Research shows blood oximeters aren’t properly reading Patients of Color

Discrepancies in Diagnoses

MARYLAND – Individuals with darker skin tones may have difficulty using certain medical equipment according to recent studies.

Discrepancies in Diagnoses

Imagine having a heart or lung condition and you reach for a pulse oximeter, and because your skin happens to be darker, it misreads your oxygen saturation, and now, you need serious medical attention. Well, medical professionals have acknowledged their life-saving tools, aren’t helping everyone.

Pulse oximeters were invented in 1974. The tool is clamped onto the fingertip to estimate pulse rate and blood oxygen level. Studies dating back to the 1980s show devices are often not calibrated for darker skin tones, which could lead to flawed readings.

Potential Problems

The director of the ICU at Atlantic General Hospital Dr. Atif Zeeshan explains the meter uses infrared lights to determine the blood oxygen, which causes some of the problems. “Melanin also absorbs more infrared light. So, if somebody is of a darker complexion and more melanin, potentially it may look as if you have a higher oxygen level… This became more apparent during the Covid epidemic when we realized there could be discrepancies.”

In 2013, the FDA recommended device developers have a range of skin pigmentation, clinically testing 15% of the group that’s more melanated. Dr. Zeeshan says they are aware of the discrepancy, so they don’t let it impact their practice or their patients and treat everyone accordingly. “These devices may not give you an accurate reading, and anybody who is critically ill, and we suspect we are not getting an accurate reading, we always check a blood gas, which is the invasive way.”

Transparent Trials 

Health Equity Officer for Atlantic General Hospital Dr. Nakita Cropper tells us biases can lead to bad outcomes. “When there are errors or even biases introduced into healthcare, it can result in worsened outcomes for patients… Historically, Clinical trials oftentimes do not include any African Americans, or less than 5% of African- Americans in the study.”

Accessible and Accurate 

In 2022 a study found more than 3,000 hospitalized Asian, Hispanic, and Black patients received less supplemental oxygen than White patients, which was directly linked to their pulse oximeter readings. Dr. Cropper says she believes FDA is taking a step in the right direction to ensure health care is accessible and accurate for all. “This entire topic was re-surfaced, and based on the covid experience the FDA and other agencies are now working hard to rectify the situation.”

The FDA held two advisory panel meetings in 2022 and last year to discuss ways to improve device performance, and they are currently reviewing a new draft guidance that will identify FDA-cleared devices. Some pulse oximeters that are on the market may already meet the updated recommendations.

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