Clinical engineering development in China

Chapter 17

Clinical engineering development in China Li Bina, Zheng Kunb, Xia Huilingc, Jiang Ruiyaod, Guo Chenchenb a

Shanghai Medical Equipment Quality Control Center, Shanghai, China, bClinical Engineering, Children’s Hospital of Zhejiang University School of Medicine, Hangzhou, China, cClinical Engineering, Inner Mongolia Autonomous Region People's Hospital, Hohhot, China, dClinical Engineering, Shanghai 6th People’s Hospital, Shanghai, China

Development review of Chinese clinical engineering The main development stages of clinical engineering in China Dr. Cesar Caceres coined the term clinical engineering (CE) in the 1960s, and Chinese clinical engineering began in the 1970s, as more and more medical devices began to be applied in hospitals and engineers and technicians began to work in hospitals. Zhejiang University was the first university in China to initiate an academic program for biomedical engineering in 1977. In 1978, some medical colleges also began to establish biomedical engineering education programs, which opened up professional education in this field. Clinical engineering in China has gone through four stages of development. The first stage focused on maintenance and supply. From the 1970s and in particular from the late 1980s, many hospitals established clinical engineering departments. In 1992, the Chinese College of Clinical Engineering was formally established. During this stage, the main responsibility for the hospital clinical engineering department was medical device procurement and maintenance. Some clinical engineering technicians received very good training from manufacturers. The maintenance of medical equipment played an important role in technical support for the hospitals. The US-based Project Health Opportunity for People Everywhere (HOPE) foundation and the former Zhejiang Medical University (now the Zhijiang University School of Medicine) opened a clinical engineering program in 1984. HOPE also cooperated with the Children’s Hospital affiliated with Zhejiang Medical University to establish the first national NICU,

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and in a­ ddition established an emergency ICU (EICU) in ­cooperation with an ­affiliated second hospital. During this period, HOPE dispatched clinical engineers to apply advanced medical equipment technology management and support the collaborated programs. Concepts and methods including project management (PM) were introduced to the CE community of Zhejiang and Shanghai. The second stage of development featured the adoption of quality and risk management. Since the late 1990s, quality control methodology has been introduced into Chinese hospitals. Some hospitals started inspection and quality control for medical equipment. Developed regions in China began to implement systematic quality control programs with preventive maintenance and continuous quality improvement. In 2005, the Shanghai Municipal Health Bureau established the first medical equipment management quality control center (MDMQCC) in China. The quality control center was attached to the Shanghai No. 6 People’s Hospital. From 2005, many areas in China successively established medical equipment quality control centers, and organized professional teams to carry out regional medical equipment management with quality control. The third stage of development featured technology convergence and integration. After entering the 21st century, IT technology began to develop at a rapid speed, and new technologies such as medical digital technology, network technology, and mobile technology were continuously developed and integrated. Promotion of the diversified development of technology integration and the convergence of clinical engineering technology and information technology was witnessed and quickly developed. The current fourth stage of development features systematic medical technology service and management. In recent years, the international medical community has

Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00017-1 Copyright © 2020 Elsevier Inc. All rights reserved.

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made great progress and development in value-based health care and the role of clinical engineering has been recognized and a­ ppreciated gradually. The World Health Organization (WHO) points out that health technology is essential for the proper functioning of health systems and that medical devices are especially important in disease ­prevention, diagnosis, quality, and rehabilitation. Medical devices are not only used as a material basis in hospitals, but also as an important part of medical technology. The functions of the clinical engineering department are also gradually transforming into technical management and technical services. Some leading clinical engineering departments in China are actively exploring participation of the management of medical technology at the C-suite level.

Establishment and development of the Chinese Medical Association and Clinical Engineering The Chinese Society of Clinical Engineering (CSCE) of the Chinese Medical Association was formerly a medical instrument professional committee affiliated with the China Biomedical Engineering Society. On October 11, 1993, the CSCE of the Chinese Medical Association was formally established. As a formal independent professional organization, its members are mainly clinical engineers from domestic medical institutions and healthcare delivery organizations (HDOs) at all levels, as well as experts and professor from universities. The main missions of the Society are: to carry out academic and technical exchanges at home and abroad; to edit and publish science and technology books and periodicals; to carry out clinical engineering continuing education and technical training; and to recommend and commend outstanding scientific and technological achievements, best practices, and talents. The CSCE has experienced four periods of development. (1) During the start-up period (1993–2002), it started the Society journal, actively organized seminars and academic conferences, and continuously expanded the influence of the Society, actively promoting the establishment of 12 branches of clinical engineering associations in medical associations of provinces, municipalities, and autonomous regions. (2) During the construction period (2003–09), the Society entered a stage of rapid and standardized development. In this construction period, CSCE actively promoted the transformation of the CE discipline toward medical equipment quality control and quality assurance, supplies management and logistics, information technology, and clinical engineering. (3) During the development period (2009–13), the Society entered a stage of rapid development and prosperity, increasing the membership, establishing the Youth Research and Development Fund, and launching the outstanding clinical engineers

and the “Ten National Top Clinical Engineers” youth selection activities. It also c­ arried out the selection of key disciplines, and through role models, promoted the overall construction of the discipline and enhanced the understanding and affirmation of the discipline of clinical engineering. (4) During the new transition period (2014 to present), the Society entered a transformational adjustment, standardized various academic exchange activities, and consolidated the CSCE foundation. It also organized and published the white paper “China Clinical Engineering Development Research Report,” translated nine books of the WHO Medical Device Technical Series and 10 national textbooks for biomedical engineering and clinical engineering through the People’s Health Publishing House, selected some outstanding engineers to participate in international clinical engineering exchange activities, and held the first international conference for clinical engineering and medical technology management (ICEHTMC) in Hangzhou, hence contributing to the development of international clinical engineering.

The development of clinical engineering chapters of the Medical Association in various provinces and cities in recent years With the development of medical technology and China’s reform and opening up in the 1980s, Chinese hospitals introduced more advanced medical equipment. More and more professional clinical engineers and technicians also entered the hospital to engage in the management and maintenance of medical devices. In order to strengthen the professional management of medical equipment in hospitals, some regions, including Anhui, Xinjiang, Liaoning, Yunnan, Shandong, Chongqing, and other provinces and cities, successively established medical device management branches or clinical engineering chapters within the provincial Medical Association. When the Chinese Society of Clinical Engineering was established in October 1993, only six provinces and cities established clinical engineering chapters of the Medical Association; after that point, the branch organizations already established in each province were generally unified into clinical engineering chapters of the Medical Association. The following list shows the establishment of clinical engineering chapters of the Medical Association in each province (Table 1). Judging from the establishment times of various a­ reas, the number of clinical engineering chapters established in various regions after the turn of the 21st century increased, showing the momentum of rapid CE development. After 25 years of development, 20 provinces and cities have established chapters, which includes about 64.5% of the total provinces and p­ rovince-level municipalities (excluding Hong Kong, Taiwan, and Macao).

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TABLE 1  The list for the establishment of clinical engineering chapters of the Medical Association of each province and province-level municipality. Names of provincial and municipal branch

Date of establishment

Duration

Remark

1

Anhui Clinical Engineering Chapter of Medical Association

July 1, 1985

5

Formerly the Medical Device Branch

2

Xinjiang Clinical Engineering Chapter of Medical Association

July 1, 1990

4

3

Yunnan Clinical Engineering Chapter of Medical Association

August 20, 1990

7

Formerly the Medical Device Association

4

Liaoning Clinical Engineering Chapter of Medical Association

March 13, 1992

7

Formerly medical equipment management and maintenance

5

Shandong Clinical Engineering Chapter of Medical Association

June 11, 1992

4

Formerly the Medical Device Professional Committee

6

Chongqing Clinical Engineering Chapter of Medical Association

January 1, 1993

5

Formerly the Medical Device Association, Renamed to Clinical Engineering Chapter of Medical Association in 2014

7

Zhejiang Clinical Engineering Chapter of Medical Association

August 1, 1994

6

8

Shanxi Clinical Engineering Chapter of Medical Association

August 1 1996

5

9

Jilin Clinical Engineering Chapter of Medical Association

August 6, 1997

6

10

Hubei Clinical Engineering Chapter of Medical Association

October 28, 1999

5

11

Neimenggu Clinical Engineering Chapter of Medical Association

August 1, 2001

3

12

Shanghai Clinical Engineering Chapter of Medical Association

September 2, 2004

5

13

Sichuan Clinical Engineering Chapter of Medical Association

August 1, 2005

4

14

Jiangsu Clinical Engineering Chapter of Medical Association

October 15, 2008

4

15

Heilongjiang Clinical Engineering Chapter of Medical Association

May 30, 2008

3

16

Henan Clinical Engineering Chapter of Medical Association

January 1, 2011

3

17

Guangdong Clinical Engineering Chapter of Medical Association

December 24, 2011

2

18

Beijing Clinical Engineering Chapter of Medical Association

December 21, 2013

2

19

Hunan Clinical Engineering Chapter of Medical Association

January 11, 2014

2

20

Hebei Clinical Engineering Chapter of Medical Association

December 5, 2014

2

No.

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Some major achievements of the Chinese Society of Clinical Engineering in recent years Forming professional consensus In 2012, the writing of a white paper on clinical engineering development (published in November 2015) was initiated In 2012, in order to achieve the goals of establishing a safe medical system and professional clinical engineering, promoting consensus, and facilitating the practice, entrusted by the Hospital Management Research Institute of the Ministry of Health, the Chinese Society of Clinical Engineering cooperated with the Clinical Engineering Research Base of the Hospital Management Research Institute of the Ministry of Health and some medical device companies to begin this project. Based on the investigation and survey of the status quo and challenges of clinical engineering in China, this white paper elaborated the following topics: clinical engineering development overview, medical device industry development and medical technology advancement, medical equipment maintenance program, medical device quality and risk and logistics engineering management, clinical engineering and technology management, clinical engineering and informatics, human resources, and discipline construction. Furthermore, the white paper systematically summarized the achievements and experience of clinical engineering construction, and analyzed the clinical engineering development trends, put forward opinions and suggestions for clinical engineering development, provided a reference for health authorities to make relevant decisions in clinical engineering, and provided norm guidance and consideration for all levels of medical institutions in formulating their clinical engineering programs.

Completion of “Entering Twenty Years of Clinical Engineering” in 2013 Since the Chinese Society of Clinical Engineering was established in 1993, clinical engineers and professionals from generation to generation have carried forward the spirit of hard work and kept pace with the times, and have made many remarkable achievements in academic organization, the education system, scientific research, academic exchange, and technology applications. The CSCE has played a very positive role in promoting the reform and development of clinical engineering in China. In 2013, on the occasion of the 20th anniversary of the establishment of the Chinese Society of Clinical Engineering, the Society selected experts and scholars at all levels to write “Entering Twenty Years of Clinical Engineering,” which addressed the following topics: development history review, organization construction and management, academic activities and achievements, government decision support, talent training

and awards, exchanges and cooperation with international and Hong Kong and Taiwan regions, development outlooks, local CE chapter introduction, etc. It explained in detail the development history of the Society, milestones of the Society, and the outstanding colleagues, giving recognition and a comprehensive and objective record of the activities of the Society in different periods and its role as a bridge and link in the Chinese clinical engineering community. This book invigorated the spirit of CE professionals and has far-reaching significance for realizing the new take-off of clinical engineering disciplines.

Working out the “Biomedical engineering Textbook” Assigned by the National Health Commission and organized by the People’s Medical Publishing House, 10 textbooks were composed on the 13th Five-Year Plan of the National Health Commission of the People’s Republic of China for the first round of the biomedical engineering specialty (clinical engineering direction) in universities and colleges. This project was sponsored by the People’s Medical Publishing House, the Chinese Society of Clinical Engineering, and China Medical Device Magazine. It includes the introduction of clinical engineering management, medical equipment principles and clinical applications, medical materials and supplies, medical device technology assessment, digital medical equipment introduction, medical equipment maintenance, medical equipment quality testing and calibration, clinical engineering technology evaluation, medical device technology horizon scanning, and introduction to clinical engineering research. This series of textbooks was officially published in August 2017. From more than 50 hospitals and colleges across the country, nearly 70 textbook review committee members, editors, deputy editors, and representatives participated in the preparation work. This compilation of biomedical engineering planning textbooks represents the first time that People’s Medical Publishing House relied on the CE academy. This was also the standardization process for the body of knowledge (BOK) of clinical engineering disciplines, which is of great significance in the development of clinical engineering.

Chinese translation of nine books of the WHO Medical Device Technical Series released in November 2015 Medical devices are important parts of health technology and are essential for the effective operation of healthcare delivery. They play a vital role in the prevention, diagnosis, and treatment of diseases and the rehabilitation of patients. The WHO medical device technical series is a set of books for the global health system coauthored by experts from the WHO and other member states. It includes all important issues related to medical devices, such as medical device

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regulation, research, management, action plans, tools, and guidelines to enhance the rational use of medical devices. The Chinese translation by CSCE was a project sponsored by the Hospital Management Research Institute of the National Health Commission of the People’s Republic of China. In 2016, CSCE’s Chinese translation version was approved by the WHO publishing house. The Chinese translation of the first nine publications in the WHO medical device technology series was completed in September 2017 and published by the People’s Medical Publishing House. During the publishing ceremony, the WHO Medical Devices Coordinator Ms. Adriana Velazquez Berumen was invited to be present and give a speech. The Chinese translation of the other 10 books in the WHO medical device series was also launched in March 2018. The series of books is aligned with the formulation of national technical strategies related to the “development, learning, research, management, and use” of medical devices, and provides guidance to medical and health practitioners as well as the medical device industry, and promotes the integration of medical device supervision and international standards.

Conducting academic exchange activities Regularly host the National Clinical Engineering Academic Annual Congress The Chinese Society of Clinical Engineering adheres to the purpose of its father organization, namely the Chinese Medical Association, strengthening academic exchanges through Academic Conference, Clinical Engineer Salon, Clinical Engineering Experts High-Level Forum, Youth Committee Annual Conference Academic Conference and CE Forum of China International Medical Equipment Fair (CMEF). Since 1993, the National Clinical Engineering Academic Annual Congress has been held in Beijing, Shanghai, Nanjing, Wuhan, Kunming, and Hangzhou, etc., every 1 or 2 years. So far, 16 national clinical engineering academic conferences have been held. The annual conference is large scale and highly attended, including a main forum and five to eight special subforums. The congress invites many domestic and foreign experts from clinical engineering, information technology professionals, and hospital administration to attend and deliver academic reports. Nearly 1000 people from 31 provinces, cities, and regions attend the conference, and more than 100 domestic and foreign industry experts and engineers are gathered to give insightful academic speeches. They focus on the frontiers of clinical engineering and digital medicine and the development trends of healthcare technology. The conference normally receives 300–500 papers, covering dozens of provinces and cities nationwide. A lot of stakeholders in the clinical engineering community from all over the ­country come to attend the congress, to discuss together, to exchange academic ideas and views, to enlighten each other

and learn from each other, and to network and constantly inspire original innovation. It is believed that all the conferences hosted by CSCE play a vital role in facilitating the development and progress of the CE profession.

Organized Clinical Engineering White Paper Road Show in various provinces and cities across the country In order to popularize the core concepts in the field of clinical engineering and to build consensus, the Chinese Society of Clinical Engineering, the China International Medical Exchange Foundation, and various local clinical engineering chapters have co-organized clinical engineering management training in most provinces/municipalities across the country since 2016. Based on the China Clinical Engineering Development Report, the medical device technology series issued by the WHO, and the National 13th Five-Year Plan Teaching Materials (10 volumes) for clinical engineering academic education, this Road Show taught the core concepts and introduced the international and domestic advanced management experience and technical guidelines in the field of clinical engineering to the heads of the clinical engineering departments of the national secondary and tertiary hospitals. The seasoned and experienced 26 instructors chosen by CSCE formed a strong lecturer group to conduct the training. Each training course was cosponsored and organized by local provincial or municipality clinical engineering associations. The number of attendees in each training course was about 100–300, and the training lasted about 2 days and 12 h. Up to now, 23 training courses have taken place in 23 provinces/ municipalities. The number of participants was about 4500 in total and the total number of training hours was 276 h.

Co-organized “Flying Over the Hump” Health Technology Management (HTM) training series Cosponsored by the China Biomedical Engineering Society and/or the China Association of Medical Equipment, CSCE hosted the “Flying Over the Hump—2015 HTM China Tour” medical technology management training, launched in 10 cities, namely Chongqing, Guangzhou, Jinan, Wenzhou, Harbin, Shanghai, Urumqi, Wuhan, Nanjing, and Beijing in May, July, and September 2015. Some guest speakers from the United States were invited, including experts from nongovernmental organizations, American College of Clinical Engineering (ACCE), AAMI, ECRI, etc., to introduce international experience and best practices of medical technology management, to discuss how to help hospital equipment and consumables managers to have a more ­forward-looking vision, and strategic and more effective ­ management methods. It covers medical device management strategy, ­planning and budgeting, procurement, efficient operation, equipment maintenance, and financial management. The

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“Flying Over the Hump” course was aimed at the practice improvement in terms of hospital medical technology management. From the whole life-cycle management concept of medical devices, the recognized best practice program has established a complete management system for all aspects of medical equipment from planning and procurement to final decommission. At the same time, it gave a large number of guiding principles and methods with operability, as well as best practice cases sharing under the actual operation of American medical institutions, further improving the medical technology management level of middle and senior managers, and promoting hospitals to improve overall operational efficiency and increase patient safety. Health Technology Management (HTM)/CE professionals play an important role in ensuring the continuous and effective supply of medical services, while reducing the incidence of medical device adverse events and benefiting patients.

Actively promoting the participation of clinical engineering personnel in acquisition and implementation of major national research and development projects In 2016–17, the National Ministry of Science and Technology issued the National Key R&D Program Application Guide, and the Chinese Society of Clinical Engineering actively responded. Union Hospital ­affiliated with College of Huazhong University of Science and Technology, the Sixth People’s Hospital affiliated with Shanghai Jiaotong University, the Ruijin Hospital affiliated with Shanghai Jiaotong University, the General Hospital of the People’s Liberation Army and the First Affiliated Hospital of Zhejiang University worked together, organizing medical workers to participate in the demonstration and evaluation of innovative products in the “Digital Diagnostic Equipment” guide of the Ministry of Science and Technology. During the project application process, Shanghai, Beijing, Wuhan, Zhengzhou Chongqing and Zhejiang, along with other national CE counterparts, communicated and collaborated; after the successful writing of the application materials, the formulation of the budget, the preparation of the report materials, the online application materials submission, and the two rounds of evaluation, many projects led by CE were finally approved. For example, the project for comprehensive evaluation of medical magnetic resonance products, construction and application of stereotactic radiotherapy equipment, research and practice of positron-emission tomography (PET)-computed tomography (PET-CT) comprehensive evaluation system and training system, based on the comprehensive evaluation and training of medical ultrasound imaging systems in hospitals of different levels, and research on an endoscope comprehensive evaluation system and training system, in

total were awarded more than 30 million RMBs funding by the Ministry of Science and Technology’s key research and development plan “Digital Diagnostic Equipment R&D.” Clinical engineers actively participated in the declaration and implementation of major national research and development projects. With more than 2 years of continuous efforts, the CE profession achieved breakthroughs in national major scientific research project bidding in clinical engineering disciplines, and this also demonstrated our scientific and technological research capabilities.

Professional training and continuing education There are two types of certification programs for clinical engineers, namely the Certified Clinical Engineer (CCE) Program for senior-level clinical engineers and the Registered Engineer Certification Program for entry-level clinical engineers, respectively.

CCE certification program Strengthening international academic exchanges and letting the voice of Chinese clinical engineers reverberate in the international academic arena have always been important endeavors of CSCE. Since 2005, the International CCE training course along with the CCE certification program have been launched and sponsored by CSCE. The program recognizes those who demonstrate the required CE competency. The BOK of the CCE certification program consists of comprehensive CE knowledge fields, namely medical equipment management, technology assessment and risk management, project management, department management, CE-IT integration, training, etc., supplemented by professional skills. So far, eight sessions were successfully held consecutively in 2005, 2007, 2008, 2010, 2011, 2012, 2014, and 2016. The clinical engineer certification exam is divided into an English written test and an oral test (from the beginning of 2012, compliance with medical device regulations in Chinese was added as a part of the oral test). The exam questions adopt a similar pattern to the CCE certification exam in the United States, and the participants are required to answer in English, with the exception of part of the oral exam using Chinese pertinent to medical device regulation compliance. Dr. David Yadin, founder of the ACCE, and Professor William Hyman from Texas A&M University, Professor James Wear, and other experts were invited as examiners. More than 600 clinical engineers in total from major hospitals in the country participated in the clinical engineer certification exams, of which 273 passed both written and oral exams and received their certificates as CCEs. This program has improved the overall level of Chinese clinical engineers. Its establishment helps to ­better

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FIG. 1  The distribution of CCE personnel: 273 clinical engineers from 24 provinces, municipalities, and autonomous regions have passed the certification.

establish and enhance the position of clinical engineer in the hospital, and is conducive to career growth for clinical engineers (Fig. 1).

Registered engineer certification program Continuing education in clinical engineering is partly based on two levels of qualification certification, and it provides training in professional skills and equipment management for all levels of personnel to achieve lifelong continuing education. In addition to the abovementioned CCE program, there is a certification program for entry-level CEs, namely the Registered Engineer Certification Program. This program is targeted to help practitioners with their daily technical work. The certified registered engineer should demonstrate that he or she possesses the required BOK and competency for the profession. This program is administered at the provincial or regional level with CSCE and/or CCCE’s oversight. The registered engineer is similar to the resident physician: it is the professional qualification for clinical engineering practitioners with needed continuing education. The candidates include CE technicians, junior clinical engineers, medical device industry field engineers, and related CE senior students. The certification contents are based on basic knowledge, basic theory, basic skills (three basics) and relevant medical equipment principles, maintenance, quality inspection, etc. The Chinese Society of Clinical Engineering issued the “Management Guidance for Clinical Engineering Registered Engineer Certification” and the “Registration Procedures for Registered Engineer Skills Test Bases,” which state guidance and process in terms of general rules, organization management, application procedures, written examination, hands-on skill examination, appeal, continuing education needed, etc. The Association developed a specific website for the CE certification program, set up the Registration Certification Examination Platform, and established the Registration Certification Examination Question

Bank. So far, during 2012–16, three sessions were held, and in total 147 people from 10 different regions and provinces got their certificates; the general pass rate is about 50%. The program is not only conducive to establishing and improving the status of clinical engineering personnel in the hospital, but also beneficial to the management and sustainable development of clinical engineering personnel, and is conducive to promoting the accelerated construction of clinical engineering disciplines in China.

Joint training courses for EMBA, HTM, and hospital operation management in conjunction with Peking University and Tongji University In 2011, the leading group of the Chinese Society of Clinical Engineering initiated a training course with the collaboration of academia such as Peking University and Tongji University. This training course focused on high-quality training for senior managers and clinical engineers. It aims to expand the vision and management skills of senior clinical engineers and promote their career growth. (1) Organized a senior seminar titled “Purchasing and Logistics Management.” In order to improve the procurement management, negotiation skills and logistics management capabilities of clinical engineering personnel, the Association and Johnson & Johnson jointly held a course titled the “Advanced Training Course on Purchasing and Logistics Management.” Mr. Zhang Zhonghao, a senior logistics manager and lecturer with rich teaching and practical experience, was invited as the main speaker. In 2011, three such sessions were held in Weihai, Chongqing, and Hangzhou, respectively. The training course was warmly welcomed in the CE community. The seminar was held for two consecutive years and the trainees reached 300 people in total.

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(2) Held the “Hospital Operations Management” (HOM) seminar. The Association jointly organized the HOM Program with the EMBA Center of Shanghai Tongji University and Johnson & Johnson, mainly for the directors of clinical engineering departments. It is an executive training program and specially designed for senior engineers and device management talents in hospitals to enhance their management philosophy and capability. The courses include: establishment of hospital quality management system and quality control tools and methods, calculation and control of hospital operating costs, hospital financial, technical management related to hospital operations, and hospital safety management. All the courses are divided into three models, which are to be finished in 8 days total within a duration of 10 months. Since 2011, the program has been held for five consecutive years and it has trained more than 500 people in the field of clinical engineering. (3) Held the “Hospital Management Excellence in Operational Leadership” seminar. The Association has teamed up with the Peking University’s Guanghua School of Management’s EDP Center and Philips to launch a high-end training program for hospital excellent operational leadership. It aims to help improve HOM in China, improve efficiency, and enhance performance. In all, 56 people have obtained the certificates of completion issued by the Peking University after they completed the course.

Talent selection Medical equipment troubleshooting and quality control skill competition With the steady advancement of the country’s comprehensive medical reform, medical safety has become a focus and has been pushed to a higher level with new and more stringent requirements for medical equipment safety and effectiveness. This has brought new challenges for medical equipment management in terms of safety and effectiveness for all hospitals. As a regional collaborated CE initiative aiming at enhancing the maintenance capability of medical equipment, the provincial CE associations of Shanghai, Jiangsu, Zhejiang, and Anhui provinces have pioneered the competition program annually since 2012. It has been extremely welcomed by all the front-line engineers and technicians and prevailed quickly in the whole country. The competition has emphasized “multiparty cooperation, equipment hands-on skills, teamwork” with the objective of improving practical ability for clinical engineers and technicians. It delivers the spirit of “friendship first, competition second.” The competition consists of three major sessions,

namely, typical case study review competition session, theoretical knowledge competition session, and hands-on practice of troubleshooting and quality control competition session. Best teams and individuals are awarded afterwards. Starting in 2012, more than six competitions were successfully held in the East China region of Shanghai, Suzhou, Nanjing, Weihai, etc. with annually chosen equipment, namely, ventilator, patient monitor, ultrasound, DR, endoscopy, and dialysis machines, respectively. This project started in the East China area and soon spread nationwide. In 2018, the first National Clinical Engineer Skills Competition organized by the Chinese Society of Clinical Engineering was held in October and November. Eight different medical equipment devices were chosen for the competition and 48 teams consisting of 240 clinical engineers and technicians from more than 20 provinces participated in this event. These 48 teams were selected and organized based on regional competition. The eight medical equipment devices were dialysis machine, ultrasound, DR, ventilator, patient monitor, defibrillator, infusion pump, and digestive endoscopy. It is believed that the overall technical and medical equipment service capability of engineering personnel in various regions will be improved through this competition.

The awarding for the national key clinical engineering disciplines in 2011 In order to further strengthen the construction of clinical engineering disciplines and promote the development of clinical engineering disciplines in China, CSCE organized the evaluation and recognition of key disciplines of clinical engineering on a national scale in 2011. In April 2011, CSCE developed the Key Discipline Evaluation Standards with reference to the evaluation criteria of other key disciplines, of which 41 were common standards for subject management, talent team, scientific research, and academic achievements; 62 were individual standards, mainly divided into two aspects: infrastructure and technical services performance. If the self-assessment of the applicator is more than 850 points, the application materials can be submitted by the local clinical engineering chapter of the Medical Association and submitted to the CSCE. CSCE conducted an on-site survey for evaluation and identification afterwards. A total of 21 hospital clinical engineering departments in the country submitted the application materials. Six hospital clinical engineering departments among these 21 applicators were finally awarded as national key clinical engineering disciplines, namely, the 301-army hospital, the Inner Mongolia Autonomous Region People’s Hospital, Wuhan Union Hospital, Nanjing Military Region Nanjing Hospital, Shanghai Sixth People’s Hospital and Jiangsu Provincial People’s Hospital. This event has achieved four

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positive effects: first, to build a group of clinical engineering disciplines at a leading national level; second, to train a group of young and middle-aged clinical engineering experts and academic leaders; third, to produce a number of high-level clinical engineering scientific and technological achievements; and the fourth is to identify some best practices of clinical engineering disciplines. The evaluation and recognition of key disciplines in clinical engineering is a milestone in the construction of clinical engineering disciplines and it bears significance for clinical engineering development in China. It will further promote the continuous advancement and innovation of clinical engineering disciplines, and continuously improve the performance of clinical engineering in the whole country and benefit patient care ultimately.

National outstanding youth of clinical engineering selection review In order to honor, encourage, and commend outstanding young talents in the clinical engineering community and strengthen the pool of clinical engineering reserve talents, CSCE held the “Top Ten Outstanding Youths” selection in 2010 and 2012. The event has received wide attention and praise from the CE community and health workers at large. After the recommendation of various provinces and cities, qualification examination, network publicity, committee voting, and the Standing Committee review, there were finally 21 outstanding young people selected as national outstanding youth of clinical engineering.

“China Medical Equipment Excellent Engineer” selection review In 2011, the “China Medical Equipment Excellent Engineer” selection event was held in Taiyuan. After the online voting, CSCE conducted screening, on-site interviewing and inspection, as well as finally voting and scoring; 10 “excellent engineers” were selected, and presented with a trophy and certificate at the academic annual meeting in October. The selection activities have received very positive responses at all levels of medical institutions across the country, enabling hospital administrators to have a new and good understanding for clinical engineering. At the same time, it also encouraged the work enthusiasm of clinical engineering professionals. The “China Medical Equipment Excellent Engineer” along with the later add-on for best CE team Selection Program are cosponsored by the Chinese Society of Clinical Engineering, Chinese College of Clinical Engineers, Clinical Engineering Branch, Chinese Society of Biomedical Engineering, Clinical Engineering Branch, Chinese Association of Research Hospitals, Clinical

Engineering Branch, Chinese Association of Nonpublic Hospitals, People’s Medical Publishing House, China Medical Equipment magazine, and others. The program aims to improve the equipment service and management level of clinical engineering professionals, strengthen the operation and maintenance, quality control and scientific research capabilities of clinical engineers, and accelerate the construction of clinical engineering disciplines. Since 2010, the event has been successfully held for eight sessions, and about 600 outstanding clinical engineering professionals have been selected from more than 2000 applicants covering more than 30 provinces across the country. Among them, there are more than 100 top 10 in the country, 48 in research/management, and 34 excellent hospital teams. From 2014 to 2017, they were ­co-organized by the Southwest Hospital of the Third Military Medical University, the Xiangya Hospital of Central South University, the Biomedical Instrument Professional Committee of the Hubei Biomedical Engineering Society, and the Southern Hospital of Southern Medical University. The ninth “China Medical Equipment Excellent Engineer” selection event was co-organized by the Fujian Medical Association Clinical Engineering Branch, Fujian Provincial Hospital, and the Second Hospital of Nanping City, Fujian Province. The final contest was held in Jianyang, Fujian on September 15, 2018. “China Medical Equipment Excellent Engineer” has become one of the most recognized professional awards in the CE community. The event organizers commended the winners at the “International Clinical Engineering Day” global celebration event and awarded the honorary certificates; the “People’s Health News” published the results of the selection; the provincial and municipal health departments also issued various encouragement policies to recommend and to commend the awarded persons in the form of a recommendation to join the CE society, presentations of awards at conferences, media reports, and providing opportunities for further professional training, and so forth.

Other noted events After-sales service satisfaction survey Shanghai MDMQCC was set up by Shanghai MOH in 2005, which is affiliated with Shanghai Sixth People’s Hospital. The MDMQCC is responsible for supervising MD management of 120 top hospitals in Shanghai. It is one of the first MDMQCCs in China. From 2008, Shanghai MDMQCC started an investigation of after-sale service quality of MD manufacturers in Shanghai. The survey covered 15 categories and more than 50 brands of medical equipment after-sales service. According to the satisfaction survey results of each manufacturer’s service, MDMQCC makes annual rankings and awards for MD manufacturers. The project has continued

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for 11 years and has won National Hospital Technology Innovation awards in 2011. At present, the project has been extended to more than 20 provinces in China, and has made outstanding contributions in improving the quality of MD after-sales service.

Participate in the publication of the “Safety Management Regulations for Clinical Use of Medical Devices (Trial)” The Chinese Society of Clinical Engineering actively participated in the discussion on the formulation of policies related to medical device management by the Ministry of Health. In August 2010, after the Ministry of Health issued the Medical Device Safety Management Regulations (Trial), the Chinese Society of Clinical Engineering recommended eight experts to participate in the edit of the “Interpretation of the Safety Management Regulations for Clinical Use of Medical Devices (Trial)” by the management of the Ministry of Health Medical Services Supervision Department and the Ministry of Health Hospital Management, to provide technical support and operational guidance for the administrators of grassroots health administrative departments, medical institutions, medical device administrators, users, and maintainers to understand and grasp the distant and regulatory provisions of the Code more accurately. In October 2010, the Medical Management Division of the National Health Commission launched a special spot check on rational clinical use and safety management of medical devices. Seven experts from the Chinese Medical Society and Clinical Engineering participated in the investigation of the clinical safety management of medical devices in 30 hospitals in Beijing, Shanghai, Guangdong, Hubei, Liaoning, and Zhejiang, where they analyzed the problems found in the inspection and suggested countermeasures and suggestions.

Participation in the preparation of the national medical device management quality control center By the end of 2017, 14 provinces and ­m unicipalities in China had established provincial and municipal MDMQCCs, which respectively initiated quality control of medical equipment management in the region. At present, under the leadership of the National Health and Family Planning Hospital Management Research Institute, 14 medical equipment quality control centers of various provinces and cities actively participated in the drafting of relevant quality control center management norms, and preparations for the establishment of a national-level MDMQCC.

International exchanges Successfully held the first international clinical engineering and HTM academic congress (ICEHTMC) in Hanghzou in 2015 As one of the main coorganizers, CSCE put forth great efforts to make the first ICEHTMC a success.

Collaborated programs with ECRI (4) Training courses for medical devices relevant to adverse events investigation have been conducted once a year since 2013, and nearly 500 HTM professionals attended these courses. (5) Chinese translation of ECRI Health Device Journal was published on the CSCE website and the Journal of China Medical Device during 2011–13.

American subject matter experts who attended our annual CE Congress or CMEF CE Forum and shared their best practice and knowledge Many subject matter experts including Yadin David, Malcolm Ridgway, William Hyman, Binseng Wang, James Wear, Jeff Lerner, Elliot Sloane, Samantha Jacques, Kevin Bennet, Steve Grimes, Mario Castaneda, Tobey Clark, Anthony Montagnolo, Robert Stiefel, Tom Judd, Andrew Currie, Jennifer Jackson, Ilir Kullolli, and Alan Lipschultz visited us at our annual congress or other relevant events.

Participated in the AAMI and ACCE conferences in the United States in 2017 On June 9–12, 2017, a CSCE expert delegation (hereinafter referred to as the visiting group) went to the United States to attend the AAMI Annual Meeting and conduct local hospital visits and exchanges. The participants in this international exchange were: Professor Li Bin, the vice chairman of CSCE; Professor Zheng Kun, vice chairman of CSCE and head of foreign affairs division; Prof. Xia Huilin, deputy Secretary-General of CSCE; and Zhang Yue, Academic Department of the Chinese Medical Association. This was the first time that the CSCE sent a delegation to participate in the AAMI academic activities. The visiting activities enabled us to have a comprehensive understanding of the overall development level of clinical engineering in the United States, and have deeper contacts and exchanges with mainstream academic groups such as AAMI, ECRI, ACCE, etc., and have further contacts with more American clinical engineering experts and scholars. It also enabled these organizations and personnel to understand Chinese clinical engineering and CSCE better.

124  SECTION | 2  Worldwide clinical engineering practice

Further reading David, Y., Dan, Z., Hyman, W., Kun, Z., 2011. Clinical engineering development in China. J. Clin. Eng., 68–71. David, Y., Qiang, Z., Dan, Z., Mingchen, P., Kun, Z., Bin, L., Shenglin, L., Huiling, X., 2014. Quality and safety should be the objective for inhouse clinical engineering. China Med. Dev. 8, 1–4. 57. Huiling, X., 2013. Walking Into the 20  Years of Clinical Engineering. China City Press, Beijing.

Qiang, Z., Guanxing, G., Dan, Z., 2015. The White Paper on Chinese Clinical Engineering. Hubei Scientific & Technology Publishing House, Wu Han. Wang, B., 2011. Medical Equipment Maintenance: Management and Oversight. Morgan & Claypool Publishers. WHO Medical Device Technical Series, 2017. Human Resources for Medical Devices. World Health Organization. Yuanhai, J., Mingchen, P., 2009. Clinical Engineering Technology. Scientific & Technology Publishing House, Beijing.