Joint Implants: 4 Corners, the TGA, and Proposed Reforms

The 4 Corners program on ABC television which aired on the 16th of May explored the failure and subsequent recall of the DePuy Orthopaedics ASR hip replacement device, raising questions regarding the regulation of joint implants in Australia.

The DePuy Orthopaedics device obtained an inclusion on the Australian Register for Therapeutic Goods (ARTG) by utilising the Mutual Recognition Agreement between Australia and the European Union, and their existing British Standards Institute (BSI) CE Marking.

In August 2010 DePuy Orthopaedics recalled ASR hip replacement devices implanted in about 93,000 people worldwide, due to a high rate of repeat surgeries. After intervention from the TGA the ASR hip prosthesis was removed from the Australian market in December 2009. The TGA had acted upon data from the Australian National Joint Replacement Registry (NJRR) that showed an unacceptably high need for repeat joint replacement in patients who had received an ASR hip.  Australia was the first country in the world to take regulatory action to ensure the removal of the DePuy Orthopaedics ASR hip replacements from the market.

As part of TGA reforms in the medical devices regulation reclassification of joint implants is under consideration. Joint implants such as hip, knee, and shoulder will be up-classed, moving from Class IIb to Class III medical devices.  This new classification brings greater scrutiny for manufacturers and distributors of these devices. In addition, Class III and Class IIb implantable devices will be required to have TGA conformity assessment, regardless of pre-existing CE Marking certifications.

In the meantime, the 4 corners report serves as an important reminder to medical device manufacturers, distributors, and consumers that the performance and safety of all medical devices is paramount.

To watch the 4 Corners Episode visit http://www.abc.net.au/iview/#/view/767840

For further information on the TGA reforms visit http://www.tga.gov.au/newsroom/consult-devices-reforms-101130.htm