examined again to further refine and improve the entire process.

Results: In the first-stage FMEA, 81 process steps were identified. Moreover, 80 failure modes and their categorized causes were recognized. Checklists and data books containing the corresponding applicator information were verified and updated. Next, based on outcomes of our first-stage FMEA, we chose to implement the commissioning process in two phases. The second stage of FMEA identified error-prone steps in our newly updated processes. This second stage of analysis resulted in the development of new tools and checklist items.

Conclusions: The two-stage FMEA approach successfully directed the transition to the Flexitron system by identifying the necessary changes in the checklists and workflows for all applicators utilized in our clinic. It also led to the decision to use a two-phase commissioning approach. This allowed for minimization clinical downtime, avoidance of an extra source change, and facilitation of efficient staff training. Additionally, multiple project-level failures were discovered. Our experience and outcomes from this FMEA-guided transition should provide valuable information to the brachytherapy community.

Keywords: FMEA; HDR brachytherapy; Quality management; Risk analysis.