A critical assessment of the impact of the European Union Tissues and Cells Directive (2004) on laboratory practices in assisted conception.

The European Union's Tissues and Cells Directive (2004) establishes an extensive framework of standards for all tissue banks throughout the EU. This article considers how the requirements of the Directive might be expected to achieve the stated goals of promoting the safety of assisted conception treatments and/or facilitating the achievement of higher success rates. While there will certainly be some significant costs to implementing these systems, there are substantial benefits and returns, for example, quality improvement and risk minimization. However, there are grave problems with the feasibility, effectiveness, and probable adverse impacts of applying arbitrary clean room air quality standards to assisted conception facilities, especially IVF laboratories. This is likely to have negligible impact on the already low risks of both culture contamination and operator infection, but would severely compromise the ability to maintain gametes and embryos under optimum environmental conditions. Proper consideration must therefore be given to the particular circumstances that affect reproductive tissues (indeed, the same is true for all areas of tissue banking), to ensure that the final technical regulations are founded upon realistic expectations based on objective evidence from process-based systems. The creation of the highest quality embryos, and healthy children, must always remain the primary focus of assisted conception treatment.