Regulation of the re-manufacture of single use medical devices (SUDs)

May 2004

The regulation of the re-manufacture of SUDs was implemented in December 2003 with a two-year transition period. This means that any facility wishing to re-manufacture medical devices labelled as "single use" or "single patient use" will need to comply with the regulatory requirements for a manufacturer of medical devices as described in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.

The potential risks of cross infection / contamination associated with using inadequately cleaned and sterilised medical devices is well known, however additional risks associated with re-manufacturing SUDs such as device failure, material degradation, biocompatibility and endotoxic reactions caused by the residues from reprocessing are less known but do raise significant concern.

The issue on how best to address the complex issues surrounding the re-manufacture and reuse of SUDs has been the subject of much discussion over the last 10 years.

In 2001 the Australian Health Ministers Advisory Council (AHMAC) agreed that the practice of re-manufacturing SUDs should either cease or be regulated by the TGA to the equivalent standard as the original manufacturer.

In 2002 National Coordinating Committee on Therapeutic Goods (NCCTG) accepted a proposal for the regulatory framework for the re-manufacture of SUDs (based on the 2002 Therapeutic Goods (Medical Devices) legislation). This was followed by an extensive consultation with stakeholders.

In October 2002 the therapeutic goods (medical devices) legislation was implemented, and the regulation of the re-manufacture of SUDs, under this legislation commenced in December 2003.