Should Nurse Call Systems be considered as ME Equipment or System?

Roland chung

Trusted Information Resource
#1
Hello folks,

As you can see from the caption, I have a question on the nurse call systems. I am not sure if such systems fall within the scope of 93/42/EEC Directive?

Any thoughts would be appreciated.
 
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Peter Selvey

Staff member
Super Moderator
#2
There's two questions here: is it medical under regulations? and, is it medical electrical equipment under IEC 60601-1?

From the regulatory side, it depends on the regulation and also the manufacturer's intended purpose statements. But, it seems likely to be considered a "medical device", for example, in Europe.

For IEC 60601-1, it is not under scope if it does not contact the patient. IEC 60950-1 would be more appropriate.

Unfortunately, regulations in Europe, US, Canada, Japan, Australia don't list 950 as a recognized/harmonized standard under medical regulations or guides. So, sometimes 601 is still used. Bit of a grey area. I recommend 950 because it covers things like TNV isolation which might be applicable.
 

Roland chung

Trusted Information Resource
#3
Peter, you are right. There are actually two questions.

From the 'medical device' definition of MDD Directive, I do not see some words are suitable for the nurse call system which is used to inform alarms or events.

Nurse call system is PC based. I also feel 60950 is more appropriate. Anyway, if 60601_3rd edition used, it would be also OK since MOOP level is allowed. I would think the requirements of TNV isolation in 60950 also can be adopted.
 

Peter Selvey

Staff member
Super Moderator
#4
Actually I had in mind equipment (e.g. patient monitor) which uses a nurse call system to inform of an event.

If it is just a patient button that triggers a general purpose nurse call, it's probably not medical. It comes down to the instructions for use (IFU) statement, e.g. something specific like "can be used by the patient to call the nurse when urgent attention is required" it might be seen as medical, but if the IFU says "not to be relied on for patients that may require urgent medical attention" then maybe not.
 
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