Clinical & Trials
Use Error
In one line
User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.
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.
Why it matters
Use errors are addressed via design changes, mitigations, training, or labeling, evaluated through formative and summative usability studies.
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.
Sources