Usability as a Pillar of Safety in Medical Devices
Usability in medical devices is not just about design or user experience — it is a fundamental component in ensuring the safety of the patient, the user, and everyone involved in the use environment.
Usability refers to the characteristics of the user interface that make it easier for users to perceive and understand information, supporting accurate decision-making and safe interaction with the device.
According to international standards, it is the manufacturer’s responsibility to establish, document, implement, and maintain a usability engineering process. This process must be carried out by competent personnel, with the appropriate skills and experience, and it must be properly planned and documented.
Why is this process so important?
Because safety is defined as freedom from unacceptable risk. One of the key contributors to risk is use error, whether accidental or intentional (abnormal use). These errors can lead to serious consequences such as exposure to physical hazards or a loss of clinical functionality.
That’s why the usability engineering process must analyze all possible interactions between the user and the device, including:
- Transport
- Storage
- Installation
- Operation
- Maintenance
- Disposal
Each of these stages can influence safety in different ways. By applying usability engineering as a method to identify and minimize use errors, manufacturers can reduce risks associated with normal use and better understand those arising from abnormal use.
It’s important to note that not all forms of incorrect use can be controlled by the manufacturer. However, usability engineering is deeply connected to risk management.
To reduce use-related risk, manufacturers should prioritize the following actions (in descending order of effectiveness):
- Inherent safety by design
- Protective measures within the device or manufacturing process
- Information for safety — which must be perceivable, understandable, and supportive of correct use.
Integrating usability into the development process is not just best practice — it’s essential for delivering safer, more reliable medical devices.
Have a look at this flyer with a summary of the key points: USABILITY IN MEDICAL DEVICES
