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Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery
Andy Yuanguang Xu1, Jagdish Bhatnagar1, Greg Bednarz1
1Department of Radiation Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA.
Journal of Applied Clinical Medical Physics
|October 31, 2017
Summary
This study applied Failure Modes and Effects Analysis (FMEA) to Gamma Knife radiosurgery, identifying specific failure modes to enhance quality management and patient safety in brain treatments.
Area of Science:
- Medical Physics
- Radiation Oncology
- Neurosurgery
Background:
- Gamma Knife radiosurgery is a precise brain treatment with low error risk.
- Potential for further risk reduction exists through systematic analysis.
Purpose of the Study:
- To apply the Failure Modes and Effects Analysis (FMEA) tool, as recommended by AAPM Task Group 100.
- To develop a risk-based quality management program for Gamma Knife radiosurgery.
Main Methods:
- A multidisciplinary team conducted an FMEA study.
- A process tree and failure mode table were created for Gamma Knife procedures.
- Failure modes were scored for occurrence, severity, and detection, with Risk Priority Numbers (RPNs) calculated.
Main Results:
- The Gamma Knife radiosurgery process involves 10 subprocesses and 53 steps.
- 86 failure modes were identified, with 40 specific to Gamma Knife (e.g., frame, helmet issues).
- Highest risk failure modes included frame adaptor attachment, fiducial assembly, and mechanical failures.
Conclusions:
- FMEA implementation improved process understanding among healthcare professionals.
- Potential weaknesses in the Gamma Knife radiosurgery process were identified.
- The study provides a foundation for a risk-based quality management program.
