The Medical Device Safety Solution implements this decision with dedicated fields on each risk record, a structured evaluation workflow, and a final risk determination that auditors can trace from hazard to disposition.
When Benefit-Risk Analysis Is Required
Benefit-risk analysis applies to a specific subset of risk records:
The three post-mitigation outcomes:
| Post-Risk Level | Benefit-Risk Required? | Next Step |
|---|
| Acceptable | No | Record final risk as Acceptable |
| Investigation | Yes | Perform benefit-risk analysis |
| Unacceptable | No (but action required) | Apply additional risk controls or redesign |
The ISO 14971 Decision Sequence
ISO 14971 defines a specific sequence for residual risk that is in the Investigation zone:
- Determine if additional controls are practicable — Can the risk be reduced further through design, protective measures, or information?
- If additional controls exist — Apply them and re-evaluate. Repeat until no further reduction is practicable.
- If no additional controls are practicable — Perform benefit-risk analysis.
- Document the benefit — What clinical or patient benefit does the device provide that justifies accepting the residual risk?
- Evaluate the balance — Does the benefit outweigh the risk?
The solution captures this sequence through four fields on each risk record:
| Field | ID | Type | Purpose |
|---|
| Additional Controls Possible | additionalControlsPossible | Yes/No enum | Step 1-2: Are further controls practicable? |
| Benefit | benefit | Rich text | Step 4: Clinical benefit description |
| Benefit-Risk Result | riskBenefitResult | Enum | Step 5: Benefit > Risk (acceptable) or Benefit < Risk (not acceptable) |
| Final Risk | finalRisk | Enum | Conclusive disposition |
Benefit-Risk Result Values
The riskBenefitResult enumeration has two values:
| Value | Display Name | Meaning |
|---|
benefitAcceptable | Benefit > Risk — acceptable | The clinical benefit outweighs the residual risk |
benefitNotAcceptable | Benefit < Risk — NOT acceptable | The residual risk exceeds the clinical benefit |
If the benefit-risk result is NOT acceptable, the device cannot be released with this risk record in its current state. Either additional risk controls must be found, the design must be changed, or the intended use must be modified to reduce the risk.
Final Risk Determination
The finalRisk enumeration captures the conclusive risk disposition. Unlike preRisk and postRisk (which have the Investigation option), final risk forces a definitive decision:
| Value | Display Name | Meaning |
|---|
acceptable | Acceptable | Risk reduced to a tolerable level |
unacceptable | Unacceptable | Risk remains too high despite all measures |
benefitAcceptable | Benefit-Risk Acceptable | Residual risk accepted because benefits outweigh it |
Practical Example
Consider a risk record for the Smart Infusion Pump:
| Step | Field | Value |
|---|
| Hazard | — | Air bubble in fluid path |
| Harm | — | Air embolism (Severity: Critical) |
| Pre-mitigation risk | preRisk | Unacceptable |
| Risk control applied | — | Ultrasonic bubble detector with auto-shutoff (Protective Measure) |
| Post-mitigation risk | postRisk | Investigation |
| Additional controls? | additionalControlsPossible | No |
| Benefit | benefit | ”The infusion pump enables precise, continuous medication delivery to critically ill patients, replacing manual IV administration that has higher error rates and cannot maintain constant flow rates. Without this device class, patients requiring vasoactive medications face significantly higher mortality risk from dosing errors.” |
| Benefit-Risk Result | riskBenefitResult | Benefit > Risk — acceptable |
| Final Risk | finalRisk | Benefit-Risk Acceptable |
The ALARP Connection
The Investigation zone in the risk matrix corresponds to the ALARP (As Low As Reasonably Practicable) principle. Risks in this zone are neither clearly acceptable nor clearly unacceptable. The benefit-risk analysis provides the documented justification for accepting residual risk in this zone.
ALARP requires demonstrating that:
- All reasonably practicable risk controls have been applied
- The cost of further risk reduction is grossly disproportionate to the benefit
- The clinical benefit of the device justifies the remaining risk
The additionalControlsPossible field captures the first criterion. The benefit field and riskBenefitResult capture the second and third.
Audit Trail
For ISO 14971 compliance, the benefit-risk analysis must be traceable. The solution provides this through:
- Risk Record fields — The four benefit-risk fields create a structured audit trail on each record
- Risk Control Plan links — Each risk control that was applied before the benefit-risk analysis is linked and classified
- Document workflow — The HARA document goes through formal review and approval, capturing electronic signatures
- Risksheet history — Changes to risk fields are tracked through Polarion’s work item history
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