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Definitions relating to the regulation of the re-manufacture of single use medical devices

Fact sheet no. 44

October 2006

Definitions

Critical medical device:

Is a device that enters, or is capable of entering sterile tissue, a body cavity or the bloodstream.

Adopted from: AS/NZS 4187:2003 Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments and the National Infection Control Guidelines January 2004

Intended purpose:

Is the purpose for which the device is intended to be used as stated by the manufacturer in information provided with the device.

Reference - Dictionary in the Therapeutic Goods (Medical Devices) Regulations 2002

Manufacturer of a medical device:

  1. Is the person responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations. OR
  2. the person who, with a view to supplying the device under the person's name, does one or more of the following using ready made products:
    1. assembles the device;
    2. packages the device;
    3. processes the device;
    4. fully refurbishes the device;
    5. labels the device;
    6. assigns to the device its purpose by means of information supplied, by the person, on or in:
      • the labelling on the device;
      • the instructions for use;
      • any advertising material
  3. However, a person is not the manufacturer of a medical device if:
    1. the person assembles or adapts the device for an individual patient; and
    2. the device has already been supplied by another person; and
    3. the assembly or adaptation does not change the purpose intended for the device by means of information supplied, on or in:
      • the labelling on the device;
      • the instructions for using the device;
      • any advertising material relating to the device

Reference: s41BG Therapeutic Goods Act 1989

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Medical device:

  1. A medical device is:
    1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
      • diagnosis, prevention, monitoring, treatment or alleviation of disease;
      • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
      • investigation, replacement or modification of the anatomy or of a physiological process;
      • control of conception;
      and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
    2. an accessory to such an instrument, apparatus, appliance, material or other article.

Reference: Section 41BD of the Therapeutic Goods Act 1989

Non-critical device:

A non-critical device is one that only comes in contact with intact skin or does not come in contact with the human body. The devices should be cleaned and disinfected if necessary

Adopted from: AS/NZS 4187:2003 Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments and the National Infection Control Guidelines January 2004

Open-but- unused:

Is the term used to refer to a SUD where the packaging has been damaged or opened but the device not used and/or did not come in contact with blood, tissue or body fluids.

Refurbishment:

Is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device.

Refurbishment of a medical device may involve the following actions:

  • stripping the device into component parts or sub assemblies;
  • checking parts of the device for suitability for reuse;
  • replacing component parts or sub assemblies of the device that are not suitable for reuse;
  • assembling reclaimed or replacement component parts or sub assemblies of the device or another used device;
  • testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications;
  • identifying an assembled device as a refurbished device.

Reference: Regulation 1.5- Therapeutic Goods (Medical Devices) Regulations 2002

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Re-manufacture:

Refers to one or more of the following activities carried out on SUDs to supply for reuse:

  • Assembly the device; or
  • Packaging the device; or
  • Processing the device; or
  • Fully refurbishing the device; or
  • Labelling the device; or
  • Assigning the device a new intended purpose by means of information supplied by on or in the labelling; the instructions for use or advertising material;

In the process, the person responsible for undertaking these activities on a SUD has:

  • Changed the intended purpose of the device;
  • Certified the device is suitable for reuse; and
  • Assumed the legal liability for the quality, safety and performance of the device.

Reuse:

Reuse means the repeated use or multiple use of any medical device which has undergone some form of reprocessing (cleaning, disinfection or sterilisation) between each episode of use.

Reusable device:

A device designed or intended by the manufacturer as suitable for reprocessing and reuse. It is not a device that is designed or intended by the manufacturer for single use only.

Reference AS 4817:2003 Cleaning, disinfecting and sterilising reusable medical devices and surgical instruments and equipment, and maintenance of associated environments in health care facilities

Semi-critical device:

A semi-critical device is one that comes into contact with intact mucous membranes or broken skin. The device should be sterilised where possible, or high-level disinfected.

Adopted from: AS/NZS 4187:2003 Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments and the National Infection Control Guidelines January 2004

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Single Use:

Single - use means the medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient.

Some single-use devices are marketed as non-sterile which require processing to make them sterile and ready for use. The manufacturer of the device will include appropriate processing instructions to make it ready for use.

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 in accordance with the manufacturers instructions for reuse on the same patient

Supply:

Supply includes:

  1. supply by way of sale, exchange, gift, lease, loan, hire or hire purchase; and
  2. supply, whether free of charge or otherwise, by way of sample or advertisement; and
  3. supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons or animals; and
  4. supply by way of administration to, or application in the treatment of, a person or animal.

Reference Section3 (1) of the Therapeutic Goods Act 1989

Symbol symbol meaning DO NOT REUSE:

The international recognised symbol described in ISO 15223:2007: - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied and means DO NOT REUSE. The synonyms for this symbol are "single use" or "use only once."

Used:

For medical devices that are supplied sterile:

  • the device has been placed into a wound or body cavity and comes into contact with blood or body fluids; or
  • has been opened but cannot be reprocessed because the manufacturer did not provide instructions on how to reprocess the device if the package is opened or damaged.

For medical devices that are supplied non-sterile:

  • the device has been applied for its intended purpose.

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

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