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Device mounted at IV pole - what about mechanical stability testing?

#1
Hello everyone,

we are developing an infusion pump and are quite happy about our progress. But now it's time to catch up with the regulatory pieces. During the checking for the 60601-1 family we got some questions and would like to reach out if anyone has any experience or can just share their opinion on the topic.

The infusion pump itself must pass the 60601-1, which especially means 9.4 Instability hazards. We want to add a standard claw to attach the device to an IV pole, like many competitor products do. In these manuals there is only the note to attach the device firmly - no additional requirement to the pole other than it must still be stable.
Do we need to test the mechanial (in)stability of the IV pole when our device is attached to it? For obvious reasons we cannot test with every pole on the market and I haven't seen any "only use these poles: ..." up to now in any manual.
Or is it in the responsibility of the personal respectively the manufacturer of the pole that only attachments of up to e.g. 7 kg can be attached?
Or does 16.7 Protection against mechanical hazards for ME systems stand? But would we have to test every or any IV pole?

Thanks in advance
 
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Peter Selvey

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#2
This is excellent case study on why we need a "third way" on risk management: based on minimizing risk under a risk/resource model rather than a being based on acceptable risk.

When you have a system of devices that are placed on the market independently, the acceptable risk model doesn't give a reasonable (or at least, easy to see) answer as to how to deal with the various risks in the system. This particular case is a classic example - stability: who is responsible? Is it manufacturer A? B? C? Do they all have to assess the system risk? Do they all have to allocate system level risk control measures? Do we have to fix the system in order to be sure about the analysis, testing and results? If so, doesn't that mean a web of contracts between all the parties involved in the system? What happens when there is a design change? And that's just scratching the surface.

A resource based model looks at the system differently and asks: which manufacturer is in the best position (can use the least amount of resources) to minimize the risk? The answer in this particular example is most of the risk can be addressed by the pole manufacturer. They can design the pole to be stable with the typical loads, configurations expected in clinical practice, and also provide labelling on the maximum weights the pole is designed for.

But it's not a matter of other manufacturers closing their eyes: they still need to look at reasonable actions or solutions that can help, especially if there are low cost effective solutions. For example, the pump manufacturer can help by labelling their device clearly with the weight, making it easy for the user to decide if the pole can safely support the device, especially if there are already other devices on the pole.

I keep saying ... one day I'll publish the "minimum risk model" but work keeps getting in the way. The subtitle is planned to be "a mathematical model for common sense in risk management". It's a bit like how most people can catch a ball without knowing the underlying physics and math, but the nerds in society nevertheless want to know it anyway. This model is a nerd's attempts to fit some math behind some of ways we successfully handle risk in the real world, and it turns out that we not only don't need to estimate risk or establish any criteria for acceptable risk, but that the acceptable risk model itself is actually a pretty bad way to make decisions. The math isn't rocket science but it needs to be laid out slowly; one day!
 

Roland chung

Trusted Information Resource
#3
There has never been a very clear requirement as to the responsibility of the accessory manufacturers and the main unit manufacturers. Because there are so many possible scenarios, they can only be analysed on a case-by-case basis.

Sorry, I may be asking a different question here. Regarding the interconnection conditions defined in IEC 60601-2-18, is it the responsibility of the endoscope manufacturers or the manufacturers of the HF surgical accessories used under the endoscope to fulfill?

Merry Christmas!!
 
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