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Failure mode and effects analysis in a dual-product microsphere brachytherapy environment
Kelly Cooper Younge1, Choonik Lee1, Jean M Moran1
1Department of Radiation Oncology, University of Michigan Hospitals, Ann Arbor, Michigan.
Practical Radiation Oncology
|May 9, 2016
Summary
A failure mode and effects analysis (FMEA) identified risks in microsphere brachytherapy programs. This proactive approach improved safety and efficiency for both new and existing microsphere products.
Area of Science:
- Medical Physics
- Radiation Oncology
- Quality Improvement
Background:
- Microsphere brachytherapy is a complex treatment requiring robust safety protocols.
- Integrating new products into existing programs necessitates thorough risk assessment.
Purpose of the Study:
- To conduct a failure mode and effects analysis (FMEA) for a new microsphere product integration.
- To identify and mitigate potential safety risks within the microsphere brachytherapy program.
Main Methods:
- A multidisciplinary team mapped processes and identified failure modes.
- Custom severity scales were developed for patient, staff, and institutional risks.
- Failure modes were scored to prioritize interventions.
Main Results:
- 173 failure mode/effect pairs identified across patient, staff, and institutional categories.
- SIR-Spheres and TheraSphere programs analyzed separately due to workflow differences.
- Programmatic changes implemented to address high-ranking failure modes.
Conclusions:
- FMEA enhanced safety and efficiency for both SIR-Spheres and TheraSphere programs.
- The analysis provided a framework for workflow and quality assurance improvements.
- The FMEA serves as a dynamic tool for ongoing program enhancement.
