Note: This meeting extract has been prepared from the ratified record of the NCCTG IVD Working Group meeting held 17 April 2002.

Preamble

The goals of this meeting were to review the regulatory options for IVDs, progress the decision regarding the most appropriate classification system for IVDs, to discuss issues pertaining to the development/ validation of in-house tests, and to explore the role of quality assurance programs in testing, and the need for additional mandatory programs.

Meeting discussions

The TGA survey on small volume tests was finalised by the Working Group and it was agreed that it would be issued to the selected laboratories by the end of April.

Following discussion by the Working Group, a list of criteria against which the success of the proposal could be measured was finalised.

The Working Group reviewed a series of papers providing information about the classification systems in use by other regulatory authorities, and then agreed to a set of principles against which classification system options could be measured. It was agreed that it is possible to have a rules-based system where the rules are not flexible but the system is still flexible enough to accommodate new technology.

Representatives from the different pathology groups in the Working Group to provide their perspective on the development, validation and rationale for use of in-house tests in their respective environments. This was followed by discussion on the recently established NPAAC sub-committee on in-house tests.

The RCPA and NRL representatives reported on their quality assurance programs, and it was was clarified that the NRL quality assurance (QA) program includes all quality assurance methods, including pre-market evaluation (to assess performance), quality assessment (ongoing performance monitoring where standard sera are sent out to participating laboratories and the whole testing process is assessed from beginning to end), and monitoring of quality control results. There was general discussion as to whether the mandatory national QA program for HIV tests should be "extended" to other tests.

Key outcomes

Outcomes of the meeting included:

• finalisation of a list of criteria against which the success of the final proposal could be measured;
• agreement to proceed with developing a new, internationally harmonised system of regulation for IVDs;
• identification that a rules-based (with exceptions) classification system is the most suitable for Australia, and establishment of a classification sub-committee to determine what models can be used in developing a valid set of rules for IVDs;
• agreement on a definition for the term "in-house test", and the need to assess whether special regulatory controls are needed for high-risk in-house tests.

Next meeting

It was agreed that the next meeting would be in the form of a 2-day workshop, to be held 3-4 July 2002.

Rita Maclachlan
Chair
5 August 2002