IEC 60601-2-24 Question: Free Flow Clamp on Set?

A

Anonymous user

#1
Hello,

We are a medical design company and we developed an advanced infusion pump, the first local infusion pump of Turkey.

I wanted to ask your opinion about free-flow clamp. Our infusion pump will only be used by our own administration sets, that?s why we want to add something unique to make the device only usable with our sets.

We are thinking on adding the free-flow clamp on our administration set. The device will not have free-flow clamp if it is not used by our sets. Do you know is there is a restriction about the place of free-flow clamp on infusion pumps?

The standard 60601-2-24 says that: ?Means shall be provided to protect the PATIENT from overinfusion as a result of FREE FLOW conditions. This requirement applies as soon as the ADMINISTRATION SET is installed in the EQUIPMENT in accordance with the manufacturer?s instructions for use.?

So as long as the hospital uses my set, there will be no free flow occurrence. Will I comply with this criteria with my set with free-flow clamp and no free flow clamp on my device, do you have any idea or comment?
 
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yodon

Leader
Super Moderator
#2
Will you key the set to your pump so that only your set can be used?

Do a risk assessment (failure mode analysis). What are the possible ways free-flow could occur? Include misuse (like using some other set). Be sure to address all those (functionally, not just in labeling!).
 
A

Anonymous user

#3
Will you key the set to your pump so that only your set can be used?

Do a risk assessment (failure mode analysis). What are the possible ways free-flow could occur? Include misuse (like using some other set). Be sure to address all those (functionally, not just in labeling!).
Thanks yodon.
We will have warning statements in user manual like "unless used by our sets, free flow protection will not be enabled" "Usage with others sets is extremely risky" etc.

In risk management file, we will only say that there are necessary warnings to guide the user use our sets. Do you think these warnings may be enough for authorities?

Or is it fatal to prevent using with another set? (Like not starting the infusion etc..)
 
#4
Infusion pumps rank amongst the most hazardous of medical devices, regularly featuring in the "Top Ten" list. (See - https://www.ecri.org/2014hazards - free registration required).

Nearly all the hazards come down to User Error. It is not realistic to expect instructions given in the manual to reach the nursing staff - the people most likely to be using the device.

I would suggest that any significant safety feature MUST be totally unavoidable by design. And in my experience, nurses are second only to soldiers in making things fit together that were never meant to be!
 

yodon

Leader
Super Moderator
#5
Pads38 has it right - and that's the view of the harmonized version of 14971 (one of the changes I completely agree with) - you can't reduce the risk of something happening by just warning the user about it. If you cannot prevent free-flow unless your set is used, ensure that the pump can only be used with your set.

Free-flow is absolutely fatal. You can search event reports (e.g., the MAUDE database) and see many, many (preventable) deaths as a result of free-flow.
 

Peter Selvey

Leader
Super Moderator
#6
I agree that warnings are often useless, and technically this fails two points in ISO 14971 - the order of preference for risk controls (inherent, protective, warnings), and secondly getting objective evidence of the effectiveness of risk controls.

That said, warnings are often used to mask the real situation which is probably OK without the warning. The warning is a quick fix to avoid the work of figuring out why the risk was not significant in the first place.

For this particular case, literature I found indicates free flow used to be a serious problem before manufacturers added free flow protection. Now the incidence is much rarer.

The core question is how likely is it that the operator will try to use another manufacturer's infusion set? I would imagine that free flow is not the only issue, infusion rate accuracy, occlusion protection, bolus amounts, air infusion etc are dependant on the correct set being used.

Maybe users know well that they must use the designated manufacturer's set. And the hospital would probably arrange things such that only certain pumps and sets are available in certain areas to avoid mix ups.

So the warning may be useless, but the real situation could be OK. Strictly, the manufacturer is required to obtain objective evidence that the actual practice is OK.

Then again, a simple key makes the whole issue go away.
 
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