Smart watches and fitness trackers have become quite popular in the last few years. Each new generation of these devices comes with increased capabilities, some including more advanced health-monitoring apps. Samsung’s Galaxy Watch 3 recently received FDA clearance for electrocardiogram (EKG or ECG), and in September 2018, the Apple Watch did as well. But what exactly does this mean?
First, let’s look at an overview of how the EKG app works. The mentioned Samsung and Apple smart watches have an electrical heart sensor built in, which documents the user’s heart rhythm and heartbeat. Then, the recorded information is reviewed by the watch software, to check for atrial fibrillation (AFib). In fact, AFib is the only heart issue that can be detected via this method. At IronRod Health, we utilize both advanced software and experienced, continuously trained human beings to assess readings from heart monitoring devices. We then use our extensive and informed experience to act on those readings accordingly, supporting patients with various heart conditions.
Second, it’s important to understand that FDA clearance does not mean full FDA approval. These smart watches being “cleared” simply means they are able to be used as a medical device. What actually received clearance is the electrocardiogram app on the gadget. The FDA considers it to be Class II, which includes devices that carry a lower risk to patients than higher class products. For comparison, below are examples from the 3 FDA classes:
Class I: Lowest level of regulatory control, uncomplicated design, extensive safety history (examples: elastic bandages, surgical instruments, tongue depressors, gauze). This category accounts for 47% of all medical devices, 95% are not required to go through the regulatory process.
Class II: Mid-level regulatory control to be certain of safety and efficacy, need to conform to particular FDA controls like functional and labeling criterion (examples: blood pressure cuffs, infusion pumps, some pregnancy test kits, powered wheelchairs). This category accounts for 43% of all medical devices. The remote monitoring services IronRod Health provides are for some devices in this category.
Class III: Highest level of regulatory control and safeguards, due to elevated risk to patients, as these devices maintain or support human life and are usually placed inside patients (replacement heart valves, pacemakers, breast implants and any implantable devices). This category accounts for 10% of all medical devices. The remote monitoring services IronRod Health provides are for some devices in this category.
Third, the EKG monitoring app on the Samsung Galaxy Watch 3 may have received FDA clearance, but it is not available to US users yet. The same thing happened when the Apple Watch received clearance as well – it was only accessible in selected countries, and there was no timeline or estimate for when a particular region could expect the app to become available. Patients with heart conditions can obtain the appropriate device (with their doctor’s orders) and set up the service quickly and easily through IronRod Health.
Fourth, a smart watch can be intimidating for people who are not comfortable with technology. Before even attempting to use the electrocardiogram app, the user would need to be at least somewhat familiar with navigating both the watch device and the phone it is connected to. There are several steps to go through before being able to utilize the app as well.
The smart watch owner would need to visit a specific webpage on either the Samsung or Apple website to research whether the EKG app is available in their area. A quick check of this information for Apple reveals two options of branded services, simply titled “ECG” and “Irregular Rhythm Notification”. It does appear that both have been released in the same countries, but if that doesn’t happen simultaneously, the app would be useless to users who need continuous EKG monitoring.
The next step is to complete a software update on the particular smartphone connected to the smart watch with the electrocardiogram sensor. This is a departure from what the customer is used to, as these software releases are normally pushed out from the company to the user, who receives a screen notification when ready to be installed, which is done by simply clicking a button on that same screen; and from that point, the download and installation happens automatically. Basically, these software updates are released according to the manufacturer’s schedule, and do not require any action on the user’s part to find or even manually start the download or installation.
Someone unfamiliar with the menus on their Apple or Samsung smart phone may have difficulty finding where to access the software update required to use the EKG app, or they may just be uncomfortable with technology in general. Assuming the software upgrade was successful, next is finding the actual app on the phone and setting it up. Apple and Samsung know we’ve all experienced issues at some point with similar undertakings, so on their respective websites, for this step, they provide one set of instructions to be used if all goes smoothly and according to plan; then two sets of more complicated and involved directives for use on a contingent basis. IronRod Health provides not only continuous remote monitoring services, with physician notification of concerning readings, but also 24/7 customer support for setting up their heart monitoring equipment or making any necessary adjustments.
Fifth, now it’s time to take an electrocardiogram using the EKG app. This can be done when the user notices a change in their heartbeat, when the app alerts the user to an irregular heart rhythm, or whenever the user feels an EKG is necessary.
This capability of the smart watch does not seem difficult to use, however, the results are certainly subject to user error. This fact is confirmed by a considerable amount of information on both phone companies’ websites having to do with “inconclusive result” feedback from the app, repeatedly receiving that reaction to the self-administered EKG, and several tips on attaining the best readings. A wide range of circumstances can affect the precision of the device’s sensor.
It could be something as simple as being too near electronics that are plugged in or having a little bit of moisture from perspiration or recent hand washing on either the back of the smart watch or the wrist itself. In the midst of a possible heart event, when an accurate ECG is paramount, it isn’t uncommon to be sweating profusely from pain, worry, or the body’s other natural physiological reactions to what is happening. Thanks in part to COVID-19, we all know how vital washing our hands frequently is, but Apple advises that their gadget could take up to 60 minutes to dry fully. For many patients, it is neither practical nor advised to wait an hour when changes in heart activity are felt. Being able to run an impromptu EKG and seeing accurate results quickly can be lifesaving. Here again, the importance of patient support is demonstrated, and IronRod Health team members are available 24/7.
Sixth, there are many disclaimers, caveats, and patient attributes that would disqualify them from using Apple’s or Samsung’s smart watches for electrocardiogram, or cause the device to not work properly, accurately, or conclusively:
Not intended for use by people under 22 years old
Heart rate at the time of reading is between 100 and 120 BPM
Pacemaker or implantable cardioverter defibrillator (ICD) is present
App is not designed to recognize or analyze signs of certain arrhythmias or heart conditions the recording may show
Certain physiological conditions may prevent some users from creating enough signal to produce a good recording
ECG app cannot detect a heart attack, blood clots, stroke, high blood pressure, congestive heart failure, high cholesterol, or other causes or forms of arrhythmia
IronRod Health has extensive experience in heart monitoring and reporting, and provides continuous training, giving our employees the expertise and knowledge to notice and act on out-of-the-ordinary readings for each patient. When we report adverse or unusual readings and events to our patients’ physicians, we can include similar issues from the past, giving a complete picture which allows healthcare personnel to make more informed, better decisions about patient care.