On Monday, a new federal proposal was unveiled that mandates medical device manufacturers, particularly those producing pulse oximeters, to collect additional data to ensure their products effectively measure oxygen levels for patients of varied racial backgrounds. The Food and Drug Administration (FDA) is advocating for enhanced testing protocols that expand the diversity of patient demographics in clinical trials for these devices.

Pulse oximeters, commonly used in healthcare facilities, play a vital role in monitoring patients’ oxygen levels by attaching a device to a finger. The device employs two wavelengths of light to determine the amount of light absorbed, which in turn provides an estimate of the oxygen content in the blood.

During the COVID-19 pandemic, these devices were crucial in assessing patients critically ill with the virus. However, research has illuminated a concern: that the accuracy of readings from oximeters may be compromised for individuals with darker skin. A 2021 study prompted the FDA to issue warnings regarding the devices, noting that they often overestimated oxygen saturation in Black patients. Such inaccuracies can result in delayed treatments, heightening risks of severe health outcomes, including death.

This highlighted issue has sparked significant discourse surrounding racial biases within medical technologies, prompting the FDA to hold various studies and discussions since 2022 to address these disparities.

The draft recommendations proposed by the FDA are not mandatory but suggest several revisions for the testing and approval processes of pulse oximeters. Key changes include:

• Enrolling a minimum of 150 patients of varying skin tones in clinical trials;
• Increasing the participation of patients with darker pigmentation to at least 25% of the study group, up from the previous requirement of 15%;
• Assessing the skin pigmentation of each participant utilizing at least two different methods—one being a researcher’s subjective evaluation and another employing scientific measures based on skin melanin levels.

These recommendations specifically pertain to professional-grade oximeters used in healthcare environments, as the FDA does not oversee the majority of over-the-counter versions, which are generally classified as “general wellness” devices. While the new guidelines will not render existing devices obsolete, the agency emphasizes the necessity of new diversity data from producers seeking modifications or enhancements for older models.

The announcement made on Monday remains a draft, with the FDA planning to accept public feedback on the proposal for the next 60 days before moving towards finalizing the guidelines.