Devices that measure oxygen in the bloodstream need federal regulation, Elizabeth Tracey reports


If you’re a person with darker skin, a device to measure oxygen in your blood called a pulse oximeter may be inaccurate, sometimes extremely so, accumulating research shows. Ashraf Fawzy, a critical care medicine expert at Johns Hopkins and one author of a study examining these devices, says while we are waiting for a technology fix, another avenue should be pursued. 

Fawzy: In the meantime there can be advances in the way that they're regulated right now. The way that they're regulated they only have to be tested, at least the ones that we use in a medical setting, have to be tested in at least 10 healthy participants in a laboratory setting with at least 200 pulse oximeter measurements with arterial blood gas measurements. And they only suggest that 15% of the sample or at least two participants are darkly pigmented and don't define that.   :29

Fawry notes that the FDA has taken one step in improving regulation and looks forward to more soon. At Johns Hopkins, I’m Elizabeth Tracey.