A11 – Monitoring Device Safety with Registries

The recent TGA review of devices has foreshadowed a much greater role for registries in monitoring the long and intermediate term safety of new devices. Already national registries have been developed in Australia for breast implants and cardiac devices. However, the science of registries is still evolving and as a result there is confusion about many aspects of registry operation and what registries can be realistically expected to provide. This session will provide an example of an established device registry to explore issues such as governance, funding, record linkage, reporting etc.


Chairperson: Belinda Martelli, Sanofi