The FDA is proposing new rules requiring manufacturers of pulse oximeters to collect more data to ensure their devices are accurate for people with dark skin. This comes after studies have shown potential inaccuracies in readings for patients with darker pigmentation.
Manufacturers of medical devices that rapidly measure blood oxygen levels would have to collect additional data to demonstrate that their products work for people with dark skin, according to a new proposal from US authorities published on Monday. The recommendations from the Food and Drug Administration ( FDA ) apply to pulse oximeters, which are devices that are placed on the fingers and used in hospitals and medical clinics to ensure that patients have enough oxygen in their blood.
The FDA wants companies to conduct more extensive studies and include more patients from different racial groups. By placing a device on a finger and then sending two wavelengths of light to the skin, the oximeter measures how much light is absorbed and estimates how much oxygen flows through the blood. Oximeters were a critical part of emergency care for COVID-19 patients during the pandemic. However, several studies have suggested that darker skin pigmentation can sometimes affect the accuracy of readings. In 2021, the FDA warned doctors about potential inaccuracies with oximeters after a study found that the devices tended to overestimate the oxygen levels of Black patients, which could lead to delays in treatment and increase the risk of death. The problem has become an example of the potential racial biases in medical technology, leading to multiple meetings and studies by FDA regulators since 2022
FDA Oximeters Blood Oxygen Skin Pigmentation Medical Technology
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