[Important points concerning quality control of blood products under the product liability law]

Two years have passed since the product liability(PL) law took effect in our country on July 1, 1995. At the start, we were uneasy about such things as an increase in lawsuits, the rise of medical care costs and the concealment of medical information. However, no-one has brought an action concerning blood products so far under the PL law. In terms of quality control of blood products, regular inspection of various instruments, reagents and manuals is the fundamental rule. Moreover, in order to ensure blood products of good quality, it is very important to select blood donors on the basis of physical examination and questionnaires on their medical condition, not to mention a range of screening tests to detect viral and bacterial infection. Since the first HIV infection through blood derived from an HIV-seronegative donor was reported in our country, it is especially desirable to improve measures for detecting HIV in window period blood for HIV antibody. There is also a problem concerning the irradiation of blood products to prevent PT-GVHD. We expect the PL law to provide a higher degree of safety of blood transfusion; however, it is also necessary to make proper use of blood products and to take the right measures in the event of adverse transfusion reaction, so as to raise the safety of blood transfusion.