An upcoming FDA advisory panel meeting will address the need to enhance the accuracy of pulse oximeters, with a particular focus on patients with darker skin. The increased use of pulse oximeters during the COVID-19 pandemic underscored limitations and risks associated with the technology, especially for individuals with darker skin pigmentation. The committee aims to discuss strategies to improve premarket studies, considering skin pigmentation, race, and ethnicity. The FDA is contemplating an update to its 2013 guidance for pulse oximeter manufacturers, seeking input on the design of a premarket clinical trial to address disparities in accuracy. The proposed trial includes 24 participants across the Monk Skin Tone scale to enhance diversity. The FDA’s decision to revisit this issue builds on a previous agreement by the advisory panel in November 2022, acknowledging the lower accuracy of pulse oximeters in darker-skinned patients. The 9.5-hour meeting will delve into recent studies and reviews, with a focus on devising measures to mitigate inaccuracies in pulse oximeter readings, particularly in diverse populations. While the FDA is not bound by advisory committee recommendations, it often considers them when making regulatory decisions.
February 1, 2024