Testing of pulse oximeters should take place clinically, Elizabeth Tracey reports


Pulse oximeters are essential to measure someone’s level of oxygen in their blood, yet they haven’t been updated since the 1970s and they’re not well regulated by the FDA. That’s according to Ashraf Fawzy, a critical care medicine expert at Johns Hopkins, whose research has shown that in people with darker skin tones inaccuracy abounds.

Fawzy: We're seeing that this problem is happening in the clinical setting. These devices are used in the clinical setting but they're being tested in healthy participants on labs. We need more testing and more regulatory guidance about how we should be approaching that testing in a clinical setting, whether it's pre market or whether it's post market it probably needs to these devices need to be shown that they work in the setting that they're going to be used.    :26

Fawzy notes that device regulation is complex and may not require new clinical trials to demonstrate efficacy or safety. He says clinical testing of current pulse oximeters would help define their limitations. At Johns Hopkins, I’m Elizabeth Tracey.