Wellness Devices vs. Medical Devices

March 15, 2017

A wrist-worn fitness tracker is great for encouraging exercise and promoting healthy behaviors, but it is not a replacement for an FDA-cleared medical device. With new devices hitting the market often, the lines appear to be blurring in consumers’ eyes.

It’s important to distinguish the two different types of devices:

Wellness Devices

Wellness devices are intended only to be used for general wellness. They present a low risk to the safety of the person using the device and to others (according to the Center for Devices and Radiological Health.) Fitness trackers, apps that track fitness and/or diet, exercise equipment and video games all fall into this category. These products and their claims do not have to comply with the same regulations by the Food and Drug Administration as medical devices.

Medical Devices

A medical device, as defined by the FDA, is intended to be used to diagnose, treat, mitigate or prevent a disease. Examples include anything as simple as a tongue depressor or bedpan to more complex devices, like oximeters, surgical lasers and pacemakers. These devices are regulated by the FDA based on their classification.

The prevalence of wellness devices is raising questions about whether they can be used in medical settings, specifically for monitoring a patient’s heart rate. Patients, and even some clinicians, have done their own impromptu testing, comparing the readings on fitness devices with a pulse oximeter in a calm, non-stressful setting. However, that type of test does not measure how devices would work if the patient was having trouble breathing or suffering from a lack of oxygen.

A recent clinical trial published in the Journal of Medical Internet Research studied wellness devices in a more challenging situation and found they have limitations. Researchers studied 50 stable patients in intensive care by monitoring them with a personal fitness tracker over 24 hours. Electrocardiographic monitoring and pulse oximetry were used as a control.

What the study showed is personal fitness trackers underestimated heart rate values and were not as accurate as medical devices. It concludes that more research is needed to determine whether wellness devices can be used to augment FDA-regulated medical devices.

Considering wellness devices have not been proven as an accurate and reliable alternative to pulse oximetry, patients should be mindful they are selecting the correct pulse oximeter. One of the most important factors in choosing a pulse oximeter is accuracy, and an independent study (done at Clinimark Laboratories in 2016) shows Nonin Medical are the most accurate even in the toughest conditions. Other considerations include warranty, customer service and which patients it will work for.

For a list of the ten questions you should ask yourself when buying a pulse oximeter, click here.