CHESTCHEST NewsAddressing pulse oximetry inaccuracies

Addressing pulse oximetry inaccuracies

November 14, 2022

On November 1, 2022, an advisory panel within the Food and Drug Administration (FDA) convened a virtual meeting to address ongoing concerns over pulse oximeters providing less accurate readings on patients with darker skin, which may contribute to health disparities among many racial and ethnic groups.

In advance of the meeting, the advisory panel, known as the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee, invited the American College of Chest Physicians (CHEST) to provide a pre-recorded statement on the topic.

Eric Gartman, MD, FCCP, speaking on behalf of CHEST, noted that the FDA requirements should include device testing that reflects ICU and ER real-world settings including testing on diverse levels of illness as well as on diverse skin tones. Current testing is being done on a population that isn’t representative of real-world settings, and, as Gartman shares, “We wouldn’t tolerate that for a medicine, so I’m not sure we should tolerate that in a device.”

During the CHEST Annual Meeting 2022, Dr. Gartman proposed the below recommendations for improvement in a session titled, Clinical Implications of Flawed Pulse Oximetry Based on Skin Tone:

  • Recognize that there is a problem

  • Conduct real-world studies to understand actual performance

  • Well-controlled data collection (SpO2 and SaO2 seconds apart, not minutes)

  • Standard definition of skin pigmentation

  • In addition to skin tone, effects of perfusion, blood pressure, medications

  • Transparent calibration algorithms that include a diverse population of skin tones (not “race” or “ethnicity”), and stricter adherence than FDA currently requires

  • Devices be held to stricter quality standards

  • Agreement with true SaO2

  • Inexpensive pulse oximeters held to same standards

In February 2022, CHEST, together with the Critical Care Societies Collaborative (CCSC), issued a formal letter to the FDA drawing attention to the new information regarding pulse oximeters.

Dr. Gartman’s full recording provided to the FDA can be found below, and coverage of the virtual panel can be found in Stat News, U.S. News & World Report and the New York Times.

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