FDA draft guidance targets racial bias in pulse oximeters

Addressing disparities in device performance

Pulse oximeters, widely used in hospitals and clinics, have faced scrutiny for potential inaccuracies in readings based on skin tone, contributing to racial disparities. Current evidence suggests that individuals with darker skin pigmentation might experience less accurate readings than those with lighter skin. To tackle this, the FDA's draft guidance outlines updated recommendations for manufacturers on gathering clinical data and refining clinical study designs to better evaluate the performance of these devices across diverse populations.

"This draft guidance is aligned with the FDA's broader commitment to helping facilitate the development of high-quality, safe and effective medical devices," said Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health. "Our recommendations are based on the best available science to address concerns about disparate performance based on an individual's skin pigmentation."

Key recommendations for manufacturers

The draft guidance emphasizes the following steps manufacturers should take to ensure pulse oximeters meet performance standards for all patients:

• Data collection. This involves incorporating clinical data from controlled desaturation studies or real-world settings to evaluate the accuracy of pulse oximeters across a range of skin pigmentations.
• Expanded clinical studies. This focuses on increasing the diversity of participants in clinical trials to ensure better representation of the intended population.
• Standardized skin tone assessment. This utilizes subjective methods, such as the Monk Skin Tone Scale, in combination with objective metrics like individual typology angle calculations to ensure a consistent and accurate evaluation of device performance across different skin tones.
• Transparent labeling. This requires the inclusion of clear and prominent labeling to indicate when a device has been validated to perform comparably across individuals with diverse skin tones.

The guidance applies to pulse oximeters intended for medical use, often utilized for monitoring oxygen saturation in clinical decision-making. It excludes general wellness or consumer devices, such as those marketed for fitness or aviation purposes, not subject to FDA evaluation.

Facilitating timely access to improved devices

The FDA anticipates that some currently marketed pulse oximeters might already meet the new performance criteria without requiring significant hardware or software modifications. For these devices, manufacturers can expedite updates to labeling to reflect improved performance across skin tones. The FDA has committed to reviewing such submissions within 30 days to ensure the rapid availability of improved devices.

Ongoing efforts and next steps

The agency's recommendations are informed by data from laboratory desaturation studies, real-world usage and FDA-funded clinical trials involving diverse populations, including pediatric and adult patients. Input from advisory committees, academic institutions, manufacturers and healthcare providers also played a pivotal role in shaping the draft guidance.

To further assist healthcare providers and consumers, the FDA has proposed creating a publicly accessible webpage listing FDA-cleared pulse oximeters demonstrating equitable performance across skin tones.

Stakeholders are encouraged to comment on the draft guidance by March 7, 2025. Once finalized, these recommendations are expected to help reduce disparities in medical device performance and enhance patient care.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.