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Clinical engineering in Japan
Chapter 14
Clinical engineering in Japan Hiroki Igeta Dept. of Clinical Engineering, Aso Iizuka Hospital, Iizuka, Japan
Overview Clinical engineer is a national qualification in Japan and it is a very unique system in that qualified clinical engineers not only manage and maintain medical equipment but can also operate it. In order to become a clinical engineer, it is necessary to take and pass the national examination after receiving 3 or 4 years of education at a designated university or college. After passing the examination, a clinical engineer license is issued and it allows the performance of maintenance, management, and operation of life support management equipment under the direction of a physician. Many license holders work for medical institutions, but some also belong to medical equipment manufacturers, dealers, and education or research institutions such as universities.
History In the past, medical doctors and nurses were responsible for operating and managing medical equipment. However, in the 1970s and 1980s, the development and advancement of medical equipment were remarkable and the equipment became complicated. The burden of physicians and nurses has also increased. In addition, cases of medical devices being operated by unqualified service representatives of manufacturers and unqualified hospital staff also occurred and subsequently became a social problem (Kawasaki, 2017, 2018). These factors have resulted in an increase in the demand for medical professions specialized in advanced medical equipment, especially in life support management equipment such as hemodialysis equipment, heart-lung machines, respirators, and the like. In May 1987, the Clinical Engineers Act was enacted introducing a new national license in the medical field and the role of the Clinical Engineer was socially recognized (Japanese Ministry of Health and Welfare, 1987).
National Certification (License) System There are about 20 national licenses for medical professions in Japan, such as medical doctors, dentists, pharmacists, nurses, medical radiology technicians, physical therapists, etc. Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00014-6 Copyright © 2020 Elsevier Inc. All rights reserved.
The clinical engineer is also one of them (Japanese Ministry of Health, 2017). As mentioned earlier, clinical engineer is a relatively new national license, and under the Clinical Engineers Act (Act No. 60 of 1987), clinical engineers can do their job by receiving the license from the Minister of Health, Labour and Welfare. Until June 2017, the licenses have been issued to more than 41,500 people in total (Japan Association for Clinical Engineers, 2017). In order to acquire a national license, it is necessary to take and pass the national examination. In order to qualify for taking the national examination, it is necessary to acquire the knowledge and skills that are necessary for being a clinical engineer in colleges and universities designated by the government for 3–4 years. Most clinical engineers receive education at a college or a university that specializes in training clinical engineers for 3–4 years and are qualified to take the examination. The passing rate of the national examination is around 80% (Japan Association for Clinical Engineers, 2017). The outline of the conditions to be qualified to take the examination is shown below. 1. Those who acquired the necessary knowledge and skills to be a clinical engineer for 3 years or more at a designated college or university. 2. Those who studied related subjects for more than 2 years at a university, etc., and acquired knowledge and skills necessary to be a clinical engineer for more than 1 year at a designated college or university. 3. Those who studied related subjects for 2 years or more at a university, etc., and acquired knowledge and skills necessary to be a clinical engineer for more than 1 year at a designated college or university. 4. Those who completed the subjects designated by the Minister of Health, Labour and Welfare at a university and acquired the necessary knowledge and skills to be a clinical engineer. 5. Those who have obtained equivalent education in a foreign country or who received a license equivalent to a Japanese clinical engineer in a foreign country, and have been approved by the Minister of Health, Labour and Welfare. 105
106 SECTION | 2 Worldwide clinical engineering practice
Those who pass the national examination need to register on the name list of clinical engineers at the Ministry of Health, Labour and Welfare by application, so that their license can be issued by the Minister of Health, Labour and Welfare, and it will be possible for them to work as a clinical engineer.
Training and education There are 79 designated universities and colleges which have clinical engineering courses in Japan (as of May 2017) (Editorial Department of Clinical Engineering, 2017). At these universities and colleges, it is necessary to educate in accordance with the contents specified by the ordinance for clinical engineering training institutions (Ministry of Education, Ministry of Health and Welfare Ordinance No. 2, 1988) (Japanese Ministry of Education and Ministry of Health and Welfare, 1988). Essential educational contents set by the ordinance are as shown in the table (Table 1) (Japanese Ministry of Education and Ministry of Health and Welfare, 1988), and each university and college builds and provides educational programs in accordance with these contents. Practical clinical training in hospitals is also mandatory in the specialized fields.
inspection of life support management equipment (including connection of the tip of the life support equipment to the body or removal from the body) under the direction of a physician using the name of “Clinical Engineer” with a license from the Minister of Health, Labour and Welfare” (Japanese Ministry of Health and Welfare, 1987). For detailed work content, the guidelines are indicated separately. Regarding the guidelines, “The Guidelines for Clinical Engineer” was indicated by the Ministry of Health, Labour and Welfare in September 1988, but a fundamental review was done in 2010, at which time “The Clinical Engineer Basic Operation Guide 2010” was enacted as new guidelines and “The Guidelines for Clinical Engineer” were abolished accordingly (Japanese Ministry of Health and Welfare, 1988; Clinical Engineering Joint Committee, 2010). The new guidelines concretely show the scope of work performed by clinical engineers and contain information about the interpretation of the law and general medical practice. Furthermore, detailed business scopes are shown for certain fields in which clinical engineers are mainly involved and have responsibilities. Those fields are shown below (Clinical Engineering Joint Committee, 2010). ●
Business scope
●
According to the Clinical Engineers Act (Act No. 60 of 1987), the clinical engineer is defined as “a person engaged as a profession in the operation, maintenance, and
●
●
● ● ● ●
TABLE 1 Essential education contents.
●
Contents Basic fields
The Foundation of Scientific Thinking Humanity and Life
Specialized basic fields
Structure and Function of the Human Body Basic Medicine Basic Science and Engineering Basic Medical Information Technology and System Engineering
Specialized fields
●
Medical Bioengineering Medical Instrument Science Biomedical Technology Medical Safety Management Clinical Medicine Practical Clinical Training
Respiratory treatment Perfusion (cardiopulmonary bypass) Blood purification including hemodialysis Operation room Intensive care Cardiovascular catheter Hyperbaric oxygen therapy Cardiac implantable electronic devices such as pacemakers, ICDs Medical equipment management Endoscope
Japanese clinical engineers perform not only maintenance and management of medical equipment but also operating it and involving the patients’ care during the operation. For example, during hemodialysis therapy, Japanese clinical engineers have responsibilities for water quality management, preparing the dialysis fluid, priming the circuit, puncturing the shunt, measuring the blood pressure, injecting the drug into the circuit, taking the blood from the circuit for blood examination, returning the blood to the patients, etc. Another example is respiratory care. Japanese clinical engineer can perform endotracheal suction on the patients under ventilator control. As explained, Japanese clinical engineers have a clinician side too. Therefore, the guideline shows detailed business scopes for clinical engineers on clinical procedures in the related fields too. In addition, radiation-related equipment and MRI are generally operated by radiology technicians in Japan, and a very limited number of clinical engineers are involved in management of this equipment.
Clinical engineering in Japan Chapter | 14 107
Japan Association for Clinical Engineers Japan Association for Clinical Engineer (JACE) is a professional organization. JACE was established in February 1990, 3 years after the license system was enacted. JACE is now acting as a Public Interest Incorporated Association after gaining the approval of the Cabinet Office in March 2002. The objective of JACE is to contribute to the promotion and development of the nation’s medical care and welfare through the elevation of the professional ethics of clinical engineers, the enhancement of their professional knowledge and skills, and the improvement of the reliability of equipment-based medical care and welfare, including life-support systems (Japan Association for Clinical Engineers, 2002). Until present (June 2018), clinical engineer licenses have been issued to more than 41,500 people in total and about 26,000 of them are actually working in medical institutions such as hospitals and clinics (as of 2016) (Japanese Ministry of Health, 2017; Japan Association for Clinical Engineers, 2017). About 18,700 clinical engineers are members of JACE (as of November 2016). JACE issues many types of guidelines for clinical engineers in specific fields and also holds academic conferences and expos every year with more than 500 presentations and usually 3000–5000 members attending. JACE has more than 40 committees for professional activities, education, examination, certification, international activities, etc. Under these committees, many activities are being performed. One of the remarkable activities is a certification system. JACE provides various types of further education courses. Some of the courses are related to JACE’s original certifications. These certificates guarantee to impart higher knowledge and skills for successful applicants. In addition, many clinical engineers join other academic societies depending on their specialties. Some of these societies also provide further education courses and sometimes original certifications to guarantee higher knowledge and skills in the specific fields.
Future of clinical engineers in Japan Japan has serious social problems such as a declining birth rate, an aging population, and a declining population. Accordingly, while the number of hospitals is decreasing (Japanese Ministry of Health, 2017), in contrast, the demand for clinical engineers is expected to be stable for a while due to the background of the advancement of medical technology and the like. However, with about 2000 new clinical
engineers licensed each year, from a long-term perspective, it is unclear whether future jobs can be secured. JACE continues to expand clinical engineers’ fields and opportunities (e.g., medical device development, etc.) through its various activities. JACE is also trying to stipulate the roles that clinical engineers play in the reimbursement system. In Japan, medical expenses are reimbursed to medial institutions by the national health insurance system, and the fees and scope of the covered areas and conditions are clearly shown on the Medical Fee Points List determined by the government. Medical institutions need to follow the list and it has great effects on their management. JACE will continue making efforts to increase the number of clinical engineer-specific criteria covered by the medical reimbursement system in order to encourage an increasing demand for clinical engineers whose employment will lead to a rising standard of medical safety. Moreover, international efforts will be strengthened in the future, such as assisting with the introduction of the Japanese clinical engineering system in developing countries where clinical engineering systems are not complete.
References Clinical Engineering Joint Committee, 2010. The Clinical Engineer Basic Operation Guide 2010. Editorial Department of Clinical Engineering, 2017. List of designated universities and colleges. Clin. Eng. 28 (7), 578–582. Japan Association for Clinical Engineers, 2002. Articles of Incorporation. Japan Association for Clinical Engineers, 2017. Commemorative Publication for the 15th Anniversary of Foundation of Japan Association for Clinical Engineers as a Public Interest Incorporated Association and 30th Anniversary of Promulgation of Clinical Engineers Act. Japanese Ministry of Education and Ministry of Health and Welfare, 1988. Ordinance for Clinical Engineering Training Institutions (Ministry of Education, Ministry of Health and Welfare Ordinance No. 2, 1988). Japanese Ministry of Health, 2017. Labour and Welfare (2017)—Health and Medical Services-Annual Health, Labour and Welfare Report. Japanese Ministry of Health and Welfare, 1987. Clinical Engineers Act (Act No. 60 of 1987). Japanese Ministry of Health and Welfare, 1988. The Guidelines for Clinical Engineer (Ministry of Health and Welfare Health Policy Bureau, Medical Division Notification No. 57, 1988). Kawasaki, T., 2017. What clinical engineers should be. J. Jpn. Assoc. Clin. Eng. 61, 9–21. Kawasaki, T., 2018. Developments in the role of clinical engineers in blood purification therapy. Blood Purif. 46, 136–142.
Clinical engineering in Japan Hiroki Igeta Dept. of Clinical Engineering, Aso Iizuka Hospital, Iizuka, Japan
Overview Clinical engineer is a national qualification in Japan and it is a very unique system in that qualified clinical engineers not only manage and maintain medical equipment but can also operate it. In order to become a clinical engineer, it is necessary to take and pass the national examination after receiving 3 or 4 years of education at a designated university or college. After passing the examination, a clinical engineer license is issued and it allows the performance of maintenance, management, and operation of life support management equipment under the direction of a physician. Many license holders work for medical institutions, but some also belong to medical equipment manufacturers, dealers, and education or research institutions such as universities.
History In the past, medical doctors and nurses were responsible for operating and managing medical equipment. However, in the 1970s and 1980s, the development and advancement of medical equipment were remarkable and the equipment became complicated. The burden of physicians and nurses has also increased. In addition, cases of medical devices being operated by unqualified service representatives of manufacturers and unqualified hospital staff also occurred and subsequently became a social problem (Kawasaki, 2017, 2018). These factors have resulted in an increase in the demand for medical professions specialized in advanced medical equipment, especially in life support management equipment such as hemodialysis equipment, heart-lung machines, respirators, and the like. In May 1987, the Clinical Engineers Act was enacted introducing a new national license in the medical field and the role of the Clinical Engineer was socially recognized (Japanese Ministry of Health and Welfare, 1987).
National Certification (License) System There are about 20 national licenses for medical professions in Japan, such as medical doctors, dentists, pharmacists, nurses, medical radiology technicians, physical therapists, etc. Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00014-6 Copyright © 2020 Elsevier Inc. All rights reserved.
The clinical engineer is also one of them (Japanese Ministry of Health, 2017). As mentioned earlier, clinical engineer is a relatively new national license, and under the Clinical Engineers Act (Act No. 60 of 1987), clinical engineers can do their job by receiving the license from the Minister of Health, Labour and Welfare. Until June 2017, the licenses have been issued to more than 41,500 people in total (Japan Association for Clinical Engineers, 2017). In order to acquire a national license, it is necessary to take and pass the national examination. In order to qualify for taking the national examination, it is necessary to acquire the knowledge and skills that are necessary for being a clinical engineer in colleges and universities designated by the government for 3–4 years. Most clinical engineers receive education at a college or a university that specializes in training clinical engineers for 3–4 years and are qualified to take the examination. The passing rate of the national examination is around 80% (Japan Association for Clinical Engineers, 2017). The outline of the conditions to be qualified to take the examination is shown below. 1. Those who acquired the necessary knowledge and skills to be a clinical engineer for 3 years or more at a designated college or university. 2. Those who studied related subjects for more than 2 years at a university, etc., and acquired knowledge and skills necessary to be a clinical engineer for more than 1 year at a designated college or university. 3. Those who studied related subjects for 2 years or more at a university, etc., and acquired knowledge and skills necessary to be a clinical engineer for more than 1 year at a designated college or university. 4. Those who completed the subjects designated by the Minister of Health, Labour and Welfare at a university and acquired the necessary knowledge and skills to be a clinical engineer. 5. Those who have obtained equivalent education in a foreign country or who received a license equivalent to a Japanese clinical engineer in a foreign country, and have been approved by the Minister of Health, Labour and Welfare. 105
106 SECTION | 2 Worldwide clinical engineering practice
Those who pass the national examination need to register on the name list of clinical engineers at the Ministry of Health, Labour and Welfare by application, so that their license can be issued by the Minister of Health, Labour and Welfare, and it will be possible for them to work as a clinical engineer.
Training and education There are 79 designated universities and colleges which have clinical engineering courses in Japan (as of May 2017) (Editorial Department of Clinical Engineering, 2017). At these universities and colleges, it is necessary to educate in accordance with the contents specified by the ordinance for clinical engineering training institutions (Ministry of Education, Ministry of Health and Welfare Ordinance No. 2, 1988) (Japanese Ministry of Education and Ministry of Health and Welfare, 1988). Essential educational contents set by the ordinance are as shown in the table (Table 1) (Japanese Ministry of Education and Ministry of Health and Welfare, 1988), and each university and college builds and provides educational programs in accordance with these contents. Practical clinical training in hospitals is also mandatory in the specialized fields.
inspection of life support management equipment (including connection of the tip of the life support equipment to the body or removal from the body) under the direction of a physician using the name of “Clinical Engineer” with a license from the Minister of Health, Labour and Welfare” (Japanese Ministry of Health and Welfare, 1987). For detailed work content, the guidelines are indicated separately. Regarding the guidelines, “The Guidelines for Clinical Engineer” was indicated by the Ministry of Health, Labour and Welfare in September 1988, but a fundamental review was done in 2010, at which time “The Clinical Engineer Basic Operation Guide 2010” was enacted as new guidelines and “The Guidelines for Clinical Engineer” were abolished accordingly (Japanese Ministry of Health and Welfare, 1988; Clinical Engineering Joint Committee, 2010). The new guidelines concretely show the scope of work performed by clinical engineers and contain information about the interpretation of the law and general medical practice. Furthermore, detailed business scopes are shown for certain fields in which clinical engineers are mainly involved and have responsibilities. Those fields are shown below (Clinical Engineering Joint Committee, 2010). ●
Business scope
●
According to the Clinical Engineers Act (Act No. 60 of 1987), the clinical engineer is defined as “a person engaged as a profession in the operation, maintenance, and
●
●
● ● ● ●
TABLE 1 Essential education contents.
●
Contents Basic fields
The Foundation of Scientific Thinking Humanity and Life
Specialized basic fields
Structure and Function of the Human Body Basic Medicine Basic Science and Engineering Basic Medical Information Technology and System Engineering
Specialized fields
●
Medical Bioengineering Medical Instrument Science Biomedical Technology Medical Safety Management Clinical Medicine Practical Clinical Training
Respiratory treatment Perfusion (cardiopulmonary bypass) Blood purification including hemodialysis Operation room Intensive care Cardiovascular catheter Hyperbaric oxygen therapy Cardiac implantable electronic devices such as pacemakers, ICDs Medical equipment management Endoscope
Japanese clinical engineers perform not only maintenance and management of medical equipment but also operating it and involving the patients’ care during the operation. For example, during hemodialysis therapy, Japanese clinical engineers have responsibilities for water quality management, preparing the dialysis fluid, priming the circuit, puncturing the shunt, measuring the blood pressure, injecting the drug into the circuit, taking the blood from the circuit for blood examination, returning the blood to the patients, etc. Another example is respiratory care. Japanese clinical engineer can perform endotracheal suction on the patients under ventilator control. As explained, Japanese clinical engineers have a clinician side too. Therefore, the guideline shows detailed business scopes for clinical engineers on clinical procedures in the related fields too. In addition, radiation-related equipment and MRI are generally operated by radiology technicians in Japan, and a very limited number of clinical engineers are involved in management of this equipment.
Clinical engineering in Japan Chapter | 14 107
Japan Association for Clinical Engineers Japan Association for Clinical Engineer (JACE) is a professional organization. JACE was established in February 1990, 3 years after the license system was enacted. JACE is now acting as a Public Interest Incorporated Association after gaining the approval of the Cabinet Office in March 2002. The objective of JACE is to contribute to the promotion and development of the nation’s medical care and welfare through the elevation of the professional ethics of clinical engineers, the enhancement of their professional knowledge and skills, and the improvement of the reliability of equipment-based medical care and welfare, including life-support systems (Japan Association for Clinical Engineers, 2002). Until present (June 2018), clinical engineer licenses have been issued to more than 41,500 people in total and about 26,000 of them are actually working in medical institutions such as hospitals and clinics (as of 2016) (Japanese Ministry of Health, 2017; Japan Association for Clinical Engineers, 2017). About 18,700 clinical engineers are members of JACE (as of November 2016). JACE issues many types of guidelines for clinical engineers in specific fields and also holds academic conferences and expos every year with more than 500 presentations and usually 3000–5000 members attending. JACE has more than 40 committees for professional activities, education, examination, certification, international activities, etc. Under these committees, many activities are being performed. One of the remarkable activities is a certification system. JACE provides various types of further education courses. Some of the courses are related to JACE’s original certifications. These certificates guarantee to impart higher knowledge and skills for successful applicants. In addition, many clinical engineers join other academic societies depending on their specialties. Some of these societies also provide further education courses and sometimes original certifications to guarantee higher knowledge and skills in the specific fields.
Future of clinical engineers in Japan Japan has serious social problems such as a declining birth rate, an aging population, and a declining population. Accordingly, while the number of hospitals is decreasing (Japanese Ministry of Health, 2017), in contrast, the demand for clinical engineers is expected to be stable for a while due to the background of the advancement of medical technology and the like. However, with about 2000 new clinical
engineers licensed each year, from a long-term perspective, it is unclear whether future jobs can be secured. JACE continues to expand clinical engineers’ fields and opportunities (e.g., medical device development, etc.) through its various activities. JACE is also trying to stipulate the roles that clinical engineers play in the reimbursement system. In Japan, medical expenses are reimbursed to medial institutions by the national health insurance system, and the fees and scope of the covered areas and conditions are clearly shown on the Medical Fee Points List determined by the government. Medical institutions need to follow the list and it has great effects on their management. JACE will continue making efforts to increase the number of clinical engineer-specific criteria covered by the medical reimbursement system in order to encourage an increasing demand for clinical engineers whose employment will lead to a rising standard of medical safety. Moreover, international efforts will be strengthened in the future, such as assisting with the introduction of the Japanese clinical engineering system in developing countries where clinical engineering systems are not complete.
References Clinical Engineering Joint Committee, 2010. The Clinical Engineer Basic Operation Guide 2010. Editorial Department of Clinical Engineering, 2017. List of designated universities and colleges. Clin. Eng. 28 (7), 578–582. Japan Association for Clinical Engineers, 2002. Articles of Incorporation. Japan Association for Clinical Engineers, 2017. Commemorative Publication for the 15th Anniversary of Foundation of Japan Association for Clinical Engineers as a Public Interest Incorporated Association and 30th Anniversary of Promulgation of Clinical Engineers Act. Japanese Ministry of Education and Ministry of Health and Welfare, 1988. Ordinance for Clinical Engineering Training Institutions (Ministry of Education, Ministry of Health and Welfare Ordinance No. 2, 1988). Japanese Ministry of Health, 2017. Labour and Welfare (2017)—Health and Medical Services-Annual Health, Labour and Welfare Report. Japanese Ministry of Health and Welfare, 1987. Clinical Engineers Act (Act No. 60 of 1987). Japanese Ministry of Health and Welfare, 1988. The Guidelines for Clinical Engineer (Ministry of Health and Welfare Health Policy Bureau, Medical Division Notification No. 57, 1988). Kawasaki, T., 2017. What clinical engineers should be. J. Jpn. Assoc. Clin. Eng. 61, 9–21. Kawasaki, T., 2018. Developments in the role of clinical engineers in blood purification therapy. Blood Purif. 46, 136–142.