FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones

Responding to complaints that pulse oximeters that measure blood oxygen levels are less accurate in people with darker skin tones, the Food and Drug Administration Monday released long-awaited guidance proposing how manufacturers should test and label these devices. 

The document recommends testing the devices on far more people and provides clearer direction on the makeup of populations — and of skin tones — they should be tested on. Previous guidelines asked for 200 data points; the new guidelines suggest manufacturers submit 3,000; they also increase the suggested sample size for studies of pulse oximeters from 10 people to 150 or more.

Read the rest…