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The Severity of a Medical Device Hazard - Risk Analysis Clarification

subbash

Involved In Discussions
#1
I am working on risk analysis.

I need clarification regarding the severity of a hazard.

Do we need to assign severity only considering that patient health is not affected....?

An example case is: App crash.

Although its not going to affect patient. From a company perspective, app crash is a severe issue to address when it happens during customer usage.

So in this case do I assign a severity as negligible or do I need to assign a severity as Major....?

Another thing is related to the aspects mentioned in IEC 60601-1, where it mentions compliance is checked in Risk Management File. Do we need to address all the points in Risk management file.
 
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qualprod

Trusted Information Resource
#2
I think the rank is assigned according to what the app produce and the case.

Suppose is an app to monitor the heart of a person, in whatever issue, or the app Is just to have a register of the appointments.
Great difference.

Hope this helps
 

subbash

Involved In Discussions
#3
I think the rank is assigned according to what the app produce and the case.

Suppose is an app to monitor the heart of a person, in whatever issue, or the app Is just to have a register of the appointments.
Great difference.

Hope this helps
Hi @qualprod,

We are working on a diagnostic ECG device. So, app is just used to display the ECG.
 

yodon

Staff member
Super Moderator
#4
Risk management will drive what's necessary to do to protect the patients.

You may well have business requirements that drive additional robustness.
 
#5
@subbash Severity is a "measure of the possible consequence of a hazard". Harm is the possible consequence of a hazard. Ergo, severity is a property of a harm; a hazard does not have a severity. See also Annex D: "that is, hazards which could inflict harm of high severity..."
 

Jean_B

Trusted Information Resource
#6
I am working on risk analysis.
I need clarification regarding the severity of a hazard.
Do we need to assign severity only considering that patient health is not affected....?
Your defined criteria for assign severity and occurrence (and possibly detection), should tell you which to assign.
If your criteria are based solely on patient health, then yes, it should be negligible.

An example case is: App crash.
Although its not going to affect patient. From a company perspective, app crash is a severe issue to address when it happens during customer usage.
So in this case do I assign a severity as negligible or do I need to assign a severity as Major....?
Question: why assign it as a risk (as your criteria and risk scope would probably totally exclude it). Your reasons could be to show that you have considered it, and assessed it as practically riskless. But is there perhaps an additional motive? Do you wish to resolve the business risk issue in the same manner as a patient risk perhaps? You're not obligated to, but neither are you prohibited from doing so. Your process will need adjusting to account for both though, most likely starting with additional non-health hazard consideration and amended or additional criteria (probably in additional columns if you're in a traditional FMEA (assumption for your base tool)) and a different threshold for action and what evidence you deem acceptable (as this is your own requirement, and not a regulatory imposed one).

Another thing is related to the aspects mentioned in IEC 60601-1, where it mentions compliance is checked in Risk Management File. Do we need to address all the points in Risk management file.
You need to address all points from IEC 60601-1 and its particular and collateral standards which are applicable to your device.This does not necessarily have a 1-to-1 relationship with risks in your FMEA. Remember to rationalize/justify your non-applicabilities.
 
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