Pulse oximeters — devices used by healthcare professionals to measure blood oxygen levels — could yield inaccurate results under some circumstances, the US Food and Drug Administration has now warned.
During the coronavirus pandemic, healthcare professionals around the world relied on pulse oximeters to identify Covid patients who might need hospitalisation. However, now the FDA has warned that the device may not always provide an accurate reading, and should therefore not be used to either diagnose or rule out Covid-19.
Instead, the body recommends looking for other indicators of low oxygen, such as bluish colouring in the face, lips, or nails, a racing pulse, or restlessness and discomfort. While the device may be useful for estimating blood oxygen levels, the FDA said that its limitations under certain circumstances should be considered.
According to the US Health Agency, a number of factors — including, poor circulation, skin pigmentation, skin thickness and temperature — can affect the accuracy of the reading.
Earlier this week, the US Centers for Disease Control and Prevention updated its coronavirus guidance to warn healthcare professionals that data from a number of studies suggest skin pigmentation can also affect the accuracy of oximeter readings. A recent study published by the New England Journal of Medicine suggested that the device may yield inaccurate readings for people with darker skin.
“The most current scientific evidence shows that there are some accuracy differences in pulse oximeters between dark and light skin pigmentation,” the U.S. Food and Drug Administration said in a statement.
In January, the World Health Organisation (WHO) listed the use of the pulse oximeter to identify Covid patients who may need to be hospitalised due to low oxygen levels.
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