Update on the regulatory framework for the re-manufacture of single use medical devices for reuse
November 2005
Since the introduction of the regulatory framework in December 2003, health care facilities have been systematically reviewing the single use devices to either replace them with reusable devices or implement a single use only policy.
Although significant progress has been made, some jurisdictions raised concern that the transition to a single use only policy could not be completed by the 1 December 2005 deadline.
The majority of health care professionals, particularly clinical nurses, infection control practitioners and central sterilising supply personnel have welcomed the regulatory controls on re-manufacturing and see this as a positive step to enhancing the quality of health care in Australia. However there has been some concern about how the regulatory framework has been interpreted and applied in some hospitals.
In October 2005 Queensland Health requested the National Coordinating Committee on Therapeutic Goods (NCCTG) to extend the 2 year transition period to enable jurisdictions to complete the process.
After due consideration of the issues the NCCTG resolution was as follows:
- The transition timeframe be extended to:
- 1 March 2006 for health care facilities to cease re-manufacturing critical devices (devices that come in contact with sterile sites) devices labelled as single use;
- 1 December 2006 to cease re-manufacturing semi critical (devices that come in contact with mucous membrane and broken skin) and non critical (either do not come in contact with the human body or only contact intact skins;
- 1 March 2006 for manufacturers to submit their applications to the TGA to re-manufacture for critical devices and 1 December 2006 for semi and non-critical devices; and
- The TGA establish a workgroup, consisting of representatives from the jurisdictions to:
- consider the scope of devices covered under this regulatory framework;
- provide training on the regulatory requirements; and
- consider the circumstances under which reprocessing would be regulated as manufacturing.
The risks associated with reusing single use medical devices extend beyond infection control to also include risks associated with material degradation, biocompatibility, and device malfunction or device failure. These issues will be explored by the working group.