The failure of some medical devices in recent years, such as the PIP breast implants and metal-on-metal hip prostheses, have raised questions about the safety of medical technologies more generally and the role of the Therapeutic Goods Administration (the regulatory agency responsible for allowing devices onto the Australian market). Two Senate Inquiries and a number of internal reviews have recommended changes to the operations, culture and communications functions of TGA. In the following piece, Graham McLean, Managing Director of Stryker South Pacific (a medical technology company which produces a range of prostheses), argues that recent reforms within TGA have resulted in a more pro-active culture and that all stakeholders, including manufacturers, clinicians, regulatory bodies and consumers, have an important role to play in promoting safety and quality in health care.
As a manufacturer of some of Australia’s most clinically successful and widely used hip and knee prostheses, Stryker Australia understands and supports the importance of high standards of quality and safety. Recent high profile device failures have highlighted the devastating consequences to consumers of unexpected quality and safety problems and the role of the national regulator, the Therapeutic Goods Administration (TGA) in maintaining Australia’s high safety standards.
Overall, TGA is well regarded internationally for its rigorous approach to the evaluation of therapeutic goods and this reputation is well deserved. However, in 2011, Inquiries into the aforementioned device failures suggested that TGA could be more proactive in addressing early signs of problems with devices and in communicating potential issues to manufacturers, clinicians and consumers. Ongoing changes within TGA have resulted in a much more open and stakeholder-focused culture along with focussed regulatory reform that has bolstered confidence in TGA’s oversight of the safety and effectiveness of medical devices.
It is also important to understand that for TGA to perform its role, accurate and timely data on devices and their manufacturers/sponsors needs to be made available, where such data is important to inform regulatory decisions. For example, TGA needs to be able to access available post market clinical data and correspond in a timely fashion with the manufacturers/sponsors regarding unexpected clinical performance, and be aware if devices are removed from registries in another country for quality or safety reasons. Other issues, such as disreputable manufacturers providing inaccurate or even false information on device performance are also relevant to the TGA’s role in regulating devices in Australia. This relies on the provision of information from a wide range of sources, including international regulatory agencies.
The Australian Orthopaedic Association National Joint Replacement Registry (NJRR) is a key source of data on the outcomes of joint replacements and is often the first to notice a concerning safety trend with a particular product. It is vital that close communication between the NJRR and TGA is maintained so that there are no delays in making regulatory decisions, such as product recalls, once a problem has been identified.
Manufacturers also have a major role in medical device safety. It is important to recognise that implant manufacturers, as a condition of registration, are obliged to enter all available clinical data into the Design History File (DHF) of the product, and this DHF is available and reportable to TGA. Such clinical data would include any published data, data from known clinical trials, and data known from registries around the world, including the Australian National Joint Replacement Registry.
Clinicians are also key partners in maintaining high safety standards. They provide data regularly to the NJRR on their use of joint replacements and receive data back on their patients’ outcomes relative to those of other surgeons. It is essential that all clinicians review this data to ensure they can identify any unusual or unexpected outcomes. Clinicians are also an important source of information about adverse events and there are online tools to report any they come across in their practices to the TGA.
Finally, consumers are also vital stakeholders in upholding our high safety and quality standards. By supporting and educating patients to pro-actively seek information about their condition and health care options, consumers can and should play an active role in all treatment decisions. Consumers should also be encouraged to report any concerns about medical device safety and quality issues both to their clinician and to the TGA. While information for consumers on reporting adverse events is available on the TGA website, Stryker welcomes the TGA’s recent website programmes to educate consumers about the role of the national regulator. For example, just as product information is available on medicines, standardised information on medical devices should be given routinely to consumers with details of how to contact TGA to report any adverse events.
As Australians, we should all be proud of our high quality health system and internationally respected regulatory agency. However, in order to continue this successful approach, we also need to recognise that we all have a role to play in maintaining these high standards of safety and quality into the future.
About Graham McLean
Graham McLean is President of Stryker South Pacific and an experienced medical technology leader.
Mr McLean has expertise in a range of key health policy and regulatory areas, including health technology, health financing, medical devices, public health and health promotion. He took up his current appointment in 2012 having previously held a number ofe He roles including Finance and Operations Director and International assignments.
Disclaimer: Jennifer Doggett provides consultancy services to Cmax Advisory, a strategic, government relations and communication agency which provides services to Stryker South Pacific.