Quality and safety assessment for the plasma master file (PMF) certification with regard to donor deferral criteria for sexual risk behaviour - Scientific guideline
HumanScientific guidelines
Directive 2004/33/EC foresees that appropriate periods of deferral including permanent deferral should be considered in the case of behaviour that implies a high risk.
In practice, it is the relevant national competent authorities for the safety and quality of blood and blood components that determine the appropriate periods of deferral on the basis of local factors, such as epidemiological risks. Such factors, and the periods of deferral can therefore vary between Member States. Nevertheless, in recent years national competent authorities in several Member States have concluded that shorter periods of deferral are appropriate and proportionate to ensure safety and quality of donation by donors with certain (sexual) risk behaviours, notably men having sex with men (MSM).
The newly published 'Position statement on quality and safety assessment for the Plasma Master File (PMF) certification with regard to donor deferral criteria for sexual risk behaviour' clarifies that the application of these nationally defined deferral periods will from now on also be considered when assessing appropriateness of locally collected plasma to be included in a plasma master file.
Keywords: Donor deferral criteria, sexual risk behaviour, plasma, plasma supply