11d·
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FDA Proposes New Guidelines to Address Racial Bias in Pulse Oximeter Readings

The FDA's draft guidance aims to improve pulse oximeter accuracy across diverse racial groups by requiring better clinical data.

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The FDA has announced draft guidance for pulse oximeter manufacturers, requiring more diverse clinical studies to improve accuracy for patients of color. Recommendations include enrolling at least 150 participants from various skin tones and evaluating pigmentation through scientific methods. This move addresses longstanding concerns about device inaccuracies, particularly for those with darker skin. The guidance follows alarming studies indicating that oximeters may overestimate oxygen levels in Black, Asian, and Hispanic patients, leading to delayed treatment and increased health risks. Public comments on the draft will be accepted for 60 days before finalization.

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From the Left

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  • Pulse oximeters show less accuracy for individuals with darker skin tones, leading to potential health risks due to erroneous readings.

  • The FDA's draft guidance aims to improve clinical testing and labeling of pulse oximeters, advocating for diversity in participant selection to ensure equitable medical device performance.

  • Experts express concerns about manufacturers' compliance with FDA recommendations, emphasizing the necessity for enforceable standards to prevent bias in medical devices.

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