A crucial device used in COVID-19 treatment may not work on dark skin, says study
The US Food and Drug Administration warned that the pulse oximeters, which have increased in use during the COVID-19 pandemic, may yield inaccurate results.
- World News
- 3 min read
The pulse oximeter has been an essential tool for medical professionals amid the coronavirus pandemic, however, the small device may not work for people with dark skin, according to multiple studies and health agencies. On February 19, the US Food and Drug Administration warned that the pulse oximeters, which have increased in use during the pandemic, may yield inaccurate results. The US Centers for Disease Control and Prevention has also updated its coronavirus clinical guidance to warn doctors and nurses that data from several studies suggest skin pigmentation can affect the accuracy of the device.
Pulse oximeters are small clamp-like devices that attach painlessly to a patient’s finger and constantly monitor the amount of oxygen in their blood. According to a study, the researchers have analysed data from over 1,000 patients. For each patient, they compared the oxygen levels recorded by a pulse oximeter to those measured by arterial blood gas, which is a much more accurate, but painful procedure.
The researchers found that in white patients, the pulse oximeter gave a misleading number 3.6 per cent of the time. In Black patients, it was 11.7 per cent of the time. Dr. Michael Sjoding said that pulse oximeters were three times as likely to miss significantly low oxygen levels in Black patients. The study also suggested that one in every 10 Black patients may be getting deceptive results.
FDA to review data
The physicians have explained the reason behind the inaccurate readings. According to CNN, experts have said that pulse oximeters work by sending two types of red light through the finger. A sensor on the other side of the device picks up this light and uses it to detect the colour of the blood. If the device isn’t calibrated for darker skin, the pigmentation could affect how the light is absorbed. Doctors have said that dark nail polish can also cause a similar effect.
Now, as public attention seems to be picking, the FDA has said that it will carefully review the available data to determine whether additional guidance or studies from the agency are needed. It is worth noting that the FDA is responsible for approving any medical pulse oximeters before they go to market. As per reports, the agency currently requires pulse oximeters to be tested on a variety of skin tones, meaning at least two darkly pigmented test subjects or 15 per cent of the subject pool, whichever is larger.
Published By : Bhavya Sukheja
Published On: 21 February 2021 at 13:03 IST