At the end of October last year I attended a session with ECRI and one of the things we were told was that ECRI had been in touch with a firm of legal experts in the field of medical cases.
The question about prosecuting a case against someone who had not followed the manufacturers procedures was asked. The advice given (as I remember it) was that provided that a proper risk assessment had been done and recorded, it would be unlikely that a prosecution would result. Of course that doesn't mean you won't end up in court!
Is any-one from ECRI (or at the session) reading this, availlable to confim, deny or correct my memory.