The study published in JAMA highlighted the lack of progress in improving pulse oximeter performance on people with darker skin tones since the FDA asked manufacturers to test the devices on a more diverse range of skin tones in 2013. The research found that only 25% of FDA approval submissions mentioned skin tone, pigmentation, or race after the guidance was released. Manufacturers have been slow to address the issue of poorer performance on darker-skinned patients, despite the known bias in these devices for decades. Calls for clearer guidance, enforcement, and legal action to ensure equitable performance on all skin tones have been made. Various challenges, including the cost to manufacturers, reluctance to admit bias, and the need for clearer FDA guidance, must be addressed to fix this ongoing problem.
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More action needed to ensure pulse oximeters work well for all
