Jan 6 (Reuters) - The U.S. health regulator on Monday

proposed a new guidance for widely used blood oxygen monitoring

devices to improve their performance across skin tones amid

growing evidence that the current ones are not reliable for

patients with darker skin.

Current scientific evidence suggests that there are some

accuracy differences in the performance of pulse oximeters among

individuals with lighter and darker skin tones, the U.S. Food

and Drug Administration said.

The devices, which clip to a fingertip, pass red and

infrared light through the skin and measure how much light is

absorbed by oxygen-carrying hemoglobin.

Doctors have long known that pulse oximeters are less

accurate in estimating blood oxygen levels in non-white

patients. The discrepancies were considered insignificant until

the COVID-19 pandemic, which exposed some of the risks of these

flaws.

"Our draft recommendations are based on the best available

science to help address concerns of disparate performance of

pulse oximeters based on an individual's skin pigmentation,"

said Michelle Tarver, director of the FDA's Center for Devices

and Radiological Health.

In its draft guidance, the agency recommended that

manufacturers gather clinical data from a group of 150 or more

healthy participants to evaluate the performance of their

devices across a range of skin pigmentations.

The proposed guidelines also take into account suggestions

for improved standards for pulse oximeters such as a stronger

criteria for their approval, from two panels of independent

experts that were held in 2022 and 2024, respectively.

The draft includes recommendations for updated labeling of

devices that are already approved. The agency said it expects

some pulse oximeters may meet the updated criteria without

significant hardware or software changes.

The regulator said the proposed guidance, if finalized,

would apply to devices that are used for medical purposes and

not those sold for general wellness.