This invention relates to a medical device, and more particularly, to a highly safe medical device. More illustratively, this invention is directed to a highly safe blood bag system having an excellent blood- or blood component-storability.
Soft bags fabricated from polyvinyl chloride are recently used to store blood for transfusion instead of rigid glass containers mainly in view of the reduced damage of erythrocytes during the storage. Use of such polyvinyl chloride soft bags has increased also for their superior workability, flexibility, transparency, resistance to vapor permeation, heat resistance, and the like. Conventional polyvinyl chloride resins which has been used for fabricating such blood storage bags contain from about 30 to 60 parts by weight of a phthalate for plasticizing purpose. Such phthalate elutes into blood during the blood storage, and it has been found out that the phthalate in blood protects membrane of various cells of the blood, in particular, erythrocytes. Despite such positive effects, the phthalate eluted into the blood may induce safety problems upon its introduction into the body by blood transfusion.