The FDA has proposed updated recommendations to improve the accuracy of pulse oximeters for diverse skin tones, acknowledging longstanding concerns over disparities in device performance.
Pulse oximeters, crucial for monitoring blood oxygen levels, have faced criticism for inaccuracies in darker-skinned patients, with studies revealing overestimated oxygen levels compared to lighter-skinned individuals. This discrepancy has impacted treatment decisions, especially during critical moments like the COVID-19 pandemic.
To address this, the FDA’s draft guidance recommends manufacturers:
• Conduct clinical studies with a minimum of 150 participants, ensuring diverse representation across the Monk Skin Tone Scale.
• Utilize standardized methods to evaluate skin tone’s impact on device accuracy.
• Clearly label devices proven to perform equitably across skin tones.
Dr. Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health, emphasized, “Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual’s skin pigmentation.”
The FDA also plans to create a public registry of FDA-cleared pulse oximeters that meet these standards. While some devices already comply, new labeling and rigorous testing will help healthcare professionals identify accurate and unbiased tools.
However, experts caution that without formal enforcement, compliance may remain limited, as seen with earlier guidance. Harvard Law faculty Carmel Shachar noted, “This guidance provides incentives for manufacturers to create better products, but more needs to be done to ensure adoption.”
