Definition
Per ISO 14971:2019, harm is physical injury or damage to the health of people, or damage to property or the environment. In the context of medical devices, harm typically refers to patient injury ranging from temporary discomfort to death.
Harm is distinct from a hazard: a hazard is the source of potential harm, while harm is the consequence.
Custom Fields
| Field | Type | Enumeration | Description |
|---|
title | String | — | Harm description (for example, “Patient burn”, “Incorrect drug dosage”, “Death”) |
description | Rich Text | — | Detailed description of the harm scenario |
severity | Enum | harm-severity (1-5) | Harm severity level used in risk matrix calculations |
status | Enum | status | Standard workflow status |
Severity Scale
The harm severity scale is a 5-level classification aligned with ISO 14971:2019 Annex E guidance:
| Value | Label | Description | Color |
|---|
| 1 | Negligible | Temporary discomfort, no injury | — |
| 2 | Minor | Temporary injury, no medical intervention required | #95A5A6 (gray) |
| 3 | Serious | Injury requiring medical intervention | #2ECC71 (green) |
| 4 | Critical | Permanent impairment or life-threatening condition | #000000 (black) |
| 5 | Catastrophic | Patient death | #E74C3C (red) |
The default severity is Critical (value 4). Unassessed harms are treated as life-threatening until explicitly evaluated. This implements a conservative risk management approach — it is serious enough to demand attention but not maximally alarming (which could lead to dismissal as overly pessimistic).
Harm Catalog
The solution includes a pre-populated Standard Harms catalog document in the Catalogs space containing 25 harm entries. This catalog provides:
- A reusable library of common medical device harms
- Standardized severity assignments
- Consistent harm descriptions across risk documents
When creating risk records in the HARA risksheet, the hasHarm link column lets you pick from the catalog. Each harm can be referenced by multiple risk records.
Role in Risk Matrix
The harm severity is a critical input to the risk matrix calculation:
In the HARA risksheet, the severity value is read-only — it is pulled from the linked harm item using the cross-item binding harm.severity. This ensures that all risk records referencing the same harm use a consistent severity value.
Link Roles
| Role | Direction | Target Type | Description |
|---|
hasHarm | Incoming | riskRecord | Risk records that reference this harm |
hasHarm role. A single harm can be referenced by multiple risk records (one-to-many).
HARA Risksheet Column
In the HARA risksheet, Harm appears at Level 4 (the leaf level) of the hierarchy:
| Level | Entity |
|---|
| L1 | Use Step |
| L2 | Hazard |
| L3 | Hazardous Situation (Event) |
| L4 | Harm |
itemLink type that connects to harm work items via the hasHarm link role. The severity column immediately follows, displaying the linked harm’s severity value.
Rendering in Document View
In the HARA template document view, harm items use:
| Property | Value |
|---|
| Layouter | paragraph |
| Fields at End | severity |
| Sidebar Fields | severity, status |
| Source Document | Catalogs/Standard Harms |
Related Pages
