FDA announces initiative to ensure pulse oximetry is equitable

Nov. 20, 2023
DRH is announcing it will hold a virtual public meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on Feb. 2, 2024

On Nov. 16, the FDA announced two new initiatives to help ensure pulse oximetry is equitable and accurate for all patients.

To that end, the FDA published a new discussion paper for public comment outlining one possible approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters, taking into consideration patient skin pigmentation and patient-reported race and ethnicity. 

The agency also announced an upcoming advisory committee on Feb. 2, 2024, where pulse oximeters will be discussed.

FDA has the annoucement.