The Food and Drug Administration (FDA) is calling for stricter testing standards for pulse oximeters—devices commonly used to measure blood oxygen levels—under a new federal proposal released Monday.
Why It Matters
The agency’s proposal aims to take a significant step toward addressing racial biases in medical technology following concerns pulse oximeters may provide inaccurate readings for people with darker skin tones.
Pulse oximeters, a staple in hospitals and clinics, work by analyzing how light is absorbed through a fingertip to estimate oxygen levels in the blood. Their role became even more vital during the COVID-19 pandemic, where accurate oxygen monitoring was crucial for patients.
However, studies have raised red flags, suggesting that these devices often overestimate oxygen levels in Black patients. This discrepancy could lead to delayed treatment and increased health risks.
Anupam Nath/AP
What To Know
In an effort to address these concerns, the FDA has proposed new draft recommendations for manufacturers aimed at adopting more rigorous clinical study designs and data validation efforts.
The FDA’s recommendations, which aim to tighten regulatory oversight, include clinical studies involving at least 150 participants with diverse skin tones, ensuring that at least 25 percent of study participants have darker skin pigmentation and using multiple methods to assess skin pigmentation, including visual evaluations and light-based measurements of melanin.
The agency emphasized that these guidelines apply to professional-grade oximeters used in medical settings and not to over-the-counter models, which remain unregulated.
While older devices already in use won’t be affected immediately, manufacturers seeking approval for updates or modifications will need to comply with the new standards.
The move comes amid growing awareness of racial inequities in healthcare and reflects a broader effort to…
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