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Fix Pulse Oximeter Biases, 25 State AGs Tell FDA

David McFarland

— 2 min read
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The attorneys general in 25 states are calling on FDA to act urgently to address the inaccuracy of pulse oximeters when used on people with darker-toned skin. In an 11/1 letter to FDA commissioner Robert Califf, the officials note that one year ago the agency held a public meeting to address concerns related to pulse oximeters’ race and color bias.

“This convening was a welcomed and much-needed first step in redressing the harms such medical devices have caused and continue to cause people of color,” the letter says. “Since the convening, however, pulse oximeters continue to be sold without clear warning labels or other guidance to protect individuals from harm.”

The letter says research indicates that pulse oximeter errors due to technical inaccuracies in reading darker-toned skin have caused Black patients and other people of color disproportionately increased time to diagnosis of illness, delayed hospital admissions, and delayed access to lifesaving treatments. “As pulse oximeters were designed and calibrated using lighter skin tones,” the letter says, “they tend to overestimate the oxygenation of blood for people with darker skin tones, leading to an underestimation of the need for healthcare and exacerbating already serious risks.”

The attorneys general say FDA should immediately:

  • require manufacturers and vendors of pulse oximeters to include clear, comprehensible, and evidence-based warning labels to all users about the reduced effectiveness of all pulse oximeter devices, prescription and over-the-counter, based on skin tones;
  • require inclusion of similar warnings in other medical devices that incorporate pulse oximeter readings, such as medical device software used for diagnosis or treatment of medical conditions;
  • update the agency’s 11/2022 safety communication with a more clear and comprehensive statement of the latest information about the current evidence base (and its weaknesses) relating to pulse oximeters;
  • issue a letter to healthcare providers about the risks and reduced efficacy of pulse oximeters for patient subgroups with darker skin tones;
  • set an accelerated timeline for the review of the Medical Devices Advisory Committee’s Anesthesiology and Respiratory Therapy Devices Panel 11/1/22 review of the devices and the public release of the review; and
  • update and finalize regulations requiring demographically representative clinical trials for previously approved medical devices like pulse oximeters.

The letter concludes that FDA should support ongoing research to provide better calibration of existing pulse oximeter devices and/or the development of new tools that work accurately and equitably across a diversity of skin tones. “FDA should prioritize development of the research base to accomplish this goal,” they say, “and should update its guidance as soon as improved technology has been tested and validated.”

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