Twenty-five state attorneys general are calling on the FDA to urgently address the inaccuracy of pulse oximeters when used on people with darker skin.
In a Nov. 1 letter to FDA Commissioner Robert Califf, MD, the group of attorneys general acknowledged the one-year anniversary of the agency's public meeting to address concerns related to the medical devices' race and color bias.
The attorneys general called the meeting a "welcomed and much-needed first step" but noted that pulse oximeters continue to be sold without clear warning labels or guidance to prevent medical harm.
"It is imperative that the FDA act now to prevent additional severe illness and mortalities among darker skinned people resulting from inaccurate or misleading pulse oximeter readings as well as inadequate diagnostic and treatment protocols and procedures," they wrote.
The state attorneys general proposed six actions the FDA should take to prevent further health risks. Actions include requiring devicemakers to include warning labels and issuing a letter to U.S. healthcare providers about pulse oximeters' reduced effectiveness for patients with darker skin tones.
Read the full letter here.