WASHINGTON — Makers of medical devices that in the blood would have to gather extra data to show that their products work for patients of color, under a new federal proposal released Monday.
The Food and Drug Administration’s apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen. The FDA said it wants companies to conduct larger studies and include more patients from different racial groups.
By snapping a device onto a finger and then sending two wavelengths of light into the skin, the oximeter measures how much of the light is absorbed and estimates how much oxygen is flowing through the blood.
Oximeters were a critical part of emergency care for patients with COVID-19 during the pandemic. But several studies have suggested that darker skin pigmentation can sometimes throw off the accuracy of readings. In 2021, the FDA about potential inaccuracies with oximeters after a the devices tended to overestimate Black patients’ oxygen levels, which could lead to and increased risks of death.
The issue has become a prominent example of the potential racial biases of medical technology, leading to multiple meetings and studies by FDA regulators since 2022.
The FDA’s draft recommendations, which are not binding, would make several changes to how companies are expected to test their devices, including:
— Enrolling at least 150 patients of different skin tones in clinical studies;
— Including at least 25% of patients with darker skin complexion in each study;
— Evaluating pigmentation of every study participant using at least two different methods, one based on a researcher’s evaluation and another based on scientific, light-based measurement of melanin levels in the skin.
The FDA recommendations apply to only professional oximeters used in hospitals, doctor’s offices and other medical settings. The government doesn’t regulate over-the-counter oximeters, which it considers “general wellness” devices.
The guidelines wouldn’t eliminate older devices currently used by doctors. But the FDA makes clear it expects to see new diversity data from manufacturers requesting approval for changes or updates to older oximeters.
Monday’s announcement is only a draft. The FDA said it will take public comments on its proposal for 60 days before beginning work on a final version.
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