“Revolutionizing Pulse Oximetry: How FDA Guidance Enhanced Diversity in Reporting”

An analysis of public FDA records revealed that there was a “low but improving adoption” of reporting diversity among participants in summary documents for FDA-approved pulse oximeters following the issuance of voluntary guidance in 2013.

Incidences of race, ethnicity, or skin tone were documented 320 times in 12.5% of 767 FDA summary documents pertaining to pulse oximeter performance assessments from 1996 to 2024, as reported by Kadija Ferryman, PhD, from the Berman Institute of Bioethics at Johns Hopkins University in Baltimore, and co-authors in a research letter published in JAMA.

References to these attributes appeared in 4.1% (17 of 412) of documents prior to the 2013 guidance, 13.8% (12 of 87) of documents around the time the guidance was issued, and 25% (67 of 268) of documents after the guidance was released (P<0.001).

“The key finding is that although references to skin color descriptors increased in performance testing following the FDA’s guidance, most public clearance documents for pulse oximeters still did not include any mention of testing involving diverse individuals,” Ferryman informed MedPage Today via email.

“Healthcare professionals working in hospital environments often do not have the option to select which pulse oximeter devices they utilize with their patients,” Ferryman stated. “As this research is rooted in public records, it implies that even if clinicians wished to conduct their own investigation into the performance of pulse oximeters across varied populations, the majority of FDA-approved device records do not provide details about testing on different skin tones.”

Pulse oximeter measurements in patients with darker skin tones frequently tend to exaggerate oxygen saturation, which has been an ongoing issue identified in numerous studies and addressed by an FDA advisory panel.

“Clinical evidence has indicated that many hospital pulse oximeters consistently report falsely elevated readings in individuals with darker skin compared to those with lighter skin — thereby demonstrating a racially and ethnically biased statistical disparity,” highlighted Carmel Shachar, JD, MPH, from Harvard Law School in Boston, along with co-authors of an accompanying viewpoint article.

“In the absence of a straightforward adjustment, pulse oximeter readings are also more inconsistent in individuals with darker skin tones compared to white individuals — meaning they are less reliable. These discrepancies combine to hinder the detection of dangerously low blood oxygen levels among those with darker skin tones,” they wrote.

“The ultimate objective should be to develop pulse oximeters that function effectively across all skin tone categories,” Shachar and colleagues emphasized. “No single entity can resolve this issue independently at present.”

For their analysis, Ferryman and her team examined the FDA’s database to identify unique device documents based on specific product codes for oximeters dating back to 1978. These summary documents constitute a standard component of the agency’s 510k pathway and encompass crucial information utilized in the FDA’s assessment and judgment to authorize the marketing of a device.

The researchers gathered summaries featuring any of 17 search terms pertinent to race, ethnicity, or skin color and subsequently verified that the terms were associated with study participants. From 1,024 oximeter approvals identified, 767 summary documents containing relevant details were retrievable from the FDA’s website.

To evaluate the effects of the FDA’s guidance, they divided results into three distinct time frames: pre-guidance from 1996-2012, a “washout period” around the time the guidance was released from 2013 to 2015, and from 2016 to 2024.

The study’s primary strength was its capacity to assess skin tone descriptors in performance testing of pulse oximeters authorized by the FDA using all publicly accessible documents, Ferryman noted.

However, limitations included the use of only publicly available documents. “Manufacturers of pulse oximeter devices do submit longer applications to the FDA that are not fully accessible to the public, so it is plausible that those confidential documents might contain information regarding skin tone that is absent in the documents we reviewed,” Ferryman stated.

The researchers also underscored the “apparent confusion surrounding notions of skin tone, race, ethnicity, and national origin” within FDA documents, suggesting that more explicit guidance about what to report could prove beneficial.

Updated FDA guidance concerning pulse oximeter testing, which is currently being developed, may address some of these challenges; however, it is unlikely that any single amendment to guidance “will be adequate to fully rectify the issues concerning the development, marketing, and distribution of fully equitable pulse oximeters,” they stated.