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Hazard Identification Techniques for Digital Clinical Safety
The deployment of digital health technologies in clinical settings brings tremendous potential for improving patient care, but it also introduces new safety risks that must be systematically identified and managed. Hazard identification is the foundational step in clinical risk management for digital health systems, enabling organizations to proactively recognize potential sources of harm before they impact patients.
This post explores three powerful hazard identification techniques specifically applicable to digital clinical safety: HAZID (Hazard Identification), Functional Failure Analysis, and SWIFT (Structured What-If Technique).
Digital health technologies—from electronic health records (EHRs) to clinical decision support systems, remote monitoring devices, and AI-powered diagnostics—interact with complex clinical workflows, human users, and existing IT infrastructure. Each interaction point represents a potential failure mode that could compromise patient safety.
Unlike traditional clinical hazards, digital hazards can be subtle, emerging from software bugs, data integration issues, usability problems, or unexpected interactions between systems. Systematic hazard identification helps teams move beyond reactive incident reporting to proactive risk prevention.
HAZID is a structured brainstorming technique that brings together multidisciplinary teams to systematically identify hazards associated with a system, process, or activity. Originally developed in the process industries, HAZID has been successfully adapted for healthcare and digital health applications.
A HAZID workshop typically involves:
Team Composition: Clinical users (doctors, nurses, pharmacists), IT specialists, risk managers, human factors experts, and patient representatives where appropriate.
Structured Exploration: The facilitator guides the team through the system systematically, examining each component, interface, and workflow stage. The team uses prompt questions organized around categories such as:
Documentation: All identified hazards are recorded with their potential causes, consequences, and existing controls. Each hazard is typically assigned a preliminary risk rating.
For a clinical decision support system, a HAZID session might explore:
Strengths: Comprehensive coverage, multidisciplinary insights, builds team awareness of risks, relatively quick to conduct, captures organizational knowledge.
Limitations: Quality depends heavily on facilitator skill and team composition, may miss rare or complex failure modes, can be influenced by groupthink, requires significant stakeholder time commitment.
Functional Failure Analysis examines how each function of a digital health system could fail to perform as intended, and what consequences those failures might have for patient safety. This technique focuses on the intended functions of the system and systematically considers failure modes for each.
The process typically follows these steps:
1. Function Decomposition: Break down the digital system into its core functions. For an EHR system, functions might include:
2. Failure Mode Identification: For each function, identify ways it could fail:
3. Consequence Analysis: Determine the potential clinical consequences of each failure mode, considering both direct patient harm and indirect effects through workflow disruption or clinical decision-making impacts.
4. Cause Analysis: Identify potential root causes—software defects, hardware failures, data quality issues, user errors, environmental factors, or system interactions.
Consider a medication administration barcode scanning system:
Function: Verify correct medication, dose, patient, and timing before administration
Potential Failures:
Consequences: Wrong medication administered, delayed treatment, nurses bypassing safety checks, loss of trust in technology
Causes: Hardware malfunction, database synchronization issues, poor barcode printing quality, inadequate user training, system design flaws
Strengths: Systematic and comprehensive, links failures directly to system functions, identifies both technical and human factor issues, provides clear structure for analysis, helps prioritize safety requirements.
Limitations: Can be time-consuming for complex systems, requires detailed understanding of system functionality, may miss hazards arising from successful but inappropriate function execution, focuses on single-system failures rather than system-of-systems interactions.
SWIFT is a systematic hazard identification technique that uses structured "what-if" prompts to explore potential hazards and deviations from normal operations. It provides a more focused and efficient approach than traditional brainstorming while maintaining systematic coverage.
1. Preparation: The facilitator develops a set of structured "what-if" prompt words or phrases specific to digital health contexts:
2. Systematic Application: The team applies these prompts to each system component, workflow stage, or user interaction:
3. Scenario Development: For each "what-if" question, the team develops realistic scenarios describing how the situation could arise and what consequences might follow.
4. Risk Evaluation: Scenarios are evaluated for likelihood and severity, and existing or required controls are identified.
For a telehealth consultation platform:
What if the video connection fails mid-consultation?
What if patient health data is displayed to the wrong clinician?
What if the remote monitoring device provides inaccurate readings?
Strengths: Efficient use of time, structured yet flexible approach, encourages creative thinking, easy to learn and apply, works well with distributed teams, prompts can be tailored to specific technology types.
Limitations: Coverage depends on quality of prompt words, may miss hazards not covered by prompts, requires experienced facilitator to prevent superficial analysis, can become repetitive if not well-managed.
Each technique offers distinct advantages, and they can be used complementarily:
Use HAZID when: You need comprehensive initial hazard identification for a new digital system, you want to build team awareness and engagement, you're early in the design process with high uncertainty.
Use Functional Failure Analysis when: You need systematic analysis of how system functions could fail, you're evaluating safety requirements for procurement or development, you want to link hazards directly to system capabilities, you're conducting a detailed safety case.
Use SWIFT when: You need efficient hazard identification with good coverage, you have limited time or stakeholder availability, you're updating hazard analysis for system modifications, you want a technique that's easy for teams to learn.
Many organizations use a staged approach: SWIFT for rapid initial screening, followed by HAZID workshops for broader exploration, and Functional Failure Analysis for detailed examination of high-risk functions.
Regardless of which technique you choose, these practices enhance effectiveness:
1. Multidisciplinary Participation: Include clinicians, patients, IT staff, human factors specialists, and risk managers. Different perspectives reveal different hazards.
2. Consider the Whole Sociotechnical System: Look beyond the technology itself to examine workflows, organizational factors, training, maintenance, and the broader healthcare environment.
3. Use Real-World Scenarios: Ground hazard identification in actual use cases and clinical workflows rather than theoretical possibilities.
4. Learn from Incidents: Review incident reports, user complaints, and near-misses from similar systems to inform hazard identification.
5. Document Thoroughly: Capture not just the hazards but the reasoning, assumptions, and context. This supports ongoing risk management and regulatory compliance.
6. Iterate and Update: Hazard identification isn't a one-time activity. Revisit and update as systems evolve, new information emerges, or organizational context changes.
7. Link to Risk Management: Ensure identified hazards feed directly into risk analysis, evaluation, and control processes as part of your clinical risk management system.
Effective hazard identification is the cornerstone of digital clinical safety. HAZID, Functional Failure Analysis, and SWIFT each provide structured approaches to systematically uncover potential sources of harm before they affect patients. By selecting the appropriate technique for your context and applying it rigorously, organizations can build safer digital health systems and protect patients in our increasingly technology-enabled healthcare environment.
The investment in proactive hazard identification pays dividends through fewer incidents, more robust systems, better-informed design decisions, and ultimately, safer patient care. As digital health continues to transform healthcare delivery, these techniques will remain essential tools in the clinical safety professional's toolkit.
