ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom

[danskin]

We are happy to pay more for less features

 

[henryhbk]

"The Series 4 is the first ECG product being offered over the counter directly to consumers."

Well I guess other than the AliveCor which has been OTC approved for human use for years:
https://www.amazon.com/Alivecor-Kar...=UTF8&qid=1538055836&sr=8-3&keywords=alivecor

And for those who are disparaging a single lead EKG, (IAAD) I use single lead EKGs in the hospital all the time (Telemetry) and when were are doing a cardiac arrest resuscitation we use single leads (The Defib/Monitor will synthesize the other leads, but you really only need one lead) to decide the rhythm; heck your implanted defibrillators really only have one lead (both logically and physically) since the case is the ground. There is some information lost without the 2D (6 lead) or 3D information (12-lead) but not for rhythm detection. The purpose of this EKG is NOT to check for ischemia which does require more leads. The lack of axis information is rarely a limitation on most EKG tasks. Now of course to differentiate afib with abberency vs. V-tach requires the precordial leads to check for concordance, but if you aren't already in the ER, using any home consumer device seems a good way to be found dead on your kitchen floor!

 

[cmaier]

A 10% failure rate straight away (before you even consider false positives/negatives) seems wildly inaccurate as a medical device to me.

Those 10 percent are not inaccurate - it doesn’t give any reading in those cases. Saying “I can’t do this” when you can’t is not inaccurate.

In any case, even if you score that against the watch, that’s not “wildly” inaccurate. I expected you to provide a study showing it was only barely correlated or something.

 

[pete2106]

Surly a company with billions and billions of dollars, the life-saving stories that will appear when the feature is available elsewhere, and a large outcry from the UK citizens will speed up the approval process.

That's not really how it works for Medical Equipment. They don't approve new devices because they're popular.
[doublepost=1538056287][/doublepost]

This timeline is absurdly long. When I asked Health Canada on twitter they said that for a device like that they could approve an application very quickly, as quickly as 15 days. No reason why it should take years in UK.

We have standards here in the UK.

 

[Bin Cook]

Perhaps Europeans are less gullible regarding the marketing gibberish Apple spews out? Just a thought.

 

[Defender2010]

Hopefully once it’s released in the USA it will be as easy as switching your iPhone/Watch Region to USA to make it appear/activate it...like some other features in the past.

 

[CmdrLaForge]

Does that mean I have to wait for Watch Version 7 or later in Europe? Ok, than I wait.

 

[Solver]

I feel sorry for all the future heart attack victims who will be wearing an Apple Watch series 4 with that feature still disabled.

 

[keysofanxiety]

As someone else here stated, these regulatory bodies do not want patients using this information for self diagnosis to then go and waste very very tight resources in their specific regions, especially the UK, which there are waiting lists months and months long to just see a doctor.

That really isn't true. Do you have a citation for this which isn't the Daily Mail?

 

[cmaier]

I feel sorry for all the future heart attack victims who will be wearing an Apple Watch series 4 with that feature still disabled.

Exactly. Apple Watch has already saved lives and improved the health of countless people.

 

[Newjackboy]

can u simply change settings to USA? or?

 

[honglong1976]

"The Series 4 is the first ECG product being offered over the counter directly to consumers."

Well I guess other than the AliveCor which has been OTC approved for human use for years:
https://www.amazon.com/Alivecor-Kar...=UTF8&qid=1538055836&sr=8-3&keywords=alivecor

And for those who are disparaging a single lead EKG, (IAAD) I use single lead EKGs in the hospital all the time (Telemetry) and when were are doing a cardiac arrest resuscitation we use single leads (The Defib/Monitor will synthesize the other leads, but you really only need one lead) to decide the rhythm; heck your implanted defibrillators really only have one lead (both logically and physically) since the case is the ground. There is some information lost without the 2D (6 lead) or 3D information (12-lead) but not for rhythm detection. The purpose of this EKG is NOT to check for ischemia which does require more leads. The lack of axis information is rarely a limitation on most EKG tasks. Now of course to differentiate afib with abberency vs. V-tach requires the precordial leads to check for concordance, but if you aren't already in the ER, using any home consumer device seems a good way to be found dead on your kitchen floor!

This came out ages ago as well

https://www.gizchina.com/2017/06/27/xiaomi-amazfit-health-band-review/

 

[Bornee35]

"The Series 4 is the first ECG product being offered over the counter directly to consumers."

Well I guess other than the AliveCor which has been OTC approved for human use for years:
https://www.amazon.com/Alivecor-Kar...=UTF8&qid=1538055836&sr=8-3&keywords=alivecor

And for those who are disparaging a single lead EKG, (IAAD) I use single lead EKGs in the hospital all the time (Telemetry) and when were are doing a cardiac arrest resuscitation we use single leads (The Defib/Monitor will synthesize the other leads, but you really only need one lead) to decide the rhythm; heck your implanted defibrillators really only have one lead (both logically and physically) since the case is the ground. There is some information lost without the 2D (6 lead) or 3D information (12-lead) but not for rhythm detection. The purpose of this EKG is NOT to check for ischemia which does require more leads. The lack of axis information is rarely a limitation on most EKG tasks. Now of course to differentiate afib with abberency vs. V-tach requires the precordial leads to check for concordance, but if you aren't already in the ER, using any home consumer device seems a good way to be found dead on your kitchen floor!

While true for visual interpretation, the risk of digital rhythm misinterpretation goes up with less data points. As a healthcare professional you use what you see, not what the machine labels it as. For a watch feature is more of a gimmick.

 

[haruhiko]

By the time you can walk into an Apple Store and buy one, the ECG will be approved...

 

[manu chao]

Maybe being dim here - but could they not just have massive disclaimers saying the readings aren't regulated/approved and are advisory only? See a doctor etc.

No, the rules are such that the risk that somebody could disregard the disclaimers is considered not acceptable. The regulators take no chances with this. If it says EKG on the tin, the authorities want to be absolutely sure that that is what is actually inside.

 

[MauiPa]

Maybe being dim here - but could they not just have massive disclaimers saying the readings aren't regulated/approved and are advisory only? See a doctor etc.

Irregular heartbeats are not hypochondria, but can be indicators of very serious conditions. Your statement is akin to someone with a cough going to the doctor. It probably is nothing, but it could be lung cancer, pneumonia, etc.

 

[HurtinMinorKey]

Over the next 20 years we are going to see 95% of what doctors do get taken over by automation. You can be sure that business interest will use regulation to stop this progress in its tracks.

 

[Khedron]

"The Series 4 is the first ECG product being offered over the counter directly to consumers."

Well I guess other than the AliveCor which has been OTC approved for human use for years:
https://www.amazon.com/Alivecor-Kar...=UTF8&qid=1538055836&sr=8-3&keywords=alivecor

And for those who are disparaging a single lead EKG, (IAAD) I use single lead EKGs in the hospital all the time (Telemetry) and when were are doing a cardiac arrest resuscitation we use single leads (The Defib/Monitor will synthesize the other leads, but you really only need one lead) to decide the rhythm; heck your implanted defibrillators really only have one lead (both logically and physically) since the case is the ground. There is some information lost without the 2D (6 lead) or 3D information (12-lead) but not for rhythm detection. The purpose of this EKG is NOT to check for ischemia which does require more leads. The lack of axis information is rarely a limitation on most EKG tasks. Now of course to differentiate afib with abberency vs. V-tach requires the precordial leads to check for concordance, but if you aren't already in the ER, using any home consumer device seems a good way to be found dead on your kitchen floor!

Out of interest, do you attach your single lead EKG to the patient's wrist? And is the use of a single lead influenced by being in an emergency resuscitation scenario?

 

[MauiPa]

This came out ages ago as well

https://www.gizchina.com/2017/06/27/xiaomi-amazfit-health-band-review/

alivekor just got approval. not years ago. I know, because I wanted to get one, but couldn't

 

[jona2125]

When it’s works in the UK, I’ll upgrade from my Nike Series 2.

You can get the Kardia Band as an alternative.

 

[MauiPa]

"The Series 4 is the first ECG product being offered over the counter directly to consumers."

Well I guess other than the AliveCor which has been OTC approved for human use for years:
https://www.amazon.com/Alivecor-Kar...=UTF8&qid=1538055836&sr=8-3&keywords=alivecor

And for those who are disparaging a single lead EKG, (IAAD) I use single lead EKGs in the hospital all the time (Telemetry) and when were are doing a cardiac arrest resuscitation we use single leads (The Defib/Monitor will synthesize the other leads, but you really only need one lead) to decide the rhythm; heck your implanted defibrillators really only have one lead (both logically and physically) since the case is the ground. There is some information lost without the 2D (6 lead) or 3D information (12-lead) but not for rhythm detection. The purpose of this EKG is NOT to check for ischemia which does require more leads. The lack of axis information is rarely a limitation on most EKG tasks. Now of course to differentiate afib with abberency vs. V-tach requires the precordial leads to check for concordance, but if you aren't already in the ER, using any home consumer device seems a good way to be found dead on your kitchen floor!

I thought Apple said "wearable" offered ......
Alivecor has been offered only recently since it got approval. I tried to get one, couldn't in US until it got approval. I was however, able to buy a handheld made in China, I bet its not approved.

 

[manu chao]

This timeline is absurdly long. When I asked Health Canada on twitter they said that for a device like that they could approve an application very quickly, as quickly as 15 days. No reason why it should take years in UK.

Things are simply more laissez-faire in North America. In Europe, the government just has different standards when it comes to avoiding any risk of customers being taken for a ride or even merely given potentially inaccurate information in medical matters.

Might the technological process that allows incorporating previously expensive and bulky technology into (mainstream) consumer products warrant a slight recalibration of the approach in such matters? Sure, but there's unlikely to be a lex Apple that applies to this product only. It would take a more comprehensive rethinking of how to best regulate such products.

 

[jona2125]

alivekor just got approval. not years ago. I know, because I wanted to get one, but couldn't

AliveCor's KardiaBand has had approval in the US for almost a year now and almost 2 years in the UK, and their heart monitor used with the iPhone was FDA cleared in very early 2015

 

[Bornee35]

Out of interest, do you attach your single lead EKG to the patient's wrist? And is the use of a single lead influenced by being in an emergency resuscitation scenario?

Also have to consider sensor strength. ER sensors pull from 120VAC, and can easily detect 10mV signals. A 1.12 watt-hour battery on the other hand has reduced capabilities. Hence my gimmick stance, and confusion as to why its considered a medical device.

 

[AppleHaterLover]

Ah, the good old UK.

I'm surprised they didn't make Apple put a warning label on the box that says that you might choke if you swallow your Watch.