Single-Use Devices
Overview
A single-use medical device is one that is intended by the manufacturer to be used once, on a single patient, and then discarded. In Australia, the labelling of a device as single-use carries both a regulatory meaning (the manufacturer has not validated reuse) and a legal implication for anyone who reprocesses and reuses such a device.
Single-Use Labelling Requirements
Manufacturers of single-use devices must label them clearly as single-use using the internationally recognised ISO 15223 symbol (a "2" with a diagonal line through it) or equivalent textual instruction. The IFU must make the single-use nature of the device clear.
Reprocessing of Single-Use Devices
The reprocessing (cleaning, disinfection, sterilisation, and reuse) of devices labelled as single-use is a significant regulatory and safety issue. In Australia:
- A manufacturer who reprocesses and re-supplies a single-use device becomes the manufacturer of that reprocessed device for regulatory purposes — with all associated obligations, including compliance with the Essential Principles, conformity assessment, and ARTG inclusion
- Healthcare facilities that reprocess single-use devices for use within their own facility occupy a different position, but significant safety risks and governance obligations apply
- The TGA has published guidance on the position of healthcare facilities that reprocess single-use devices
The original manufacturer's ARTG inclusion does not cover the reprocessed device. A reprocessed single-use device supplied for use on patients requires its own ARTG inclusion unless it falls within a specific exemption.