It is no different to any other device or medication… IF it fails it falls on the manufacturer and FDA
while with previous versions of recell system it was more of a shared responsibility model. There was a person who had to be trained and qualified to use the device. So for any failures responsiblities would have been shared between AVH, FDA and a person who used multi step recell system.
I think that element of taking additional responsibility partially could explain the slow rate of adoption
as for the actual risk of failure, it is verryyy low… it has beem scientifically tested, FDA approved plus a proven track record of applying on patients…
It is no different to any other device or medication… IF it...
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