MO-D-BRB-07: Failure-Mode and Effects Analysis Study for CyberKnife Stereotactic Radiosurgery.

Area of Science:

• Medical Physics
• Radiation Oncology
• Quality Assurance

Background:

• Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) are advanced cancer treatments.
• CyberKnife is a robotic SRS/SBRT delivery system requiring robust quality assurance (QA).
• Existing QA procedures may not adequately address all potential failure modes.

Purpose of the Study:

• To conduct a Failure Modes and Effect Analysis (FMEA) for CyberKnife radiosurgery.
• To evaluate the sensitivity of current QA procedures.
• To identify areas for new QA implementation to enhance patient safety.

Main Methods:

• Interviews with multidisciplinary CyberKnife team members to identify failure modes.
• Development of a patient flow chart to map failure modes.
• Correlation of failure modes with existing QA procedures using a matrix.

Main Results:

• 180 failure modes identified; 85% were process or human errors, 15% technical.
• Significant overlap in failure modes between CyberKnife and Gamma Knife systems.
• Effective QA includes physics second chart review and pre-treatment time-out checklists.
• New checklists, procedure guidelines, and an ARIA-CyberKnife DICOM interface were developed or are being implemented.

Conclusions:

• This is the first FMEA study for CyberKnife SRS.
• The study transitions QA from experience-based technical checks to a comprehensive technical, process, and human safety approach.
• This framework supports medical physicists in delivering safer SRS/SBRT treatments.