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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.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    ISO·2FDA·1
    1. 1
      IEC 62366-1
      Tier 1 Verified
      ISOiso.org
    2. 2
      ISO 14155 Standard Page
      Tier 1 Verified
      ISOiso.org
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Tier 2 Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.