Development of Clinical Engineer Certification in China Submitted by Name: Dan Zhou Affiliation: CED Collaborator Location: Beijing, China E-mail address for contact: ZD99@vip.sohu.com

Country Estimates in Brief Population The population was 1,332M on April 1st, 2011 Population Growth Rate 1.21% Life Expectancy at Birth 77 – females 74 - males Infant Mortality Rate 6.3/1000 (live births under 1 year) Number of Health Centers in Country 13,326 - governmental hospital Including: 2,002 Tertiary hospitals 6,971 Secondary Hospital 921,927 - Basic medical and health institutions 34,992 - Professional public health institutions Total Expenditure on Health as % of GDP 5.15% of GDP (2015) from state budget Global CE / HTM Success Stories

Country's Health Technology Program Background Before 2005 Qualified clinical engineer (CE) groups in hospitals turned out to be a key factor to ensure the safety, effectiveness, and reliability issues of equipment. Hospitals have not yet set up the occupation positions for CE. CE have no appropriate professional qualification certification and occupation access. There is serious insufficiency of CE technical personnel. The number of engineering technical personnel is equal to 5% of all health care staff. The clinical engineering staff with Bachelor degree or above only accounted for 37%. Human resources of medical engineering in China cannot keep up with the development of new technology and equipment. March 2016 Global CE / HTM Success Stories

Country's Health Technology Program What we did... International clinical engineer (CE) certification was introduced From 2005 to 2012, the Medical Engineering Division (MED) of China Medical Association (CMA) hosted six sessions of international clinical engineering (CE) certification with advanced training courses and certification examination. More than 800 clinical engineering technical staff from hospitals and universities participated in the examination; 252 people passed and were awarded an international CE certification covering 18 provinces and 90 tertiary hospitals across China. The CE Association of China was set up to establish a continuing education system for biomedical engineering staff. We established the professor advisory committee to oversee this process for the whole nation. A Chinese exam question bank and the theoretical exam questions were developed. March 2016 Global CE / HTM Success Stories

Country's Health Technology Program What we did... The Chinese Registered Professional Clinical Engineer (PE) Certification training and examination course was improved. We established a two-level certification system: CE Certification for Senior Clinical Engineer, while PE for Junior Engineer All PE certification candidates need to pass 3+X exam consisting of online three basic theories tests and then a technical operation test including maintenance of CT/MRI, logistics management, and metering. Only 25% of candidates passed both the theoretical and technical exams and were authorized as PE. The professor committee members were selected from across the whole nation and Chinese theoretical and technical exam questions bank have been built. Two Chinese PE Certification examinations were held since 2012. 256 people enrolled in the examination; 78 people passed the exam and obtain a registered clinical engineer certification (PE) on the first. March 2016 Global CE / HTM Success Stories

Conclusions and Action Plan Outcome Improving the professional discipline and human resources of CE. Within the 252 CEs awarded CE certification, 9 people were promoted as vice presidents of 3A hospitals, half were selected as president of provincial CE societies, and most were promoted as the head of CE departments. They became the main leaders and guarantee of further CE development in China. Promoting quality control (QC) of medical devices. In recent 10 years, QC is stressed in every certification session. QC is carried out in over more than 1,000 hospitals in China. More than half of submitted papers in annual conferences for the CE branch of CMA are about QC. One good example is the story in West China Second Hospital, Sichuan University, Chengdu. Under the leadership of Xi Wang, whose group provided excellent candidates in the first CE certification exam, they developed the national standard of infant incubators and carried out training every year. There have been no more adverse events or medical disputes about infant incubators in the whole area since that time. March 2016 Global CE / HTM Success Stories

Conclusions and Action Plan Finish the editing of teaching materials for two-level certification. Cooperate with institutions at university level, to integrate the undergraduate curriculum with PE teaching materials. Set the normalized continuing education system for CE and PE. Recommend the certification to government, and establish an officially authorized clinical engineer training and certification system. March 2016 Global CE / HTM Success Stories