Adverse Event Reported during Non-Approved Indication Use

[HelviReg]

One of our clients is using a device he purchased to us to perform a clinical trial outside our CE mark indications. He is the sponsor and the investigator, we are not involved in his activity at all.

However he has reported us an adverse event (no SAE). This event is not related to the indication under trial (it already occured with the cleared indications and is part of our risk analysis) but rather to the (abnormal) use of the device.

Do we have to treat the event as part of our NC and vigilance processes ?

Thank you for your help,

Vivien

 

[Ronen E]

Do we have to treat the event as part of our NC and vigilance processes ?

Sounds to me that you do.

By the way, "abnormal use" usually means in this context that someone has willfully used it against the IFU (not a use error). Are you saying that the AE occurred because the device was used for a cleared indication, but not in the way you (the manufacturer) instructed, and in spite of clear warnings / other measures taken to prevent such use?

 

[HelviReg]

Thank you Ronen for your reply.

Well concerning the abnormal use, I've put it between brackets because the user has willfully disabled all the features we provide to avoid such event. Then he failed to detect the issue on time and act accordingly (what the features would have done). I guess I cannot state this is a real abnormal use since we allow disabling these features, even if we strictly advise their use in our IFU. The leading event is not a SAE anyway.

 

[Ronen E]

Thank you Ronen for your reply.

Well concerning the abnormal use, I've put it between brackets because the user has willfully disabled all the features we provide to avoid such event. Then he failed to detect the issue on time and act accordingly (what the features would have done). I guess I cannot state this is a real abnormal use since we allow disabling these features, even if we strictly advise their use in our IFU. The leading event is not a SAE anyway.

Just to clarify, according to my best judgement (which may be wrong), if the manufacturer provides reasonably accessible means of disabling some protective measures, and the user does so, it's not an Abnormal Use (as defined by IEC 62366) even if some printed warnings against such actions are provided.

Abnormal Use is a situation where intentional misuse occurs after all reasonable means for preventing it have been depleted by the manufacturer. Obviously this is not the case in this example, because the manufacturer could have refrained from providing the means to disable the protective measures.

 

[HelviReg]

I definitely get your point and further arguing here if it's an abnormal use or not would lead us to far from the original topic

Thank you for your time!