Background
Home care medical devices are the fastest-growing segment of the medical device industry with associated safety and usability challenges. Human factor studies in the home environment present many difficulties resulting in limited knowledge of device use in this setting. This systematic review aims to identify usability challenges reported directly by end-users in the home environment.

Methods
A systematic review of the literature was conducted concentrating on studies involving end user reporting. Reported challenges were grouped into a) device-user, b) device use environment and c) device-user interface challenges.

Results
3471 studies were screened and 202 underwent full-text review. Only twelve studies had direct involvement of end users. Multiple challenges were identified, with device-user interface problems being the most common. No effective, standardised method was found to collect patient/user feedback on usability challenges in the post-market stage, leading to a knowledge gap.

Conclusions
This study brought together multiple usability challenges reported by individual studies. Involvement of medical device end-users in usability studies is essential and their experiences must be effectively utilised in device design.