Medhealth Review

FDA Worried About Inaccuracies in Pulse Oximeters Due to Skin Colour

The U.S healthcare industry has to tackle a new controversy. Many recent studies convey that pulse oximeters don’t function equally well for all. Pulse oximeters work based on color. In other words, skin color has an effect on its accuracy. 

Pulse oximeters utilize light to measure blood oxygen levels. It is a relatively easy method to measure oxygen levels without using needles or devices. These devices rose to popularity during the coronavirus pandemic as blood oxygen levels directly indicated the covid-19 infection. 

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Many recent studies have indicated that the patient’s pigmentation can affect the readings. As a result, the FDA issued warnings regarding possible inaccuracies. The devices seem to overestimate oxygen levels in black patients. 

Medical experts are worried that such significant discrepancies can occur in commonly used devices being relied upon across the healthcare industry. Therefore, FDA is making all possible efforts to ensure medical devices are accurate, effective, and safe for all, irrespective of skin color or physical features. 

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The Problem

Melanin is what’s responsible for human skin tone. It can absorb light. Since pulse oximeters work using light, more melanin in the skin can affect the readings. 

Experiments confirm these suggestions. When clinical readings were very low for a group of black patients, the pulse oximeter readings were quite normal. Complete reliance on pulse oximeters can have dire consequences on treatment and its results. 

“Now we’re more acutely aware of how health care disparities impact people of color. So we’re really motivated to solve these problems and make health care more equitable for everyone,” says Ashraf Fawzy, Physician at Johns Hopkins.

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