Is a computer used in hospitals considered a medical device?

M

MIREGMGR

#11
I'm not discussing "who will be blamed" in a subjective or popular sense. My topic is legal liability.

One reason that makers of life safety critical functions often don't choose to control them with off-the-shelf, consumer-type computer hardware is because the lack of assured continuous functionality, assured absence of hardware errors and validly determined MTBF leaves them exposed to liability.

Two reasons that makers of off-the-shelf, consumer-type computer hardware often include in the Terms and Conditions of Sale page in the owner's manual/flyer a statement that the subject hardware shall not be used for critical control functions, often specifically mentioning medical systems and nuclear operations, are: (1) to try to limit their exposure to liability; and (2) because the two named control-system types are subject to specific regulatory requirements, and such hardware makers don't want to be gigged for failure to systematically conform to those requirements.

I'm not a lawyer, so any discussion I offer on such subjects must not be regarded as legal advice. If this matters to you, consult your lawyer.
 
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sagai

Quite Involved in Discussions
#12
I'm not discussing "who will be blamed" in a subjective or popular sense. My topic is legal liability.
liability could be a scary word and I have tried to avoid, that's all.

I must admit I have never actually see that exclusion in a personal computer Terms and condition and highly unlikely that the manufacturer could foresee all the potential misuses.

Is it actually helping the original poster?
 
#13
Trying to understand the original posted question let us assume this situation:

(1) You supply a computer with a general purpose operating system to a hospital; you supply it "tweaked" for hospital use (keyboard can be disinfected, it is on a hospital style cart).
Is it a medical device?
No.

(2) It is supplied with a database for storing patient records.
Is it a medical device?
No.

(3) You supply it knowing that it will be taken into theatre and hooked up to the anaesthetic machine to keep records and show data.
Is it a medical device?
No - but -
The hospital (the RESPONSIBLE ORGANISATION) is creating a MEDICAL ELECTRICAL SYSTEM for which there are significant safety requirements. See section 16 of IEC 60601-1.

(Note: The capitalisation shows defined terms within IEC 60601-1 - I am not shouting!)

(4) You supply as in (3) but with an input card to which is attached a blood pressure cuff; software on the PC graphs the blood pressure.
Is it a medical device?
Yes.

For the test requirements see IEC 60601-1.

Borderline medical device / non-medical device decisions are dealt with in this document:
http://www.google.co.uk/url?sa=t&rc...q4GoBA&usg=AFQjCNFEkCtCjcvFsUV1Nel7HpfCivPVjg
 
R

rinaric15

#14
Re: ISO 13485 Is a computer a medical device?

Every day hospitals and clinics which are attached to them churn out enormous volumes of data regarding patients, ailments, prescriptions, medications, medical billing details, etc. Such medical records are now all recorded into a medical billing software. Such mammoth databases are known as Electronic Medical Records and Electronic Health Records. These databases are operated by a set of computers and servers, and come in handy during medical alerts and emergencies. The concept of EHR is a bit broader than the EMR, as the database is accessible from different clinics and hospital. Thus, a patient?s medical history can be retrieved from any hospital by medical practitioners.
 
M

Matthies

#15
Re: ISO 13485 Is a computer a medical device?

Thanks Pads38 for the borderline pdf file.
I hereby understand that we do not sell medical devices, but devices which must be tested according to hospital(customer)s safety requirements.

We import UL 60601-1 certified products which are already tested and comply with IEC/UL 60601-1 3rd Edition Medical Electrical Equipment Standard.
If we only place HD or RAM in the unit do we have to do the same tests again?
 
L

lyang

#16
Without knowing the market you intend to sell/distribute your device/software it is difficult to determine. With Europe, the device must meet MDD definition of a medical device and EU is more relax in some cases than the US. The US, they categorize by type so if you fall into a PACS, image guided system, decision support system, etc... then you are that classification of said category.

The suggestion would be to discuss your business plan with a regulatory consulting firm and they can advise you so you don't waste a lot of investment and realize it is cost prohibitive due to regulatory hurdles. Emergo is a firm I've used before that can help and they have a very wide network of professionals in many markets who can assist.

My two cents on your video. You have information systems and medical devices for USA. I listed a couple I saw above and they are class II for FDA.

Best of luck on the endeavor.
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#17
The suggestion would be to discuss your business plan with a regulatory consulting firm and they can advise you so you don't waste a lot of investment and realize it is cost prohibitive due to regulatory hurdles. Emergo is a firm I've used before that can help and they have a very wide network of professionals in many markets who can assist.
Emergo are top notch, but can be cost prohibitive in their own right... :lol:
 
#18
Re: ISO 13485 Is a computer a medical device?

We import UL 60601-1 certified products which are already tested and comply with IEC/UL 60601-1 3rd Edition Medical Electrical Equipment Standard.
If we only place HD or RAM in the unit do we have to do the same tests again?
I would suggest that you have a look at the standard IEC 62353 - Medical Electrical Equipment - recurrent test and test after repair.

This gives guidance on a series of tests, based on the tests of IEC (UL) 60601-1 but done in such a way as to avoid damage. The "full" tests of 60601 have the potential to permanently damage a device; this is OK because they are a 'one time only' type test.

You can get a guidance booklet on IEC 62353 from here:

http://www.rigelmedical.com/Includes/get_download.php?id=80

(Disclosure - No connection other than as customer / user)
 
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