A Case Study on Health Equity Through the Lens of Pulse Oximetry

This case study examines how the practices surrounding medical care during the COVID-19 pandemic sparked a health equity movement focused on pulse oximetry, ultimately prompting significant action from the U.S. Food and Drug Administration (FDA). During the pandemic, allegations of disparities in pulse oximetry readings, particularly among people with darker skin pigmentation, were raised with an urgent demand for action. This case study will delve into the series of events that led to these revelations and the subsequent changes in regulatory practices. It will also explore the perspectives and lessons from industry stakeholders who navigated these challenges firsthand.

This discussion is particularly relevant for the RAPS conference audience, as it highlights how the FDA is advancing its strategic priority promoting equity in healthcare technologies. It also demonstrates how external factors and evolving healthcare trends can drive regulatory action, even in well-established device categories. Furthermore, the talk will explore the regulatory tools employed by the FDA to achieve a meaningful resolution and how the industry is responding to these changes. This case study underscores the vital intersection of health equity, regulatory action, and technological advancement.