25 Attorney Generals Write Open Letter to FDA on Pulse Oximetry Accuracy25 Attorney Generals Write Open Letter to FDA on Pulse Oximetry Accuracy
They asked the regulatory body to immediately take six actions to ensure the safety and effectiveness of such devices.
November 7, 2023
After decades of long-standing worries connected to the accuracy of pulse oximetry dependent on skin tone differences, the COVID-19 pandemic underscored the concerns after the machines were used extensively to assess the effect of the virus on the lungs, resulting in conflicting results. In 2021, FDA began to review the data, with researchers publishing papers in 2022 showing that inaccuracy in pulse oximeter readings led to disparities in the treatment of Black patients with COVID-19 by hours, including supplemental oxygen rates and delayed treatment.
On Nov. 1, 2022, FDA convened an advisory committee open to the public where they discussed the mounting evidence from real-world studies suggesting performance of pulse oximeters can be affected by skin pigmentation.
One year on, attorney generals from 25 states have come together in a letter to FDA to “encourage the FDA to act with urgency to address the inaccuracy of pulse oximetry when used on people with darker toned skin.”
They wrote that since the committee meeting a year prior, pulse oximeters have continued to be sold “without clear warning labels or other guidance to protect individuals from harm.”
The letter called on the administration to immediately take six actions to ensure the safety and effectiveness of the device. “As you know, regulation of medical devices such as pulse oximeters, including their ‘safety and effectiveness,’ is the responsibility of the FDA 21 U.S.C. § 360k(a),” they wrote. “We therefore respectfully ask the FDA to take immediate action to ameliorate further unnecessary health risk to people with darker skin tones.”
The actions are as follows:
Require manufactures and venders of these devices to include clear, comprehensive, and evidence-based warning labels to users about the reduced effectiveness of all pulse oximeter devices based on skin tones. The requirement would be applied to both prescription and over-the-counter products. They said that the information should include “an appropriate, simple narrative and a pictograph indicating a warning for patients with darker skin tones.”
Require inclusion of a similar warning for other medical devices that incorporate pulse oximeter readings, like software used for diagnosis or treatment of medical conditions.
Update the November 2022 Safety Communication on “Pulse Oximeter Accuracy and Limitations” with more clear and comprehensive statements of the latest information regarding “the current evidence base (and its weaknesses) relating to pulse oximeters.”
Issue a letter to healthcare providers about the risks and reduced efficacy of the devices for patients with darker skin tones, including a reference to the National Institutes of Health’s March 6, 2023, updated treatment guidelines for COVID-19, “which recommend ameliorative actions to counterbalance pulse oximeters’ known deficiencies by, for example, ensuring close monitoring of clinical progress in both clinical and home settings…,” according to the statement.
Set an accelerated timeline to review the Medical Devices Advisory Committee’s recommendations, and publicly release the review. They want FDA to ask for public comment, indicating the range of additional requirements or recommended actions it is considering.
Update and finalize regulations that require demographically diverse clinical trials for previously approved devices like pulse oximeters. “Clarify and expand on guidance that clinical studies for these devices must be demographically representative, in order to ensure that studies have the necessary statistical power to detect differences in accuracy between demographic groups (particularly based on skin color),” the attorney generals wrote.
The letter ended with the attorney general’s expressing the need for medical technology that works consistently and regardless of skin tone.
“Ultimately, patients of color need and deserve technology that works as well for them, as it does for the predominantly white patient population with whom this tool was originally designed and tested,” they wrote. “To this end, the FDA should support ongoing research to provide better calibration of existing pulse oximeter devices, and/or development of new tools that work accurately and equitably across a diversity of skin tones. The FDA should prioritize development of the research base to accomplish this goal, and should update its guidance as soon as improved technology has been tested and validated.”
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