Medical device reforms - product names
The product name proposal as outlined in the TGA Blueprint will not proceed at this time. The Government has decided to instead pursue emerging opportunities to better identify medical devices approved in Australia, through leveraging the Australian Government's eHealth initiatives and other international commitments.
The reform was proposed as a solution to address the identification issues at an individual product level. The primary rationale for this reform proposal was to improve the identification and traceability of medical devices to enhance TGA's device recall processes and compliance capabilities, as well as allowing consumers to determine whether a particular device was included on the ARTG.
The existing legislative provisions result in around 92% of ARTG entries for medical devices actually including more than one individual device of the same kind (i.e where the devices have the same sponsor, manufacturer, medical device classification and nomenclature code). The remaining 8% of the 43,000 current ARTG entries relate to high risk devices and these are able to be identified at an individual product level.
The TGA Blueprint proposal would have required sponsors to nominate the product name of all the individual devices included under each ARTG entry for each kind of medical device.
Feedback to consultation in 2010 indicated strong support from consumers but much of the industry opposed the proposal based on the cost of providing and maintaining product name data. As a result the Government committed to consult further, and targed consultaton with key stakeholders was undertaken, building on the 2010 consultation outcomes and on the the emerging opportunities.
There have been a number of developments since 2010 which mean progressing with the original mechanism would not to be the most effective or efficient approach. It is expected that new developments can achieve the same intent of being able to identify medical devices at the individual product level. These include:
- announcements in Europe and the USA to implement the use of Unique Device Identifiers (UDIs) for medical devices (i.e. unique codes stored in a central database that identify a particular device at the product level (including product name) that are intended to be available with or on the device). This will have significance as the originators of the majority of medical devices used in Australia are in Europe or the USA
- in Australia, the development of the National Product Catalogue, which is a database developed as an eHealth initiative containing product and pricing data for healthcare purchasers and includes medical devices that can be identified by name and by ARTG entry
- the 1 July 2012 reclassification of hip, knee and shoulder joint implants from medium risk to high risk devices which means that these devices, like other high risk devices, will be required in any event to be individually identified
- the announcement of post market medical device registers for breast implants and cardiac devices in the 2013-14 Budget which would also assist to identify these high risk devices.