A Groundbreaking Analysis

A groundbreaking analysis reveals that reporting on the diversity of participants in FDA-approved pulse oximeter testing has seen a notable increase since the agency issued voluntary guidance in 2013. Despite initial concerns about the underrepresentation of racial and ethnic diversity in clinical trials, public FDA records show a clear trend toward better inclusion over time.

Study Insights from Johns Hopkins University

Kadija Ferryman, PhD, from the Berman Institute of Bioethics at Johns Hopkins University, and her colleagues conducted an extensive study, published in JAMA, uncovering critical findings regarding the representation of race, ethnicity, and skin tone in pulse oximeter performance testing documents. They analyzed data from 767 FDA summary documents covering the period from 1996 to 2024 and revealed that reports mentioning race or skin tone were included just 320 times—an encouraging yet still inadequate statistic.

Significant Improvements in Reporting

The research indicated a significant shift in diversity reporting: only 4.1% of documents before the 2013 guidance included such details. This proportion rose to 13.8% around the time of the guidance and jumped to 25% afterward—an impressive increase thanks to heightened awareness and regulatory efforts (P<0.001).

Ongoing Challenges

However, Ferryman emphasizes the ongoing challenges. “Although there's been a rise in mentions of skin descriptors post-guidance, the reality remains that most public clearance documents still lack critical information about testing on diverse populations,” she stated. This lack of data means that many clinicians, who often have no choice of which pulse oximeter devices to use, may be unaware of the devices' performance across different skin tones.

Disparities in Device Performance

Research has shown that pulse oximeters tend to overestimate oxygen saturation levels in individuals with darker skin, a concerning trend that highlights a racial and ethnic bias in medical devices. According to Carmel Shachar, JD, MPH, of Harvard Law School, the disparity is not just statistical—it can lead to missed diagnoses of life-threatening conditions due to inaccuracies in readings.

Call for Reforms

The authors call for urgent reforms, stating, “The ultimate goal should be to have pulse oximeters that work effectively for all skin tones. This is a complex issue that requires cooperative action among multiple stakeholders.” Solutions may lie in future FDA guidance revisions currently under development, but experts warn that these alone will not be enough to ensure equity in pulse oximeter performance.

Thorough Documentation and Review

Ferryman’s team utilized the FDA’s historic database to gather data on devices cleared since 1978, ensuring thorough documentation through a review of over 1,024 oximeter clearances. They aimed for clarity in the review process, which included a meticulous examination of how skin tone and race were reported in performance assessments.

Need for Greater Transparency

Despite the positive trends observed, the study's limitations also highlight the need for greater transparency. Not all documentation is publicly available, raising concerns about potential critical data that could aid in understanding device performance across different demographics.

Conclusion and Future Directions

As the healthcare industry moves toward more equitable practices, the necessity for clear reporting standards in clinical trials and medical device testing is more urgent than ever. The faces of health technology must reflect the diversity of the population it serves—this is not just a regulatory issue but a humanitarian imperative. Stay tuned for more updates as further guidance is developed!