Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition

#1
Hi everyone,

For the past year I've been working in a team developing a HAND-HELD dosing device for people that today administer their prescription drugs with pills or capsules. The idea is to load the device with pellets and then dispense pellets on the demand of the "patient".

The reason for "patient" and not PATIENT is that the definition of patient in the IEC 60601-1 states:
  • PATIENT: living being (person or animal) undergoing a medical, surgical or dental procedure
    NOTE A PATIENT can be an OPERATOR
Is it your opinion that the administering of drugs through a device like ours really makes a medical procedure? And if it does, the PATIENT is rather an operator of the device when handling it, and a PATIENT in the procedure of taking the drugs from the device?

If anyone has any experience from similar cases or just feel confident in their interpretation of the PATIENT definition please let me know!

Kind Regards,
Oscar
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
That might be so. But looking at our device it is really a question of storing and delivering the right amount for treatment. Sort of like what a jar is for tablets and capsules.

Thank you for your input Ronen E!
The terminology “dosing device” suggests that the device does more than just dispense or make the pallets available. A jar doesn’t do that.

Jar equivalence aside, let’s take your argument one step further. At the time of dispensing (or dosing) no medical procedure takes place, right? All that happens is pellets moving around. So the “patient” is not really a patient, just an operator. If that’s the case, there is no patient for that device (they only become real patients later, when the device is not in use), and the device has no medical purpose so it’s not a medical device and IEC 60601 doesn’t apply to it.
 
#7
Hi Oscar,

Is your end goal only to define what PATIENT is? Or is it to determine if your device falls within the scope of 60601-1? To me it would sound that this is a dispensing device and it wouldn't necessarily be considered MEDICAL ELECTRICAL EQUIPMENT (therefore out of scope). It does not have an APPLIED PART nor does it transfer energy to/from the PATIENT.

Of course, I don't know the details f the device so I might be wrong; still, something worth considering.
 

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