--- title: "Use Error, Definition | MedTech Terms" description: "User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/use-error#term", "name": "Use Error", "description": "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. 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It clarifies that this does not necessarily imply user fault, but rather a deviation from the expected outcome." } }, { "@type": "Question", "name": "What is the distinction between a 'use error' and a 'user error'?", "acceptedAnswer": { "@type": "Answer", "text": "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." } }, { "@type": "Question", "name": "How are use errors typically identified during device development?", "acceptedAnswer": { "@type": "Answer", "text": "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." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Use Error [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence) # 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 Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per [IEC 62366-1](/terms/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. 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](/terms/mdr-reporting), in Annex I, Section 14.2, highlight the importance of designing devices to minimize use error and ensure [safe](/terms/safe-note) and effective operation. ## What this means in practice Use errors are addressed via design changes, mitigations, training, or [labeling](/terms/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 How does IEC 62366-1 define a use error? [IEC 62366-1](/terms/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. What is the distinction between a 'use error' and a 'user error'? How are use errors typically identified during device development? ## Cross-references ### See also Closely related context worth reading. - [ Use-Related Risk Analysis(URRA) ](/terms/urra) ## Related terms Grouped by theme ### 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. ](/terms/human-factors)[ Standards IEC 62366-1 Application of usability engineering to medical devices. ](/terms/iec-62366-1) ### 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 ](/terms/summative-formative?from=risk-and-usability)[ Quality & Risk Use Specification Defined description of intended users, uses, use environments, and patient populations for a device. Adjacent lesson ](/terms/use-specification?from=risk-and-usability)[ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971?from=risk-and-usability)[ Regulatory Labeling All written, printed, or graphic matter on or accompanying a device. ](/terms/labeling?from=risk-and-usability) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Risk & Usability Deep Dive](/paths/risk-and-usability)Lesson 7 of 9 Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 FDA· 1 1. [1 IEC 62366-1 Verified ISO · iso.org ](https://www.iso.org/standard/63179.html) 2. [2 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) 3. [3 FDA - Clinical Trials and Human Subject Protection Verified FDA · fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=use-error) Learn in 60 seconds Card Lesson Quiz 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. Remember this Watch out: Assuming use errors are solely due to user incompetence rather than design flaws can lead to ineffective risk mitigation. Related terms - [Human Factors Engineering(HFE) ](/terms/human-factors) - [IEC 62366-1 ](/terms/iec-62366-1) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) - [Adaptive Trial Design ](/terms/adaptive-trial) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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