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James O. Wear: Certification in the United States, Canada and Asia
these technologists to be certified for certain work. In • Medical Instrumentation (16%)
2012, lecturers at one school were tested as assessors
• Clinical Engineering (16%)
and certified by CATHMA with Certification for Clinical
• Medical Imaging System (16%)
Engineering Assessors. Lecturers who completed five
• Major Area: (Biomechanical or Biomaterial or Medical
weeks of training and passed the exams were certified
Electronics or Medical Information (28%)
by CATHMA with Certification for Clinical Engineering
Trainers. Medical Equipment Technician (core exam)
• Anatomy (20%)
CeRtIFICAtIon In tAIWAn • Electronics & Electrical Safety (40%)
Certification in clinical engineering in Taiwan is per- • Medical Instrumentation (40%)
formed by the Taiwan Society for Biomedical Engineering
Biomedical Engineer (core exam)
11
(TSBME). In 2000, TSBME established the Certification
• Anatomy (20%)
Executive Committee for CE certification. During 2001,
they certified clinical engineers by application. In 2003, • Medical Devices, Safety Regulation & GMP (10%)
• Major/Minor (Biomechanics plus Biomaterial or
they initiated a recertification program for CCE. The first
Medical Electronics plus Medical Instrumentation)
testing for certification of clinical engineering and tech-
Major 45% and Minor 25% (70%)
nologists of medical equipment was in 2007.
The TSBME provides certification for clinical engi-
CeRtIFICAtIon In JAPAn
neers, medical equipment technicians and biomedical
engineers. In 2010 they had certified 93 clinical engineers, Clinical engineering in Japan is different from other
132 medical equipment technicians and 224 biomedical parts of the world. 12,13 It is the only country that the
engineers. The clinical engineers and medical equipment government certifies clinical engineering technologists
technicians are for working in the hospitals and the bio- (CETs). The CETs must graduate from a clinical engi-
medical engineers are for working in the medical device neering training school which can be a university, junior
industry. This is the only certification that has separate college or training school and pass a national exam to be
certification for hospital and industry engineers. certified. The CETs are also called clinical engineers. The
To become certified an individual must be a member CETs are paramedical staff and specialize in the medical
of TSBME. The requirements to take the certification equipment essentials in medical care. About 35% work
exam are as follows: in hemodialysis and about 20% in maintenance. Others
work in respiratory, operating room, ICU, heart related,
• Clinical Engineer: MS degree in biomedical or
hyperbaric and other areas.
related field plus at least one year of CE experience
plus working in a hospital for more than 10 years. The clinical engineer system was established in 1987
by the Clinical Engineers Act. This act created the CET
• Medical Equipment Technician: BS degree in
as a professional medical position responsible for the
biomedical or related field plus at least one year of
operation and maintenance of life-support systems under
CE experience plus working in a hospital for more
than 4 years. the direction of doctors. This act established a national
• Biomedical Engineer: BS degree in Engineering plus qualification including passage of the 180-question exam
at least two years of BME experience plus working in medicine, engineering and medical technology. In 2010
in BME field for more than 4 years. there were about 28,000 certified CETs and about 18,000
current working in the field. The certification of the CETs
The content of the assessment exams by the TSBME
is most equivalent to the CBET in the ICC system in the US.
for each of their certifications is as follows:
In addition to the CET certification by the government,
Clinical Engineer (core exam plus oral exam)
the Japan Society for Medical and Biological Engineering
• Anatomy (24%)
J Global Clinical Engineering Special Issue 1: 15-22; 2018 20