Harmonising quality to the lowest clinical diagnostic standard? The case against regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories

A revised framework for the regulation of in vitro diagnostic devices (IVDs) will come into force on July 1, 2010 that aims to 'ensure that public and personal health are adequately protected', but which instead may lead to adverse outcomes in clinical diagnosis and management. The regulatory process aims to regulate all IVDs, including those used by clinical diagnostic laboratories, which are already subject to scrutiny as part of the current laboratory accreditation process. The intended aim of the IVDs regulatory process also appears to imply that the current procedure for regulation of clinical laboratories and their use of current IVDs is somehow inadequate and is placing the public at risk, although the evidence clearly indicates the opposing view, showing ongoing improvements over time in clinical diagnostic practice, driven by current accreditation requirements. In contrast, existing evidence related to regulation of IVDs in the USA, for example, highlights several failings in this process that leads to ongoing use of inappropriate test panels or methodologies in clinical diagnostics. This is largely due to direct and indirect costs associated with, and the efort needed to fulfl, regulatory requirements. The end result is that manufacturers of IVDs will conform to existing regulatory standards ahead of clinical best practice standards, and that future improvements to clinical best practice standards may not be translated into clinical practice because the regulatory burden may act as an impediment to manufacturers to undertake any future improvements in existing IVDs. It is therefore difcult to identify how the new framework will achieve its goal of 'ensuring public and personal health' with respect to the regulation of IVDs used in clinical diagnostic laboratories, since 'public and personal health' is best served by the timely introduction of appropriate diagnostics. Thus, the alternative outcome, that public and personal health will sufer following its implementation is the clear danger.