Blood oxygen monitors face scrutiny from FDA panel

Devices that monitor blood oxygen levels in the hospital and at home need to be more carefully regulated, a Food and Drug Administration advisory panel indicated at a meeting Tuesday.

The devices are everywhere in healthcare settings, and people regularly purchase them for at-home use. But research over the past few decades has steadily shown that they don’t work as well for people with darker skin tones — a disparity that became even more critical during the covid pandemic. The FDA issued an alert saying that the devices have “limitations” in 2021.

“We need to take appropriate steps to remove the growing uncertainty around these devices and ensure the health and safety of the public,” anesthesiologist Jesse Ehrenfeld said to the panel...

Continue reading…