What it does
This instrument, the Therapeutic Goods (Medical Devices,Authorised Supply) Rules 2022, authorises specified health practitioners to supply specified kinds of medical devices that are not included in the Australian Register of Therapeutic Goods (the Register). It is made under subsection 41HC(6) of the Therapeutic Goods Act 1989 (the Act) (see s 3). The core operative provision is section 5, which provides two alternative authorisations:
- supply by a health practitioner to that practitioner’s own patient where the device and purpose are the ones listed in Schedule 1 and where the practitioner complies with the conditions in s 5(2); and
- supply by a health practitioner to a patient of a different treating practitioner listed in Schedule 1, where the supply is requested by the treating practitioner and the supplier complies with the narrower conditions in s 5(4) (see s 5(1), (3)).
The instrument defines key terms used for reporting obligations. It imports several definitions from the Act (s 4 note), and defines adverse event and defect for the purpose of the instrument. An adverse event is defined as an event occurring in relation to a person in Australia following use of a medical device that led, or might have led, to death, serious injury or serious deterioration in health; the instrument expressly notes that an adverse event may not necessarily be causally related to the device (s 4). A defect is defined expansively to capture any malfunction, deterioration, or inadequacy in design, production, labelling, instructions for use or advertising materials that might lead to death or serious harm (s 4).
Schedule 1 lists the specific kinds of devices, their permitted purpose, and the health practitioner(s) authorised to supply them. The list is highly granular: many entries identify named systems, commercial brands, and in some cases catalogue or part numbers. The majority of listed items are orthopaedic implants or components for revision arthroplasty and are authorised to be supplied by orthopaedic surgeons; other items include dental dressings, bone graft substitutes, a device for in vitro fertilisation, a catheter lock solution for nephrology use, and others (Schedule 1; see e.g. items 1, 4, 7-11, 15-16, 19-37 in the table).