The FDA has proposed new draft guidance aimed at improving the performance of pulse oximeters across diverse skin tones, addressing previous concerns about potential inaccuracies.
Pulse oximeters estimate blood oxygen levels and played an essential role during the COVID-19 pandemic. However, the agency informed patients and healthcare providers in 2021 that some pulse oximetry devices have limitations and a risk of inaccuracy in people with dark skin pigmentation.
The proposed recommendations aim to guide medtech manufacturers in collecting clinical data and refining study designs to ensure accurate performance across all skin tones.
“This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices,” said Dr. Michelle Tarver, 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.”
Key elements of the draft guidance include gathering clinical data to evaluate device accuracy across skin tones, increasing the number of study participants, and using subjective and objective methods to assess participants’ skin pigmentation. The FDA recommends using the Monk Skin Tone Scale, a subjective measure, and calculating the individual typology angle (ITA), an objective method, to determine device performance across diverse populations accurately. The agency also proposed that pulse oximeters meeting the updated criteria include clear labeling to indicate their accuracy across skin tones.
The FDA noted that some pulse oximeters on the market could already meet these performance standards without requiring significant hardware or software modifications. For those devices, the FDA plans to speed up the review of updated labeling to ensure quick access to these technologies.
While the guidance applies to pulse oximeters used in medical settings, it does not include devices marketed as general wellness or sporting products, which the FDA does not evaluate for clinical decision-making. The FDA proposed creating a publicly available list of FDA-cleared pulse oximeters with verified performance across skin tones to help healthcare providers and consumers identify appropriate devices.
The FDA’s recommendations are informed by controlled testing, real-world data, and input from scientists, clinicians, and manufacturers. The agency says two FDA-funded studies on pulse oximeter accuracy in patients with varying skin tones also contributed to the guidance.