Medical device risk management has its own vocabulary that everyone involved in the risk management process must learn and use correctly and consistently—otherwise, the probability of miscommunication and the potential of errors increases. This risk management glossary includes some of the most commonly used terms in medical device risk management.
- Abnormal use: A conscious, intentional act or unintentional act that violates normal use and is beyond further reasonable means of UI-related risk control by the medical device manufacturer.
- Action error: error in the performance of an action, and not primarily related to cognition or perception deficiencies.
- Basic safety: Freedom from unacceptable risk caused by physical hazards when the device is used under normal and single fault conditions.
- Cognition error: An error related to a deficiency in cognition.
- Correct use: Normal use without use errors.
- Essential performance: The performance of a clinical function, different than that related to basic safety, where loss or degradation past the limits indicated by the manufacturer causes an unacceptable risk.
- Expected service life: The time period specified by the product manufacturer during which the medical device is expected to remain safe for use.
- Fault: An unnatural condition for a part.
- Formative evaluation: A UI evaluation that is conducted to explore UI design strengths, weaknesses and unanticipated use errors.
- Harm: An injury or damage to the health of people or damage to property or the environment.
- Hazard: A potential source of harm.
- Hazardous situation: A circumstance in which people, property or the environment are exposed to one or several hazards.
- Hazard-related use scenario: A use scenario that could result in a hazardous situation or harm
- Instructions for use (IFU): Information provided by the product manufacturer to inform the user of the medical device’s intended purpose and proper use, as well as of any precautions to be taken.
- Intended use: The use for which a medical device is intended according to the specifications and IFU provided by the manufacturer.
- Intended purpose: The use for which a product is intended according to the information presented on the label, in the IFU or sale materials and as specified in the clinical evaluation.
- Malice: Intentional act to harm people, property or the environment.
- Misuse: Incorrect use of the medical device.
- Normal use: Operation according to the instruction for use.
- Perception error: An error related to a deficiency in perception.
- Primary operating function: A function that involves user interaction and is related to the device’s safety.
- Product failure: The inability of a device to achieve its purpose.
- Residual risk: The risk remaining after the implementation of risk reduction measures.
- Risk: A combination of the harm’s probability of occurrence and its severity.
- Risk analysis: A systematic use of accessible information to identify hazards and estimate risk.
- Risk assessment: A process including risk analysis and risk evaluation.
- Risk control: A procedure in which decisions are made and measures implemented to reduce risks to specified limits.
- Risk estimation: A process used to assign values to the risk.
- Risk evaluation: A process of the estimated risk against specific risk criteria to determine the risk’s acceptability.
- Risk management: A systematic use of management policies, practices and procedures related to the tasks of analysing, evaluating, controlling and monitoring risk.
- Risk management file: A set of records produced by risk management.
- Summative evaluation/study: A UI evaluation that is conducted at the end of the UI development to obtain objective evidence that the UI can be used safely.
- Usability: A characteristic of the UI that facilitates use and thus establishes effectiveness, efficiency and user satisfaction in the intended use environment.
- Use error: A user action or lack of user action while using the medical device, which results in a different outcome than that intended by the manufacturer and expected by the user.
- Use failure: Failure of a user to achieve the intended and expected result from the interaction with the medical device.
- Use scenario: Specific sequence of tasks performed by a specific user in a particular use environment and any resulting response of the medical device.
- User: Any healthcare professional or layperson who uses a medical device.
- User interface (UI): A means by which the user interacts with the medical device.
