A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people with darker skin, creating a standard skin pigmentation assessment and better labeling guidelines to ensure users know the limitations of the devices.
On 1 November, FDA convened a meeting of its Anesthesiology and Respiratory Therapy Devices Panel to discuss how to improve the development of pulse oximeters and how they are regulated. While pulse oximeters have been on the market for decades, their use skyrocketed during the COVID-19 pandemic as people bought over-the-counter devices to monitor their oxygen levels. Their increased use drew attention to the fact that the devices were not as accurate as expected for people with darker skin…
