FDA, skin tone and pulse oximeter

FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the devices.
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a major upgrade to ensure they work just as well for people of all skin tones. The U.
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color.
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale and another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.
FDA recommends fixing racial disparities in pulse oximeter readings
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people with darker skin — an effort that comes years after research showing that the devices’ inaccuracies led to delays in covid-19 treatment for Black patients.
FDA Drafts New Recommendations for More Inclusive Pulse Oximeter Testing
The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger,
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones. The long-awaited guidance released Monday comes in response to mounting evidence that the devices,
Decades-Old Problem Of Pulse Oximetry Across Skin Tones Targeted By New Draft FDA Guidance
Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that an oxygen saturation reading for someone with darker skin may read as much higher than it actually is.
Pulse oximeters may misread oxygen levels in people of color
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color
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FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
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Fixing pulse oximeters requires federal might and possible legal action, researchers say
The devices remain unreliable in darker skinned people. Researchers say more guidance, enforcement and even legal action may ...