skin tone, FDA and pulse oximeters

FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients of color during the pandemic.
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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.
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.
Study: Only 25% of pulse oximeters tested for skin-tone bias post-FDA guidance
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states
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 changes to make them more accurate.
Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance
"The most important finding is that although there were more mentions of skin color descriptors in performance testing after the FDA's guidance, a majority of the public clearance documents for pulse oximeters did not include any mention of testing in diverse individuals," Ferryman told MedPage Today in an email.
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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale and another scale, called the individual typology angle (ITA), which is based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 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.
FDA recommends fixing racial disparities in pulse oximeter readings
Experts say this call is critical to incentivizing manufacturers to fix racial disparities in the accuracy of the devices’ readings.
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
Healio1d
Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
The American Journal of Managed Care5d
Racial and Ethnic Bias in Pulse Oximetry Is Failing Patients
Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...
EurekAlert!2d
Pulse oximeters infrequently tested by manufacturers on diverse sets of subjects
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
Healio3d
AAP updates recommendations for screening newborns for congenital heart disease
The AAP published updated recommendations for screening newborns for critical congenital heart disease with a new algorithm it said could catch more infants than the previous one. Screening for ...