Point-of-care manufacturing of medical devices

Project overview

Healthcare facilities in Australia are developing point-of-care (POC) manufacturing capabilities using methods such as 3D printing to produce a wide variety of medical devices. POC manufacturing regulations apply to those people (e.g., health practitioners) manufacturing these medical devices, in both public and private settings.

POC manufacturing often takes place:

• in facilities regulated by entities other than the Therapeutic Goods Administration (TGA)
• by people who manufacture devices as a component of clinical practice

These manufacturing processes are often different to traditional medical device manufacturing practices and the framework for medical device regulation may not always be appropriate.

The introduction of new requirements in 2021 for personalised medical devices has highlighted the scale and scope of POC manufacturing, and the need to further review the current regulations to determine whether refinements are needed to protect patient health and safety, contribute to positive patient outcomes, and support the introduction of innovative technologies that seek to improve manufacturing at the POC.

Consultation

To commence the information gathering for the review of the current regulations, we conducted four (4) surveys targeting specific sectors where POC manufacturing takes place:

1. The allied health sector
2. The dental sector
3. Manufacturing hubs within hospitals
4. Policy and governance teams within hospitals that have a manufacturing hub.

For an overview of the survey results see our publication Medical devices manufactured at the POC – Analysis of survey responses by sector.

National symposium on POC manufacturing of medical devices

In June 2023, we convened a National Symposium to present the results of the four surveys and to discuss issues associated with POC manufacturing as identified by survey respondents and gaps in regulation.

Attendees included nominated representatives and observers from:

• TGA
• Australian Health Practitioner Regulation Agency (Ahpra) and its National Boards
• National Alliance of Self Regulating Health Professions (NASRHP)
• National Disability Insurance Agency (NDIA)
• The Australian Commission on Safety and Quality in Healthcare (ACSQHC)
• The Aged Care Quality and Safety Commission (ACQSC)
• State and territory government health department.

For a summary of the meeting and agreed outcomes, see our National Symposium on Point-of-care Manufacturing of medical devices page.

Steering Committee and Working Groups

National Symposium participants agreed the TGA, in collaboration with other regulators and state and territory governments, would establish a steering committee and the TGA would establish sector-specific working groups (WGs).

Information on the terms of reference, membership, and meeting communiques of the Point-of-care Manufacturing of Medical Devices Steering Committee and sector-specific Working Groups.