Publications

Published: 12 December 2013

Joint Adverse Events Notification System for Medical Devices

Prescriber Update 34(4): 42-43
December 2013

Information about adverse events relating to medical devices can now be searched online. The joint adverse event notification system for medical devices (JAENS-MD) is a searchable database of medical device adverse event report information for Australia and New Zealand.

Summary information from the medical device adverse event reports is published in the JAENS-MD. This includes general information about the device involved as well as a list of reports associated with the device and a description of the adverse event.

Medsafe and the Australian Therapeutic Goods Administration (TGA) regularly receive adverse event reports associated with medical devices. These reports come from a wide range of sources, including members of the public, GPs, nurses, other healthcare professionals and the therapeutic products industry. These reports may be indicative of a quality or safety issue that needs to be addressed in some form.

The reports in the JAENS-MD commence from 1 July 2012 (for TGA) and from 1 Jan 2013 (for Medsafe). There is a lag of up to three months between a report being received and it appearing in the database. The lag allows time to analyse each adverse event report and to request additional information if needed.

It is important to read the information on the website about how to use the JAENS-MD. In particular, it is important to understand its limitations and that the reports provide only limited information about a device and its use.

The JAENS-MD can be found on the Australia New Zealand Therapeutic Products Agency (ANZTPA) website.