FDA to Hold Public Hearing on Addressing Pulse Oximeter Inaccuracies

Following studies that suggest minorities and individuals with darker skin tones may experience problems with pulse oximeters, federal health officials plan to perform a comprehensive review next year to evaluate the safety and accuracy of the medical devices, which are commonly used to assess blood oxygen levels.

The U.S. Food and Drug Administration (FDA) will hold a public advisory committee meeting on pulse oximeters on February 2, 2024, which will focus on how to improve the performance of the devices for patients of different races and ethnicities with darker skin pigmentation.

According to a press release issued earlier this month, the meeting will also include a discussion about how to effectively conduct clinical trials for the pulse oximeter devices, and who should be included to make sure the devices are effective for all patients.

Pulse oximeters are small devices placed on the fingertip, which use light beams to estimate the oxygen saturation of the blood and pulse rate. The readings give information about the amount of oxygen in the blood without having to draw a blood sample.

During the COVID-19 pandemic, pulse oximeters were commonly used to measure blood oxygen levels in patients to detect whether they were at risk of medical distress or required medical intervention, including but not limited to administering oxygen, intubation, and other treatments.

However, the FDA issued a safety communication about pulse oximeter problems in 2021, after discovering that they may provide inaccurate readings for people with darker skin. The warning indicated that factors like skin color and even dark nail polish can interfere with the readings, with Black patients nearly three times as likely to receive inaccurate or false readings than white patients.

During the pandemic, people of color often received delayed care for COVID-19 due to poorly designed pulse oximeters, which failed to accurately identify low blood oxygen levels the same way in people with darker skin than in white patients, making them less likely to receive life-saving attention.

The FDA’s investigation into the accuracy of pulse oximeters was announced following a discussion paper published earlier this month titled, Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity, which outlined recommendations on how manufacturers should conduct premarket studies to evaluate the devices to ensure darker skin color is taken into consideration for accurate readings.

Included in the recommendations that will be discussed at the advisory meeting are the type and amount of data that manufacturers should provide to the FDA for evaluating the effectiveness of the devices for premarket review, including prescription and over-the-counter indications, and labeling considerations.

The panel will also discuss multiple factors that can affect the accuracy of a pulse oximeter reading, such as skin pigmentation, poor circulation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.

The FDA invites the public to comment on the published paper until January 16, 2024, as these recommendations and comments will be considered in the upcoming virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on February 2, 2024.