A use-related risk (German: nutzungsbedingtes Risiko) is a term used in practice for a risk associated with the use of a medical device. It can arise from the interplay of user, task, user interface, and use environment. Use errors or other use-related factors can be part of a foreseeable sequence of events that leads to harm via a hazardous situation. The risk results from the probability of occurrence of this harm and its severity.
How do use-related risks arise?
Many serious incidents with medical devices are not caused by technical malfunctions but by difficulties in use. Use-related risks typically arise from the interplay of several influencing factors: user-related factors such as lack of experience, insufficient training, time pressure, or physical and cognitive limitations; product-related factors such as unclear user interfaces, hard-to-understand labeling, unfavorable controls, or insufficient feedback; and context-related factors such as poor lighting, noise, distractions, or emergency situations. From a regulatory perspective, IEC 62366-1 is based on the assumption that risks must not be considered exclusively in terms of the product but arise precisely from the interaction between human and product.
Delimitation from use error
Use-related risk and use error are often confused but describe different concepts. A use error is the actual erroneous action or omission of a user. A use-related risk, by contrast, describes the combination of probability and severity of a harm that can arise from use. It exists before the actual error and should be reduced primarily through design. Example infusion pump: The feature of the user interface is similarly designed controls, the use error is the selection of the wrong function or setting, and as a consequence a wrong dose is programmed and delivered. The hazardous situation is that the patient is exposed to too high a medication dose, and the possible harm is a health injury due to overdose. The risk results from the probability of this sequence and the severity of the harm.
| Use error | Use-related risk | |
|---|---|---|
| What it is | The actual erroneous action or omission of a user | The combination of probability and severity of a harm that can arise from use. Exists before the actual error |
| Example infusion pump | Selection of the wrong function or setting | Results from the probability of the sequence leading to overdose and the severity of the harm |
Connection with risk management
Use-related risks are an important part of risk management according to ISO 14971 and of usability engineering according to IEC 62366-1. They are typically identified on the basis of the use specification, user profiles, context and task analyses, known usability problems, and formative evaluations. This information supports the identification of hazards, hazardous situations, and hazard-related use scenarios. The associated risks are evaluated and controlled in the risk management process according to ISO 14971.
Role in the usability engineering process
The identification of use-related risks is not a one-time step but accompanies the entire development process: from the use specification through context and task analysis to the use-related risk analysis and the formative and summative evaluation. Not every use-related risk has the same relevance. Particularly important are risks associated with critical tasks and hazard-related use scenarios, that is, courses of use in which a use error can lead to a hazardous situation with serious harm. These scenarios are typically the focus of the summative evaluation and must be adequately addressed in the validation.
Risk reduction through human factors engineering
Human factors engineering aims to reduce use-related risks as early as possible in the development process, for example through simplified workflows, clear presentation of information, ergonomic controls, physical protection against mix-ups, or improved feedback to users. Design solutions are in principle preferred over warnings or training because they have been shown to be more effective. Use-related risks also arise with medical device packaging, for example when a package does not sufficiently support aseptic presentation and thereby promotes contamination of sterile products.
A use-related risk exists before the actual use error. It results from the probability and severity of a harm that can arise from use, and it is the primary starting point for design measures.
It usually arises from the interplay of user, product, and context of use, rarely from only one of these sources alone.
Frequently asked questions (FAQ)
Is a use-related risk the same as a use error?
No. The use error is the actual erroneous action. The use-related risk results from the probability and severity of a harm that can arise from use. It exists before the error and is the primary starting point for design measures.
Do use-related risks arise only from poor product design?
No. They typically arise from the interplay of user-related, product-related, and context-related factors, for example time pressure, unclear user interfaces, and poor lighting together. Rarely does the cause lie in only one of these areas alone.
How are use-related risks prioritized?
Risks associated with critical tasks and hazard-related use scenarios are particularly critical, that is, courses of use in which a use error can lead to a hazardous situation with serious harm. These are treated with priority in the use-related risk analysis and are the focus of the summative evaluation.
Do you want to identify use-related risks before they become use errors? We support you in the systematic use-related risk analysis.
More about our usability engineeringSources
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 14971:2019, Medical devices, Application of risk management to medical devices