California Attorney General Rob Bonta has submitted a comment letter to the U.S. Food and Drug Administration (FDA) urging immediate action to address inaccuracies in pulse oximeters that affect communities of color. This move follows the FDA's invitation for public comment on its draft guidance, which aims to provide recommendations for testing pulse oximeters' performance.
Pulse oximeters are commonly used medical devices that measure blood oxygen levels, playing a crucial role in managing various health conditions. However, research has shown these devices often yield inaccurate results for individuals with darker skin tones. The COVID-19 pandemic highlighted these discrepancies, raising concerns about their impact on healthcare equity.
Attorney General Bonta commended the FDA's efforts to tackle this issue, stating: "The FDA is charged with protecting public health. I commend the agency for not shying away from addressing racially biased and inaccurate results in pulse oximeters — a reality that was especially evident during the COVID-19 pandemic."
Bonta emphasized the need for equitable healthcare by noting: "We cannot accept that inaccurate results from pulse oximeters are more likely when used to monitor patients with darker skin. My office has been at the forefront of the calls to right this wrong, and we will continue fighting for a more equitable healthcare system."
The comment letter highlights several key points:
1. Faulty pulse oximetry has led to denial of care or inadequate treatment in severe COVID-19 cases among patients with darker skin, potentially resulting in organ failure and death.
2. The proposed guidance includes maintaining a list of devices proven effective across all skin tones to enhance transparency.
3. Recommendations for manufacturers include gathering clinical data to improve device efficacy on diverse skin tones.
4. The FDA should require real-world testing environments where low-oxygenated blood is common.
5. Any delay in implementing these recommendations would be unacceptable as improved pulse oximeters are urgently needed.
In November 2023, Attorney General Bonta led a coalition of 25 attorneys general urging the FDA to strengthen guidance and provide clear warning labels regarding incorrect readings for patients of color.
A copy of the comment letter is available online.