Is a computer used in hospitals considered a medical device?

[Matthies]

Dear all,

Our company sells computers to hospitals and our company wants to be ISO 13485 certified.
The design of the computers is done elsewhere in a factory with ISO 13485, but we only add/change hard drive or RAM memory or wifi modules, but opening the device is necessary to perform this task.
Our computer systems (touch screen panel PC or Tablet like systems) are used in hospitals for basic use, but some are used in surgery operationg room and display heart rate and blood pressure.


My questions are:
Is a computer that is used in a hospital a medical device and if so of which class?
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Please help and thanks in advance!

 

[stephano2013]

Re: ISO 13485 Is a computer a medical device?

Is a computer that is used in a hospital a medical device and if so of which class?

Answer: Consider ISO 13485 section 3.7, definition of medical device. If the article (software, pc, instrument etc.) is intended to be used for monitoring of disease or injury etc. it is defined as a medical device.
If you have a software only administrating the patient data, it is not a medical device. But in your case: The computer is used to monitor body functions, so it is a medical device. The class of the device depends on the country you sell the product.

I am not an expert on the other questions. Maybe someone else can answer.
Stephan

 

[Matthies]

Re: ISO 13485 Is a computer a medical device?

Thanks Stephano for your quick reply!

So for the systems that are intended to be used for monitoring of disease or injury etc. it is defined as a medical device and so only for these items we have to apply ISO 13485 terms if i am correct?

 

[sagai]

Re: ISO 13485 Is a computer a medical device?

Matthies,
the term "medical device" is important for the Manufacturer of the medical device.
When your company manufacturer general purpose hardware and your customers are hospitals, these are not necessarily stiulate that you need to comply with any medical device related regulatory requirement.

The real question is at the moment for me whether or not your company produce a medical purpose product that is for hospitals.

Solely selling computer hardware for hospitals does not necessarily mean that you sell medical device regardless the complexity of such hardware.

Do you commercialize the heart rate, blood pressure software that runs on your hardware too?


This bit is not clear to me.

Cheers!

 

[Matthies]

Re: ISO 13485 Is a computer a medical device?

Dear Sagai for your quick reply!

We sell the computers with a version of an operating system only, so no software for monitoring heart rate, blood pressure or things like that.
The computers will be placed in operating rooms and some systems will be used in hospital rooms for patients infotainment use.
Will this mean that we do not deliver medical devices?

 

[sagai]

Re: ISO 13485 Is a computer a medical device?

let me ask a question ....

Is it possible in any mean with a normal use of your product (the hardware itself) to harm or adversely effect patient health in any means?

 

[Matthies]

Re: ISO 13485 Is a computer a medical device?

Thanks again Sagai for staying on top of this topic!
If the product is used and working properly, i would say no harm or adversely effect to patients' health will be done.
But what if the system malfunctions for example due to component failure?

 

[sagai]

Re: ISO 13485 Is a computer a medical device?

Trying to find another example ....

Let say that I am manufacturing computer controlled machine gun, and I do not actually develop the software that actually controls the gun and no other way to use this gun other than having that software piece running.
What adverse event could result without uploading the software and start using that software together with my hardware?

or ... think about tablets in general.
Apple, Samsung what so ever have no liability for the use of their hardware in a hospital environment running a diagnostic, whatever medical purpose software.

It could be a device actually if your company would upload that software and commercialize the software and the hardware for hospitals claiming medical use.


Cheers!

 

[MIREGMGR]

Re: ISO 13485 Is a computer a medical device?

Apple, Samsung what so ever have no liability for the use of their hardware in a hospital environment running a diagnostic, whatever medical purpose software.

Certainly the named computer hardware makers and probably all others want to have no such liability, and employ phalanxes of lawyers to fine-tune their owner's-manual notifications and other legal communications to try to achieve such a stance.

Maybe there are countries where such a stance is achievable. My understanding though is that in most USA states, a maker of a product simply cannot absolve themselves of liability, via communications that are not provably presented to and agreed to by the buyer prior to the sale, for the malfunctioning of their product. All that the maker can do is try to keep the bounds of their liability as narrow as possible, and provide technical legal conditions on which defending lawyers can try to get liability suits dismissed, narrowed or otherwise favorably modified.

Of course, the maker of a hardware system is only liable for the hardware system's malfunctions...not for it being incorrectly applied, and not for software errors.

 

[sagai]

Re: ISO 13485 Is a computer a medical device?

I doubt when someone uses an off the shelf computer to control the cooling system of the nuclear power plant than the manufacturer of the off the shelf computer would be the one to be blamed for a nuclear catastrophe only because let say the hard drive once became faulty and the cooling stopped.