127 Accessibility and Ease of Use in Neuromodulation Devices

Abstract

INTRODUCTION: Inclusive design is an engineering process that requires the product development team to balance the needs and limitations of many stakeholders, including those of the end user, regulatory organizations, and the designing institution. However, some patients confront challenges in using neuromodulation devices. These challenges include visual or hearing impairment and mobility and dexterity limitations that affect operation of the device components. METHODS: A primary set of points based on the seven principles of universal design, Twenty-First Century Communications and Video Accessibility Act (CVAA), Section 508, Web Content Accessibility Guidelines (WCAG), and the Americans with Disabilities Act (ADA) were created to obtain ratings of neuromodulation device characteristics for accessible operation. The author team developed a list of FDA-approved devices for brain, spinal, and peripheral pain neuromodulation available in the United States in 2021 and a standard survey was administered to evaluate each component. Data were gathered from representative patient-operated components of neuromodulation systems including device controllers and chargers to compare and rank the inclusivity of each. RESULTS: A representative number of neuromodulation devices in each category were assessed. Current data show multiple areas to improve the inclusivity of these devices. Multiple disabilities are not adequately considered during design. Inclusivity scores for the considered disabilities are summarized. CONCLUSION: Many currently FDA-approved neuromodulation devices are limited in their utility for disabled patients. Incorporating the recommendations of universal design into future devices will increase quality of care for our diverse and aging population.