From Dose to Diagnosis: Broadening the Reach of FMEA Thinking

Introduction

Failure Mode and Effects Analysis (FEMA) represents a systematic approach to identifying and prioritizing potential failures in clinical processes. The methodology involves scoring failure modes on three key criteria: severity (impact on patient or staff safety), occurrence (likelihood of failure), and detection (probability of identifying the failure before patient impact). The product of these scores yields a Risk Priority Number (RPN) that guides resource allocation for quality improvement initiatives.

While FMEA gained prominence in radiation oncology through Task Group 100’s 2016 report1, its application in other medical physics specialties has been limited. However, the fundamental principles underlying FMEA, such as systematic risk assessment and stakeholder engagement, offer valuable frameworks for addressing quality challenges across the broader medical physics community.

FMEA Thinking: Beyond Formal Processes

Recent implementations suggest that the benefits of FMEA extend beyond formal departmental analyses. “FMEA thinking” represents an approach that incorporates the core principles of severity, occurrence, and detection into routine clinical conversations and decision-making processes, without necessarily requiring comprehensive process mapping or formal scoring exercises.

 

Table from AAPM TG-1001

This approach recognizes that valuable insights often emerge from structured stakeholder conversations guided by FMEA principles, rather than exclusively through formal analytical processes. Such conversations can rapidly identify hidden risks and facilitate cross-disciplinary problem-solving while requiring minimal additional resources.

Applications in Radiation Oncology

Departmental Risk Assessment

A comprehensive departmental FMEA conducted at one institution involved separate stakeholder meetings with diverse groups, including dosimetrists, therapists, nurses, front office staff, and schedulers. This approach created environments for candid feedback while ensuring representation from all operational areas.

The process revealed several high-priority failure modes that had been outside the typical scope of physics oversight. Notable findings included missed Decadron administration at treatment completion, which scored highly for severity but poorly for detectability. Additionally, chin positioning errors during breast treatments demonstrated unexpectedly high occurrence scores (9/10), indicating a more frequent problem than previously recognized.

Process-Specific Analysis

For complex, infrequent procedures such as HDR syed treatments, detailed process mapping proved valuable in systematic risk identification. The approach involved breaking workflows into subprocesses and individual steps, enabling targeted identification of potential failure points and implementation of appropriate controls. Process mapping was a key component in reviewing the steps for this specific procedure. 

Quality Control Optimization

FMEA principles have been applied to reassess existing quality control procedures. Analysis of automated QC systems, such as the Varian MPC phantom, demonstrated how risk scoring can inform optimal frequencies for independent verification. When reviewing monthly QC checks for onboard imaging systems, MV/kV imager center alignment scored highest for risk, leading to daily independent measurement of this parameter while maintaining less frequent verification for lower-scoring components.

Extension to Diagnostic Imaging

Treatment Planning MRI Quality

A systematic quality issue involving suboptimal treatment planning of MRIs provided an opportunity to apply FMEA thinking in diagnostic imaging. Problems included incorrect slice thickness, absence of geometric distortion corrections, and utilization of 1.5T scanners when 3T systems were available.

The approach involved separate meetings with ordering medical oncologists and MRI technologists to understand respective workflows and communication gaps. Two primary failure modes emerged from this analysis:

1. Inappropriate order specifications: Physicians ordering diagnostic scans rather than treatment planning MRIs, often requiring only additional sequences appended to diagnostic studies
2. Protocol optimization deficiencies: MRI protocols lacking treatment planning-specific parameters such as geometric distortion corrections and appropriate slice thickness

Implemented solutions included physician and technologist training programs, standardized order forms for treatment planning studies, and facility-specific protocol optimization with corresponding staff education.

Nuclear Medicine Applications

Regulatory Compliance Enhancement

Nuclear medicine departments face unique challenges where many potential failure modes relate to regulatory compliance rather than direct patient safety, though these domains often overlap. A modified FMEA approach2 incorporated bifurcated severity scoring, separating patient-related risks from administrative/regulatory consequences.

Table from George et. all2

One facility experiencing declining RAM license audit scores and high staff turnover underwent departmental risk assessment using FMEA principles. The facility was performing complex procedures, including Y-90 and I-131 therapies, with limited staff experience. 

Stakeholder meetings involving technologists, authorized users, management, and executive leadership identified general unawareness of job-specific regulatory requirements as the highest-scoring failure mode. This finding led to the implementation of weekly on-site training sessions focused on regulatory compliance specific to individual roles.

Notably, framing quality issues in FMEA terminology facilitated executive buy-in for resource allocation, as institutional leadership teams typically demonstrate familiarity with FMEA concepts and recognize their validity for risk management.

Future Applications and Emerging Opportunities

Several areas present promising opportunities for expanded FMEA application:

Image-guided spine surgery represents a high-complexity, high-severity environment where equipment undergoes frequent movement and use in demanding surgical conditions. The interconnected nature of system components and potential for severe consequences make this an ideal candidate for systematic risk assessment.

Quantitative MRI presents challenges in independent validation of physician-reported results, creating opportunities for FMEA-guided development of quality assurance protocols.

Emerging theragnostics procedures continue to increase in complexity and regulatory requirements, suggesting natural applications for systematic risk assessment during protocol development.

Strengths and Limitations

Strengths

• Enhanced stakeholder engagement: The approach naturally encourages cross-disciplinary conversations that might not otherwise occur
• Rapid problem identification: Structured discussions can quickly surface high-priority risks requiring attention
• Role transformation: The methodology repositions medical physicists from compliance-focused “box checkers” to proactive problem solvers
• Institutional credibility: Executive familiarity with FMEA concepts facilitates support for quality improvement initiatives

Limitations

• Subjective scoring: Without supporting historical data, scoring relies heavily on subjective assessments that may vary among stakeholders
• Dependence on honest input: Effectiveness requires open, honest stakeholder participation, which may be challenging in certain organizational cultures
• Resource requirements: Meaningful implementation requires time allocation for stakeholder meetings and follow-up activities

Practical Implementation Framework

Not every situation demands a formal FMEA review, and often time a lack of resources can be preventative. Oftentimes FMEA is best used in day-to-day decision making by stepping back and considering the contributing factors of occurrence, detectibility, and severity in thought process. Successful implementation of FMEA thinking requires systematic consideration of fundamental questions during routine clinical activities:

• Purpose clarification: Why is a particular QC task being performed?
• Failure identification: What specific failure modes is the task designed to prevent or detect?
• Probability assessment: How likely is performance drift or failure over time? (occurrence) 
• Consequence evaluation: What would be the severity of consequences if failure occurred? (severity) 
• Detection capability: How easily can problems be identified before impacting patient care? (detection) 

This framework encourages medical physicists to view quality control as a means to achieve optimal clinical outcomes rather than an end in itself. Given the challenge of keeping regulatory standards current with rapidly evolving technology, physicists must apply standards thoughtfully and contextually rather than reflexively.

Conclusion

FMEA thinking represents a practical evolution of formal FMEA processes that can be readily implemented across medical physics specialties. By incorporating systematic consideration of severity, occurrence, and detection into routine clinical conversations, medical physicists can identify hidden risks, improve processes, and strengthen institutional relationships. The approach offers particular value in diagnostic imaging and nuclear medicine, where formal FMEA implementation has been limited despite significant opportunities for quality improvement.

Success requires commitment to stakeholder engagement and willingness to move beyond traditional compliance-focused activities toward proactive problem-solving. The result is enhanced patient safety, improved operational efficiency, and expanded recognition of medical physics contributions to institutional quality initiatives.

 

References

1. Huq, M.S., Fraass, B.A., Dunscombe, P.B., Gibbons, J.P., Jr., Ibbott, G.S., Mundt, A.J., Mutic, S., Palta, J.R., Rath, F., Thomadsen, B.R., Williamson, J.F. and Yorke, E.D. (2016), The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Med. Phys., 43: 4209-4262. https://doi.org/10.1118/1.4947547
2. S George et al. Enhancing safety: Multi-institutional FMEA and FTA on ¹⁷⁷Lu-based radio-pharmaceutical therapy. J Appl Clin Med Phys. 2024

 

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Content Basis & Scope

This resource communicates information to the public in accordance with the AAPM Code of Ethics. The content presented is based on one or more of the following: scientific studies, expert consensus, and professional experience in diagnostic and therapeutic medical physics.

Last updated: August 2025