FDA panel to examine ways to better evaluate pulse oximeters for skin color bias

The issue of pulse oximeters providing inaccurate readings for individuals with darker skin tones is being examined by a panel of experts for the US Food and Drug Administration (FDA). The FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee is meeting to discuss ways to improve the accuracy and performance of pulse oximeters in patients with darker skin. Research has shown that the sensors of these devices can be affected by pigmentation, resulting in inaccurate oxygen readings. The panel aims to ensure that pulse oximeters perform accurately for all skin tones before entering the market. The issue of racial disparities in the accuracy of pulse oximeter readings has gained attention during the Covid-19 pandemic. A study found that flawed readings were associated with differences in the treatment of different racial groups. The development and testing of medical devices historically have not included diverse patient populations, leading to disparities in outcomes. The FDA panel’s discussions are expected to lead to new practice guidelines and the development of devices that are suitable for all patient groups.