Skin Tone Warnings on Pulse Oximeters Sought by 25 Attorneys General

Attorneys general from 24 states and Washington, D.C. have sent the FDA a letter urging the agency to strengthen guidance and provide clear warning labels regarding incorrect pulse oximeter readings for patients of color. 

The letter comes on the heels of the one-year anniversary of the FDA’s Medical Devices Advisory Committee’s Anesthesiology and Respiratory Therapy Devices Panel which addressed concerns related to pulse oximeters’ race and color bias. Multiple studies have shown that many pulse oximeters give inaccurate readings for non-white individuals.

 The attorneys general state that “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.” 

Read the attorneys’ letter here.

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