The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Researchers from UCSF are leading an effort to find out which pulse oximeters work equally well on all skin colors.  NBC News ...
Draft recommendations from the FDA call for larger, more inclusive studies to ensure pulse oximeters work for people with ...
to discuss improving pulse oximeter performance. It also noted that the FDA was considering the “utility of a clinical trial design that includes the entire range of skin pigmentation and also ...
"The ultimate goal should be to have pulse oximeters that work effectively for the full range of skin tones," Shachar and colleagues added. "No single actor can at present solve this problem alone." ...
In 2013, the FDA issued premarket guidance for developers of pulse oximeters in which it recommended that they have “a range of skin pigmentation” represented in their clinical testing of the ...
That is, they could be struggling for air despite normal pulse oximeter results. The potential for racial disparities in pulse oximetry was first revealed in a study published 34 years ago.
But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely indicated that she was getting plenty of air on her own.