Manufacturers of medical devices designed to quickly measure oxygen levels in the blood could be forced to collect more data to prove that their products are effective in people with dark skin, according to a new proposal presented by US authorities on January 6. .
The guidelines, issued by the Food and Drug Administration (FDAfor its acronym in English), are aimed at pulse oximeters, devices worn on the fingers and used in hospitals and clinics to monitor oxygen levels in patients’ blood.
The FDA wants companies to make larger studies and include a greater diversity of patients from different racial groups to ensure the accuracy and effectiveness of these devices in all populations.
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Oximeters were a critical part of emergency care for patients with COVID-19 during the pandemic. However, Several studies have suggested that darker skin pigmentation can sometimes affect the accuracy of readings.
- How does an oximeter work? 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.
In 2021, the FDA warned doctors about possible 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 getting treatment and increased risks. risks of death.
The problem has become an example of the possible racial biases of medical technology, which has led to multiple meetings and studies by health regulators FDA from 2022. The preliminary recommendations of the FDAwhich are not binding, include changes to how companies should test their devices, including:
- Enroll at least 150 patients of different skin tones in clinical studies.
- Include at least 25% of patients with darker complexion in each study.
- Assess the pigmentation of each study participant using at least two different methods, one based on a researcher’s assessment and one based on scientific measurement of melanin levels in the skin using light.
The recommendations of the FDA They apply only to professional oximeters used in hospitals, doctors’ offices, and other medical settings. The US government will not regulate over-the-counter oximeters, which it considers “general wellness” devices.
The FDA makes it clear that it expects to see new diversity data from manufacturers seeking approval for changes or upgrades to older oximeters.
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