The U.S. Food and Drug Administration (FDA) has proposed new guidelines aimed at improving the accuracy of pulse oximeters for people of all skin tones, addressing concerns that these essential medical devices may not work equally well across diverse populations.

Pulse oximeters, the small devices that measure blood oxygen levels via a clip on the finger, gained prominence during the COVID-19 pandemic. However, recent studies, including one from 2021, revealed that these devices often overestimate oxygen levels in Black patients, potentially delaying critical treatment and increasing health risks.

To tackle these disparities, the FDA released draft recommendations on January 6, urging manufacturers to conduct more inclusive clinical studies. The proposed changes emphasize the importance of diversity and precision in device testing.

Among the key measures, the FDA suggests enrolling at least 150 participants with varied skin tones in each clinical study, with at least 25% representation from individuals with darker skin—an increase from the current 15%. Additionally, the new guidelines call for scientific evaluations of skin pigmentation using advanced melanin measurement techniques to ensure greater accuracy.

These recommendations apply exclusively to professional-grade pulse oximeters used in medical settings such as hospitals and clinics. Over-the-counter devices, often sold as "general wellness" tools, remain unaffected by the proposed rules.

The FDA's draft guidelines do not require existing devices already on the market to comply with the updated standards unless manufacturers seek modifications or approvals for new versions.

The agency is seeking public feedback on the draft guidelines, inviting comments over the next 60 days before finalizing the recommendations.

This move is seen as a significant step toward ensuring equity in healthcare technology, addressing long-standing biases, and enhancing patient care for individuals with darker skin tones.