Jump to top navigation | Jump to main navigation | Jump to content
Therapeutic Goods Administration logo

Guidance regarding the re-manufacture of single use medical devices for reuse

Fact sheet no. 36

October 2006

The regulatory framework

The regulatory framework for the re-manufacture of medical devices labelled as single use (SUDs) applies to those persons who, in the process of re-manufacturing a SUD, also meet the definition of a manufacturer under section 41 BG Therapeutic Goods Act 1989 (the Act).

Section 41BG defines a manufacturer of a medical device as:

  1. The person responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name; or
  2. The person who, with a view to supplying the device under their name does one or more of the following to a ready made device:
    • Assembles the device,
    • Packages the device,
    • Processes the device,
    • Fully refurbishes the device,
    • Labels the device, or
    • Assigns the device its purpose

When an SUD is re-manufactured for reuse it undergoes these steps of manufacture and the intended purpose of the device is changed from single use to reusable.

Commencement of regulation

The regulatory framework for the re-manufacture of SUDs was introduced on 1 December 2003 with a two-year transition period.

This means that, by 1 December 2005 facilities planning to continue re-manufacturing SUDs need to have:

  • Undergone Conformity Assessment by the Therapeutic Goods Administration (TGA);
  • Obtained a TGA Conformity Assessment Certificate; and
  • Included the remanufactured SUDs on the Australian Register of Therapeutic Goods (ARTG).

Conformity assessment may include, among other things:

  • Review of documentation and onsite audit of the re-manufacturers quality management system to ISO 13485:2003 - Medical devices quality management systems - requirements for regulatory purposes;
  • Assessment of the design dossier/ technical file; and
  • Assessment of compliance to the essential principles for safety and performance.

Individuals who re-manufacture SUDs for their own use

Individuals who re-manufacture SUDs (eg single use enteral feeding tubes, urinary catheters,) for their own personal use and are not intending to supply the re-manufactured devices under their own name are not manufacturers under the Act and are not captured under the regulatory framework for the re-manufacture of SUDs.

Health care professionals who give advice on reusing SUDs

Healthcare professionals who give advice to their patients about the reuse of the SUDs are not manufacturers under the Act. They are not undertaking any work on the device or supplying the device, but are providing advice on how the device may be cleaned for reuse.

The healthcare professional providing this advice may be professionally liable for any harm visited on the patient as a result of the advice given with respect to cleaning and reuse etc. In a negligence case the nurse may be required to provide the evidence on which his/her recommendations for cleaning were based.

This situation applied long before the implementation of regulation for the re-manufacture of SUDs.

Devices labelled as "single patient use"

"Single patient use" means - "more than one episode of use of a medical device on one patient only, the device may undergo some form of reprocessing between each use."

Unless the manufacturer specifies otherwise, "single patient use" devices are able to be reprocessed and reused on the same patient in accordance with the manufacturer's instructions. The intended purpose of the device has not changed, and the reprocessing for reuse is consistent with the manufacturer's instructions/intent.

However if the single patient use device is re-manufactured and put into general supply for use by other people, the person undertaking the re-manufacture would be captured as a manufacturer under the Act.

Devices such as pill cups, asthma spacers, nebulisers

Pill cups

Pill cups used in the process of dispensing medicines such as pills, tablets or capsules do not meet the definition of a medical device under the Act and are outside the regulatory controls of the TGA.

Asthma spacers and nebulisers

Asthma spacers and nebulisers labelled as single use are only intended to be used once and those labelled as single patient use are only intended to be used for one patient. A person who reprocesses these devices and supplies the device for reuse on other persons would be captured as a manufacturer of a medical device and would need to comply with all the regulatory requirements under the Act.

In this situation the options available are:

  • Use only once or for one patient consistent with the intended purpose on the label
  • Use nebulisers and asthma spacers that are labelled "reusable" and follow the manufacturer's instructions for reprocessing.

Disclaimer

This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.

Further information

The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:

Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email:
Website: http://www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606

© Commonwealth of Australia 2006

Top of page