Abstract
During the 1950s, 25% of recipients of four or more whole blood transfusions in New York City, USA, developed jaundice, and this was accepted as a ‘fact of life’. At that time, the only transfusion transmitted infectious diseases (TTID) of importance were syphilis and ‘serum hepatitis’, later recognized as hepatitis B. Syphilis screening was introduced in the 1940s and the first assays for hepatitis B surface antigen in the early 1970s. In the early 1980s, the tragedy of AIDS brought serious consequences for blood recipients but also brought attention and resources to the prevention of TTID, resulting in the introduction of additional screening tests in the U.S. and in several other countries [1]. As new screening tests, donor screening procedures and quality systems were developed, they were cumulatively added to the list of donor eligibility and blood processing requirements. Obsolete procedures were removed only under exceptional circumstances. Gradually, multiple layers of safety became part of regulatory requirements including in addition to testing and quality systems, more extensive donor history questionnaires in which donors are asked about potential exposure to transmissible agents (e.g. history of risk behaviours, travel); deferral files listing donors who were deferred because of travel, risk behaviour or reactive screening tests results; quarantine of untested and unsuitable components, kept separately to avoid inappropriate release for transfusion. It should be noted that donor history questions [2] and deferral files [3] have lower sensitivity and poorer predictive value than donor screening tests. In addition, requirements for donor notification and counselling after positive test results were instituted under the presumption that knowledge about their positive results would discourage positive donors from returning to donate. Also, the movement towards volunteer, non-remunerated donations as opposed to replacement donations (made by donors referred by a patient to ensure admission to a hospital) or paid donations was intensified.
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