IEC 60601-2-24 for the Safety of Infusion Pumps

T

tal k

#1
I have two questions regarding this standatd:

1. Do you know the rational behind the 13.33kPa of back pressure required in the accuracy testing? If the device infusion site is the subcutaneous tissue and not the blood vessel, can it be tested in lower back pressure? how low?

2. What is the maximum amount of air bubble can be injected to the subcutaneous tissue before alarm activation?

Thanks!
 
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Peter Selvey

Staff member
Super Moderator
#2
Back pressure can exist for several reasons. One is due to the difference in height ("head of water") between the pump and the patient - pressure of 100mmHg is equivalent to about 130cm of water which can be both positive or negative. Small gauge needles can also create some positive back pressure, and also high flow rates can produce significant back pressure just from pushing water through the tubing. Although water is practically not compressible, under flow conditions there can still be a significant pressure drop along the tubing. Contrast injectors have a huge pressures (in the MPa range) mostly to overcome the pressure drop along the small tube at high flow rates, the pressure at the patient site is still relatively low (int the kPa range).

For the air bubble side, the rational for 51.104 (Annex A) in IEC 60601-2-24 states that:

Infusion of 1 ml of air within 15 min is not considered to be a SAFETY HAZARD. Bubbles of less than 50 μl of air each are omitted in summing up the 1 ml.
From experience, many manufacturers go well below this limit, but part of that may be just marketing / sales. I've heard that hospital purchasing depts line up the specs side by side when making decisions. If manufacturer A has 0.1mL detection, while B has 1.0mL, it might look bad. Note the existing edition of -2-24 is fairly old, there might be new literature with revised information.
 

Roland chung

Trusted Information Resource
#3
I don't think the 100 mmHg back pressure is for simulating the height difference. Because we have already set the height (between liquid container and pump) when performed the accuracy test of infusion pump according to Figure 104a of 60601-2-24.

The standard requires to set a height, says, 130 cm and conduct the test at a back pressure of 100 mmHg, it is contrary to your point of view.

It is also not for simulating pressure created by needle. Just same principle as the height, needle (e.g. 18G) should always be used in the accuracy test.

What I want to say is the test setup indeed simulates the clinical practice except for the liquid used. I would think the 100 mmHg may be created by viscosity liquid and high infusion rate. I also think the infusion site is also a factor. Different sites could create different resistance to the infusion.
 

Peter Selvey

Staff member
Super Moderator
#4
The original question was the rationale behind the test, not the details of the test itself. Although the test set up in 104a has the pump at the same level as the needle, in the real world this will not be the case and there can easily be significant back pressure due to height difference.

The standard does not say how to create the back pressure. Actually, it does not say where this back pressure should be measured. But, from basic principles the back pressure should be at the delivery point (the needle), and the best way to simulate it is to use a height difference (136cm).

The main point is to declare how the pump responds to changes in backpressure. A non-occluding pump, for example, is likely to have significant changes in flow based on backpressure.
 

Roland chung

Trusted Information Resource
#5
1. Do you know the rational behind the 13.33kPa of back pressure required in the accuracy testing? If the device infusion site is the subcutaneous tissue and not the blood vessel, can it be tested in lower back pressure? how low?
If I understood, the original question was why 13,33 kPa is specified in the accuracy test and whether infusion site would affect this back pressure.

And I guessed the accuracy of pump in question was not good enough when tested at a back pressure of 13.33 kPa. The poster want to know if it is possible to test at lower back pressure, says, 10.66 kPa. Because of the pump is for subcutaneous infusions, not for intravenous infusions. And the maximum venous pressure likely to be encountered in clinical practice is approximately 2.67 kPa.
 
T

tal k

#6
Peter and Roland, thank you very much for your answers.

I thought the difference between the tissues back pressure is much greater.
Beside the tubing affect, high flow rate and viscosity, can you thing of anything else that can cause this pressure?
 
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