Why was Drip-Rate Infusion Pump removed from IEC 60601-2-24:2012?

Roland chung

Trusted Information Resource
#1
If anyone knows why drip-rate infusion pump was removed from the IEC 60601-2-24:2012? Does it mean that the accuracy test for drip-rate mode is not necessary any more?

Thank you!
 
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Peter Selvey

Staff member
Moderator
#2
It's not clear and there seem to be some issues with the upgrade from the 1998 edition to 2012 edition. For example, Type 5 has been deleted from Note 1 definition but still referred to in the accuracy tests

(and by the way, it never made sense to refer to Type 1 - 5 since this was a "note" and yet used as a formal definition in the text).

I believe there are some other errors and confusing points in the standard which pop up in practical application.

Beyond that there is the whole issue of syringe pump testing which is extremely weakly dealt with (huge variations in performance with different syringes, gets hidden as the manufacturer can choose which data to display in the operation manual).

Expect a bit of an overhaul in the future.

This might also be the reason why it is yet to be adopted in Europe as a harmonized standard
 

Roland chung

Trusted Information Resource
#3
If a nurse used a non-compatible syringe and did not follow the IFU to perform calibration prior to infusion and then got a bad accuracy, this should have nothing to do with manufacturer.
 

Peter Selvey

Staff member
Moderator
#4
Things might have improved (I haven't been involved in testing recently), but my experience with syringes is they have a huge amount of variable stiction, the stop start motion, where the syringe sticks for a few minutes and suddenly jumps forward with bolus. It was also worse with some brands compared to others.

The standard says you need to put the performance data in the operation manual, but there is no criteria or requirement to select data that is representative.

As such, it was common practice among manufacturers to wait for a good result and use that one in the operation manual.

Actually this is not just for syringe pumps, I found other examples of infusion pump manufacturers selecting "optimistic" data, and it is common in other medical devices to fudge the data.

The difference is that the variability with syringe pumps can be huge and clinically significant.

For my side, the standard should require enough samples to show for example a trumpet curve that covers 95% of cases. It's an issue raised in the rationale, just not mentioned in the normative text.
 
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