Medical Device Software - Apps which can control medical devices

[JoCam]

Hi All,

Is an app downloadable to a mobile phone or tablet that can be connected via bluetooth, wifi or GSM to control an electrical/electronic medical device remotely by a healthcare provider classed as medical device software. The electrical/electronic medical device itself can be operated without the app.

Regards,

Jo

 

[Al Rosen]

Hi All,

Is an app downloadable to a mobile phone or tablet that can be connected via bluetooth, wifi or GSM to control an electrical/electronic medical device remotely by a healthcare provider classed as medical device software. The electrical/electronic medical device itself can be operated without the app.

Regards,

Jo

The answer in a word is "yes". There are risks with the app just as with any software controlling a medical device. What would your argument be for not considering it medical device software.

 

[BhupinderSinghPawa]

The intended use of the software is to interface and control another medical device, i assume for a medical purpose, then it is software as a medical device (though not part of medical device itself). It is an independent software that runs on an independent platform (mobile phone / tablet) with interface mechanisms of bluetooth / wi-fi / GSM.

 

[yodon]

The intended use of the software is to interface and control another medical device, i assume for a medical purpose, then it is software as a medical device (though not part of medical device itself).

Not to put too fine a point on it or get pedantic but since it's controlling a device, I don't think it would be classified as SaMD. Per the GHTF definitions (see http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf):

Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.

Regardless, I agree that the answer is, as Al Rosen succinctly stated: yes!

 

[JoCam]

Hi Al,

Thank you for you response.

I believe it to be medical device software, however a design consultant has stated that it is firmware. Struggling to understand their reasoning and not conversant with the applicable standards I looked to the Cove for confirmation.

Thanks again,

Jo

 

[Al Rosen]

Hi Al,

Thank you for you response.

I believe it to be medical device software, however a design consultant has stated that it is firmware. Struggling to understand their reasoning and not conversant with the applicable standards I looked to the Cove for confirmation.

Thanks again,

Jo

Firmware is software programmed permanently into memory. I don't understand your consultant's reasoning.

 

[Mark Meer]

...I believe it to be medical device software, however a design consultant has stated that it is firmware...

It doesn't make a difference. "Software", "Embedded Software", "Firmware", as far as regulations go, they are treated the same.

...Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device...

I realize this is an EU sub-forum, but it's worth noting that the US FDA would classify this as SaMD.

From their website: What are examples of Software as a Medical Device?

"Software that is connected to a hardware medical device but is not needed by that hardware medical device to achieve its intended medical purpose is Software as a Medical Device and not an accessory to the hardware medical device."

 

[yodon]

I believe it to be medical device software, however a design consultant has stated that it is firmware.

That used to be a pretty common thought. Clearly, your consultant is a bit behind the times.

 

[sagai]

I am always lost having read of this classification scheme that looks at software as a "software only medical device".
Even though we are looking at a single desktop computer, there are a bunch of soft error potentials (memory problems mostly) those could remain undetected and could affect the software behavior adversly.
So, what is the definition of hardware medical device?
Sorry for digress.
Cheers

 

[Michael Ayers]

Apologies for digging this old thread up, but I have come across a similar situation to the initial poster.

Just to summarise what has already been discussed... It is my understanding that an app installed on a smartphone which controls (or at least gives information to) a medical device can, in its own right, be a medical device. This is because it would fulfill the definition of a medical device from the Medical Device Regulations that says:

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes... diagnosis... treatment...etc...

If the app on the smartphone was supporting a medical device, but not with respect to it's specific medical purpose (e.g. an app that was used to help the user clean the device), it may instead be classified an an accessory to a medical device. The definition of an accessory from the Medical Device Regulations says:

‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

However, regardless of whether it was a medical device in its own right, or an accessory to a medical device, it would be treated the same way in the regulations.


In the example I have recently come across (Dana Diabecare RS insulin pump and AnyDana smartphone app), the manufacturers have stated that the medical device and smartphone app are considered as a single medical device.

- Are manufacturers able to decide themselves whether to designate their smartphone apps as part of the device or as a stand alone medical device?- - What are the restrictions to saying that both the device and the app are a single medical device (e.g. do they have to be provided together)?
- What are the implications of these two situations?