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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.

Official Sources​

Healthcare facilities that reprocess single-use devices without explicit manufacturer validation may face significant liability if adverse events occur. Additionally, staff involved in reprocessing may be personally liable. Many healthcare facilities now require documented risk assessments and governance approval before proceeding with reprocessing. Consultation with the TGA and legal advisers is strongly recommended before establishing reprocessing programs.