Usability Testing of medical device Instructions For Use (IFUs)
There is a huge diversity of Medical Devices on the market. Ever more complex Devices are available 'over the counter' and rely almost wholly on their Instructions For Use (IFUs) for safe and effective use. In many cases, failure to use the device properly can put patients at risk.
Importantly, more patients are treated at home where just a few years ago they would have been treated in secondary care. Advances in Medical Device technology and support services has facilitated this change. How can device manufacturers demonstrate that their device or combined drug device is being used correctly by the patients, carers or healthcare professionals?
The application of usability testing techniques can identify issues that the target user could have with respect to safe and effective use of the Medical Device. The application of usability testing and communications expertise in an iterative process can refine instructions for use to minimise these issues and reduce the risk.
Do you consider usability testing of IFUs as part of your risk management?
