Device manufacturers have made little progress in improving the performance of pulse oximeters on people with darker skin tones, according to a study published in JAMA. The study analyzed FDA approval documents for 767 oximeters approved between 1978-2024 and found that only 25% of submissions mentioned skin tone, pigmentation, or race, even after the FDA suggested diversifying testing in 2013. This lack of improvement is concerning, as pulse oximeters have been known to provide inaccurate readings on darker-skinned patients for decades.
The researchers found inconsistencies and confusion in how terms related to skin tone, race, and ethnicity were defined and used in the documents. This lack of clarity highlights the need for better guidance and enforcement to ensure that pulse oximeters work effectively on all skin tones. The study authors expressed frustration at the ongoing neglect of this issue, especially given the impact it has on patient care.
Pulse oximeters became a topic of interest during the Covid-19 pandemic when they were used to assess oxygen levels in patients. Studies have shown that these devices can lead to delays in treatment and higher mortality rates for patients with darker skin. In response to these findings, the FDA has issued warnings and held advisory meetings to address the issue. However, the publication of new guidance has been delayed, prompting criticism from health equity leaders and physicians.
Some manufacturers have argued that their devices work well on a range of skin tones, but more research is needed to create more equitable devices. The editorial in JAMA emphasized the need for clearer FDA guidance and incentives for manufacturers to develop and test more equitable devices. Legal action, such as lawsuits under Section 1557 of the Affordable Care Act, may also be necessary to hold manufacturers accountable for producing biased devices.
Overall, the study highlights the urgent need for improvements in pulse oximeter performance on darker skin tones. Better guidance, enforcement, and legal action may be necessary to ensure that these devices provide accurate readings for all patients. The health and safety of marginalized groups depend on the development of more equitable medical devices.
