What is the distinction between a 'use error' and a 'user error'?

While often used interchangeably in common parlance, 'use error' in MedTech emphasizes that the deviation from intended device operation may stem from design, training, or labeling issues, not solely user fault. 'User error' often implies the user is solely to blame, which is a perspective discouraged in human factors engineering for medical devices.

How are use errors typically identified during device development?

Use errors are typically identified through human factors engineering activities, such as formative and summative usability studies, task analysis, and risk assessments. These studies involve observing users interacting with the device in simulated or real-world environments.

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Use Error

User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Per IEC 62366-1, a use error is a user action or lack thereof while using a medical device that leads to a different result than that intended. It is not necessarily user 'error' - it often reflects design issues. IEC 62366-1 separates use errors from abnormal use, which is deliberate misuse outside reasonable control. Manufacturers find foreseeable use errors through task analysis, formative evaluations and post-market data, then reduce them through design first, protective measures second, and labeling or training last. Repeated use errors in complaints are a common trigger for CAPA and design changes.

What the regulation says

Regulators emphasize that medical device manufacturers must identify and mitigate use errors throughout the product lifecycle. The FDA, in its guidance "Applying Human Factors and Usability Engineering to Medical Devices," and the EU MDR, in Annex I, Section 14.2, highlight the importance of designing devices to minimize use error and ensure safe and effective operation.

What this means in practice

Use errors are addressed via design changes, mitigations, training, or labeling, evaluated through formative and summative usability studies.

Examples

A healthcare professional accidentally presses the wrong button on an infusion pump due to similar button shapes and proximity, leading to an incorrect dose delivery.
A patient fails to properly assemble a home-use medical device because the instructions for use are unclear and lack sufficient visual aids.
During a surgical procedure, a surgeon misinterprets an alarm on a monitoring device due to ambiguous auditory cues, potentially delaying critical intervention.

Common pitfalls

•Assuming use errors are solely due to user incompetence rather than design flaws can lead to ineffective risk mitigation.
•Failing to adequately document the analysis of use errors and their resolution can result in non-compliance during audits.
•Ignoring the potential for use errors in labeling or training materials can leave manufacturers vulnerable to regulatory scrutiny.

Frequently asked questions

IEC 62366-1 defines a 'use error' as an act or omission of an act that results in a different outcome than that intended by the manufacturer or user. It clarifies that this does not necessarily imply user fault, but rather a deviation from the expected outcome.

Cross-references

Editor's picks

· Hand-selected related concepts

Clinical & Trials

Human Factors Engineering(HFE)

Engineering discipline focused on safe and effective device use by intended users.

Standards

IEC 62366-1

Application of usability engineering to medical devices.

Risk & Usability Deep Dive

· From this learning path

Quality & Risk

Summative vs. Formative Evaluation

Iterative usability studies (formative) vs. final validation testing (summative) of a device's user interface.

Adjacent lesson

Quality & Risk

Use Specification

Defined description of intended users, uses, use environments, and patient populations for a device.

Adjacent lesson

Standards

ISO 14971

International standard for the application of risk management to medical devices.

Regulatory

Labeling

All written, printed, or graphic matter on or accompanying a device.

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Sources

3 sources

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Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1

Link health: 3 verified· last checked 2026-06-20

ISO·2FDA·1

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Updated: 5/5/2026

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User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.

·Use errors are addressed via design changes, mitigations, training, or labeling, evaluated through formative and summative usability studies.
·It is not necessarily user 'error' - it often reflects design issues.
·IEC 62366-1 separates use errors from abnormal use, which is deliberate misuse outside reasonable control.

Remember this

Watch out: Assuming use errors are solely due to user incompetence rather than design flaws can lead to ineffective risk mitigation.

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