Electrosurgical devices/surgery IFU contraindications

[W3r0nika]

Hello, can anyone explain to me why the IFU in electrosurgical devices/surgery is contraindicated mental illness?
Do any such contraindications have to be supported by any clinical article in clinical evaluation?

thank you in advance

[yodon]

I'm guessing it's just taking a conservative approach. We worked on one device that excluded pregnant women from indicated use. There was no physiological rationale but they didn't want to chance it.

So I think it's probably more the opposite: if you do indicate it for use with a certain population, you'd want the clinical evidence to show safety and efficacy. There's a chance that after clinical trials or use that you do find out that use isn't indicated for a population and you need to narrow the indications down but otherwise, it's just eliminating risk.

[Mark Meer]

In Reply to Parent Post by yodon

...
We worked on one device that excluded pregnant women from indicated use. There was no physiological rationale but they didn't want to chance it.
...

Ditto for us..and also children too.

Certain contraindications may derive simply from predicate programs (e.g. US FDA 510(k)). The original (predicate) device manufacturer may have decided to be conservative, and all subsequent similar devices simply included the same contraindications to simplify the predicate comparison. Changing a contraindication is one of those things considered a major change, and so even if the predicate manufacturer was being overly conservative, having to justify changing it would only complicate 510(k) clearance.