I’ll admit that when I listened to Apple’s event last week – where they announced FDA approval for the Watch 4’s ECG trace feature – I considered whether this may be the beginning of the end for dedicated portable medical devices.
Fingertip pulse oximeters and portable ECG monitors are cheap, effective ways to monitor important data such as heart rate, rhythm, and oxygen saturation. This can be really important for people suffering from transient conditions, such as paroxysmal atrial fibrillation. In atrial fibrillation (AF) the two atria of the heart will lose their timed, rhythmical contractions, and begin to quiver (fibrillate). For some people, this stays permanently, but for others, it’s on and off (paroxysmal). For the latter, it can be very frustrating during the initial phases because they may actually be able to feel the AF, but of course, every time the doctor checks their heart rhythm, the AF has abated and it appears normal. Even a 24-hour ECG tape may not catch the condition if the patient does not go into AF during this period. For these patients, having their own pocket-sized ECG Monitor is a God send, allowing them to record their heart rhythm as soon as they feel their symptoms, and send it to their doctor for interpretation.
Other people may not feel their AF directly, but may notice related symptoms such as unexplained tiredness, and their doctor may recommend they invest in a home monitoring device to periodically check their heart rate or even oxygen saturations. In many instances, bouts of AF will be displayed on a pulse oximeter as a fast or irregular pulse rate. Whilst many pulse oximeters also display a simple ECG trace, this is not as good as a dedicated portable ECG like the PM10 (that’s has FDA approval in place for many years and is well reviewed by patients and professionals alike) that requires two points of contact rather than one (in turn, it is of course not as interpretable for subtle rhythm disturbances as a full 12-lead professional ECG monitor). Yet, it can sometimes be enough to alert the wearer that there is something wrong. And that is precisely how Apple will (or should) be marketing their Watch 4.
My only concern as a health professional who works in cardiology myself is that, without that active intent to buy a dedicated medical device, there may be a related lack of research performed on the part of the user. For as many false positives (movement artefact, for example) as the Apple Watch may throw off – and that is probably even more of a concern for us with our already over-burdened NHS than the Americans with their privatised system where people must pay, one way or another, for their appointments – there will also be false negatives. Dangerous, false reassurance, for those who don’t really know what they are looking for. Even if Apple adds some automation to the detection of unusual rhythms, anyone who has seen an electrophysiologist at work can tell you that even the most sophisticated detection software is no substitute for the eye of a skilled interpreter. Every 24 hour or week-long tape a patient wears is painstakingly eyeballed by an electrophysiologist, with the software simply there to highlight potential issues. It will invariably get it wrong.
If there are questions or concerns from users, who will be there to support them? For all devices stocked and sold here at Lift Your Way, we are on hand to support you in its correct usage. We can’t diagnose you remotely, but with knowledge of your condition, we can certainly advise. Who at Apple is going to be able to support a customer with T-wave inversion showing on their ECG, with Wolff-Parkinson-White, or even simple AF? If end users stop buying from medical specialists, will this expertise begin to die out, being found only within our increasing inaccessible hospitals?
For now though, at a price point of £399-£499, the Apple Watch 4 is more a gimmick than a genuine threat to the small medical device market. It’s unlikely that they’ll be equipping it with a fingertip probe any time soon for accurate measurements of oxygen saturations. If anything, this new media attention may simply increase awareness of this technology and result in a temporary increase in sales.
For our professional clients, too, the Apple Watch will not be an option now or even in the foreseeable future. The Watch is a personal device, tied into practically every aspect of a person’s life nowadays, through their diary management, apps and phone contacts, and now their own heart rhythm. It’s not a device that will be useful to a doctor, dentist, paramedic or first responder, who need to ability to switch between different patients.
After my initial concern, I feel comfortable to conclude that the small medical device market is safe, for now. All of our clients already choose us because we are local, and because they want the reassurance of lifelong support from medical equipment specialists. Our team, in case you didn’t know, is made up of industry specialists in health and fitness. Although we do make an effort to be the most competitive suppliers on the internet, our clients don’t tend to pick us because of price. If they did, they wouldn’t go for genuine Contec products at all – they’d pick the unregulated pulse oximeters off auction and marketplace sites.
If you are a professional user and would like to purchase a fingertip pulse oximeter at a discount (because you can reclaim the VAT, either by being VAT exempt or VAT registered), please visit our B2B store at Finger On Pulse.
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