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Update on the regulation of the re-manufacture of single use medical devices

Time frame for semi-critical1 and non-critical2 devices extended to 1 July 2007

October 2006

Since December 2003, health care facilities have been systematically working toward meeting the December 2005 deadline to cease re-manufacture of single use medical devices for reuse.

In October 2005, jurisdictions raised concern that due to the need to clarify a number of issues relating to the interpretation of the regulatory framework, the December 2005 timeframe was not achievable for those medical devices classified as semi and non-critical devices.

Consequently, a working group was established under the auspice of the National Coordinating Committee on Therapeutic Goods (NCCTG) consisting of representation from the jurisdictions, private hospitals and medical practitioners to:

  • Clarify the definitions, terminology and scope of devices covered under this regulatory framework;
  • Clarify the re-manufacturing requirements for specific medical devices;
  • Consider the circumstances under which reprocessing would be regulated as manufacturing;
  • Make recommendations to the NCCTG on information and guidance to assist the states and territories to develop and implement jurisdictional policies to align with the national regulatory framework for the re-manufacture of single use devices for reuse; and
  • Make recommendations to the NCCTG on realistic timeframes for implementation of policies for semi-critical and non-critical single use devices.

As an outcome of the NCCTG working group, the NCCTG has agreed to extend the transition timeframe to 1 July 2007 for hospitals to cease re-manufacturing Semi-critical and Non-critical single use devices for reuse.

Further clarification on a number of issues relating to the interpretation of the regulatory framework as discussed by the working group will be made available in the coming weeks.

1 Semi critical devices are those devices that come in contact with mucous membranes or non-intact skin

2 Non-critical devices are those devices that only come in contact with intact skin or do not come in contact with the human body

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