FMEA-guided transition from microSelectron to Flexitron for HDR brachytherapy

Area of Science:

• Medical Physics
• Radiation Oncology

Background:

• The transition from older brachytherapy afterloader systems to newer ones, like the Flexitron, requires careful planning to ensure patient safety and treatment continuity.
• Failure Mode and Effects Analysis (FMEA) is a systematic risk assessment tool that can be applied to complex clinical processes.

Purpose of the Study:

• To apply a two-stage Failure Mode and Effects Analysis (FMEA) to manage the transition from the Elekta microSelectron to the Flexitron high dose-rate afterloader system.
• To identify and mitigate potential failures and vulnerabilities during the system upgrade.

Main Methods:

• A two-stage FMEA was conducted. The first stage involved lead brachytherapy physicists identifying vulnerabilities during the transition.
• The second stage, performed two months post-implementation, re-examined the process map to refine improvements.
• Identified failure modes, causes, and process steps were documented, leading to updates in checklists and data books.

Main Results:

• The first-stage FMEA identified 81 process steps and 80 failure modes, resulting in updated checklists and data books.
• A two-phase commissioning process was implemented based on the first-stage FMEA findings.
• The second-stage FMEA identified further error-prone steps, leading to new tools and checklist items.

Conclusions:

• The two-stage FMEA effectively guided the transition to the Flexitron system, optimizing checklists and workflows.
• This approach minimized clinical downtime, avoided extra source changes, and facilitated staff training.
• The study provides valuable insights into FMEA-guided transitions for the brachytherapy community.