Medical Device Design Flaws for Children With Medical Complexity at Home

Children with medical complexity (CMC) are a growing population of pediatric patients with disabling multisystem conditions leading to reliance on medical devices and disposable supplies. These products are essential for CMC, but prior research has linked problems with home devices to emergency care and hospitalizations. We aimed to understand parent experiences with in-home devices and identify opportunities for improvement.

A cross-sectional qualitative study of English and Spanish-speaking parents of CMC was conducted using semistructured interviews. Parents could also opt to send pictures with descriptions of their children's home device use. Applied thematic analysis and content analysis were used to identify key themes and preferred design attributes.

We conducted 17 semistructured interviews with parents of CMC. Eight parents submitted 97 total pictures. Five main themes emerged: (1) lack of communication and education about product availability; (2) frequent, major device design flaws, often with safety and health risks; (3) parents of CMC often addressed unmet device needs and flaws with improvised problem-solving strategies; (4) structural barriers reduce access to efficacious and high-quality in-home devices; and (5) parents of CMC value a variety of medical devices design attributes.

Parents of CMC reported that the current landscape of medical devices functionally available to CMC for life at home and in the community is inadequate. These findings raise concerns that medical device design flaws can pose safety risks and negatively impact the health of CMC. Future work should incorporate user input into tailoring both medical product design and coverage.