For years, pulse oximeters have been a quiet yet vital presence in hospitals, clinics, and homes. These small devices, usually clipped onto a finger, measure blood oxygen saturation—an essential metric for assessing breathing and heart function. They became especially familiar during the COVID-19 pandemic, when many households purchased them to monitor symptoms at home.
Yet beneath their convenience and widespread use lies a troubling reality. Studies and patient reports have shown that pulse oximeters are not always equally accurate for everyone. In particular, people of color—especially those with darker skin—face a higher risk of misreadings. This inaccuracy can mean the difference between early intervention and dangerous delays in treatment.
Now, the U.S. Food and Drug Administration (FDA) is considering changes to ensure that these devices work reliably for all patients, regardless of skin tone.
Why Pulse Oximeters Matter So Much
Pulse oximeters provide information that can guide critical medical decisions. If oxygen saturation drops too low, it signals that a patient may be in respiratory distress, requiring oxygen therapy or hospitalization. Conversely, stable readings offer reassurance that conditions are under control.
Doctors rely on these devices to decide when to escalate care, admit someone to the hospital, or adjust treatment plans. Families at home use them to monitor loved ones with chronic illnesses like COPD, asthma, or COVID-19. For such a small device, its influence is enormous.
But if readings are skewed, especially in communities already facing disparities in healthcare, the consequences can be severe.
How Bias Creeps Into Medical Devices
At first glance, it might seem puzzling that a device as simple as a pulse oximeter could produce biased results. The answer lies in how it works.
Pulse oximeters use light to measure how much oxygen is bound to hemoglobin in the blood. The device shines light through the skin and detects how it is absorbed. But darker skin tones can alter how light is absorbed and reflected, leading to artificially high oxygen readings.
If a patient’s oxygen is lower than the device indicates, they may appear healthier than they are. That false reassurance can delay urgent care and contribute to worse outcomes.
The Human Stories Behind the Data
Statistics reveal the problem, but human stories bring it into sharper focus. Families have shared experiences of loved ones—often people of color—who appeared stable according to their pulse oximeters but were, in fact, dangerously ill. Some of these stories emerged during the COVID-19 pandemic, when accurate oxygen readings could mean the difference between life and death.
Imagine a patient struggling to breathe but told by their device that oxygen levels are “normal.” Hours later, they collapse and arrive at the hospital in critical condition. For many, these scenarios are not hypotheticals but lived experiences. The emotional toll is profound, blending frustration, grief, and a sense of being unseen by the very tools designed to protect them.
FDA’s Response and Next Steps
The FDA has acknowledged these disparities and is weighing changes to the way pulse oximeters are tested, regulated, and approved. Currently, manufacturers are not required to test devices on a sufficiently diverse population. This oversight leaves gaps in accuracy across skin tones.
Potential changes under consideration include requiring companies to study device performance in racially and ethnically diverse groups, updating labeling to reflect limitations, and setting stricter accuracy standards. The agency has also held advisory meetings to hear from experts, clinicians, and patients, ensuring that reforms are informed by both science and lived experience.
A Moment of Reckoning for Medical Technology
The debate over pulse oximeters represents something larger: a reckoning with how bias, intentional or not, can seep into medical technology. Devices designed to be neutral tools can reflect the blind spots of the systems that created them.
For years, design and testing processes often assumed a “default” patient population—typically lighter-skinned, male, and Western. As a result, devices like pulse oximeters worked better for some people than others. Recognizing this problem is a crucial step toward ensuring that technology serves everyone fairly.
Communities Demand Better
Communities of color, patient advocates, and healthcare professionals have called for greater accountability. They argue that in a country as diverse as the United States, no medical device should leave entire populations at risk.
Their voices carry both urgency and hope. Urgency, because the harm caused by inaccuracy is ongoing. Hope, because reforms can make a tangible difference in how future patients are treated. These demands are not just about numbers or devices but about dignity, fairness, and trust in healthcare systems.
Trust and Equity in Medicine
Trust is a fragile thing in medicine, especially among communities historically underserved or mistreated. The realization that a widely used device may not work equally well for all threatens to deepen existing mistrust. But addressing the problem head-on offers an opportunity to rebuild confidence.
Equity in medicine is not just a principle; it is a necessity. Accurate readings for every patient, regardless of skin tone, are fundamental to safe care. As the FDA considers reforms, the conversation extends far beyond one device. It raises questions about how medical technologies are designed, tested, and validated for a diverse population.
How Healthcare Providers Adapt Today
In the meantime, clinicians are not powerless. Many hospitals and doctors are aware of the limitations of pulse oximeters and use them alongside other clinical observations. A patient’s breathing patterns, skin color, energy level, and overall appearance are weighed carefully, especially when treating patients of color.
Some providers recommend additional testing, such as arterial blood gas measurements, to confirm oxygen levels when readings and symptoms do not align. These adaptations are imperfect but reflect a growing awareness of the need for vigilance and sensitivity.
The Emotional Weight of Injustice
For patients and families, the issue carries emotional weight. It is painful to know that a loved one’s health could be jeopardized simply because of skin tone—a characteristic unrelated to the illness at hand. The sense of injustice lingers, reinforcing the need for systemic change.
Conversations around the dinner table, in waiting rooms, and on social media reveal both frustration and determination. People want answers, but more importantly, they want action. The problem has been identified; now it must be fixed.
Looking Ahead: Designing Fairer Devices
The path forward is clear but demanding. Manufacturers must commit to testing devices on racially and ethnically diverse populations, not as an afterthought but as a standard practice. Regulators must enforce these requirements and ensure accountability. Healthcare providers must continue to advocate for patients whose needs have historically been overlooked.
Technology can be a force for equity, but only if it is built with equity in mind from the start. Pulse oximeters remind us that fairness cannot be assumed; it must be engineered.
A Call to Humanize Healthcare
At its core, this issue is about humanizing healthcare. Every patient deserves to be seen fully and accurately, not through a distorted lens of biased design. Every family deserves to trust that the tools used in hospitals and homes are reliable for them, regardless of race.
As the FDA considers changes, the conversation must remain rooted in the humanity of those affected. Policies and technical standards are vital, but the ultimate goal is simple: to protect lives equally.
Conclusion: From Recognition to Reform
The story of pulse oximeters and skin tone bias is not one of failure alone but of awakening. It highlights how blind spots in technology can have human consequences, and how awareness can spark reform.
The FDA’s consideration of changes represents a pivotal moment, one that could reshape not only how these devices are regulated but also how medical technology is approached more broadly.
For patients and families, the hope is clear: that future generations will never question whether a device designed to measure their health truly measures them. For the healthcare system, the responsibility is equally clear: to ensure that no one is left unseen, unheard, or underserved because of the color of their skin.
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