Pulse oximeters used to test blood oxygen levels, an increasingly common precaution during the pandemic, maybe giving a false sense of security according to an FDA warning.
One of the warning signs of having contracted the virus can be low levels of oxygen in their blood, even if they feel well, and a factor that can be an early indicator that medical care is needed
It’s led to an uptick in pulse oximeter sales – Best Pulse Oximeter next day Delivery
Typically small clips that fit onto the end of a finger, use light to estimate the blood’s level of oxygen saturation and the pulse rate.
Oxygen saturation is expressed as SpO2 and is given as a percentage.
For healthy individuals, a reading of 95- to 100-percent is typical, though those with lung issues or living at higher altitudes can commonly record lower numbers.
The sensors also typically measure pulse rate, abbreviated PR.
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Not all pulse oximeters are created equal
Although the core technology may be the same, there are different types of the pulse oximeter. The biggest distinction is prescription versus over-the-counter (OTC), with the former typically found in doctors’ offices and hospitals.
They must be reviewed by the FDA and get 501(k) clearance, with clinical testing to ensure they’re accurate in their readings. They can only be bought with a prescription.
OTC pulse oximeters, meanwhile, are more generally available. “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,” the US Food and Drug Administration points out.
“OTC oximeters are not cleared by the FDA and should not be used for medical purposes.”
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“Patients with conditions such as virus pandemic should not rely solely on pulse oximeter measurements to monitor their health at home as they are not a substitute for a medical diagnosis by a health care provider”
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Consumers can buy over-the-counter oximeters in stores or online, but they’re not intended for medical use and don’t undergo FDA review, according to the FDA alert.
Prescription oximeters undergo FDA review and are typically used in hospitals and doctor’s offices, though sometimes patients receive a prescription to use one at home.
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The FDA guidance gives tips to help patients and caregivers take an accurate reading and interpret the results correctly.
Importantly, changes or trends in measurements are more meaningful than a single measurement, according to the guidance.
If patients are concerned about a pulse oximeter reading, they should contact their healthcare worker, especially if their symptoms become worse or they think they may have the virus.
The FDA is evaluating the current research about pulse oximeter accuracy, particularly with a focus on studies that evaluate whether the products are less accurate for people with darker skin.
Based on new findings, the FDA may update its pulse oximetry guidance and will inform the public if new information becomes available.
The FDA also encourages consumers to report any pulse oximeter issues through the MedWatch Voluntary Reporting Form.
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Cheap pulse oximeters may not be especially accurate
The reality is, the FDA warns, that while prescription pulse oximeters have to reach a certain level of accuracy, the same isn’t true for OTC models. SpO2 readings are only to be considered an estimate of overall oxygen saturation.
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“For example,” the FDA explains, “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%.”
If you’re using an OTC pulse oximeter, then, it should be as part of general awareness of the virus symptoms rather than the only aspect.
Most important of all, even if the numbers on the screen say you’re in the normal range, that shouldn’t override how you’re feeling and any other symptoms you’re experiencing, particularly if there’s been a chance of exposure to someone with the virus recently.
FDA regulated products
Types of FDA Regulated Products
- Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
- Medical devices such as diabetes glucose-test kit, hearing aids, breast pumps, and many more products.
- Combination products such as prefilled drug syringes, auto-injectors, metered-dose inhalers, contact lens coated with a drug, and nasal-spray.
- Special nutritional products such as dietary supplements, medical foods, and infant formulas.
- Ever wonder if there are pulse oximeters made in the USA?
- How many medical device manufacturers are there in the United States?
It is also gaining popularity in other parts of the world as it can help detect Congenital Heart Defects and other heart and respiratory conditions.
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- Pulse oximeters FDA approved and more…
The term PRBPM refers to pulse rate (PR) and beats per minute (BPM) and the serious question is what PR and BPM mean on a pulse oximeter.