• What Is The Best Pulse Oximeter For Home Use
• Pulse Oximeter For Medical Professionals
• What Is The Best Home Pulse Oximeter Accuracy
• Best Home Pulse Oximeters Accurate

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It’s fair to say that the novel coronavirus pandemic has changed the way people shop—and also the items they shop for. There has been a shortage of things one might expect: toilet paper, disinfectant wipes, and thermometers. But, there are other—more surprising—items like yoga mats, yeast, and, more recently, pulse oximeters.

So, what, exactly, is a pulse oximeter?

It’s an electronic device that clips onto a patient’s finger to measure heart rate and oxygen saturation in his or her red blood cells—the device is useful in assessing patients with lung disease. Pulse oximeters started to fly off store (and online) shelves when people learned that low oxygen saturation levels can be a sign of COVID-19.

The logic is that shortness of breath, a symptom of the disease, may not be easy—or even possible—for a person to reasonably self-assess. What’s more, doctors report that some COVID-19 patients suddenly develop a condition called “silent hypoxia,” where people look and feel comfortable—and don’t notice any shortness of breath—but their oxygen levels are dangerously low. It happens to patients both in the hospital and at home, but it is a particular problem in the latter case because the symptom may indicate severe COVID-19-related pneumonia, requiring a ventilator. That’s why some people may want or need to monitor their oxygen saturation levels at home.

Should you buy a pulse oximeter?

There is debate among doctors about whether or not people need a pulse oximeter in their medical supply kits at home. “In normal times, unless a patient has true lung disease, there is no need for them to use pulse oximetry monitoring,” says Denyse Lutchmansingh, MD, a Yale Medicine pulmonologist. But these aren’t normal times. The American Lung Association advises against buying pulse oximeters unnecessarily and recommends people focus their awareness on other COVID-19 symptoms. However, in a recent New York Times opinion piece, an emergency physician from New Hampshire said if resources were directed toward earlier detection of silent hypoxia, doctors could do more to keep those patients off ventilators.

There are additional factors to consider, says Dr. Lutchmansingh. One is that knowledge of the virus is rapidly changing, which means advice can shift, as it did when the Centers for Disease Control and Prevention (CDC) changed its face mask recommendation in April to one that urges people to start wearing cloth masks in public. “We’re working very fast with limited pre-existing data. We are extrapolating a lot based on prior coronavirus infections, like severe acute respiratory syndrome [SARS] and Middle East respiratory syndrome [MERS],” she says.

At this point, Dr. Lutchmansingh says the benefits of pulse oximetry monitoring are most clear among patients who have COVID-19 symptoms such as cough, fever, and shortness of breath. “If you are symptomatic that is a reasonable time to check your oxygen. That is something we’ve been trying to do from an outpatient standpoint,” she says. “We have COVID-19 patients who we are monitoring at home and one of the deciding factors for bringing them into the hospital is their oxygen level.”

But for people who are young and healthy—and have no COVID-19 symptoms—she questioned the need to buy a pulse oximeter.

What Is The Best Pulse Oximeter For Home Use

How to buy it, what to do with it

If you do have a pulse oximeter and are checking your oxygen levels, it’s important to know that a level between 95 and 97% is considered normal by the American Lung Association; anything below that would be a reason to call a doctor, and anything under 90% would be a reason to go to the emergency room.

Dr. Lutchmansingh also advises people who plan to use a pulse oximeter to ask a medical professional to guide them. “It’s helpful to know your baseline level,” she says. “If there are changes, a medical professional can talk about what’s causing those changes and take any additional measures to investigate it.” Changes might be related to a non-COVID pulmonary problem that may be undiagnosed, such as asthma or unrelated pneumonia, she says. In addition, your reading may be inaccurate if your fingernails are dirty or you have artificial nails or are wearing nail polish.

As far as which pulse oximeter to buy, “There is no standardization,” she says. “You are buying in good faith.” According to Consumer Reports, prices for pulse oximeters range from $25 to $100, if you can find one, as shortages have been reported. Phone apps and exercise trackers like Fitbits are not the best tools for checking oxygen levels, Dr. Lutchmansingh says. “One can always go the route of ‘something is better than nothing,’ but we don’t know how accurate they are,” she says. “But if you have one of those things [apps or trackers] and the numbers are low, I would still advise that you talk to your doctor.”

Buying a pulse oximeter to ease the anxiety

There is another consideration—some people stock up on anything that eases their fear and anxiety, says Dr. Lutchmansingh. “There is such wide variance to this disease,” she says, explaining that it’s still difficult to predict who will become severely ill, and it’s understandable that people would want to be prepared for any eventuality. “There is the medical component to this, and then there is the anxiety component. People are scared. If they feel there is some action they can take, some sort of monitoring they can use, it’s hard not to take advantage of it,” she says.

“However, it’s not necessarily helpful for people to buy things just to have them, because there is a difference between gathering data and using data,” she says. “It’s not just information in a bubble. You can get all your numbers, but if you don’t know how to interpret them, all you have are numbers.”

Meanwhile, shortness of breath and low oxygen levels are just two possible symptoms of COVID-19, and it’s important to know all of the symptoms, Dr. Lutchmansingh says. The CDC provides a list of symptoms that could appear anywhere between 2 to 14 days after exposure to the virus that causes COVID-19. That list includes cough, fever, shortness of breath, difficulty breathing, chills, repeated shaking with chills, muscle pain, headache, sore throat, and loss of taste or smell.

Patients and members of the community who have questions can call the Yale Medicine/Yale New Haven Health Call Center COVID-19 hotline at 203-688-1700 (toll-free, 833-484-1200).

Click here to read about a philanthropic gift of 100 wearable pulse oximeters to the Yale Medicine Department of Internal Medicine.

Date Issued: February 19, 2021

The Coronavirus Disease 2019 (COVID-19) pandemic has caused an increase in the use of pulse oximeters, and a recent report (Sjoding et al.) suggests that the devices may be less accurate in people with dark skin pigmentation. The U.S. Food and Drug Administration (FDA) is informing patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered. Patients with conditions such as COVID-19 who monitor their condition at home should pay attention to all signs and symptoms of their condition and communicate any concerns to their health care provider.

Recommendations for Patients and Caregivers

How to take a reading:

Pulse Oximeter For Medical Professionals

• Follow your health care provider’s recommendations about when and how often to check your oxygen levels.
• Be aware that multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish. To get the best reading from a pulse oximeter:
  • Follow the manufacturer’s instructions for use.
  • When placing the oximeter on your finger, make sure your hand is warm, relaxed, and held below the level of the heart. Remove any fingernail polish on that finger.
  • Sit still and do not move the part of your body where the pulse oximeter is located.
  • Wait a few seconds until the reading stops changing and displays one steady number.
• Write down your oxygen levels with the date and time of the reading so you can easily track changes and report these to your health care provider.

How to interpret a reading:

• When taking pulse oximeter measurements, pay attention to whether the oxygen level is lower than earlier measurements, or is decreasing over time. Changes or trends in measurements may be more meaningful than one single measurement. Over the counter products that you can buy at the store or online are not intended for medical purposes.
• Do not rely only on a pulse oximeter to assess your health condition or oxygen level.
• If monitoring oxygen levels at home, pay attention to other signs or symptoms of low oxygen levels, such as:
  • Bluish coloring in the face, lips, or nails;
  • Shortness of breath, difficulty breathing, or a cough that gets worse;
  • Restlessness and discomfort;
  • Chest pain or tightness; and
  • Fast or racing pulse rate.
  • Be aware that some patients with low oxygen levels may not show any or all of these symptoms. Only a health care provider can diagnose a medical condition such as hypoxia (low oxygen levels).

When to contact your health care provider:

• If you are concerned about the pulse oximeter reading, or if your symptoms are serious or getting worse, contact a health care provider.
• If you think you may have COVID-19, contact your health care provider or local health department about getting a diagnostic test for COVID-19. Pulse oximeters cannot be used to diagnose or rule out COVID-19.

For more consumer information on pulse oximeters, see Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy.

Recommendations for Health Care Providers

• Be aware that multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish. Review the information in the sections below to better understand how accuracy is calculated and interpreted.
• Refer to the device labeling or the manufacturer’s website to understand the accuracy of a particular brand of pulse oximeter and sensor. Different brands of pulse oximeters and even different sensors (finger clip versus adhesive) may have a different accuracy level. Pulse oximeters are least accurate when oxygen saturations are less than 80%.
• Consider accuracy limitations when using the pulse oximeter to assist in diagnosis and treatment decisions.
  • Use pulse oximeter readings as an estimate of blood oxygen saturation. For example, a pulse oximeter saturation of 90% may represent an arterial blood saturation of 86-94%.
  • When possible, make diagnosis and treatment decisions based on trends in pulse oximeter readings over time, rather than absolute thresholds.

Device Description

A pulse oximeter is a device that is usually placed on a fingertip. It uses light beams to estimate the oxygen saturation of the blood and the pulse rate. Oxygen saturation gives information about the amount of oxygen carried in the blood. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.

Most pulse oximeters show two or three numbers. The most important number, oxygen saturation level, is usually abbreviated SpO₂, and is presented as a percentage. The pulse rate (similar to heart rate) is abbreviated PR, and sometimes there is a third number for strength of the signal. Oxygen saturation values are between 95% and 100% for most healthy individuals, but sometimes can be lower in people with lung problems. Oxygen saturation levels are also generally slightly lower for those living at higher altitudes.

There are two categories of pulse oximeters: prescription use and over the counter (OTC).

• Prescription oximeters are reviewed by the FDA, receive 510(k) clearance, and are available only with a prescription. The FDA requires that these pulse oximeters undergo clinical testing to confirm their accuracy. They are most often used in hospitals and doctors’ offices, although they may sometimes be prescribed for home use.
• Over-the-counter (OTC) oximeters are sold directly to consumers in stores or online and include smart phone apps developed for the purpose of estimating oxygen saturation. Use of OTC oximeters has increased as a result of the COVID-19 pandemic. These products are sold as either general wellness or sporting/aviation products that are not intended for medical purposes, so they do not undergo FDA review. OTC oximeters are not cleared by the FDA and should not be used for medical purposes.

For more information on pulse oximeter regulation, see Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff.

Interpretation and Limitations of Pulse Oximetry

Pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. In many cases, the level of inaccuracy may be small and not clinically meaningful; however, there is a risk that an inaccurate measurement may result in unrecognized low oxygen saturation levels. Therefore, it is important to understand the limitations of pulse oximetry and how accuracy is calculated and interpreted.

FDA-cleared prescription pulse oximeters are required to have a minimum average (mean) accuracy that is demonstrated by desaturation studies done on healthy patients. This testing compares the pulse oximeter saturation readings to arterial blood gas saturation readings for values between 70-100%. The typical accuracy (reported as Accuracy Root Mean Square or A_rms) of recently FDA-cleared pulse oximeters is within 2 to 3% of arterial blood gas values. This generally means that during testing, about 66% of SpO₂ values were within 2 or 3% of blood gas values and about 95% of SpO₂ values were within 4 to 6% of blood gas values, respectively.

However, real-world accuracy may differ from accuracy in the lab setting. While reported accuracy is an average of all patients in the test sample, there are individual variations among patients. The SpO₂ reading should always be considered an estimate of oxygen saturation. For example, if an FDA-cleared pulse oximeter reads 90%, then the true oxygen saturation in the blood is generally between 86-94%. Pulse oximeter accuracy is highest at saturations of 90-100%, intermediate at 80-90%, and lowest below 80%. Due to accuracy limitations at the individual level, SpO₂ provides more utility for trends over time instead of absolute thresholds. Additionally, the FDA only reviews the accuracy of prescription use oximeters, not OTC oximeters meant for general wellness or sporting/aviation purposes.

Many patient factors may also affect the accuracy of the measurement. The most current scientific evidence shows that there are some accuracy differences in pulse oximeters between dark and light skin pigmentation; this difference is typically small at saturations above 80% and greater when saturations are less than 80%. In the recently published correspondence by Sjoding, et. al., the authors reported that Black patients had nearly three times the frequency of occult hypoxemia (low oxygen levels in the blood) as detected by blood gas measurements but not detected by pulse oximetry, when compared to White patients. It is important to note that this retrospective study had some limitations. It relied on previously collected health record data from hospital inpatient stays and could not statistically correct for all potentially important confounding factors. However, the FDA agrees that these findings highlight a need to further evaluate and understand the association between skin pigmentation and oximeter accuracy.

All premarket submissions for prescription use oximeters are reviewed by the FDA to ensure that clinical study samples are demographically representative of the U.S. population, as recommended by FDA guidance, Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff. As described in this guidance, FDA recommends that every clinical study have participants with a range of skin pigmentations, including at least 2 darkly pigmented participants or 15% of the participant pool, whichever is larger. Although these clinical studies are not statistically powered to detect differences in accuracy between demographic groups, the FDA has continued to review the effects of skin pigmentation on the accuracy of these devices, including data from controlled laboratory studies and data from real world settings.

FDA Actions

The FDA is committed to the continued evaluation of the safety, effectiveness, and availability of medical devices, especially devices in high demand during the COVID-19 pandemic. The FDA is evaluating published literature pertaining to factors that may affect pulse oximeter accuracy and performance, with a focus on literature that evaluates whether products may be less accurate in individuals with darker skin pigmentation. The FDA has been working on additional analysis of premarket data, as well as working with outside stakeholders, including manufacturers and testing laboratories, to analyze additional postmarket data to better understand how different factors including skin pigmentation may affect pulse oximeter accuracy. Based on these findings, the FDA may reassess the content of the pulse oximetry guidance document.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with a Pulse Oximeter

If you think you have a problem with a pulse oximeter, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

What Is The Best Home Pulse Oximeter Accuracy

Questions?

Best Home Pulse Oximeters Accurate

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.