Improved safety and quality in intravascular brachytherapy: A multi-institutional study using failure modes and...

Area of Science:

• Medical Physics
• Radiation Oncology
• Cardiology

Background:

• Intravascular brachytherapy (IVBT) is a critical treatment modality.
• Ensuring patient safety in IVBT requires rigorous quality assurance (QA) and risk management.
• Previous analyses have not comprehensively addressed failure modes in IVBT radiation delivery.

Purpose of the Study:

• To highlight safety considerations in intravascular brachytherapy (IVBT) programs.
• To provide relevant quality assurance (QA) and safety measures for IVBT.
• To establish the effectiveness of these safety and QA measures.

Main Methods:

• A multi-institutional failure modes and effects analysis (FMEA) was conducted on the radiation delivery component of IVBT.
• Failure modes were identified, and their severity, occurrence, and detectability were rated before and after implementing safety practices.
• Risk priority numbers (RPN) and relative risk rankings were calculated, leading to the development of a QA safety checklist.

Main Results:

• The analysis identified 40 failure modes, with the highest RPNs attributed to incorrect source train length, vessel diameter, and missing radiation history.
• Proposed QA and safety measures, including ten novel recommendations, improved occurrence and detectability.
• These measures reduced the average RPN from 116 to 58 and the median RPN from 84 to 40, with significant reductions in the highest-risk failure modes.

Conclusions:

• Several high-risk failure modes were identified in intravascular brachytherapy (IVBT) procedures.
• Practical safety and quality assurance (QA) measures were developed and validated.
• The implemented measures effectively mitigate risks, enhancing the safety of IVBT treatments.