Smartwatches Are Not Substitutes For ECG Machines, Learn The FDA Classification

Smartwatches and fitness trackers are becoming very popular with each passing day. Each new iteration offers more capable sensors that can detect AFib, fluctuation in blood pressure, heartbeat and overall well being. These metrics can help users adjust workout habits for more effective results.

According to the Pew Research Center, 1 in 5 Americans used a smartwatch or fitness tracker in 2020. Many of them are being used to diagnose ailments or spot abnormalities in heart rhythms, which isn’t their intended purpose. This can be a problem, says Stuart Long, CEO of InfoBionic, provider of mobile cardiac monitoring systems.

“These devices can give consumers all sorts of information, but they cannot substitute more specialized technology for diagnostic purposes. Specifically built technology provides continuous monitoring of many cardiac conditions. This gives clinicians more information to make an accurate and timely diagnosis.”

The most common heart rhythm disorder is AFib or atrial fibrillation. It’s a heart condition that causes irregular and often an abnormally fast heart beat. In such a situation, both upper chambers of the heart, the atria, beat irregularly due to abnormal firing of electrical impulses. This causes the heart to become less effective at pumping blood throughout your body.

If left unchecked, it could cause serious health problems to sufferers. It’s estimated that about 12.1 million Americans will receive an AFib diagnosed by 2030. Cardiologists monitor AFib using ECG machines, which are dedicated medical devices intended to monitor electrical activity of the heart in real-time for the prevention, diagnosis, or treatment of diseases like AFib.

These FDA-approved devices are extremely accurate at spotting problems that require medical interventions. Many patients use these machines for remote monitoring purposes to allow for a more thorough monitoring process with data that physicians can use for a medical diagnosis. Not all FDA-approved devices are considered equal in functionality.

Here are the 3 categories that the US’ Food and Drug Administration (FDA) uses to classify the registration of medical devices:

Class 1
The US FDA defines Class I devices as devices which are “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”

Class 2
Class II medical devices are more complicated than Class I devices and present a higher category of risk because they are more likely to come into sustained contact with a patient. This can include devices which come into contact with a patient’s cardiovascular system or internal organs, and diagnostic tools.

Class 3
Class III devices as products which “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.” Just 10 percent of the devices regulated by the US FDA fall into Class III. This classification is generally extended to permanent implants, smart medical devices, and life support systems.

What this means is that your smartwatch and fitness tracker (usually Class 1) should not be used to diagnose an illness or problem. Instead, they should be used to supplement ECG medical devices (usually Class 3) that your doctor requests that you. If you’re worried about sudden changes in your body or abnormal readings on your smartwatch, it is imperative that you seek the counsel of a trained physician.