Failure modes and effects analysis study for accelerator-based Boron Neutron Capture Therapy.

Area of Science:

• Oncology
• Medical Physics
• Radiation Therapy

Background:

• Boron Neutron Capture Therapy (BNCT) is increasingly used in clinical oncology with new accelerator-based systems.
• Detailed risk assessments for these advanced BNCT systems are currently lacking.

Purpose of the Study:

• To provide comprehensive risk data for institutions implementing accelerator-based BNCT.
• To identify and analyze potential failure modes (FMs) in BNCT procedures.

Main Methods:

• Failure Mode and Effects Analysis (FMEA) was applied to accelerator-based BNCT treatment processes.
• A multidisciplinary team scored occurrence, severity, and detectability of identified FMs.
• Risk Priority Numbers (RPNs) were calculated, categorizing FMs into high, very high, and other risk levels.

Main Results:

• 165 FMs were identified, with 30 classified as high risk and 17 as very high risk.
• 71 FMs were specific to accelerator-based BNCT, including 18 high-risk and 5 very high-risk.
• Staff education and confirmation countermeasures showed significantly higher severity.
• Patient-derived FMs tended to have higher occurrence, while FMs involving medical doctors and nurses showed higher occurrence due to patient interaction.

Conclusions:

• This is the first FMEA-based risk analysis for BNCT, offering crucial data for quality assurance.
• Understanding BNCT-specific risks and implementing adequate countermeasures are essential for safe and effective treatment.
• Multidisciplinary team discussions are vital for developing comprehensive strategies against identified failure modes.