Medical devices


Medical device testing: why diversity matters


A lack of diversity in medical device testing can lead to clinicians unknowingly deploying devices that perform inadequately in certain demographic groups. Stuart Grant and Sheena Macpherson highlight the impact on patient outcomes and how to manage the risks.


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.


The current state of device testing Recent FDA analysis of clinical trials conducted between 2015 and 2019 reveals that White participants composed 78% of participants at US trial sites,3


despite representing only 61%4 of the


country’s population. This disparity has remained remarkably consistent over time, with data from 2014 to 2021 showing minimal improvement in representation across most therapeutic areas.5 A recent trial of a transcatheter aortic valve implantation (TAVI) device demonstrates how these testing limitations may affect clinical


practice.6


Despite heart valve disease affecting


men and women equally, women comprised only 34.9% of trial participants. In another trial of a similar device, researchers found critical sex- specific differences in complications.7


Women


experienced significantly higher rates of atrial fibrillation than men (16.3% versus 10.1%) while cardiac perforation occurred five times more frequently in women (3.0% versus 0.6%). The National Academies of Sciences,


Engineering, and Medicine has quantified the economic impact of these disparities in clinical drug trials.8


Their analysis, using the


Future Elderly Model (FEM), estimates that health inequities, partially attributable to lack of representation in clinical research, will cost society over $11 trillion through to 2050. Even a modest 1% improvement in health disparities through better trial representation could yield over $40 billion in gains for diabetes and $60 billion for heart disease alone. These figures encompass not only


direct healthcare costs but also reduced life expectancy, reduced quality of life and fewer productive working years among underrepresented populations.


Impact on clinical practice The limitations in device testing create daily challenges for healthcare professionals across all clinical settings. A stark example emerges from recent FDA data showing that fewer than 20% of approved medical products have clinical trial data regarding treatment benefits or side effects for Black patients.5


This leaves clinicians


in the difficult position of making treatment decisions without sufficient information about how devices might perform in this population. A sparsity of literature on other ethnic groups suggests that these may be even worse represented. These challenges manifest differently across


specialties. In critical care, pulse oximeter inaccuracies in patients with darker skin tones can delay recognition of deteriorating conditions, potentially affecting rapid response team activation and intervention timing.9 Cardiologists can also face challenges with ECG interpretation in Black patients.10 The liability implications for healthcare


providers are significant. When devices perform sub-optimally in certain populations, in addition to clinical problems it creates documentation


February 2025 I www.clinicalservicesjournal.com 19


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