(Reuters) – Pulse oximeters, devices which measure oxygen levels in blood, should not be used to diagnose COVID-19 and could give inaccurate readings under certain circumstances, the U.S. Food and Drug Administration warned on Friday.
In January, the World Health Organization included use of pulse oximeter to identify patients who might need hospitalization in its clinical advice for treating COVID-19.
But the FDA said the devices cannot be used to diagnose or rule out COVID-19, and generally it recommended not relying on them to assess health.
It recommended paying attention to other indicators of low oxygen, such as blueness of the face or a racing pulse.
The U.S. health agency said the device might be “useful” for estimating blood oxygen levels, but multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use and use of fingernail polish.
The warnings come nearly two months after a study published in New England Journal of Medicine showed that the device was three times more likely to give misleading readings among African-American patients.
During the pandemic, the devices have also become a widely sold item online, used by people to monitor their own oxygen levels at home.
However, over-the-counter oximeters sold in stores or online do not undergo FDA review and are not intended for medical purposes, the agency said.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Arun Koyyur)