Historical views of bloodletting and transfusion from the beginning to the present status in Japan
2009; Wiley; Volume: 4; Issue: n2 Linguagem: Inglês
10.1111/j.1751-2824.2009.01256.x
ISSN1751-2824
Autores Tópico(s)Traditional Chinese Medicine Studies
ResumoBloodletting appeared early in all parts of the world as one of the first medical modalities. It was depicted in Greek medicine in the 5th century B.C. and appeared as early in China and then in Korea and Japan as acupuncture with bleeding. The ancient therapy of bloodletting that was universal in the West traveled to Japan 500 years ago on the trading vessels that carried physicians and barber-surgeons to care for the body and Christian missionaries to care for the soul. Then bloodletting was replaced by blood transfusion in the 19th century, only to return less than 50 years ago as apheresis. An understanding of those transitions in medicine affords an understanding of the exchanges that occur between world cultures. In Japan the transition continues and has led to advanced practice of blood transfusion and apheresis today. The first recorded bloodletting in Japan was performed on Emperor Ingyo in the 5th Century A.D. The third year of his reign, a physician came to the imperial court from Korea and cured the Emperor. This is the first record of a foreign physician in Japan. Ancient Japanese Medicine was strongly influenced by Chinese medicine coming via Korea. Therapeutic bloodletting may have begun in China as far back as the Stone Age. Stone knives and other sharp-edged tools were used to relieve pain and to treat disease. The ancients knew them as bian stones. In the book, Analytical Dictionary of Characters, Shuo Wen Jie Zi, Xu Shen wrote during the Han dynasty (206 B.C. to 220 A.D.) that bian meant, ‘using stones to treat diseases’. The earliest extant medical treatise in China, the Canon of Medicine, Nei Jing, was compiled between 475 B.C. and 221 B.C. and contains even earlier information. It reads that in ancient China, acupuncture had already consisted of two methods: acupuncture with bleeding and acupuncture without bleeding. Over half of the methods in Nei Jing are acupuncture with bleeding. The book describes regional differences in therapeutic modalities in ancient China: ‘the East was practicing bloodletting using stones, the West was mostly using decoctions, the North using moxibustion and the South needles of as many as nine types’. However, acupuncture with bleeding declined in China, and was used in only a few cases. In the Tang dynasty (618–907), the systems were based on Buddhism and Taoism. In these feudal systems, the basic ethical commitment of ‘filial piety’ is to ‘do not harm to our body, hair, skin, etc, because these are from our parents’. Also, during the late Ming dynasty (1368–1644), because of the development of acupuncture without bleeding and moxibustion techniques, acupuncture with bleeding was again at an ebb. Dr. Maruyama has added the following thought: ‘Acupuncture points in Nei Jing show not only surface veins but also some big arteries. So, if some doctor who is poorly knowledgeable in medicine performed this treatment, a lot of bleeding will occur in patients, causing a life-threatening situation. After the publishing of Nei Jing, many doctors tried acupuncture with bleeding and a lot of dangerous situations occurred. Following this, acupuncture with bleeding quickly reached the lowest ebb’. In 1543, Europeans first visited Japan. Before long, the Japanese had only limited trade with neighbors in the region. Portuguese trade with Japan began, and the daimyos of the Kyushu region were vying with each other to lure the Europeans to their ports. In 1549, Francisco de Xavier of the Society of Jesus, came and started missionary work. The daimyo of Kyushu tolerated the foreign religion. The first true Western physician was the Portuguese, Luiz de Almeida. He opened a Western hospital in Kyusyu in 1557. In all European countries at that time, bloodletting was the most important surgical procedure. The Spanish arrived in 1592 and the Dutch in 1600. Christianity did not fit in with the Japanese system based on Buddhism, and the Christians had many troubles with the Japanese leaders. Westerners were excluded by Ieyasu Tokugawa, the first Shogun of Edo period who assumed control of the country in 1603 even though at first he was tolerant of Christianity. But he decided to exterminate the Christians. Even though foreign trade was still encouraged, in 1624 the Spanish and in 1639 the Portuguese were excluded from Japan. By 1641, Japan had adopted a rigid policy of national seclusion and suppression of Christianity. Thereafter, for 214 years, the Tokugawa authorities excluded foreigners, except the Dutch and the Chinese who could still only trade through the ‘Dejima’ island in Nagasaki harbor. Even though Western Medicine had been introduced and performed by the Portuguese as a means of missionary work, Western medications and especially surgery continued to be used in Osaka, Sakai and Nagasaki, despite the exclusion of foreigners by the national isolation policy. Dosan Manase (1507–1594) was a student of the Sanki school. Sanki Tashiro visited China as a monk and studied the medicine of Li and Zhu for 12 years. At this time, Chinese knowledge, including medicine, was brought through monks to Japan. There were some monks who were excellent physicians. Sanki returned to Japan, and he lived in the Kanto area. At that time Kanto was an out-of-the-way place and his medicine did not become popular. However, his student Dosan opened a school in Kyoto after finishing the Sanki school. A lot of students studied in the Dosan school that continued until the end of the Edo period as the biggest school in Japan. Dosan wrote about acupuncture with bleeding as a treatment technique in his book Keiteki-shu. Dosan and his students used bloodletting only in limited cases. Dosan treated the Jesuit priest, Padre Melchior de Figueiredo and then he became a Christian with his 800 students, 10 years later publishing Keiteki-shu. The Dutch East India Company provided physicians, or at least barber-surgeons, for its employees at Dejima. These doctors, especially Dr. Wilhelmus ten Rhyne, Dr. Engelbert Kämpfer, Dr. Charles Peter Thunberg and Dr. Franz von Siebold, influenced Japanese Medicine. Some doctors including ten Rhyne and Kämpfer introduced Japanese acupuncture and moxibustion to Europe. However, bloodletting did not become popular in Japan. A Japanese Dutch Surgery book, Oranda-geka-ryouho, written in 1670 reported, ‘These people are essentially hot, so they undergo effective bloodletting from a basilic vein. For Japanese, moxibustion is utilized more effectively’. That was explained to the Royal Society in London as: ‘...they let no Blood. They make use of causticks, by applying some nerve or other the powder of Artemisia or Mugwort, and Cotton, which they set on fire’. In 1720, the Shogun Yoshimune Tokugawa lifted the ban on the importation of foreign books and Chinese translations (except those directly concerned with Christianity), because of interest in astronomy and the calendar. Up until that time, Japanese knowledge concerning anatomy and blood circulation was limited. In 1754, the first human anatomical study in Japan was attempted by Toyo Yamawaki at an execution. Gempaku Sugita and others translated the Tafel Anatomia in 1774. Kogyu Yoshio (1724–1800), a top official interpreter attached to the Nagasaki Commissioner’s office, was interested in Western Medicine. At first, the Japanese had studied Western medicine from Dutch doctors at the factory in Dejima by sitting back and watching. Kogyu could read Dutch medical books and after reading these books, he asked Dutch doctors questions about the methods described. He mastered the procedures of bloodletting, tumor excision, mercury medication for syphilis, etc. Over 600 people studied Western medicine from him and his name appears frequently in the early Japanese story of Western medicine. The Japanese already practiced acupuncture learned from China and they blended Western bloodletting with acupuncture in a unique treatment form called ‘Shiraku’. Tomon Yamawaki (1740–1786), son of Toyo Yamawaki, studied Dutch bloodletting from Kogyu. He also studied bloodletting from a Chinese book Shazhang Yuheng by Guo Zhisui published in 1674. Dr. Maruyama mentioned that the acupuncture points in this book are closer to Western bloodletting than bloodletting in Nei Jing. He thought that Guo Zhisui wrote this book under the influence of a Western doctor who visited China during that time. In 1723, this book was republished and became popular in Japan. Eventually Tomon performed a new Japanese style of bloodletting using Sanryoshin, a sharp-edged needle with a tip in deltoid form, the same as Fengzhen described in Nei Jing. Gengai Ogino (1737–1806), one of the students of the interpreter Kogyu, published a book called Shiraku-hen in 1771. It tells of Western bloodletting, cupping and leeching and the use of a ceramic bowl to collect blood in the manner of the barber-surgeons. Such bowls had been produced in the famous Arita porcelain for export to the West since late in the 17th century. Another manuscript with bloodletting directions and illustrations appeared in 1802 as a handwritten transcription of lectures by a physician called Yokokusai (Fig. 1). Both books depict the venous circulation occluded by a tourniquet on an arm that is supported by a stick reminiscent of the itinerant barber-surgeon’s walking stick. The popliteal space and the scalp were also sites for bleeding. Western bloodletting practice in Japan. (From Yokokusai-iben, 1802. Collection of the Naito Museum of Pharmaceutical Science and Industry, Kakamigahara, Gifu, Japan). Shiraku-hen also illustrated not only Japanese needles, but also the classic Western ‘thumb’ lancet with its tortoise-shell covers and the German spring lancet with interior spring mechanism as it appeared in Lorenz Heister’s book on surgery (Nuremberg, 1719) (Fig. 2). Gengai calls the spring lancet the ‘machine-needle’. The spring lancet was a device that could slice into a vein without exerting manual pressure and was preferred by the Dutch. For those ignorant of anatomy it could phlebotomize a prominent vein without injuring other vessels. Tomon Yamawaki calls the spring lancet the ‘box’ lancet, describing the blade as popping out of a box. Japanese illustration of Western bloodletting lancets. (Right upper) Lancet with tortoise shell covers. (Right lower) German spring-lancet. (Left) Japanese Shiraku needles. (From Shiraku-hen. Collection of author TM). Many doctors performed bloodletting in their treatments using their own new bloodletting techniques that were an eclectic style combining Western and Chinese influences. In the latter part of the 18th century, the Japanese thus developed and recognized their own bloodletting technique as a useful form of treatment, and Shiraku became popular among the masses. Kogyu was in Edo in 1769 as interpreter for the Djima’s director and physician on the annual Dutch tribute visit to the Shogun when the doctor was called to see a Japanese medical student and bled him. The recorder of the event, Genpaku Sugita, was impressed with the therapy and borrowed a book by Heister in a Dutch translation from Kogyu, and copied its illustrations. Others translated it partially into Japanese including the bloodletting part. In 1819, a Japanese book was published with the figures and legends of Heister, showing not only bloodletting but also early concepts of blood transfusion. Evidently Japanese in Edo period already knew of transfusion. A book that described blood transfusion was published in Japan in 1876. This textbook of Pathology by Henry Hartshorne, a Professor at the University of Pennsylvania, shows details of blood transfusion its history and methods. With the end of their ‘Golden Age’, the Dutch East India Company lost supremacy over the seas and it was American warships that steamed into Tokyo Bay in 1853 to open Japan to the World. Treaties were signed but the shogunate proved unable to deal with an in-rush of rapacious Western powers. In 1868, the new Meiji government was established and opened trade with the West and adopted a vigorous policy of modernization under Western influence. Medicine was accepted from the West and Chinese medicine was dismissed. Japan would have liked to introduce British medicine but in 1870 the government decided on German medicine. The use of the lancet was disappearing in Western medicine and bloodletting therapy was being replaced worldwide by its opposite, blood transfusion. The first blood transfusion in Japan may have been given by Dr. Julius Karl Scriba (1848–1905) a German doctor who taught surgery at Tokyo University, but there is no record. In 1916, Dr. Shichiro Goto, Professor of Surgery at Kyusyu University Medical School, and Dr. Hiroshige Shiota, Professor of Surgery at Tokyo University Medical School, went to Europe separately and studied transfusion practices in a field hospital during World War I. They were surprised at the power of blood transfusions, in terms of patient outcomes, and Dr. Goto bought a French Jeanbrau type transfusion instrument. In February 1919, Professor Goto performed a 300 ml blood transfusion using a syringe during surgery on a patient with thoracic empyema. For the emergency transfusion he did no testing. In June 1919, Professor Siota performed a 200 ml blood transfusion using a French Jeanbrau type transfusion instrument for an anemic patient with myoma of the uterus. He borrowed the instrument from Dr. Goto. Before transfusion, Dr. Shiota performed the Wassermann reaction and a hemolysis test between patient’s serum and donor’s red cells. Both blood transfusions were successful. Donors were patient’s relatives. In 1919, Dr. Makoto Saito, Professor of Aichi Medical College (presently Nagoya University School of Medicine) performed a blood transfusion on a patient with trauma. In 1920, Dr. Goto described his method for transfusion ‘The first 5 gram of blood should be given in 1 min and then 25 mL transfused slowly. After the 25 mL transfusion, closely monitor patient for 2–3 min. Then remaining blood can be transfused. Before transfusion, test donors by the Wassermann reaction and for malaria’. In 1927, another Japanese medical journal said that ‘Blood donors should be good health by physician examination: no tuberculosis, syphilis, anemia, hemophilia, malaria or other blood parasitic diseases and no agglutination between donor blood and patient blood’. In 1926, a Japanese Medical journal described ABO blood group and agglutination tests. However, at this time, getting standard antisera for anti-A and anti-B was very difficult. Dr. Hiroshi Iijima made standard antisera using the same tests as Landsteiner, and then compared them with an antisera brought from Vienna, on the Trans-Siberian railroad. Only one ampoule of every was usable. In 1930, transfusion had saved the life of Prime Minister Hamaguchi after an assassination attempt. At the time, the method generally used was ‘direct transfusion’, in which the donor would lie next to the patient and blood would be collected with a syringe and immediately given to the patient. Prime Minister Hamaguchi recovered after such a transfusion at Tokyo Station given by Professor Shiota from a donor who was a son of Prime Minister. Dr. Torii studied stored blood in 1922 but it was not practical until after World War II. The first blood donor service was established at Aichi Medical College (presently Nagoya University School of Medicine) on campus in 1926. Dr. Iijima established the Japan Transfusion Association donor service in Tokyo in 1931. The model was the British Red Cross Blood Transfusion Service but that was all voluntary and in Japan it was paid and there was no regulation by the government. People thought this system could make money. Many others began to compete. Dr. Iijima decided on a donation interval of 1 month between donations in a volume of 10 ml per 1 kg. However, other associations did not protect the donors even that much and blood quality decreased. In World War II, the Japanese military tried stored blood, dried blood and even animal blood on the battlefield. Because of problems with transportation, stored blood was not used. However, the Japanese military started to study and produce dried plasma and vaccines after 1939, but most was not used because of the difficulty of transportation to the battlefields. The Japanese were astonished at the dried plasma captured from the American military. Blood donors were scarce in Tokyo, because of absence of donor associations. Attempt to establish a nation-wide association for blood donations were held around the end of World War II, but did not result in any actual blood collection activities except in a few areas. The Ministry of Health and Welfares (MOHW) provided blood donation and transfusion regulations in 1945 and 1947, but those were invalidated by enactment of the New Constitution in 1948, and there was no blood on the hospital shelves in Japan. World War II ended in 1945. In the confusion after the war, commercial systems to collect and deliver paid blood donors to hospitals (donor dealings) continued to be without regulation. Persons concerned about blood donors asked about syphilis, malaria infections and general health. Serological tests for syphilis (STS) and cross-matching should have been done, although it can be assumed that proper history taking and testing could have been ignored. In 1948, two patients with uterine myoma developed syphilis due to transfusion of fresh blood collected at hospitals from paid donors, who were registered to donor dealings. The Supreme Court found the hospital guilty of failing to ask the donors about syphilis. Following this incident, the General Headquarters of the Allied Powers (GHQ) directed the Japanese government to establish stored blood supply system. While the preparation by the government was underway, another blood bank was established within the Central Hospital of the Japanese Red Cross Society (JRC) with the American Red Cross (ARC) support. When the Korean War started in 1950, the U.N. Blood Bank was established at the 405th U.N. Medical General Laboratory in Tokyo with JRC support to collect blood from voluntary donors. The first shipment of blood from Japan (69 bottles) was sent to the 805th Evacuation Hospital in Pusan, Korea, on the night of 7 July 1950. Probably blood from paid donors also was sent to Korea during the war. In 1951, the first commercial blood bank was opened to collect blood from paid donor to provide stored blood, as well as to collect source plasma and to make frozen-dried pooled plasma. The bank exported the dried plasma abroad, including the U.S., where polio was prevalent among children at that time, and made anti-sera to A and B antigens. The next year, JRC started to collect blood from voluntary non-remunerated donors. Many commercial blood banks were established thereafter, mainly in metropolitan areas and local large cities (37 facilities around 1958 by report) and continued to thrive in the background of economical poverty in society at that time; the 1954 drug price scheme, which covered stored blood, is assumed to be one of the reasons of commercial blood bank prosperity. Although direct and/or paid donors were common in hospitals, surpluses of donated blood were preserved for other patients. In June 1952, MOHW published the ‘Standards for Physicians and Dentists regarding Blood Transfusion’, and in 1956, the ‘Control Law on Blood Collection and Dealing Blood Donation’, with punitive policies, in blood banks. However, in the 1960s, prospering commercial blood banks not only caused many paid donors to develop severe anemia, but also caused many recipients to develop post-transfusion hepatitis (PTH). It was reported in the late of 1950s that satisfactory donors among applicants presenting for paid donation were only approximately 57%, gradually decreasing to 50% in 1963. It also was reported that some paid donors were bled of more than their blood volume in a week or month, with up to 1400 ml drawn at one time. Moreover, PTH developed in recipients of 50·9% (some reported 70%), 40% of which later was found to be HBV infection. Hepatitis virus infection among the paid donors was probably spread by insufficient sterilization of blood collection apparatus and intravenous injections of iron sharing a single syringe. With paid donors getting severe anemia and many recipients developing PTH, a ‘Fear of Yellow Blood’ caused nation-wide campaigns against paid-donation. University students in Kanto (eastern) and Kansai (western) areas conducted surveys to examine the situation of paid blood donation. As a serious social problem, it was featured in newspapers almost everyday. Then in March 1964, American Ambassador to Japan, E. Reischauer was attacked by a thug, received paid blood and developed PTH. In August of the same year, the government moved to change policy from paid to voluntary non-remunerated donations. This Government Decision on the ‘Promotion of Voluntary Blood Donation’ unveiled its key policies: the voluntary donor recruitment promoted by both the government and local governments, and almost monopolistic management of blood collection performed by JRC. Based on these policies, JRC established blood centers (JRCBC) in most prefectures throughout the country; JRC changed the name of the facility from ‘Blood Bank’, the term associated with the negative image, to ‘Blood Center’. Unable to continue to sell blood, a few commercial blood banks started to develop and manufacture plasma fractionation products. In 1963, the number of blood units collected nation-wide a little less than 3 million (200 ml/unit), with more than 99% from paid donors. In 1966, the following 2 years of the ‘Government Decision’, the number of blood units collected had remarkably decreased by about 31%. The voluntary donation rate in this year was about 1%, and the rest of blood came from paid and replacement donation. To cover the shortage of blood in hospitals, directed blood was often used. Following the Government Decision, students made recommendations to local governments throughout the country to promote voluntary blood donation. Owing to these efforts by students and JRCBC, the donation rate continued to increase by 10% each year thereafter. In 1969, selling and buying blood was stopped, and all the whole blood was from JRC voluntary donors by 1974, when the donation rate reached 3·5%. The effort of JRCBC to collect blood during this period should be recognized as virtually with little financial support from the government. A main measure to collect blood was a number of blood donation vehicles, which steadily increased from 50 in 1965 to 180 for 1975. In 1985, 86% of donors used donation vehicles (359 in total). Additionally, this reform of blood policy also resulted in a dramatic decrease in the incidence of PTH, or to 16·2%. In 1972, HBV screening was introduced, which contributed to reducing the incidence of PTH to 14·3%, but not as much as expected. However, HBV infections in PTH decreased from 40 to 10%. Modern wars usually need a lot of blood and blood products, especially human serum albumin (HSA), for treatment of the wounded. When the Vietnam War came to end in 1975, the United States had an excess of unused blood products, and Japan’s, already rising economy, additionally health insurance and drug pricing systems well established, was a good market. Although MOHW organized the ‘Study Group on Blood Donation and Transfusion’ to discuss how to manage blood programs in future, and the Study Group proposed new blood policies including self-sufficiency of source plasma, MOHW allowed manufactures to import blood products and source plasma. That was regrettable considering the tragedy of AIDS due to imported blood products that then began in 1980s. Blood component therapy was promoted in the latter half of 1970s, which resulted in a large consumption of fresh frozen plasma (FFP) without an increase in source plasma. Many clinicians wanted combined use of both red cell concentrates (RCC) and FFP instead of using whole blood. FFP was also used as an alternative to HSA. A strong demand solely for FFP led to the mass disposal of RCC. The amount of HSA provided in 1975 was 40 000–50 000 l as source plasma, which was mainly collected from paid plasma donors. In 1979, several foreign manufacturers entered the market, resulting in fierce competition, and the provision of HSA rapidly increased to 3·84 million liters as source plasma, the highest ever, by 1985; this volume was said to correspond to one-third of total HSA production of the world. Then Japan’s self-sufficiency for HSA dramatically decreased to less than 5%. The situation was not different for the intravenous immunoglobulins (IVIG) and anti-hemophilic factors (AHF). As a result, about 40% (1800 patients) of hemophiliacs developed AIDS/HIV-infection following treatment with imported unheated concentrates of AHF. This incident, the ‘HIV-Tainted-Blood Scandal’, was brought to court later. It is important to note that no case of AIDS/HIV-infection other than in hemophiliacs was reported in persons living in Japan before 1985. In order to resolve these problems, MOHW established the ‘Committee on Blood Donation and Transfusion’. Based on reports submitted, MOHW introduced the methods of ‘400 ml whole-blood collection’ in addition to 200 ml and ‘plasma and/or platelet apheresis’ in 1985, as well as the ‘Guidelines for the Appropriate Use of RCC, FFP, and HSA’ in 1986. These became basic policies of MOHW for balancing supply and demand and self-sufficiency solely through domestic voluntary blood donations. Facilities for blood collection (called blood donation rooms) in accordance with the new standards were established throughout the country (37 in 1986, 97 in 1996, and 111 in 2006). In 2006, some 40% of donors visited these facilities, and 51% used blood donation vehicles (313 in total). Although a donation rate increased year by year until 1985, when it reached 7·3% (8·7 million donors), the highest ever, it has been on the decrease, particularly those in their teens and twenties, since 1986, with a donation rate of 4·1% in 2007. However, the total blood collection did not change to maintain at the level of 2–2·1 million liters. On the other hand, the amount of FFP and HSA provided decreased by 15 and 30%, respectively, in a few years after the guideline was published and leveled off for the following decade from 1987 to 1997. HIV and HTLV-I antibody screening and HCV screening were introduced in 1986 and 1989, respectively, which resulted in no HTLV-I infection by transfusion and a remarkable decrease in PTH to 2·1%, which, eventually, was reduced to 0·48% because of sensitivity improvement since 1992. Twenty-two HIV-positive donors (0·19/100 000) were identified in 1986 and 1987. Although a retrospective survey was conducted to examine them, the results were not published. Since then, there has been an increase in the number of HIV-infected donors (2·1/100 000 in 2007). In 1989, MOHW published the ‘Guidelines for Implementation of Transfusion Practices’ to help improve the safety of blood transfusion in hospital, where approximately 5% of the total blood units used through the country was collected. The guidelines recommended that a medical doctor in charge of transfusion should be appointed and a hospital transfusion committee should be set up. In the same year, the ‘Committee on New Blood Program Promotion’, was established to discuss measures to achieve self-sufficiency of all blood products including source plasma. In a report, the committee recommended that supply systems for plasma fractionation products should be integrated, and asked JRC to provide source plasma derived from voluntary donors to commercial plasma manufacturers, which then stopped collecting source plasma themselves from paid donors in 1990. The import of source plasma also decreased, from 80 000 in 1992 to 20 000–25 000 l in 1995 or later, most of which was source plasma containing specific immunoglobulins. By 1992, self-sufficiency of heated concentrated plasma-derived AHF was achieved by JRC. In 1996, lawsuits filed by plaintiff groups consisting of the victims of HIV-contaminated clotting factor administrations were settled. The main issues included measures to ensure the safety of blood and blood products, clarification of the responsibility for blood program policies, and insufficiency to obtain informed consent from patients. In March 1998, MOHW organized the ‘Special Committee on Planning and System Reform’ under the Central Pharmaceutical Affairs Council to discuss legislation regarding guarantee of safe blood supply. Following the submission of a report in December 2000, the ‘Law to Ensure the Stable Supply of Safe Blood’ (the so-called Blood Law) was enacted in July 2002. The law stipulates that the government has the responsibility for blood programs (blood safety, supply, collection, appropriate use of blood and blood products, and so on.), each part of the system (local government, blood and plasma manufactures and pharmaceutical companies) should fulfilled its own responsibility. Medical institutes should lead in the appropriate use of blood and blood products as well as reporting adverse transfusion events in hospitals. MOHW started a steering committee under the Standing Committee for Blood Programs in 2003. The law also includes punitive clauses, designed to prohibit the buying and selling of blood. In 1999, nucleic acid amplifying testing (NAT) for HBV, HCV, and HIV was introduced. Originally, the testing was introduced for 500 sample pools at first, and later for 50, and eventually 20 in 2005. While residual risks were recently estimated to 10∼15 cases for HBV, one case for HCV and one case for bacterial infection per year and, that for HIV was estimated to be one case every 2 or 3 years. No confirmed case for transfusion-associated graft-versus-host disease (TA-GVHD) has been reported in cases using irradiated blood products except FFP. About 40–50 cases for transfusion-related lung injury (TRALI) are assumed to develop each year. A high level of safety for blood and blood products has been secured in Japan. Also in 1999, the second revision of the ‘Guidelines for both the Appropriate Use of Blood Products and Appropriate Transfusion Practices’ were produced by MOHW, which resulted in decrease of FFP and HSA year by year again, and 40 and 60% reduction in 2007, compared to 1985. The self-sufficiency for HSA in 2008 was 60%. Various efforts to achieve blood self-sufficiency solely from voluntary donations are being made, e.g. a 2006 report submitted by the ‘Committee on Plasma Fractionation Productive Systems’. In conclusion, we should remember that the use of blood and blood products has brought not only good fortune, but also unfortunate tragedy in the past.
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