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Attorney General Josh Stein Urges FDA To Address Pulse Oximeter Issues

For Immediate Release:
Thursday, November 2, 2023

Contact:
Nazneen Ahmed (919) 716-0060

(RALEIGH) Attorney General Josh Stein urged the U.S. Food and Drug Administration (FDA) to strengthen guidance and provide clear warning labels about incorrect pulse oximeter readings for patients of color. Pulse oximeters are routinely used to measure blood oxygen levels, which help determine medical care for illnesses including heart failure, sleep apnea, and respiratory conditions. Recent studies indicate that patients of color, particularly patients with darker skin, are more likely to get inaccurate results from pulse oximeters.

“Doctors and health care providers use pulse oximeters every day in clinics and hospitals across the country to diagnose and treat patients,” said Attorney General Josh Stein. “The FDA must act swiftly to make sure everyone understands the risks of these devices for patients of color so we can make sure all North Carolinians get the care they need.”

First invented in the 1980s and developed primarily based on tests involving a predominantly white population, pulse oximeters are now widely used because they are the only rapid, noninvasive way to measure oxygen saturation. Pulse oximeter use dramatically increased during the COVID-19 pandemic, when the readings were sometimes the only objective measure for determining what kind of treatment a COVID patient would get. When health care resources were stretched thin, a patient’s pulse oximeter reading could mean the difference between being allowed to come into the hospital for treatment, monitoring symptoms at home, or getting access to a lifesaving medication. Researchers have known for decades that darker skin tones could reduce a pulse oximeter’s accuracy, but the COVID pandemic led to a significant increase in evidence and wider awareness of the implications of this bias. The medical device’s inaccuracies may lead to delays in treatment and hospital admissions, which can lead to severe or life-threatening consequences and contribute to lower quality health care.

In the letter, the coalition commends the FDA’s implementation of safety communications about pulse oximeter accuracy and the convening of the Medical Devices Advisory Committee to further address the negative impacts of this device on patients of color. However, the FDA has yet to indicate clear warning labels or provide additional guidance to protect people from harm, as pulse oximeters are currently sold over the counter and used in hospitals and clinics.

In the letter, the attorneys general ask the FDA to:

  • Require pulse oximeter manufacturers and vendors to include warning labels to all users about the device’s effectiveness based on skin tones.
  • Call for similar warnings to be included in other medical devices that incorporate pulse oximeter readings, such as medical device software used for diagnosis or treatment of medical conditions.
  • Issue guidance to health care providers about the risks and reduced efficacy of pulse oximeters for patients of color.
  • Implement an expedited timeline for the FDA to swiftly review the Medical Devices Advisory Committee’s recommendations.

Attorney General Josh Stein is joined in sending this letter by the Attorneys General of California, Arizona, Colorado, Connecticut, Delaware, the District of Columbia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, and Ohio.

A copy of the letter is available here.

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