Saturday, December 3, 2022

The Evolution of OTC vs. Prescription Wearable ECG Monitoring Devices – Differences and Considerations for Use: By Ann Demaree, MBA, BSN, RN, Senior Vice President, Cardiac Insight LLC

From eyeglasses to watches, over-the-counter (OTC) consumer wearable devices have evolved over the years in sophistication as well as in breadth of use. These innovations allow us as consumers to track our individual fitness biometrics, such as the number of steps taken each day, measure our level of stress and performance. Additionally, OTC wearables increasingly include biometrics that used to be solely in the realm of medical professionals, including electrocardiograms (ECGs) and pulse oximetry.

In 2018, Apple Inc. was the first company to announce that its watch series could enable wearers to obtain an ECG from one’s own wristwatch. Since then, more companies and brands are offering similar health tools. The Food and Drug Administration (FDA) has even cleared specific manufacturers’ OTC devices as “over-the-counter” Class II medical devices.

“While OTC wearable devices are designed to allow for augmented individual monitoring of body parameters, identifying deviations that can empower people to make educated decisions on their personal fitness and health, the question is, just how accurate are they and where should they fit within the ideal healthcare ‘ecosystem’?”

Are OTC wearables a substitute for a medical diagnosis?

There is some evidence to support that “over-the-counter” or OTC devices can be helpful, but in no case are they labeled, or intended, as substitutes for a physician visit or to replace data from doctor-prescribed wearable devices and sensors typically used to enable definitive physician diagnosis. This is especially true in the case of life-threatening conditions such as cardiac disease, which remains the leading global cause of mortality and morbidity.

A new study published in  the Circulation (AHA Journals) from AF-SCREEN International Collaboration recommends that companies marketing Afib and ECG screening devices should “…report the accuracy and performance of their products…and avoid claims about clinical outcomes unless improvement is demonstrated in randomized clinical trials.”  While the study found that monitoring OTC devices could increase early diagnosis of Afib, the report also warned that health care professional–led randomized controlled studies using multiple ECG recordings or continuous ECG monitoring to detect AFib have failed to demonstrate a significant reduction in stroke.

Overall healthcare professionals are recommending caution when citing the efficiency of these OTC monitoring devices, and the good news is that many consumers concur. A survey of 2000 patients found that the majority of patients (61%) believed they would feel safer with a health monitoring device provided by their doctor and that OTC devices should not replace a doctor’s care or testing decisions.

OTC Wearables versus Prescription ECG Wearables: What are the Differences?

Consumers should be aware that OTC wearables are not as accurate or comprehensive as the ambulatory ECG wearable patch monitors prescribed by their physicians. OTC wearables can be helpful as everyday monitoring ‘supplements’ but typically are labelled for use with specific limitations, including age, types of abnormal rhythm or parameter detection, exclusions, disclaimers, specific environmental conditions, etc.

While OTC wearables may be labeled to indicate irregular heart rhythms suggestive of atrial fibrillation (AFib), ambulatory prescription ECG patch monitors are FDA-cleared diagnostic tests intended to detect and report on typically a much broader range of abnormal cardiac rhythms and conditions while patients wear them at home during their daily activities.  This is due to their more sophisticated data collection algorithms, more costly and higher resolution ‘ECG front end’ medical device grade hardware and reporting parameter sophistication intended for review by qualified medical professionals and their staff. Prescription ECG wearables are subject to the rigorous requirements of verification and validation testing needed to obtain FDA clearance to claim intended use as a physician’s diagnostic tool, according to their specific labeling.

Another difference is length of analysis and recording. Because OTC wearables might only record up to 30 seconds of ECG at a time and are not chest-worn using medical grade skin adhesives, they are less likely to detect abnormal conditions as frequently or accurately compared to prescription ECG devices that offer continuous chest-worn monitoring and can be worn from over seven to 14 days.

How prescription healthcare devices outperform OTC wearables

While there is popular buzz around the performance of OTC wearables there are no major clinical trials that have evaluated the clinical implications of OTC wearables in cardiovascular diagnosis. One important goal for OTC wearables and cardiac health is earlier detection of AFib, the most common cardiac arrhythmia and an often silent ‘disabler and killer.  Afib is a significant contributor to stroke, heart failure and death. In several cases, however, OTC devices have been reported to have a high rate of false positives for AFib, which can create needless user anxiety.

Conversely, false negatives from an OTC wearable device can give patients a false sense of security which may lead them to ignore symptoms that need urgent medical attention. Other discrepancies in the accuracy and consistency of measurements, such as those arising from skin color variations, sex, body weight, contact pressure, wrist circumference, or motion artifact from physical activity can also compromise the accuracy of OTC monitors, although continuous improvements are underway by the major manufacturers.

Prescription ECG patch monitors are validated, wearable digital devices for heart rhythm monitoring, detection and physician diagnosis, designed to provide the highest degree of accuracy possible to enable earliest physician verification and treatment. They are indicated, specific to their respective FDA-cleared product labeling, for assessment of patients with relevant symptoms or for follow up during or after treatment.

With their low profile, water-resistant, wireless, and self-adhesive form factor, most prescription ECG wearables are easy to use, well-tolerated for use during a patient’s daily activities, including brief showering and have high patient adherence. The current generation of prescription ECG monitoring devices are equipped with revolutionary sensors for ambulatory cardiac rhythm monitoring and can be used in an outpatient setting for seven to 14 days at a time, recording continuously as patients go about their routine activities.

OTC Versus Prescription ECG Wearables and Data Privacy Concerns

The AF-SCREEN International Collaboration study iterated that the “…direct interaction between companies delivering OTC devices with ECG monitoring and consumers creates new regulatory gaps in relation to data privacy and the registration of consumer apps and devices.”

Since many prescription ECG wearables also use third party technical analysis service models that bring PHI (Protected Health Information) outside of the healthcare data network, however, this is not a concern solely for OTC wearable device subscriptions. At least one FDA-cleared prescription ECG wearable can be used entirely at the point of clinical care, such as the physician’s office or clinic, and it does not require any patient data outsourcing for technical analysis and reporting. Alternative prescription ECG wearable solutions are now available when patient data privacy is of concern.

So, while a smartwatch or any OTC device can be a valuable adjunct for health monitoring, it’s best to go with the ‘professionals’ and recognize the importance of maintaining access to the prescription wearable ECG devices they have come to rely on.

My personal goal is proactive creation of an ecosystem that improves earliest patient access to quality cardiac care, with healthcare professionals who have access to a complete range of diagnostic solutions.

From a consumer smart watch to a prescription ECG wearable to the best cardiac treatment − the common denominator is oversight by a team of qualified healthcare professionals working in partnership with patients, community healthcare systems and healthcare technology innovators. Providing a comprehensive, seamlessly connected diagnostic ‘toolkit’ for population cardiac health monitoring with step-ups to best prevent, diagnose and treat heart disease is a win-win for all of us.

Editor’s Note: Ann Demaree brings over 25 years of medical technology design, commercialization, industry consulting and M&A partnering experience. Licensed as an RN in Oregon and North Carolina. She has served as Industry Advisor to the Oregon Health & Science University Biomedical Innovation Program (BIP) and Clinical Translational Research Institute (OCTRI) since 2012.

 

 

 

 

 

 

 

 

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