IVD Risk - destruction of patient samples - Harm to property?


Quite Involved in Discussions
Hi All,

Taking into consideration the definition of harm includes damage to property and the environment I've got a quandary on situations where the device causes damage to the testing sample.

My thoughts are that the destruction of the sample is the either the hazardous situation and this would lead to several potential harms to patient (and potentially user)

1. New sample would need to be prepared from existing patient material - Low severity, inconvenience to user
2. New material would need to be obtained from patient - High severity, potentially requires invasive surgery to obtain material from patient
3. Delay to diagnosis as a result of either of the above - Severity to patient dependent on clinical condition being diagnosed

Would you consider the destruction of the patient sample a harm in itself, as being property damaged by the device?
I have always considered damage to property as a result of things like fire/explosions/flooding etc.

Additionally, considering the nature of the sequence of events with IVD risk, defining the hazard as a "delay to examination result" as one of the generic device performance hazards, as defined in TR24971 Annex H, seems appropriate for examples 1, and 3 - but for example 2 the only hazard I can think of would be "unable to perform examination" which doesn't sit right with me currently.




Trusted Information Resource
In the case you describe (loss or destruction of a sample collected from a patient), I think it is worth considering potential harms to the patient that could result from the loss of a sample. For example, if the sample was originally collected via surgical means I believe that requiring additional cuts to the patient could be appropriately considered to be a patient harm. Also, if the sample was a blood draw form a patient with a very low blood volume (e.g. a neonatal patient), I think it would be appropriate to consider the potential harms if otherwise unnecessary blood samples are drawn. See also spinal taps, etc.

I think you have a good handle on this.


Quite Involved in Discussions
I think you have a good handle on this.

That's what I thought - I'm being told otherwise by a team lead... The many perils of intense self doubt.

Despite IVDs having a somewhat indirect relationship between the hazard and harm when it comes to performance and intended use based risks, I think based on the potential for harm being a direct result of the destroyed sample, then the destroyed sample should be the hazard of note, and then the mechanism by which the sample was destroyed the hazardous situation.
Regardless of how it's defined, the situations are captured and assessed, and the harm & severity is defined in relation to the patient.


Trusted Information Resource
This risks may be low, and if that assessment aligns with the team lead's "gut feeling", then just use the opportunity to reinforce that the documenting the risk management process is making the information and results more obvious to people not as quick-witted as he or she.


Involved In Discussions
I think this is one of the areas where we have to consider the real intent of medical device risk management, which is (in my view) to protect the health and safety of human beings. Considering "damage to property or the environment" is really only needed because that damage may itself result in a risk to human beings (because, for example, the local environment becomes contaminated or otherwise unsafe, or other equipment being used in the environment becomes unsafe and/or its performance becomes compromised). From that perspective, if the "damage to property or the environment" is so minor that no impact to any human beings is reasonably foreseeable, then, to a certain extent the damage doesn't really matter.

Unfortunately, in most situations, you likely don't know the downstream, human-health/safety-impacting effects of such property/environment damage. So have to assume a "worst case" and assign a relatively high severity to such a harm, out of an abundance of caution.

However, in the case you're describing, you know what would happen if the sample is destroyed. You know that the downstream effect is that a new sample will have to be obtained, and the patient will have to be re-swabbed/pricked/probed to obtain the new sample. So you can use this information to assign a more appropriate severity rating than you would otherwise be able to if you didn't know the downstream effect.

In the end, the purpose of the effort isn't to add rows to a spreadsheet, it is to determine whether or not "damage to property/environment" is an acceptable risk. If you know the downstream effects of such damage, then you could consider them when making that determination. If you don't know the downstream effects, you should consider a worse case situation, and move forward accordingly.


Quite Involved in Discussions
I think this is one of the areas where we have to consider the real intent of medical device risk management, which is (in my view) to protect the health and safety of human beings.

Whilst I completely agree, I've been pulled up by 14971 focussed auditors by not having any damage to property or environment in my risk files before...

WEEE and unwanted outputs and waste usually go to environmental easily.

However, in the case you're describing, you know what would happen if the sample is destroyed.
That was my exact approach in discussing it - the damaged sample (be it sample tube, prepared slide, or any others) is inconsequential when you know what the severity of the impact to the patient as a result is much greater. The probability of having to take a new patient sample over preparing a new test from a previously taken sample is different - however are we talking of different hazards here?

Only sample destroyed vs. portion of sample destroyed?

Different harms associated with each one, with the portion simply being user inconvenience.
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