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BACKGROUND: In spite of the fact that autologous blood is safest for a patient to receive, it is not generally appreciated that adverse reactions during donation and transfusion may occur. This study was conducted to assess the state and the risk of autologous blood transfusion in Japan in 1997. STUDY DESIGN AND METHODS: Results of a nation-wide questionnaire-based survey are presented. The questionnaire assessed the number of autologous blood donations, donation procedures, and the adverse reactions associated with donation, preservation, recombination erythropoietin administration and transfusion. RESULTS: Between November 1996 and October 1997, 10,697,000 ml (or 53,485 units, 200 ml = 1 unit) prestorage blood donation were made by 14,200 patients (averages; 1.9 donations/patient, 753 ml/patient, 398 ml/donation). Of these, 87% were transfused to the patients and the remainder were discarded. Using hemodilution and blood salvage intra- or postoperatively some 2,540,000 ml of blood was collected and > 70% of patient-donors received such blood. Adverse reactions were observed with 1.6% (428/26,905) of donations including 6 angina and 2 asthma attacks. There were 63 (0.2%) problems with 28,705 donations and 117 (0.5%) errors/problems reported for 24,929 units transfused; the most frequent problems were clotting on the units and breakage of the bags during storage. Hypotension using hemodilution (3.7%), coagulation (0.9%) or bacterial contamination (0.4%) using salvage were often observed. A 10-20 ml volume of autologous fresh-frozen plasma was transfused to the wrong recipient. CONCLUSION: Autologous blood transfusion accounts for at least 1.1% (2.8% estimated) of the red cell supply in Japan. Errors and adverse reactions are not infrequent in autologous blood programmes. By introducing systematic safety policies, we will be able to make autologous blood transfusion safer.