Attorney General Bonta to FDA: Better Pulse Oximeters Needed Now to Address Inaccuracies Impacting Communities of Color

OAKLAND — California Attorney General Rob Bonta today announced submitting a comment letter to the U.S. Food and Drug Administration (FDA) urging the agency to immediately take steps to fulfill its promised actions to address inaccurate results in pulse oximeters based on race. On January 7, 2025, the FDA invited the public to provide comment on its draft guidance that, when finalized, will provide recommendations concerning non-clinical and clinical performance testing of pulse oximeters. Today’s letter responds to that invitation. Pulse oximeters are routinely used to measure blood oxygen levels, which inform medical care for a wide range of illnesses including heart failure, sleep apnea, and respiratory conditions. Researchers have known for decades that pulse oximeters often do not provide accurate results for darker skin tones. The COVID-19 pandemic led to a significant increase in evidence and wider awareness of the implications of these inaccurate results based on skin color.

“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,” said Attorney General Bonta. “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.” 

In the comment letter, Attorney General Bonta writes that: 

• Faulty pulse oximetry has led to some patients’ denial of care in emergency rooms for severe cases of COVID-19, or not receiving supplemental oxygen they needed while being treated in intensive care units, and likely also led to cases of organ failure and death for patients with darker skin. 
• The proposed guidance would maintain a list of devices that have been shown to work equally well on all skin tones on its website “to further promote transparency.” This proposal is essential to inform healthcare professionals and protect the general public.
• Importantly, the Draft Guidance includes recommendations for manufacturers on how to gather clinical data to help improve the efficacy of pulse oximeters on people with a wide range of skin tones. For the Draft Guidance to have its intended effect, the FDA must continue to demand that manufacturers provide clinical data and proof of efficacy.
• The FDA should additionally require manufacturers to test pulse oximeters in a variety of real-world settings where patients are known to have low-oxygenated blood. One of the reasons that incorrect readings from pulse oximeters have persisted for so long is because of a lack of testing on patients in real-world settings.
• Any further delay in finalizing and enforcing the FDA’s recommendations for clinical testing and warning labels would be unconscionable. All patients need better pulse oximeters now.

On November 1, 2023, Attorney General Bonta led a coalition of 25 attorneys general in submitting a letter to urge the FDA to strengthen guidance and provide clear warning labels regarding incorrect pulse oximeter readings for patients of color. Regulation of medical devices, like prescription pulse oximeters, is the primary responsibility of the FDA.

A copy of the comment letter can be found here.