Dosage auto-calculation in apps

Unfortunately we will have to remove the auto-calculation of insulin dosage from the iOS and Android apps in the next update. By including a calculation function it means the app is classed as a "medical device" and as such needs to be regulated by the MHRA. This involves a long and expensive certification process (thousands of pounds) which as DAFNE Online is done in our spare time as DAFNE graduates is something we simply cannot afford to do. We were approached by the MHRA who in no uncertain terms told us to either remove the apps from sale or get them certified; we did however manage to agree with them that by removing the calculation function from the apps then it would declassify them as medical devices so the rest of the functions can remain and they can stay on sale in the app stores.

I know this was a useful feature for many of you, so I apologise that it will be disappearing from the apps. We will work with the NHS DAFNE team to see what is possible regarding certification, but in the short term we needed to get the apps back under compliance to allow them to continue to be available for DAFNE Graduates.

Simon

I noticed the change first thing this morning.
Not impressed.

Simon ,
firstly many thanks for your work on the daphne app I have used it for many years and find it a very valuable tool. Really disappointed with the removal of the auto calc insulin function being removed from the app. Is there anyone at MHRA i can write too and voice my disgust at this stupid decision.

Regards
Mike

I was a BETA tester for the development of this app and have used it continuously since then. I found that particular feature very useful, especially as I have varying QA:CP ratios throughout the day.
As far as I can see the change forced on you by the MHRA makes it more likely that a dosage mistake will happen.

What makes this foolish on many levels is that (and it is not an exhaustive list);
a) It is a app for recording values, it does not administer or control any equipment and there is always a person between the calculated value and the administration of dosage. As far as my reading of Directive 93/42/EEC goes, I can't see how this qualifies as a "medical device". (although I'm happy to be corrected on this).

b) I'm based in Australia, the MHRA is the designated competent authority (CA) responsible for medical devices for the UK. The app is available worldwide, not just within the MHRA CA jurisdiction. (As an aside, I imagine that both Keith and Simon are residents of the UK, so that if a court case were to be raised for some form of dosage related problem, under Article 2 of the Brussels Regulation, the the claimant(s) would sue in the domicile of the defendant(s), in this case the UK court systems - perhaps that is why the MHRA gets a look in on this app)

Now that I've vented my spleen, is there anyway to roll back to the previous version?

Regards, John

I agree with all of the above comments, we are severely disappointed too as all we are in it for is to help people who've done the DAFNE course, as we have. The MHRA is the regulatory body but it is the European Commission who sets this rule for all of Europe. Anything which performs a calculation must be labelled as a medical device and suitably certified. Penalties can be hard for non-compliance and as much as I love working on DAFNE Online I'm not willing to pay a massive fine/go to prison (I'm sure you'll understand).

John as you rightly say both Keith, Mark and I are UK based so are subject to the EC and UK law. Unfortunately there is no way to go back to a previous version (if there was I would have had to remove them from the app store as I'd still be non-compliant in the eyes of the MHRA).

If anyone knows of anybody who can help with the certification process please do let us know, as we would really like to get this feature back in.

If you want to get in touch with the MHRA then the gentleman who has been in touch with us is Leo Syron and he has said that I can share his information here: [email protected]

This really blows, it takes away a lot of functionality from the App. I agree with all the above comments and can imagine the developers frustrations. Maintain the rage guys and hopefully you can get the required certification, or get around it with a "suggested" dose or some watertight disclaimer when you first install.

bummer as it was a very useful tool after completing the DAFNE NZ course, I noticed my control lis bit all over the show after the update, the calc helped me keep in touch with my CP calculations.

Hi Everyone, Yes I'm very disappointed regarding the removal of the auto calculation as this is an invaluable tool! Noboby at the hospital was aware of this removal either!

Apparently there is another app called RapidCalc. It's only on iOS, is a paid app $10, it doesn't link with the DAFNE app. However, it's been based on the smart features of an insulin pump so it's possibly more reliable than other insulin bolus calculators.

I have sent this e-mail to the address you provided. Probably won't make any difference, but I wanted to make my feelings, and opinion, known!:

I am a DAFNE graduate and have been using this app ever since completeing the DAFNE course in 2008. I was appalled when I realised that the latest update has removed the auto calculation of QA insulin from the app.The auto calculation of QA insulin is an invaluable component of this app as I have variable insulin doses depending on time of day. It also reminds me to reduce my dosage if my BG is low, especially before driving, as a low BG when driving is extremely dangerous for myself, and other road users! I think it is very short sighted of you to insist that this part of the app be removed as it will make diabetic control for DAFNE graduates more difficult and, therefore, could, in the long term, end up costing the NHS more money in hospital admissions. Obviously, we don’t rely entirely on this calculation, and use it at our discretion, but it is a useful guide in moments of uncertainty, e.g when going hypoglycaemic! It is not a “medical device” as it does not have to be followed strictly. It is, as I say, just a very useful guide, which can be ignored if required. There are obviously no diabetics in the team which made this decision. Maybe you should talk to some, especially DAFNE graduates!
I have spoken to my diabetes nurse and she thinks this is a ludicrous decision too. She doesn’t see how this can be classed as a medical device either.

I sincerely hope you will rethink & reverse this decision.

Annette Bell (Mrs)