The delay supports additional time for the Therapeutic Goods Administration (the TGA) to consult with the medical device industry and health care professionals on guidance material relating to the reforms.
It also provides time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context and ensure that the transition in Australia is implemented effectively.
Painaustralia has been working closely with the TGA as part of the Medical Devices Consumer Working Group to ensure that these reforms reflect the concerns that millions of Australian consumers share.
We are disappointed to learn that these significant reforms will be delayed. While medical devices can improve people's lives, when they fail, the consequences can be disastrous.
Painaustralia CEO Carol Bennett outlined concerns, stating “‘we have seen such catastrophic failures in medical device regulation, breast implants, more recently surgical mesh, hip implants, heart valves.’
Mandatory medical device reporting obligations are long overdue as indicated by reviews and inquiries over many years. We need to see some practical improvements such as a patient database for contact tracing, community awareness and information campaigns so that consumers are well-informed of developments relating to the devices already implanted as well as any devices they may be considering for their treatment. These safety nets should go hand in hand with broader reforms that are aimed at reducing harm and enabling better pain management.
Further information about the reforms can be accessed on the TGA’s website.