Medical device regulation – a challenging and changing area

Today’s rapidly evolving healthcare system, along with the expectations by patients and clinicians of rapid access to new treatments, has created some important challenges for regulators. In Australia the responsibility for the regulation of medical devices falls to the Therapeutic Goods Administration (TGA). The TGA’s role is defined by law – the Therapeutic Goods Act 1989 – and we work to ensure that manufacturers of the medical devices supplied in Australia comply with this legislation. In several ways, regulation of devices poses greater challenges that that of prescription medicines. On one hand, the range of technologies and of products is greater, while on the other, it is more challenging to gather in-depth clinical data prior to regulatory submission. To assist in communicating our expectations around the nature of clinical data required from industry for different types of devices, the TGA has recently published detailed clinical evidence guidelines.

Globally, we are seeing medical device regulatory systems becoming more established and many companies no longer view regulatory oversight as a hurdle to market access; rather they view regulation as an integral part of their quality management systems. There is a corresponding need for regulators to provide timely access to new technologies while still maintaining the requirement for demonstrated safety and performance.

Here, the TGA is working to implement Government-agreed reforms arising from a recent review into therapeutic goods regulation. These reforms will establish a priority review pathway for novel medical devices that treat life threatening or seriously debilitating conditions; set up a framework to allow designated commercial bodies in Australia to undertake medical device assessments; and make use of assessments from comparable overseas regulators more extensively in our decision-making. The review also proposed a register for higher-risk implantable devices. This is a complex area. There is already an established register in place for joint replacements used in orthopaedic surgery, and more recently registries for cardiac devices and breast implants have been established. Over the next 12 months the government will consider options for how these and other registries can be developed on a sustainable basis.

All results from TGA’s laboratory testing of devices are now publicly reported and we have stepped up information-sharing with overseas regulators.

Equally importantly, we are strengthening the post-market monitoring systems for devices. New approaches for gathering safety “signals” for devices are possible through analysis of large sets of de-identified patient data from hospital admissions and discharges, Medical Benefits Schedule item claims, and increasingly, electronic health record data. All results from TGA’s laboratory testing of devices are now publicly reported and we have stepped up information-sharing with overseas regulators. For companies and individuals that do not do the right thing, TGA will have stronger compliance and enforcement powers to protect the public, and graduated penalties that allow us to respond appropriately to the full range of non-compliant behaviours.

Coupled with these domestic activities is the work that we are undertaking with the International Medical Device Regulators Forum (IMDRF). The IMDRF is a group of medical device regulators from around the world re working to accelerate convergence of regulatory requirements internationally. While this work aims to ease the burden on industry and regulators through greater alignment of regulatory requirements, a number of international events have demonstrated that some types of devices require a higher level of independent assessment prior to reaching patients. As with the regulation of medicines, the TGA expends significant resources assessing overseas production facilities to ensure they meet rigorous standards of quality management in their manufacture of medical devices, including working closely with leading international regulators.

While the TGA has a broad range of responsibilities across all therapeutic goods, it is important to know that we have no legal powers to regulate medical practice. We are however improving the use of medical devices in our health care systems. At the moment we are looking at a consumer-focused initiative around the potential introduction of patient information leaflets and patient cards for implantable devices. We want to better understand what information consumers need in order to make informed decisions so we are looking at how implantable device information should be tailored to more effectively support the consent process between patients and surgeons. We are also working on the details of a patient implant card which will be given to patients so that they will always have available to them the specific details of the implants they have received. These patient implant cards will make it easier for individuals to communicate with their health professionals and the TGA about any issues they may be experiencing with their implantable devices.

TGA has established the inSite program to educate hospitals to encourage reporting of medical device adverse events.

While reporting of adverse device outcomes is mandatory for device suppliers, in Australia there is not a corresponding requirement for mandatory adverse event reporting from health care professionals, so we are more actively encouraging voluntary reporting. TGA has established the inSite program to educate hospitals to encourage reporting of medical device adverse events.

We welcome participation of all individuals in the TGA’s consultation processes and welcome consumers making use of established representative and advocacy groups, such as the Consumers Health Forum, to consolidate and represent their views. We engage with consumers actively – both through formal consumer membership of each of our advisory committees as well through holding several public forums each year. These forums may either just be for consumer representatives to specifically invite consumer input. In the last year we have conducted over a dozen public consultations on proposed reforms to the regulatory framework, and we have received valuable submissions from both consumer organisations and individual consumers in each of these consultations.

It is an exciting time for medical innovation. Technologies such as 3D-printing can better match devices to individual characteristics – for example, hip and knee joint replacements can better suit patients with non-standard anatomies. Software-based devices, including medical apps on mobile phones have a myriad of applications, from monitoring blood glucose levels in diabetes through to identifying cardiac arrhythmias. Precision medicine treatments based on a diagnostic test for a particular genetic marker much better target the use of particular medicines in treatment of specific cancers and rare diseases.

Device regulatory systems need to evolve to accommodate these developments in technologies. We need to consider how to have checks in place so that 3D-printed medical devices are at the same performance and safety standards as conventionally manufactured devices but at the same time not hinder technological innovation. Medical apps have revolutionalised the ability to collect patient data, often in remote care situations, and have greatly improved patient care in some cases. However, we need to be confident that the data such apps produce is reliable. Also, remotely controlled devices such as pacemakers can potentially be subject to software hacking, which would have tragic consequences. With precision medicines, we need to be able to check that the diagnostic test used to check for a genetic marker is most appropriate one to be used in combination with the targeted medicine.

The TGA and regulators everywhere are making their expectations clearer. Moving forward, the regulators, the regulated industry, and the community that we serve can work together to continue improving how medical devices contribute to the health and wellbeing of all Australians.

Photo by Tim Boote on Unsplash