We welcome the opportunity to make this submission in response to the consultation paper on proposed regulatory changes related to personalised and 3D printed medical devices released by the Therapeutic Goods Administration (TGA) in November 2017.
New manufacturing technologies present many challenges and possibilities. They tend to fit in a more decentralised and distributed system than traditional technologies, and are part of a rapidly evolving and immature market. They also reinforce non-traditional innovation paradigms that are similarly decentralised and distributed. Regulating their use in health effectively is vital both to patient safety and improving health outcomes. Striking a balance between managing risk and enabling growth presents opportunities for the TGA to keep patients safe and promote innovation.
Consumers expect medical devices to be regulated, and would be surprised to learn how many custom- made medical devices currently avoid scrutiny. Confidence in an effective safety and quality regime is essential to maintain a functioning health system, and changes to how custom- made medical devices are regulated is required to maintain this confidence. CHF supports the TGA’s efforts in this area. We believe that including all custom-made products on some form of register is necessary, and recognise that treating custom-made devices in the same regulatory manner as mass-manufactured devices will see fewer such devices see use with consumers. A balance is required, and our recommendations look at ways to maintain the balance between safety and innovation, as well as take advantage of the unique advantages that custom made medical devices present to consumers, health professionals and manufacturers.
The core principles we have followed in developing our submission are based on the issues of access, choice and accountability.
Consumers deserve access to the best healthcare possible. For custom-made medical devices to be accessible, several factors must be addressed. Costs to the patient and the health system must be kept in mind when making regulatory changes. Further, access requires that effective innovation is not stifled, and ideally is promoted and supported.
A patient-centred approach requires clear communication between consumers, health professionals and manufacturers so the consumer can make an informed choice about their health care. With custom devices of any kind, a clear communication of the benefits and risks is vital, as is communication of the limits to which a device or manufacturing process has been validated scientifically.
Consumers can only be protected from harm effectively when there is clarity around who is accountable at each stage of the process. Who is responsible for communication, consent, documentation, adverse event reporting and recalls are only possible when the party responsible is accountable, and the relevant information recorded and maintained.