Golden State Today

California Attorney General Rob Bonta has urged the U.S. Food and Drug Administration (FDA) to address inaccuracies in pulse oximeters that affect communities of color. In a comment letter submitted to the FDA, Bonta emphasized the need for immediate action to improve these medical devices, which are used to measure blood oxygen levels.

The FDA had previously invited public comments on its draft guidance regarding non-clinical and clinical performance testing of pulse oximeters. This guidance aims to provide recommendations for ensuring accurate readings across different skin tones. The COVID-19 pandemic highlighted the discrepancies in pulse oximeter readings for individuals with darker skin, leading to increased awareness and evidence of this issue.

Attorney General Bonta stated, "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." He further emphasized the importance of equitable healthcare, saying, "We cannot accept that inaccurate results from pulse oximeters are more likely when used to monitor patients with darker skin."

In his letter, Bonta pointed out that faulty pulse oximetry has resulted in denial of care or inadequate treatment for patients with severe COVID-19 cases and other conditions. He advocated for maintaining a list of devices that perform equally well on all skin tones on the FDA's website to promote transparency.

The draft guidance also includes recommendations for manufacturers on collecting clinical data to enhance device efficacy across diverse skin tones. Bonta stressed the necessity for real-world testing environments where patients have low oxygen levels, as this could prevent incorrect readings.

Bonta warned against delays in finalizing and enforcing these recommendations, stating that all patients require better pulse oximeters immediately. Previously, on November 1, 2023, he led a coalition of 25 attorneys general urging the FDA to strengthen its guidance and warning labels concerning incorrect readings affecting people of color.

A copy of Attorney General Bonta's comment letter is available online.