IFU Changes - How it is ensured that IFU changes reach Surgeons

[Edugar]

If a new IFUs version is released, how is it ensured, in a realistic way, that the surgeon really takes notice of the changes in the IFUs (bearing in mind that only the device, without the IFUs, is presented to the surgeon during the surgical procedure)?

 

[yodon]

Other than training, it's probably not possible. You could try to get confirmation but that may be difficult.

I think this is one of the reasons why, in the harmonized 14971, you cannot reduce risk through labeling alone.

 

[MIREGMGR]

Is the nature of your device that you do in-services or other in-person training?

If the change is patient-risk- or outcome-significant, don't let anyone use it for whom you don't have evidence of completed training.

 

[Edugar]

Thanks for your comments.

The device is an implant, widely used in a specific surgical speciality, and it does not need special training. When the product is introduced in the hospital, the sales rep. explains specific details. Afterwards, the experienced surgeons transmit their experience to the new surgeons.

Almost always the changes of the IFUs do not represent patient risk issues. But obviously it is interesting that IFUs changes reach the surgeons; and the habitude to check periodically the IFUs is not generally extended.

 

[pkost]

If the change is due to a risk to the patient, you should consider issueing a field safety corrective action - FSCA do not have to just be recalls, they can be for informational purposes as well i.e. IFU updates. Certainly within the UK the MHRA distributes to hospitals and the hospital should communicate to the relevent parties.

Additionally, as advised in previous posts, most implantables I've worked with have sales reps attend theatre and advise the surgeons on appropriate techniques...The sales reps will know all the surgeons using your products, should have a good relationship with them and should be in a position to communicate changes to them.