Risks and Usability Challenges in the Use of Medical Devices in the Home Setting/Environment

This systematic literature review examined risks associated with home-use medical devices and the extent to which usability challenges are addressed in published studies. Following PRISMA guidelines, authors searched multiple databases for English-language human studies published from 2019 to May 30, 2024. Of 628 titles screened, 55 articles met the inclusion criteria and were analyzed for device category, adverse events, and usability challenges classified into three components of the device-user system: users, use environments, and user interfaces. The most common device categories were electrosurgery, phototherapy, venous access, dialysis, and drug delivery. Results showed that approximately 38% ( n  = 21) of studies did not describe usability challenges and only 11% ( n  = 6) addressed all three human factors domains. Most studies (89%, n  = 49) involved patients and/or caregivers as end users. Reported challenges included physical, cognitive, cultural, and environmental barriers that could affect safe and effective use. This review highlights the need for integrating human factors for device safety and effectiveness.