On the latest 24x7 podcast, host Keri Stephens was joined by Dr. Scott Lucas, Vice President of device safety at ECRI, to explore the impact of racial inequities on the accuracy of medical devices, specifically pulse oximeters.

The conversation delved into how these devices might perform differently based on skin tone, potentially affecting the medical care provided to people with darker skin.

Pulse oximeters have been shown to sometimes give less accurate readings for individuals with darker skin tones. This is because darker skin absorbs more light, which can interfere with the device's ability to accurately measure blood oxygen levels. Lucas explained the technical aspects of how pulse oximeters function and why this discrepancy can be clinically significant, especially when patients are on the borderline of needing medical intervention.

The discussion also covered recent public attention to this issue, heightened during the COVID-19 pandemic when home use of pulse oximeters increased significantly. Recent studies comparing device readings with actual blood draws have confirmed the variability in accuracy, prompting the FDA to focus on improving device testing and standards.

Dr. Lucas highlighted that current FDA guidance requires more representation of diverse skin tones in the testing phases of device development to improve accuracy across all patient populations. The proposed guidelines include methods like the Monk Skin Tone Scale, which provides a more detailed representation of various skin tones.

Addressing how these findings could impact healthcare more broadly, Dr. Lucas emphasized the importance of ensuring that medical devices are designed and tested to be effective for all racial groups. This is particularly critical as medical technology, including AI, continues to evolve.