Additional comments by Government Senators
An issue highlighted by both this inquiry and the inquiry into medical
devices is the need for greater clarity of the role of the TGA and the role of
the Chief Medical Officer (CMO) in high risk implantable medical device
While the TGA, through the recall process, has responsibility for
informing sponsors that the medical device is no longer on the ARTG and
therefore unable to be used in Australia, it is less clear who, if anyone, has
responsibility for providing general clinical advice to the population of
patients who continue to have their high risk medical devices implanted.
Nothing can, nor should, replace the clinical advice provided directly
to individual patients by their treating health professional; however it is
clear from evidence that there was an expectation from consumers that either
the TGA or the CMO would provide general clinical advice.
In the case of the PIP recall the convening of an expert clinical group
(albeit two years after the recall) by the CMO to develop such general advice
and monitor any change in evidence emerging from the work of the TGA, would
appear to be an appropriate model.
Government Senators suggest that the more routine use of such a model in
the case of high risk medical device recalls be explored by DoHA and the CMO
and that a clear set of protocols be developed.
Senator Claire Moore Senator
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