FDA Urged to Address Skin Color Bias in Pulse Oximeters
During a public meeting, patients, researchers, and advocates urged the FDA to take swift action to ensure pulse oximeters work well in patients with darker skin, better inform clinicians about their limitations, and recall problematic versions. Testimony highlighted the frustration over the lack of progress in addressing the devices' inaccuracies in darker-skinned patients, leading to delayed treatment and potential harm. The FDA is considering using the Monk skin tone scale to improve testing and performance standards, but panelists expressed concerns about sample sizes and the need for more transparency from device manufacturers. While FDA officials and panelists are committed to making the devices more equitable, they emphasized the importance of careful and deliberate changes to avoid introducing additional harms or reducing access.