Ok, it’s now 04 July 2020.
So, when will ECG be released in Australia.
I upgraded my Apple Watch specifically to get ECG, promised by Apple at that time.
Who is responsible in the Medical profession here for this absurd level of procrastination, please tell me...
Apple Watch
Given the registration hasn't occurred the issue is hardly solved!
Interesting that Apple doesn't seem to be able to negotiate the relatively easy TGA registration process, especially since there exists what is known as a Global Medical Device Nomenclature code (recognised by the TGA) that covers the hardware and another that covers the software! Would hate to think it is just laziness on Apple's part or that they won't provide any details to TGA, which to be frank is usually less than the US and the same as the UK and EU.
For information, the relevant codes are below. Registration takes less than a day to complete the form and usually an answer is received within a couple of days.
Hardware
Name
Wearable multiple physiological parameter recorder
Definition
An electrically-powered, wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiograph, haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a local application (e.g., smartphone) or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).
Software
Name
Smartphone camera home cardiovascular monitoring application software
Definition
A software program designed for use in a smartphone/watch with a built-in camera to periodically measure, via transcutaneous optical reading, and display cardiovascular parameters (e.g., pulse wave, heart rate variability, SpO2, blood pressure, LVEDP) for assessment of cardiovascular function to assist diagnosis of disease (e.g., arrythmia, cardiac autonomic neuropathy); it may also be used to provide general lifestyle/fitness advice or during a controlled Valsalva manoeuvre to facilitate cardioversion of supraventricular tachycardia (SVT). This is a home-use device which may allow for remote communication of data with a clinician; it may in addition be used in a clinical setting.
Apple should put forward an application to the TGA.
Most likely iOS 14.5 and watchOS 7.4. That would follow the behavior for other countries giving approval in the past.
Has Apple done this step?
How does the TGA approve medical devices? A sponsor of a medical device must apply to the TGA toinclude their device on the AustralianRegister of Therapeutic Goods (ARTG). A sponsor is a person or company who is legally responsible for supplying a medicine or medical device.
Thanks for your thoughts however I believe we need to understand where Apple are at with their application, then go to the elected representative with the issue that need sorting, just going to our elected representative with no solid info would be like trying to pick off a certain duck flying in a flock of ducks with a pea shooter.
Unfortunately this string has shown that there are a lot of theories and impressions of what is happening but we are not talking so someone directly involved who can provide the facts.
If we could talk to that person then I am sure we would all be able to help .
Apple Headquarters Cupertino would be the one that handles that not Apple Australia. Maybe you should try and get Australian Apple users to petition your agency to change their rules. As far as working together to make this happen most of us would have no influence in Australia to get anything changed.
The original question was
Robert J McInnes wrote:
Who is responsible in the Medical profession here for this absurd level of procrastination, please tell me...
We gave the answer: It isn't really procrastination, the Australian government has to make changes for Apple's device to be approved. Some people on this thread disagree with this response but it's the only dang answer. We can't help people who won't accept that answer.
Why would Apple make a formal application for approval of a device that the regulations clearly say would not be approved? And while the TGA would have to report an application they would not have to report discussions with a manufacturer.
Apple has received approval for the single-axis ECG in lots of countries can you provide an explanation why they would decide to just skip Australia and move on?
As posted here earlier there are some new regulations that are going into effect in 2021.
Rather than making assumptions wouldn’t it be more straight forward got Apple to give straight answers about whether they have applied to the TGA and if so, an expected timeline? The buck stops with Apple. They should tell their customers wat is going on.
That list was only discovered AFTER I made the purchase in store. I took so called “Specialists” at their word that this was a feature available in Australia because at no point during my conversations with staff on the day or when discussing upgrading previously was it mentioned that these features aren’t available. Even on the website it is listed in very small print that most people won’t see or read prior to purchase.
As previously stated - it needs to be explicitly stated in an obvious way (I.e alongside the list of features and in the same font size as the features) that the irregular rhythm feature and the ECG features in particular are not available because people get product information from a variety of sources, and omission of features will not be noticed when these features have been advertised elsewhere.
Also again, staff in stores need to be more aware of what features aren’t available and make this known to customers when discussing products. There is a reasonable expectation from the customer’s perspective that staff in the store will provide accurate product information about the items they are selling. They didn’t meet these expectations in my case and clearly in the case of others contributing to this thread.
What humiliation? I agree with you that as it stands currently it would not be approved and they have had private discussions with the TGA about this. And I think they are still pursuing it. But in the end almost all of the rest of the world will have it and Australia won’t.
It depends how long ago you purchased it and where you purchased the watch from. If it is within the normal returns period for the retailer you purchased it from, just take it back and ensure you have your receipt.
If you are returning it outside of the returns period, I don’t like your chances of getting a refund. You can call Apple Australia (131 622) and discuss the possibility of returning the item with a salesperson.
Boeing7474 wrote:
Firstly I only use apple features for indicative values not medical value.
if you few apple has misled you consumer law would support you obtaining a full refund on the device.
the watch is good for many things so why detract from the purchase with negativity.
Apple Pay is probably the best example of what you are saying.
I bank with a bank that provided Apple Pay support recently that is not apples fault.
call the TGA or ACCC seek professional advice get fact not speculation on the matter.
I am more concerned you place so much value in a PED that is primarily an wrist interface to apple iPhone
Very well said!
Deggie..... did you know that 2 other smart watches with approved ECG capability are available in Australia ? both Winings new watch and the N58 have approval and ECG applications that work here. so i ask you on what basis can you suggest that Apple is not the "hold up here"??
this is another example of Apple saying we will only do things the apple way and unfortunately once again the users loose out.
SamoAt18 wrote:
Oops!
Another Senior Moment on my part.
Yes. I did act on that and I also wrote to the Apple CEO - perhaps naively but I had read that he sometimes responds to emails received.
Sadly, so far, not to mine
I still think that doing both the feedback page and a paper letter is a good thing. The information in the feedback link gets collated and tracked so, if lots of people give the same feedback, I suspect it's more likely to trigger action. And, well, you never know with a paper letter. Who knows, maybe Mr. Cook is just thinking really hard about it? ;-)
Apple Watch: ECG In Australia
