The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform similarly in individuals with different skin pigments, according to a press release.
Panelists at an FDA Medical Devices Advisory Committee meeting in 2022 previously pointed out that pulse oximeters show clear “disparate performance” for darker skin pigmentation.
Additionally, a recent systematic review published in British Journal of Anaesthesia demonstrated this fault of pulse oximeters by finding that among individuals with darker skin tones, pulse oximeters often overestimated their oxygen saturation levels.
In this review, pulse oximeter inaccuracy due to darker skin tones was found in 30 out of 44 assessed studies.
Prior to issuing this draft guidance, the FDA’s Medical Devices Advisory Committee met in February 2024 to discuss proposed changes to premarket studies assessing pulse oximeter performance, which were generally well received by the panelists.
The recently published draft guidance recommends the use of controlled desaturation laboratory studies for device analysis but also states that real-world data collection could be used in certain cases. Additionally, studies focused on determining pulse oximeter accuracy and performance should involve many participants, according to the release.
When assessing skin tone, the guidance recommends subjective and objective methods. According to the release, the Monk Skin Tone Scale is an example of a subjective method, whereas calculation of individual typology angle is an example of an objective method.
The last main recommendation in the guidance is to provide a labeling statement after achieving performance accuracy in a new premarket submission. This statement should “clearly identify that the pulse oximeter has demonstrated that it performs comparably across groups of individuals with diverse skin pigmentation,” according to the release.
Notably, the FDA stated in the release that the drafted recommendations outlined above and in the guidance document are for pulse oximeters used for medical purposes rather than those used for general wellness or sporting/aviation.
“This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe and effective medical devices,” Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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.”
The FDA noted that the guidance document is not yet finalized. Comments are currently being accepted regarding the document.