Submission
AMA submission to the Therapeutic Goods Administration – mandatory reporting of medical device adverse events by healthcare facilities
In this submission the AMA supports, in principle, the mandatory reporting of medical device adverse events by those healthcare facilities that are capable of doing so and where a demonstrable benefit exists.
Healthcare facilities that are frequent users of medical devices, such as hospitals, should be included in mandatory reporting, while medical practices and RACFs should be exempt. The TGA must ensure that adverse event reporting comes with clear definitions, and that regulatory and administrative burden is minimised. Included healthcare facilities must be adequately resourced and supported to carry out mandatory reporting.
