Consultation: Australian Medical Device Regulations definition of Central Circulatory System (CCS)

We asked for feedback on whether to amend the definition of the CCS within the Australian medical device framework which is reflected in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). The Australian definition currently includes devices that come into contact with the common iliac arteries, which is consistent with the definition outlined in guidance published by the International Medical Device Regulators Forum (IMDRF) and as adopted by other countries such as Singapore, but is not aligned with the definition adopted in the European Union (EU).

Four submissions were received, all of which were from medical device sponsors (suppliers). They all supported removing iliac arteries from the definition of CCS to align with the definition adopted in the EU. The reason cited for this was a decreased regulatory burden for devices with EU certification, where sponsors may not have to provide additional and/or different evidence to the TGA. This in turn, would encourage and allow these devices to be supplied more easily to the Australian market. Respondents pointed out that if the inconsistency continued, there would be an extra cost and regulatory burden for approval to include their devices in the Australian Register of Therapeutic Goods (ARTG). Respondents also noted that Australia is already missing out on a number of these devices due to the cost, processes, documentation and time to meet the differences between these regulatory requirements.

Respondents noted that Australian patients would benefit from amending the definition to exclude iliac arteries from the definition of the CCS, through greater access to more medical devices for the treatment of iliac arteries pathologies without increased risks.

A small number of responses, all from medical device sponsors, were received. Noting there were no responses from clinicians or health care workers, we undertook further targeted consultation to understand the clinical implications and risks associated with amending the definition of the CCS by removing iliac arteries from the definition. By removing iliac arteries from the definition of CCS, devices used in those arteries would be in a lower risk classification.

Several clinical colleges and surgical groups were invited to comment on the risks and implications of removing the common iliac arteries from the definition of the CCS. We received three responses from the Australian and New Zealand Society for Vascular Surgery (ANZSVS), the Royal Australasian College of Surgeons (RACS) and the Cardiac Society of Australia and New Zealand (CSANZ). These organisations expressed strong support to retain the current definition of the CCS and to remain aligned with the IMDRF guidance. They were concerned that a change may have potential safety implications for devices used in these vessels. It was also noted, as an aside, that the use of Latin is uncommon in modern clinical practice.

We also received advice from the Prostheses List Advisory Committee’s Clinical Advisory Groups (CAGs) for cardiac prostheses and cardiothoracic prostheses. Both CAGs indicated that the common iliac arteries are definitely considered part of the central circulatory system by clinicians and should not be removed from the definition in the Regulations.

We have reviewed all responses and considered the risks associated with removing iliac arteries from the definition of CCS. Clinical groups and associations expressed support to retain the current definition of the CCS. Therefore, on balance, the TGA intends to not amend the definition of the CCS within the Australian Regulations.