The US Food and Drug Administration (FDA) has taken a major step to address long-standing disparities in the accuracy of pulse oximeters, devices that measure blood oxygen levels.
For years, research has shown that these devices tend to provide less accurate readings for people with darker skin tones. The FDA's new draft guidance aims to ensure that pulse oximeters are tested more effectively across all skin tones, helping to prevent biased and potentially harmful readings.
FDA Urges Inclusive Testing to Address Pulse Oximeter Skin Tone Disparities
Pulse oximeters, which became widely used during the COVID-19 pandemic, clip onto a person's finger to estimate oxygen levels in the blood. These devices work by sending light through the finger, where sensors measure how the blood absorbs the light.
However, the technology has limitations, especially for individuals with darker skin. If pulse oximeters are not calibrated properly for darker skin tones, the readings can be overestimated, leading to inaccurate health assessments.
In response, the FDA has published draft recommendations to manufacturers, urging them to conduct more inclusive testing and clearly label their devices.
One of the key recommendations is that manufacturers should include at least 150 participants with diverse skin tones in their clinical trials.
According to Stat, this includes ensuring that at least 25% of participants fall within each of the skin tone categories, based on the Monk Skin Tone scale, which is a system used to categorize skin pigmentation.
The guidance also calls for prominent warnings on product labels, informing users that skin color may affect the performance of the pulse oximeter.
FDA officials emphasized that this guidance reflects the agency's commitment to improving medical devices for all users, especially those affected by these disparities. While the recommendations are not mandatory, they are expected to influence the manufacturing process for pulse oximeters, which are commonly used in hospitals and healthcare settings.
The FDA has also proposed creating a public registry of devices that meet the new standards, further ensuring transparency and promoting consumer trust.
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FDA's New Pulse Oximeter Guidelines Could Boost Health Equity
Studies conducted over the years have shown that pulse oximeters can inaccurately measure oxygen levels in people of color, leading to potentially dangerous outcomes.
For example, research published in 2022 found that Black, Hispanic, and Asian patients were often given less oxygen than necessary due to faulty pulse oximeter readings, CNN said.
In some cases, this contributed to patients not receiving timely medical care, which could have worsened their condition or even resulted in death.
In light of these concerns, experts have praised the FDA's efforts but remain cautious about the effectiveness of voluntary guidelines. Some worry that manufacturers might not fully comply with the new recommendations.
However, public health professionals hope that the increased transparency and testing standards will push for more equitable care and improve the accuracy of pulse oximeters for all patients.
The FDA is currently seeking public input on these draft recommendations, with comments due within 60 days. Following this review period, the agency will finalize the guidance.
The updated recommendations are expected to be an important step in reducing health disparities, but only time will tell if they lead to meaningful changes in the market.
By addressing these inequities, the FDA is striving to ensure that pulse oximeters work effectively for people of all skin tones, improving health outcomes and enhancing the reliability of this essential medical tool.
