The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes. These include devices with a function that estimates the amount of oxygen in arterial blood and pulse rate.

WHY IT MATTERS

During the COVID-19 pandemic, medical researchers and clinicians gathered evidence that pulse oximeters did not always provide accurate readings for darker skin tones. 

In 2023, the FDA issued a warning about potential risks of inaccuracy under certain circumstances and said it became aware that pulse oximeters could be less accurate in people with dark skin pigmentation. The agency then scheduled public meetings last year to reassess its existing pulse oximetry guidance. 

The new proposed update, posted on its website, sharpens recommendations for gathering real-world and laboratory clinical data to evaluate device performance accuracy across the range of skin pigmentations, using both subjective and objective methods to standardize evaluations of pulse oximeter products used in healthcare delivery.

The guidance, Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations, suggests new performance information in product labeling and applies only to certain pulse oximeters used primarily for medical purposes in hospital settings or doctors’ offices, FDA said in a statement Monday.

Some pulse oximeters that are currently marketed may meet the updated performance criteria without the need for significant hardware or software modifications, the agency explained. 

If a sponsor of such a device submits only "updated labeling to reflect the collection of clinical data that demonstrates comparable performance across skin pigmentations without device modifications," the agency said it would provide an expeditious review within 30 days "to help ensure the public has prompt access to safe and accurate pulse oximeters."

The updated pulse ox guidance does not apply to general wellness products or sporting/aviation products the FDA does not review or evaluate before being made available to the public, the FDA noted.

Comments received by March 10 will be considered before the agency begins work on the final version of the guidance, it said.

THE LARGER TREND

Research published in the New England Journal of Medicine in 2020 showed that, after comparing measurements of arterial oxygen saturation with pulse oximetry, Black patients were three times as likely to have occult hypoxemia than white patients.

Johns Hopkins School of Medicine has been drawing attention to FDA’s medical device regulation of pulse oximeters, critical of how the agency handled its 510(k) review process in getting these products to the medical, consumer and other industry markets and calling out the agency's reaction time. 

In response, a spokesperson for FDA told Healthcare IT News in July that it was still engaging stakeholders and gathering input from clinical researchers to inform the update. Previously, the FDA said on its Center for Devices and Radiological Health Guidance Agenda that revisiting pulse ox guidance was a priority and intended to publish updates in FY 2024.

In a lawsuit filed to halt the sale of flawed pulse oximeters by the Roots Community Health Center in Oakland, California, the healthcare organization called it a striking example of how systemic racism can drive healthcare and population health outcomes.

According to the American Heart Association, heart disease death rates are also highest among Black Americans, and racial bias inherent in light-sensing and other technologies could be potential links to the demographic's elevated risks.

Medtronic announced in October that it was dismissed from the federal lawsuit filed against CVS, Walgreens, GE Healthcare and many other medical technology companies. A company spokesperson said that Medtronic has been improving the diversity of its clinical studies, educating medical providers on the proper use of pulse oximetry and investing in technology improvements over the last two years. 

"We are pleased that Medtronic, which holds a dominant share in the pulse oximeter market, has agreed to prioritize patient safety by providing labels and brochures alerting their California hospital customers of the potential flawed readings for people with darker skin pigmentation," Roots stated by email after the announcement. 

ON THE RECORD

"This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices," said Dr. Michelle Tarver, FDA's CDRH director, in a statement. "Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual’s skin pigmentation."

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.