Setting Expected Service Life for an an Electrical/Electronic Medical Device

Roland chung

Trusted Information Resource
#21
@ Peter

Anyhow, you have to verify the effectiveness first, then record the results. But you are correct to point out that in most cases, this verification is subjective and most manufacturers do not have the supporting evidence. For example, the number of probability is changed from P=4 to P=2 due to the warnings in IFU (means 99% effective).

If we do the verification of mitigation(s) used for each risk, then heavy workload can be expected. So what is best practice in this regard?

@ Marcelo

The verification of effectiveness is related to risk acceptability, so it's not related to the risk (probability x severity) per se. If you can show that the risk control measure is acceptable based on your risk acceptability criteria, you do not need to re-check the risk (*but obviously in this case you should not be using your risk acceptability criteria as the matrix (which unfortunately most people do :-/().
I cannot get your point. The residual risk evaluation is related to risk acceptability. The effectiveness is the reason why risk can be reduced to defined acceptable range.
 
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kreid

Involved In Discussions
#22
Taking note of the above interesting discussion, I am thinking of changing the "Device lifetime" as declared in my IFU.

I want to change it from 2 years to 1 year.

Do you think there will be any regulatory or legal impacts if I do?

I am wondering about whether the FDA would be interested (for example would they expect a new 510k) and also what would the existing customers position be when repurchasing the device and finding the lifetime had been halved?
 

Ronen E

Problem Solver
Staff member
Moderator
#23
in most cases, this verification is subjective and most manufacturers do not have the supporting evidence.
Excuse me for barging in.

First, if there's no supporting (objective) evidence then it's not really a verification.

Second, the effectiveness of an IFU change can be objectively quantified in a systematic usability study (the word systematic doesn't necessarily say that it has to be of huge scale). The fact that the change is effected via people's perception doesn't mean it can only be judged subjectively. We have statistics and experiment design at our disposal. In my opinion such objective evidence is rarely available not because it's impossible to get it, but because either the manufacturers are looking for an easy way out (lazy?) or it would take too long, or cost too much, or any combination of the above.
 
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Ronen E

Problem Solver
Staff member
Moderator
#24
Taking note of the above interesting discussion, I am thinking of changing the "Device lifetime" as declared in my IFU.

I want to change it from 2 years to 1 year.

Do you think there will be any regulatory or legal impacts if I do?

I am wondering about whether the FDA would be interested (for example would they expect a new 510k) and also what would the existing customers position be when repurchasing the device and finding the lifetime had been halved?
I don't think that the FDA will mind since you are not adding or extending a claim; you are reducing one.

Regarding recurring purchases it's mostly a business question; I'm quite sure that some of your clients won't like it too much.

In my opinion your greatest concern is with devices already purchased (but not yet expired). If the change is a result of new information at your disposal, or of reconsidering information you had earlier, and not of a change in the device (eg a new model), then your clients might be concerned that the devices that they already possess won't live up to the initially specified lifetime. If anything will actually happen in the interval between 1 and 2 years you might need to provide some embarrassing explanations, to your clients and maybe even the FDA.
 

kreid

Involved In Discussions
#25
Thanks for your reply Ronen:

In my opinion your greatest concern is with devices already purchased (but not yet expired). If the change is a result of new information at your disposal, or of reconsidering information you had earlier, and not of a change in the device (eg a new model), then your clients might be concerned that the devices that they already possess won't live up to the initially specified lifetime. If anything will actually happen in the interval between 1 and 2 years you might need to provide some embarrassing explanations, to your clients and maybe even the FDA.
Yes that is the area of my concern too.
In fact the two year figure in the IFU came from someone extrapolating the test protocol into the IFU.

The guarantee was for a year and so the testing covered two years and so someone decided that it might look good in the IFU -a daft situation.

But the point that you make is now a real situation and problem.

Thanks again for your comment
 
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