By Stewart Eisenhart, Emergo Group
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, has launched a new searchable database of adverse event information, the Database of Adverse Event Notifications (DAEN), available to the public.
The database contains reports on adverse and near-adverse events involving medical devices on the Australian market going back to July 2012. DAEN search results are presented either as medical device summaries, which include general details of medical devices involved in reports, or as lists of reports, which display more in-depth information on medical devices and adverse event reports.
The TGA plans monthly updates of the DAEN. Allowing centralized accessibility to adverse event information on medical devices to the public raises the stakes in terms of post-market vigilance for manufacturers holding medical device registration in Australia.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.