Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance

Key takeaways:

• Most of the summary documents discussing race and ethnicity/skin tone came from 2016 to 2024.
• More than half of the documents used the word “pigment.”
• Fewer documents used “skin tone” and “demographic.”

Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance summary documents discussing race and ethnicity/skin tone rose, according to a research letter published in JAMA.

“FDA-cleared pulse oximeter summary documents showed low but improving uptake of reporting of participant diversity after the voluntary guidance was released,” Kadija Ferryman, PhD, assistant professor in the Berman Institute of Bioethics at Johns Hopkins University, and colleagues wrote.

Using the FDA’s database, Ferryman and colleagues analyzed 767 510(k) clearance summaries for pulse oximeters to determine how mentions of race and ethnicity or skin tone in these documents have changed since the release of the 2013 guidance requesting device testing that includes “a range of skin pigmentations” by comparing documents from 1996 to 2012 (n = 412), 2013 to 2015 (n = 87) and 2016 to 2024 (n = 268).

Of the 96 summary documents that discussed race and ethnicity or skin tone, most were from the 2016 to 2024 timeframe (67 documents; 25%), whereas the 2013 to 2015 timeframe and the 1996 to 2012 timeframe had fewer documents mentioning these topics (12 documents [13.8%] and 17 documents [4.1%], respectively).

Notably, descriptors varied across the documents, according to the study. More than half of the 96 summary documents described skin color as “dark” (75 documents) and used the word “pigment” (50 documents). In contrast, a smaller number of documents used the words “skin tone” (16 documents) and “demographic” (nine documents).

Additionally, researchers reported that few documents mentioned derivatives of Africa (six documents) and derivates of Asia (four documents) and that these mentions referred to the characteristics of participants involved in the testing.

“The lack of standardization suggests more explicit guidance about what to report — with consistent enforcement — may be helpful,” Ferryman and colleagues wrote.

Researchers also evaluated Fitzpatrick scale mentions and found 14 documents, with all but one from 2023 to 2024.

“These data suggest the importance of consistent enforcement of FDA guidance and the limits of voluntary compliance and self-regulation to drive market innovation in more equitable pulse oximeters,” Ferryman and colleagues wrote.

As Healio previously reported, proposed changes to premarket studies assessing pulse oximeter performance were generally well received by the panelists at a Medical Devices Advisory Committee meeting held Feb. 2, 2024.