How to measure severity if my product is designed for emergency use and failure would result in death?

[silentmonkey]

We are generating a design FMEA for a product intended for use in emergency situations, specifically when the patient is suffering from a life-threatening complication. The product is designed to intervene and ultimately save the patient's life.

If a failure were to occur and the device's function is compromised, the product would be unable to save the patient's life and therefore result in death. For the purposes of risk management and producing a sound design FMEA, would each risk item where the device's function is compromised automatically result in a maximum severity rating?

I find this logic a bit excessive as the patient is already dying whether the product is there or not. Am I thinking about this situation in the right way?

Thanks!

 

[Ron Rompen]

IMO, yes, if the device fails and the patient dies, then you assign the maximum severity rating. If the equipment HAD functioned as designed, there is a potential (don't know the details of your product so I can't comment on that) that they would have survived.

 

[silentmonkey]

IMO, yes, if the device fails and the patient dies, then you assign the maximum severity rating. If the equipment HAD functioned as designed, there is a potential (don't know the details of your product so I can't comment on that) that they would have survived.

Thanks Ron! It made sense in my head but at the same time seemed a bit excessive, and it was cause for some debate at the office.

 

[indubioush]

I agree. You assign the max severity. It is in your benefit-risk analysis where you will justify the use of the device even though it is high risk (i.e., the device benefits far outweigh the risks because it is life saving for patients who have low chance of survival to begin with).

 

[monoj mon]

The product is designed to intervene and ultimately save the patient's life.

You have already answered your question by yourself. Your device is expected to prolong the survival time period of the patient and ultimately giving the physicians a fighting chance to revive the patient. That means, failure of any vital function of your device would eventually reduce that "survival time period" and would lead to death of the patient. For example, suppose you are dealing with a device to provide neurovascular embolization to treat the intracranial aneurysms. In such case, that said device is expected to intervene by occluding the blood flow into the aneurysm and thus providing a prolonged survival time period of the patient when the surgeon can provide timely intervention to treat the abnormalities. Failure of the device would cause severe harm to the patient and ultimately may lead to "death", for example,
(a) failure to occlude the blood flow may lead to rupture of the aneurysm causing hemorrhagic stroke and eventually may lead to death
(b) fragmentation of the device (or any part of it) may lead to ischemic stroke and eventually may lead to death etc.
So, in summary, any design failure of this device may lead to death as it is a very high risk device, such as yours.

It made sense in my head but at the same time seemed a bit excessive, and it was cause for some debate at the office.

My point is, while looking at the severity although it seems excessive, we also need to be in the shoes of the patient who would eventually pay the price if our device fails to perform as intended.

 

[Tidge]

Add my voice to the chorus: For patients who will suffer severe effects without the intervention of the device, it is presumably acceptable to tolerate higher levels of risk. The actual severity of a harm (e.g. death) is only one component of risk.

Keep in mind that medical device manufacturers are also required to assess the risk to users as well: it may be the case that a line of risk analysis which has death as an outcome for a patient is acceptable, but the death of an operator is far less likely to be acceptable.

 

[levatorsuperioris]

These types of devices tend to have the highest severity on each item. But your decision making is done by criticality (severity and likelihood). Nothing says extremely unlikely death cannot be acceptable.

 

[Ed Panek]

Are there any stats on the problem your device is solving if left untreated? 90% mortality? etc? Or versus the standard of care?

 

[Miner]

Are there any stats on the problem your device is solving if left untreated? 90% mortality? etc? Or versus the standard of care?

I am picturing an AED.

 

[silentmonkey]

Are there any stats on the problem your device is solving if left untreated? 90% mortality? etc? Or versus the standard of care?

Yes there plenty of stats which we have collected through our review of scientific/clinical literature; this has been included in our CER as well as our Overall Residual Risk Evaluation.