The development of medical technology has revolutionized healthcare in the United States, advancing patient treatment across the nation. In response to the ever-evolving use of technology in the healthcare system, the Food and Drug Administration (FDA) has enforced regulations to ensure the safety and effectiveness of products. However, according to the National Institute of Minority Health and Disparities, some medical devices may not function as represented in all patients because they were approved after testing almost solely on white people.
Until February of this year, the United States had no significant requirements for diversity in clinical trials. This has meant that clinical trials were frequently dominated by white males.
Currently, according to Dr. Asad Siddiqui at The Hospital for Sick Children, Black people represent only 5% of clinical testing participants in the U.S. As a result, Blacks are more likely to be misdiagnosed and underdiagnosed than whites, resulting in delayed medical treatment and life-threatening health complications.
During the pandemic, no-contact infrared thermometers largely replaced oral thermometers. Because past studies on infrared thermometers declared that pigmentation was irrelevant to the devices’ accuracy, the FDA did not require clinical trials for these devices to include dark-skinned participants.
However, multiple studies have now shown that these thermometors are not equipped to detect fevers accurately in dark-skinned patients, possibly delaying their treatment and access to care.
Emory University School of Medicine analyzed the differences between Black and white patients’ oral and infrared thermometer readings, and concluded that the infrared thermometer could not detect 26% of fevers in African-Americans. There was no significant difference in the temperature readings between infrared and oral thermometer readings for white.
The FDA’s refusal to ensure the device accurately measures temperature in all patients has resulted in the underdiagnosis among Black patients of severe and sometimes lethal hypoxemia, a common complication of Covid that requires oxygen treatment.
The FDA is coming to recognize skin pigmentation’s influence on the accuracy of pulse oximeters, however, their regulations do not yet require sufficient diversity in clinical trials.
The FDA currently only requires clinical trials to contain two dark-skinned participants or 15% of the clinical pool — whichever is larger. However, the FDA does not define “darkly pigmented” skin, leaving the term up to the researchers’ interpretation. Thus, the current guidelines do not guarantee the device’s effectiveness for the wide variety of skin pigmentation found in Americans.
Medical technology is fundamental in treating and diagnosing illness, and the FDA’s negligence in clinical trials has compromised the health of many Americans.
Clinical trials must use diverse testing groups for new medical technology to ensure equitable and accurate diagnosis and treatment for all.
