Medical device testing: why diversity matters

When delivering her daughter, Dr. Michelle Tarver experienced what could have been a fatal flaw in medical device testing. Despite being director of the FDA's Center for Devices and Radiological Health, she suffered respiratory depression because a pulse oximeter failed to accurately read her oxygen levels due to her darker skin tone. Only rapid medical intervention prevented tragedy. "Thankfully, I had a good outcome," she later reflected, "but not everybody does."¹

The scale of this problem is staggering. An investigation by the International Consortium of Investigative Journalists revealed that over a 10-year period, more than 1.7 million injuries and nearly 83,000 deaths have been potentially linked to medical devices.² This analysis identified these incidents as potentially linked to devices reported to US regulators alone; inevitably the global toll will be significantly higher.

These statistics are not just numbers but represent real patients whose lives have been impacted by the limitations of medical devices. Problems with medical devices can extend beyond individual incidents to systemic issues in healthcare delivery when devices aren't adequately tested across diverse populations. A lack of diversity in medical device testing may lead clinicians to unknowingly deploy devices that perform inadequately in certain demographic groups. This issue can compromise care quality and patient outcomes while potentially increasing liability risks for healthcare providers.