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.
Concerns about medical devices are well and truly warranted. The recent spate of device failures has revealed a poorly regulated industry that has put consumers at considerable risk of harm, including those with persistent and chronic pain. The inability of regulators to trace devices represents a systematic failure of our health and safety regulatory regime. It is also in stark contrast to the regulatory controls that are applied to pharmaceutical products.
We know medical devices can improve people’s lives. Medication delivering pumps can reduce people’s pain or help maintain a diabetic’s insulin levels. Hip and knee replacements can, where necessary, return people’s mobility.
As part of Sophie’s report, I highlighted that ‘we have seen such catastrophic failures in medical device regulation, breast implants, more recently surgical mesh, hip implants, heart valves.’ There is no doubt about the benefit of these devices in improving quality of life, but good regulation and timely information is key to consumer confidence in these products. Fundamentally, when these devices fail they can significantly reduce quality of life, pain and suffering as we have seen time and again.
The resulting scrutiny led to the announcement of much needed tightening of regulations. Painaustralia has been supportive of the reforms, working collaboratively with the TGA on a consumer co-design process for the Action Plan for Medical Devices, which aims to strengthen Australia’s medical device regulatory framework. The Plan sets out a range of actions that continue to improve the safety, performance and quality of medical devices in Australia, as well as enhancing transparency and increasing public confidence in our regulatory system.
These significant reforms are now delayed. As noted on the TGA website, the delay occurred ‘reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focussed on the COVID-19 crisis.’
While we recognise that COVID-19 has caused an unprecedented and unforeseen barrier to progress on a number of policy issues, this response was not consistent. The pandemic, for instance, did not result in a similar delay to the rollout of opioid regulatory reforms which were implemented on 1 June.
For people living with pain conditions, accessing ongoing treatments and support during the pandemic has been challenging. Many consumers have informed us of the difficulties they have experienced in accessing their usual care, script and medication provision issues as well as symptom exacerbation due to reduced physical activity and increased psycho-social stress during this period of pandemic. This is supported by evidence suggesting that mental health problems among people living with chronic pain have escalated during recent months.
Medical devices have been a life-changing intervention for many, but people with implants or those considering them have a right to be well informed. At present, there is no mechanism to ensure they can be contacted in relation to their device when large scale failures become apparent.
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.
Anything less than implementing these long overdue reforms represents a failure of our health system to inform patients and ensure health professionals do no further harm when it comes to medical devices.