WASHINGTON (AP) — The Food and Drug Administration (FDA) has announced a new draft proposal aimed at requiring manufacturers of pulse oximeters to gather extensive clinical data to ensure these devices function accurately across various skin tones. This guidance follows increasing evidence suggesting that pulse oximeters, widely utilized for measuring blood oxygen levels, are often less reliable for individuals with darker skin, as indicated by multiple studies over the years.

Pulse oximeters are vital tools in clinical settings, especially highlighted during the COVID-19 pandemic when rapid assessments of oxygen levels became crucial. However, the FDA has noted that these devices have displayed marked inaccuracies, particularly for Black patients, potentially leading to misdiagnoses and increased health risks. A 2021 safety communication from the FDA cautioned healthcare professionals about such inaccuracies, stating that the devices often overestimate oxygen levels in Black individuals, which could delay necessary treatment and contribute to higher mortality rates during health crises.

The FDA's draft recommendations suggest that manufacturers should enroll a minimum of 150 patients of varying skin tones in their clinical studies, ensuring that at least 25% of participants represent those with darker skin tones. The guidelines further stipulate that half of the patients with dark skin should have very dark skin. Additionally, the FDA emphasizes the need for thorough evaluation of the pigmentation of each participant using at least two approaches: a subjective assessment by the researcher and a quantitative light-based measurement of melanin levels.

As these guidelines are currently in draft form, the FDA will accept public comments for 60 days before finalizing the guidance. While the recommendations are not legally binding, they aim to address significant disparities in how effectively pulse oximeters operate across diverse populations, thereby promoting health equity.

It's crucial to note that these new recommendations apply exclusively to professional-grade pulse oximeters used in hospitals and medical settings; the FDA does not regulate over-the-counter versions, which are categorized as general wellness devices. Authorities are hopeful that with better data and inclusive testing, the accuracy of pulse oximeters can be significantly improved, thereby enhancing patient outcomes for all demographic groups.

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