FDA panel asks for improvements in pulse oximeters
A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The widely used instruments monitor blood oxygen levels and have been shown to work less well on patients with darker skin, possibly exacerbating health disparities in many racial and ethnic groups.
Panel members, even those who had initially been skeptical of the validity of those recent studies, said after reviewing the data they were persuaded that the devices were indeed less accurate on patients with darker skin and could lead to poorer health outcomes. “I am now convinced,” said Robert Loeb, a professor emeritus of anesthesiology at the University of Florida. “There is a problem and it has clinical significance.”
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