New guidance has been released from the FDA on the use of pulse oximeters. These medical devices are used to estimate the amount of oxygen being carried by blood. The new guidance concerns the accuracy of these devices across all skin tones. In 2024, studies indicated that pulse oximeters had a different level of accuracy when used on lighter skin tones compared to darker skin tones.
The new guidance recommends manufacturers “gather clinical data, among other things, to help improve the clinical study design and validation efforts for pulse oximeters used for medical purposes to evaluate their performance across the range of skin pigmentation,” explains the press release for the updated FDA guidelines.
How Inaccurate Are Pulse Oximeters?
The most recent study on these devices by the medical journal Epic Research found that these inaccuracies are more significant than once believed. Epic Research gathered data from over 13,000 U.S. hospitals between January 2016 and November 2023, and the findings revealed that Black patients are 31.9 percent more likely than white patients to have oxygen readings that overestimate their levels by at least four percent.
Researchers in the study explained, “Providers often order supplemental oxygen or other treatment when oxygen saturation drops below 88%.” If a reading falsely shows a patient’s oxygen levels to be much higher than 88 percent, “there may be a delay in potentially life-saving treatment, which could result in significant risk to the patient.”
“Race and ethnicity are commonly used in the field of medicine and clinical studies as a substitute for skin color,” explains Glenn Dale, MD dermatologist and professor of dermatology at Howard University, Valerie D. Callender, MD. “This recent FDA guidance on pulse oximeters that identified their inaccuracy is a perfect example of how the degree of skin pigmentation and biological variations can produce health disparities in a given population. During the COVID pandemic, Black patients were undiagnosed in their need for oxygen and their medical care was delayed.”
The FDA’s New Guidance
“The new guidance is an important step toward ensuring that pulse oximeters provide accurate readings across all skin tones. This is critical for preventing misdiagnoses, especially in patients with darker skin,” national telehealth dermatologist Anna Chacon, MD explains. “As we know, earlier studies have shown that traditional pulse oximeters can be less accurate for individuals with darker skin tones. That potentially leads to delayed treatments for serious conditions. This update from the FDA is a positive development, emphasizing the need for greater inclusivity in medical technology.”
The FDA’s guidance includes a recommendation to manufacturers to include a label warning if they cannot meet performance standards across all skin tones. Additional suggestions include creating a publicly available webpage that ranks pulse oximeter performance across skin tones, increasing the number of clinical study participants and gathering more clinical data.
“The FDA Expects some pulse oximeters that are currently marketed may meet the updated performance criteria without the need for significant hardware or software modifications,” notes the press release.
“This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices,” said Michelle Tarver, M.D., Ph.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual’s skin pigmentation.”
“Although late in this discovery, I commend the FDA for acknowledging the deficiencies in these medical devices and mandating that the manufacturers demonstrate accuracy across all skin colors and skin tones,” Dr. Callender says. “However, in addition, the FDA should extend this guidance and oversight not only to pulse oximeters, but to all medical devices that utilize Automated Intelligence (AI) technology and are used on the skin so to avoid a similar situation in the future.”
