Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER)

Harini17

Involved In Discussions
#1
Dear experts,

Greetings!

I would like to understand the differences and relation between the undesirable side-effects, side-effects, harms and risks of a device.

Also, how to address undesirable side-effects in CER to comply with essential requirements ER 3.

It would be really helpful if explained with an example.

Thanks in advance!

Harini
 
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Marcelo

Inactive Registered Visitor
#2
Harm - Damage to the patient (for example, unwanted electrical shock from a medical electrical device)
Risk - How probable is the harm to happen, and, happening, how severe it is
Side-effects - Clinical (usually) effects that may happen due to the use of a device, but are not related to the intended use (for example, in a magnetic resonance machine, people may get disoriented due to the confined space)
Undesirable side-effects - Side effects for which the risk is considered unacceptable (in the example above, depending on the acceptability criteria, disorientation might be unacceptable)

Side effects should be identified in risk management (with numerical probability), and "validated" in the clinical evaluation (by having enough clinical evidence).
 

FoGia

Involved In Discussions
#4
This makes goodsense Marcelo, I also see quite some confusion on the topic but I failed to find a good reference for the definition of side effects - neither the MDD nor the MDR define it, and this make it hard to put into practice myself.
For instance some examples provided in MEDDEV 2.12/1 rev 8 (section 5.1.3.5) leave me wondering about that definition:
A patient receives a second-degree burn during the use in an emergency of an external defibrillator. Risk assessment documents that such a burn has been accepted in view of potential patient benefit and is warned in the instructions for use. The frequency of burns is occurring within range specified in the device master record.
In that case the electric shock is part of the intended use, a burn is something to be expected and I wouldn't classify it as a side-effect (but only as a harm). In effect it seems that all harms provoked by a device could be classified as side effect. What do you think?
 

Marcelo

Inactive Registered Visitor
#5
This makes goodsense Marcelo, I also see quite some confusion on the topic but I failed to find a good reference for the definition of side effects - neither the MDD nor the MDR define it, and this make it hard to put into practice myself.
For instance some examples provided in MEDDEV 2.12/1 rev 8 (section 5.1.3.5) leave me wondering about that definition:

In that case the electric shock is part of the intended use, a burn is something to be expected and I wouldn't classify it as a side-effect (but only as a harm). In effect it seems that all harms provoked by a device could be classified as side effect. What do you think?
The intended use of a defibrillator is to restore normal rhythm to the heart, not to give burns. the electric shock is part of the way the device achieves it's intended use, but it's nor desirable to have a burn. So the burn is a side effect.
 

FoGia

Involved In Discussions
#6
OK so can we then say that side effect is just another wording for Adverse Device Effect?
I would imagine that only a minority of devices would have harms that are intended, such as ablation devices, sawblades, scalpels... etc.
 

Marcelo

Inactive Registered Visitor
#7
It depends on what you mean by "Adverse Device Effect".

If you mean the EU MEDDEV 2.7/3 revision 3 :

Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
NOTE 1: This definition includes events related to the investigational device or the comparator.
NOTE 2: This definition includes events related to the procedures involved.
NOTE 3: For users or other persons, this definition is restricted to events related to investigational medical devices..
Adverse Device Effect (ADE)
Adverse event related to the use of an investigational medical device.
NOTE 1- This includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device.
NOTE 2- This includes any event that is a result of a use error or intentional abnormal use of the investigational medical device.
Yes, a side effect would be an Adverse Device Effect if the device is an investigational medical device (as this MEDDEV is applicable to investigational medical devices).

Please note that, in this case, if the event is also a Serious Adverse Device Effect (SADE), you can exclude the device relationship if:

Not related: relationship to the device or procedures can be excluded when:
  • - the event is not a known side effect of the product category the device
    belongs to or of similar devices and procedures;
 

FoGia

Involved In Discussions
#8
yes I indeed meant ADE following the definition in ISO 14155 and used in the MEDDEV. Thank you, I learned something today!
Are there guidelines/standards that define side effects?
 

Marcelo

Inactive Registered Visitor
#9
yes I indeed meant ADE following the definition in ISO 14155 and used in the MEDDEV. Thank you, I learned something today!
Are there guidelines/standards that define side effects?
Not for devices that I remember now. That are some definitions for drugs.
 

Marcelo

Inactive Registered Visitor
#10
Just another comment, in fact, per the Adverse Device Effect (ADE) examples on the notes above, most (if not all) ADE won't be side effects, because they deal with medical device malfunctions. side effects are not related to device malfunctions, but to adverse patient reactions to a device that is working properly.

iN fact, now that we are discussing it, I think ADEs as defined above are only related to device problems (although the definition does not say that, but the examples do), so it would not include side effects.
 
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