Dosage auto-calculation in apps

September 23, 2015 18:09

Annette Bell DAFNE Graduate
Sheffield Teaching Hospitals 68 posts

If anyone is interested, I received this e-mail reply to the one I sent re this subject:

Dear Mrs Bell

Thank you for your e-mail. Details of compliance investigations are confidential, however we are able to provide some general information on apps.

Full details of the guidance on â€˜Medical device stand-alone software including appsâ€™ can be found at the following link:

https://www.gov.uk/government/publications/medical-devices-software-applications-apps/medical-device-stand-alone-software-including-apps

This guidance sets out why apps in some instances are considered to be medical devices and in the section entitled â€˜Software appsâ€™ there is a reference to the measurement of blood sugars.

Apps that are considered to be medical devices should have a CE mark as this shows it has met the legal requirements for safety, quality and performance when it is used as the manufacturer instructs.

We trust this information is helpful.

Yours Sincerely

Leo Syron
Compliance Inspector
European Regulatory Affairs
Medicines and Healthcare products Regulatory Agency
4th Floor, 151 Buckingham Palace Road
London
SW1W 9SZ
Tel 020 3080 7207
Fax 0203 118 9809
Mobile: 07770 678 430
To report suspected non-compliant medical device:
E: [email protected]

To report suspected counterfeit products:
E: [email protected]

September 24, 2015 23:25

RichFreed DAFNE Graduate
Princess Alexandra Hospital, Queensland 51 posts

Any chance of downgrading using the method described on this article..

http://www.hightechdad.com/2015/03/26/how-to-restore-a-previous-version-of-an-ios-app/

I might give the method a go in the coming weeks. I have at least 1 old phone with a prior version of the app + some actual itunes backups.

However it's kind of a non-issue for me as I have have a pump these days which is more accurate that the app for Carb ratios and fractions but I do still use the app occasionally when I'm running low in my reservoir and revert temporarily to injections or disabled bolus calcs to revert to Dafne (pump freedom can a bad thing sometimes). One thing that my pump doesn't hold a candle to in this App is adjustments. Apparently the smart people who put the software together for my pump ()Medtronic) decided that ALL T1 diabetics have a uniform insulin sensitivity no mater what BG they have. What a major failing!

September 24, 2015 23:27

RichFreed DAFNE Graduate
Princess Alexandra Hospital, Queensland 51 posts

Also what are the DAFNE program/administration saying about this development?

This is the site we are directed to for the App & online access to the manual during the official DAFNE training course we do (certainly was the case in AUS). Surely the DAFNE programs from the various jurisdictions around the world should get together & jointly fund the certification. (Make it the official DAFNE app)

September 25, 2015 09:20

Simon Site Administrator
Sheffield Teaching Hospitals 578 posts

Hi Rich,

We have brought this to the attention of DAFNE in the UK however I'm not too hopeful of help with the certification as we aren't NHS employees and they have always maintained that DAFNE Online and DAFNE are separate entities. I can't speak for DAFNE in other countries but I have a feeling it may be the same.

Simon

October 04, 2015 18:40

Peter DUAG Committee Member
University College London Hospitals (UCLH) 109 posts

RichFreed said:
Also what are the DAFNE program/administration saying about this development?

This is the site we are directed to for the App & online access to the manual during the official DAFNE training course we do (certainly was the case in AUS). Surely the DAFNE programs from the various jurisdictions around the world should get together & jointly fund the certification. (Make it the official DAFNE app)

Hi Rich,

I raised the situation with the DAFNE team at the Executive Meeting this week. The chairman was aware of the situation following the correspondence that Simon refers to above. The approach is to contact the pharmaceutical companies who sponsor some of the DAFNE activities (e.g. Abbott) to see if they would be willing to help resolve the situation. I'll keep you posted when I hear any more, but doubt that this is likely to give a quick resolution. Having said that, and as Simon has said before, the more complaints that are received, the more likely it will be that a sponsor would be willing to support a way forward. So for anyone who is impacted by the change, and hasn't posted to this thread yet, please do so making it clear that your complaint is not aimed at the site administrators who are powerless in this. Alternatively please e-mail me through the site and I will forward all correspondence to the DAFNE Executive. Thanks.

Peter

October 05, 2015 09:05

richardlogan DAFNE Graduate
Northern Health and Social Care Trust, Antrim Hospital 1 post

Hi Simon & Marke,

As someone who has had diabetes for over 30 years and has literally just completed the DAFNE program, I wanted to say thanks!
The DAFNE program has totally changed my approach to managing my diabetes and your app has helped make it something that I think I might actually be able to maintain. No doubt the dose calculation element of the app would have been extremely useful, but as I never knew it existed (until I read this thread) I can't say I miss it. Not saying I wouldn't want it added back in, but just really wanted to let you both know that what you do is very much appreciated!

Keep it up, you're doing something really worthwhile!!!

Many thanks,
Richard

October 05, 2015 16:25

Simon Site Administrator
Sheffield Teaching Hospitals 578 posts

Thanks Richard, it's good to hear a bit of positivity after all the negative reviews/comments we have had. I'm glad it's managed to help you maintain better control of your diabetes.

October 09, 2015 21:27

Yelekreb DAFNE Graduate
Cardiff and Vale University Health Board 11 posts

Here' an ariticle with a summary from a lawyers perspective: http://www.whitecase.com/publications/article/mobile-health-apps-are-they-regulated-medical-device

October 17, 2015 09:30

Pat N DAFNE Graduate
South East Kent PCT 13 posts

Hi Simon & Marke,

Very disappointed that you have had to remove the Dosage auto-calculation from the DAFNE App. I found this feature very helpful in stopping my calculation mistakes. Evil or Very Mad
We will be told we can only have straight Bananas next...Oh yes they did that already.
I still think your app is awesome but wish I had not updated and lost this feature.
Could a stand alone calculator be developed and used? Just a thought.
Please don't let the negative comments get you down, you are greatly appreciated.

Many Thanks,

Pat.

October 22, 2015 04:16

John Syer DAFNE Graduate
Diabetes Australia-Vic, Melbourne, Victoria 19 posts

Yelekreb said:
Here' an ariticle with a summary from a lawyers perspective: http://www.whitecase.com/publications/article/mobile-health-apps-are-they-regulated-medical-device

Thanks for the article link Yelekreb.

This is great food for thought (working out the carb content is left as an exercise for the reader), now all we have to do is convince the Powers That Be that the QA calculation falls under the auspices of "basic arithmetic operations" and falls outside the medical device purview, although I fear that it is more likely "intended to provide additional information that contributes to diagnosis and/or treatment" and therefore within.

September 23, 2015 18:09 Annette Bell DAFNE Graduate Sheffield Teaching Hospitals 68 posts	If anyone is interested, I received this e-mail reply to the one I sent re this subject: Dear Mrs Bell Thank you for your e-mail. Details of compliance investigations are confidential, however we are able to provide some general information on apps. Full details of the guidance on â€˜Medical device stand-alone software including appsâ€™ can be found at the following link: https://www.gov.uk/government/publications/medical-devices-software-applications-apps/medical-device-stand-alone-software-including-apps This guidance sets out why apps in some instances are considered to be medical devices and in the section entitled â€˜Software appsâ€™ there is a reference to the measurement of blood sugars. Apps that are considered to be medical devices should have a CE mark as this shows it has met the legal requirements for safety, quality and performance when it is used as the manufacturer instructs. We trust this information is helpful. Yours Sincerely Leo Syron Compliance Inspector European Regulatory Affairs Medicines and Healthcare products Regulatory Agency 4th Floor, 151 Buckingham Palace Road London SW1W 9SZ Tel 020 3080 7207 Fax 0203 118 9809 Mobile: 07770 678 430 To report suspected non-compliant medical device: E: [email protected] To report suspected counterfeit products: E: [email protected]
September 24, 2015 23:25 RichFreed DAFNE Graduate Princess Alexandra Hospital, Queensland 51 posts	Any chance of downgrading using the method described on this article.. http://www.hightechdad.com/2015/03/26/how-to-restore-a-previous-version-of-an-ios-app/ I might give the method a go in the coming weeks. I have at least 1 old phone with a prior version of the app + some actual itunes backups. However it's kind of a non-issue for me as I have have a pump these days which is more accurate that the app for Carb ratios and fractions but I do still use the app occasionally when I'm running low in my reservoir and revert temporarily to injections or disabled bolus calcs to revert to Dafne (pump freedom can a bad thing sometimes). One thing that my pump doesn't hold a candle to in this App is adjustments. Apparently the smart people who put the software together for my pump ()Medtronic) decided that ALL T1 diabetics have a uniform insulin sensitivity no mater what BG they have. What a major failing!
September 24, 2015 23:27 RichFreed DAFNE Graduate Princess Alexandra Hospital, Queensland 51 posts	Also what are the DAFNE program/administration saying about this development? This is the site we are directed to for the App & online access to the manual during the official DAFNE training course we do (certainly was the case in AUS). Surely the DAFNE programs from the various jurisdictions around the world should get together & jointly fund the certification. (Make it the official DAFNE app)
September 25, 2015 09:20 Simon Site Administrator Sheffield Teaching Hospitals 578 posts	Hi Rich, We have brought this to the attention of DAFNE in the UK however I'm not too hopeful of help with the certification as we aren't NHS employees and they have always maintained that DAFNE Online and DAFNE are separate entities. I can't speak for DAFNE in other countries but I have a feeling it may be the same. Simon
October 04, 2015 18:40 Peter DUAG Committee Member University College London Hospitals (UCLH) 109 posts	RichFreed said: Also what are the DAFNE program/administration saying about this development? This is the site we are directed to for the App & online access to the manual during the official DAFNE training course we do (certainly was the case in AUS). Surely the DAFNE programs from the various jurisdictions around the world should get together & jointly fund the certification. (Make it the official DAFNE app) Hi Rich, I raised the situation with the DAFNE team at the Executive Meeting this week. The chairman was aware of the situation following the correspondence that Simon refers to above. The approach is to contact the pharmaceutical companies who sponsor some of the DAFNE activities (e.g. Abbott) to see if they would be willing to help resolve the situation. I'll keep you posted when I hear any more, but doubt that this is likely to give a quick resolution. Having said that, and as Simon has said before, the more complaints that are received, the more likely it will be that a sponsor would be willing to support a way forward. So for anyone who is impacted by the change, and hasn't posted to this thread yet, please do so making it clear that your complaint is not aimed at the site administrators who are powerless in this. Alternatively please e-mail me through the site and I will forward all correspondence to the DAFNE Executive. Thanks. Peter
October 05, 2015 09:05 richardlogan DAFNE Graduate Northern Health and Social Care Trust, Antrim Hospital 1 post	Hi Simon & Marke, As someone who has had diabetes for over 30 years and has literally just completed the DAFNE program, I wanted to say thanks! The DAFNE program has totally changed my approach to managing my diabetes and your app has helped make it something that I think I might actually be able to maintain. No doubt the dose calculation element of the app would have been extremely useful, but as I never knew it existed (until I read this thread) I can't say I miss it. Not saying I wouldn't want it added back in, but just really wanted to let you both know that what you do is very much appreciated! Keep it up, you're doing something really worthwhile!!! Many thanks, Richard
October 05, 2015 16:25 Simon Site Administrator Sheffield Teaching Hospitals 578 posts	Thanks Richard, it's good to hear a bit of positivity after all the negative reviews/comments we have had. I'm glad it's managed to help you maintain better control of your diabetes.
October 09, 2015 21:27 Yelekreb DAFNE Graduate Cardiff and Vale University Health Board 11 posts	Here' an ariticle with a summary from a lawyers perspective: http://www.whitecase.com/publications/article/mobile-health-apps-are-they-regulated-medical-device
October 17, 2015 09:30 Pat N DAFNE Graduate South East Kent PCT 13 posts	Hi Simon & Marke, Very disappointed that you have had to remove the Dosage auto-calculation from the DAFNE App. I found this feature very helpful in stopping my calculation mistakes. We will be told we can only have straight Bananas next...Oh yes they did that already. I still think your app is awesome but wish I had not updated and lost this feature. Could a stand alone calculator be developed and used? Just a thought. Please don't let the negative comments get you down, you are greatly appreciated. Many Thanks, Pat.
October 22, 2015 04:16 John Syer DAFNE Graduate Diabetes Australia-Vic, Melbourne, Victoria 19 posts	Yelekreb said: Here' an ariticle with a summary from a lawyers perspective: http://www.whitecase.com/publications/article/mobile-health-apps-are-they-regulated-medical-device Thanks for the article link Yelekreb. This is great food for thought (working out the carb content is left as an exercise for the reader), now all we have to do is convince the Powers That Be that the QA calculation falls under the auspices of "basic arithmetic operations" and falls outside the medical device purview, although I fear that it is more likely "intended to provide additional information that contributes to diagnosis and/or treatment" and therefore within.