Human errors in medical device use constitute a significant part of medical errors. Those errors are, for most of them, directly related to an inappropriate design for user interactions. In 2000, It has been estimated that, in the US, between 44'000 and 98'000 preventable deaths and about 1'000'000 excess injuries were caused due to medical errors. In addition, it is estimated that each year the total amount of costs generated through medical errors is around $19.5 billion. Mechanical complications of devices, implants or graft is the third cause.
Therfore, use errors caused by inadequate medical device usability have become an increasing concern. Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn and to use. As some user interface provide non-intuitive or counter-intuitive displays or controls, they contributes directly to errors when used. The consequences of such designs often become apparent only when the user is using the device in an emergency or stressful situations.
As healthcare and technology evolve, less skilled users are using increasingly complexmedical devices. The design of a usable medical device is a challenging endeavour. The design of the user interface to achieve adequate and safe usability requires specific skills that differ from those required for the technical implementation of the interface.
The usability engineering process is intended to achieve reasonable medical device usability in order to minimise error of use. Since EN 62366:2008 has been harmonized, the integration of a usability engineering process in the general development process and in the risk management has become mandatory.
Medidee is experienced in the implementation of such a process as well as evaluating the usability of a device or conducting its validation with regards to usability.
Our usability services
- Assessment of risk management file
- Cross-assessment of IFU with risk management file
- Assessment of man machine / user interface
- Integration of EN 62366 and EN 60601-1-6 in QM
- Design and execution of Usability validation study