The regulatory framework that applies to re-manufacturing SUDs is the therapeutic goods legislation - the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

When a SUD is re-manufactured for reuse the intended purpose and design specifications for the device are altered from single use to reusable, the device is refurbished and undergoes a number of steps of manufacture. The person responsible for undertaking these activities is considered to be a manufacturer and needs to comply with the therapeutic goods legislation relating to the manufacture of medical devices.

There may be several reasons why a medical device is labelled as single use or single patient use. For example:

• The materials used in the manufacture of the device may not withstand repeated reprocessing;
• The design of the device may not facilitate adequate cleaning and sterilisation; or
• The device may fail to perform as intended by the original manufacturer if it is reused.

The regulation of the re-manufacture of SUDs does not include those SUDs that are opened but unused.

"Opened-but-unused" is the term used to refer to a SUD whose packaging has been opened but the device was not used and/or did not come in contact with blood, tissue or bodily fluids.

The status of a device that has been "opened but unused" is addressed by the original manufacturer as part of the labelling requirements and is considered by the TGA during the pre-market assessment of new medical devices supplied to the Australian market Since October 2002. Medical devices supplied in Australia before October 2002 have until October 2007 to comply with these labelling requirements.

Medical practitioners, dentists and other health care workers registered under a State or Territory are exempt from manufacturing controls if they:

• assemble or adapt a medical device for an individual patient,
• the device has already been supplied by another person, and
• the assembly or adaptation does not change the purpose intended by the manufacturer of the device.

Now that the re-manufacture of SUDs is regulated, health care professionals and health care facilities wishing to reuse SUDs may either:

• become a manufacturer,
• find a manufacturer to undertake the re-manufacture of the SUDs, or
• adopt a single use only policy.

Before making a decision to become a manufacturer you need to identify the devices you wish to re-manufacture. It may also be worthwhile to undertake an analysis of the costs involved with re-processing as apposed to opting for a single use policy.

If you decide to become a re-manufacturer, it would be helpful to familiarise yourself with the legislative requirements. Copies of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 can be located through the TGA website on the Legislation page <http://www.tga.gov.au/legis/index.htm>.

The TGA has also published a number of guidance documents and fact sheets on the TGA website on the Medical Devices page. The most relevant documents are:

• Overview of the new medical devices regulatory system
  <http://www.tga.gov.au/docs/html/devguid1.htm>
• Conformity assessment procedures
  <http://www.tga.gov.au/docs/html/devguid3.htm>
• The declaration of conformity
  <http://www.tga.gov.au/docs/html/devguid5.htm>
• Obligations and responsibilities of medical device sponsors and manufacturers
  <http://www.tga.gov.au/docs/html/devguid20.htm>
• Essential principles for medical devices
  <http://www.tga.gov.au/docs/html/devguid22.htm>
• Re-manufacturing single use medical devices
  <http://www.tga.gov.au/devices/fs-sudman.htm>

Before you request the TGA to undertake an initial audit of your re-manufacturing facility, you will need to have implemented and hold documentation on:

• the quality management system you have in place for re-manufacturing the device/s. The Standard for manufacturer's of medical devices is ISO 13485:2003,
• the re-manufacturing process that will ensure at a minimum:
  • the materials used to make the original device will not be affected,
  • the cleaning, disinfection and sterilisation processes are effective,
  • endotoxins do not exceed the allowable limit for medical devices,
  • the device with continue to perform as originally intended
• how the re-manufactured device meets the Essential Principles for safety and performance;
• the design dossier/technical file for the re-manufactured device; and
• the system you have in place for:
  • tracking the number of times the device is re-manufactured and reused, and
  • tracing the device to the batch/serial number of the original device.