- Email: [email protected]
Clinical engineering in India
Chapter 20
Clinical engineering in India Niranjan D. Khambete Department of Clinical Engineering, Deenanath Mangeshkar Hospital and Research Centre, Pune, India
Introduction Advanced medical technology has revolutionized modern medical practice making it possible to effectively deliver high quality and safe health care to patients. Effectiveness of healthcare delivery is closely linked to the efficient management of this medical technology and clinical engineers (CEs), who manages the medical technology, play a key role along with other clinical professionals in this h ealthcare delivery process. Therefore, for any country, it is essential to ensure that sufficient efforts are directed toward developing and strengthening of the CE profession. This chapter begins by outlining the current form of healthcare delivery systems in India and the current situation of healthcare technology management (HTM). It then goes on to describe historical as well as recent initiatives aimed at development of the CE profession in India. It provides details regarding training avenues for CEs and their professional activities and concludes with some suggestions for further development of this profession in the country.
Healthcare delivery systems in India India is the second most populated country in the world and in order to cater to the healthcare needs of such a large population, it needs to have an effective and safe healthcare delivery system. In its current form, the country’s healthcare delivery system has evolved into a mix of government-funded network of healthcare organizations and a large number of charitable and corporate healthcare organizations. Highly qualified and well-trained clinical professionals are indeed a strength of these organizations and by acquiring advanced medical technology they have brought its benefits to a large number of patients. Initiatives such as the establishment of National Accreditation Board for Hospitals and Healthcare Systems in 2006 and passing of Clinical Establishment Act by the Indian Parliament in 2010 have provided a suitable framework for quality enhancement and regulation of the h ealthcare delivery systems. Furthermore, various activities of the advisory bodies such as National Health Systems Resource Center, 132
have initiated policy-level changes for increasing the effectiveness of healthcare delivery in the country (National Accreditation Board for Hospitals and Healthcare Systems, 2015; National Health Systems Resource Centre, n.d.).
Concerns regarding current state of healthcare technology management In spite of the strengths mentioned above, one aspect that seems to have received less attention from the leaders and policymakers of healthcare system is the need to have effective systems for management of medical technology. This is evident from the literature and media reports published in recent years. A survey aimed at reviewing the status of medical equipment in one of the largest public hospitals in South India reported that out of 3790 pieces of medical equipment, 30% were found to be “out of service.” This situation was attributed to the absence of efficient procedures for equipment and vendor management, suboptimal user training and insufficient efforts toward carrying out preventive maintenance (APAC-VHS/Shiva Consultants, 2011). Another pilot survey of medical equipment safety conducted in Central India revealed that out of 41 clinicians surveyed, 39 reported that they had witnessed medical equipment-related patient safety incidents. These incidents involved various types of medical equipment such as electrosurgery units, motorized operation tables, patient monitors, surgical lamps, suction pumps, and infusion pumps (Khambete et al., 2010, 2012). Reports of serious injuries and death due to malfunction of neonatal intensive care equipment such as baby incubators and warmers have appeared in media at an alarmingly high rate. A study of these reports revealed that 15 such cases from eight different states of India were reported in the media between 2003 and 2011, and burn injuries and death due to fire were reported in 13 of them (Indian Express, 2009; The Hindu, 2008; Khambete and Sable, 2012). Concerns regarding the safety of medical X-ray equipment have also been raised more than once in newspaper reports (The Hindu, 2008; India Today, 2012; Sonawane et al., 2010). Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00020-1 Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in India Chapter | 20 133
A few reports have also highlighted issues related to medical device regulation and periodic medical device checks and raised concerns over suboptimal maintenance of medical equipment in public hospitals (The Hindu, 2012; Maya, 2013; Nagarajan, 2015). These reports, though anecdotal in nature, cannot be ignored as they do point at major gaps in the management and safe use of medical technology. Efforts have been underway historically as well as in recent years to address these issues by encouraging discussion among stakeholders and emphasizing the need to promote CE profession. An account of these early efforts is presented below followed by details of more recent initiatives.
Early efforts in establishing clinical engineering As reported by Mehta JC in 2000, efforts to establish clinical engineering profession in India were initiated as early as 1969 (Mehta, 2000). Subsequently, in the year 1970, senior medical professionals working at Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, along with the Ministry of Health, Government of India, took an initiative in forming a working group to identify the engineering needs in hospitals. These findings were implemented in PGIMER by establishing preventive maintenance protocols for the medical equipment. Bio-Medical Engineering Society of India (BMESI) was also established in the 1960s with a mission to encourage interaction between scientist, engineers, and clinicians and thus, promote research and development in all aspects of Biomedical Engineering. A similar initiative in Bangalore led to the formation of Clinical Engineering Society of India in 1997. However, in spite of achieving an initial breakthrough in bringing interdisciplinary professionals on a common platform, it appears that these societies could create limited impact on development of CE profession in India. As a consequence, the CE profession and HTM practices seem to have lagged behind other developments in the healthcare system.
Recent efforts for revival of clinical engineering These media reports highlighting the limitations in HTM practices and raising concerns about medical equipment safety have led to a feeling of urgency among professionals for reviving and strengthening the CE profession in India. Many conferences, workshops, and focus group meetings have been organized in recent past, building up consensus to speedily act and overcome these limitations through concerted action. Inputs from international experts have been sought during these events and participation of leaders of healthcare systems and health policymakers have been
e nsured to achieve maximum impact. The following overview of these initiatives highlights their key points.
Advanced Clinical Engineering Workshop (ACEW—India, 2009) The Advanced Clinical Engineering Workshop (ACEW— India, 2009), was organized in October 2009 by Sree Chitra Tirunal Institute for Medical Sciences and Technology at Trivandrum, Kerala, India and can be considered as the first major event in recent past for revival of interest in CE profession. The faculty to this Workshop included five experienced CEs from the United States of America along with senior clinicians and hospital managers from leading hospitals of India. CEs, teaching faculty, hospital managers, and students were the participants in this Workshop. The sessions covered all the important topics related to HTM with a special emphasis on training and competency requirements for certification of CEs, use of information technology in modern HTM practices and adverse event investigation. After a long time gap, this workshop provided a valuable opportunity to CE professionals from India to interact with those from abroad and compare their practices. Participants from distinct disciplines such as engineering, medicine, and management used this platform to exchange their experiences and share their concerns about the current CE practices in the country leading to a clear consensus that urgent action was needed to strengthen the CE profession in India.
International Clinical Engineering Workshop (ICEW—India, 2011) In order to sustain the momentum generated by ACEWIndia (2009), second ICEW-India (2011) was organized jointly by the College of Engineering, Pune and Sree Chitra Tirunal Institute for Medical Sciences and Technology in Pune in February 2011. Active involvement of CEs and medical device experts from the UK was the main feature of this event. A talk by the Senior Advisor to World Health Organization, Geneva, on Medical Devices and Healthcare Technology, was another important highlight of this Workshop. It also received formal endorsements from some of the country’s leading healthcare organizations, namely the Armed Forces Medical College, Fortis Healthcare Ltd, Max Healthcare Institute, and Deenanath Mangeshkar Hospital and Research Center. “Medical Device Safety” was the central theme of this Workshop and keeping in line with this theme, a low priced Asian edition of the book titled “Medical Devices: Use and Safety” by Jacobson and Murray (2011), was released during the inaugural session of this Workshop. The eminent personalities invited to the inaugural session mainly included clinicians occupying offices of high authority in
134 SECTION | 2 Worldwide clinical engineering practice
renowned healthcare organizations. The purpose behind giving them prominence was to attract their attention to the current status of CE profession in India and seek their involvement in its development. The experts equivocally acknowledged that there was a need to employ trained and certified CEs in hospitals to reduce medical device safety incidents. They also emphasized the need for setting up a National Certification Body for CEs in India and assured help and complete support to this initiative.
Impact of these workshops and follow-up activities The talks and discussions on good HTM Practices and medical equipment safety, which took place at the two main events described above seemed to generate significant interest among other medical professionals. Their impact in spreading this message beyond the cities was evident from an invitation to conduct a similar workshop for staff of Government Medical College, in Latur, a small town in the state of Maharashtra. Taking a cue from this invitation, two 1-day “Regional Clinical Engineering Workshops” (RCEWs) were organized in Latur and Mumbai in May and June of 2011, respectively. These RCEWs also provided an opportunity to the Workshop’s faculty members in gaining insight into challenges faced in implementing HTM practices in places located away from the major cities. The discussions at these RCEWs also led to the preparation of a report recommending establishment of “Department of Clinical Engineering” with full academic status in each of the Medical Colleges run by the state of Maharashtra. This report was presented to the Health Education Ministry of the state government for further consideration.
Clinical engineering conclave—2012 In order to further strengthen advocacy in support of CE profession, a roundtable meeting of experts was called in February 2012 at King Edward Memorial Hospital, Mumbai. The invitees included individuals in leadership positions in public health sectors, experts in senior positions in charitable and private healthcare sectors, representatives of medical equipment procurement agencies, accreditation bodies (National Accreditation Board for Hospitals & Healthcare Providers, NABH), Medical Council of India, Army Medical Corps, and academic institutions. International experts from the UK and from WHO were special invitees and they shared their experiences and gave valuable suggestions. The action points that emerged from these discussions identified the need for: ●
An Adverse Event Reporting System, initially in selected hospitals and then at the national level.
●
●
●
Systematic surveys on existing HTM practices in different healthcare sectors and identifying the gaps. Formation of a professional body for CEs and Biomedical Equipment Technicians (BMETs) and certification requirements. Continued advocacy at various levels of government for policies on HTM and medical device safety.
Medical Equipment Safety Workshop Series—2013 and 2014 Medical Equipment Safety Workshop Series—India, 2013 and 2014 was a continuation of efforts toward engaging healthcare authorities and professionals with problems related to medical equipment safety and initiate necessary changes. This initiative involved conducting 1-day seminar on Medical Equipment Safety in about 20 medical colleges and renowned hospitals across the country. During these seminars, information on the current situation of medical equipment safety practices was also sought from the participants through a questionnaire.
Achieving sustainability in the long run These renewed efforts in the form of Workshops and consultation meetings helped in achieving the first step toward creating an overall awareness regarding the need for good HTM practices, safe use of medical devices and development of the CE profession in India. It was also an important step forward in acknowledging that there were substantial challenges associated with the management of healthcare technology, the availability of clinical engineers and their training and establishing effective medical device incident reporting in the country.
Training of clinical engineers: Barriers and opportunities Almost throughout India, it is an established norm to provide engineering and medical education in separate educational institutions. This perhaps has led to the creation of a knowledge barrier between these two professions. On the one hand, healthcare systems, which are led by medical professionals, have been rapidly adopting modern medical technology, but on the other hand, realization for its effective management also requires a strong back up of highly trained in-house CE professionals and this has been coming up only lately. Thus, in the absence of significant demand for formally trained CE professionals, the education and training avenues for them have taken a long time to come up. Undergraduate and postgraduate programs in Biomedical Engineering have remained focused on biomedical engineering research
Clinical engineering in India Chapter | 20 135
rather than CE training because the ‘engineering’ institutions offering these opportunities have remained distant from the clinical environment.
High-level academic and training of Clinical Engineers In order to address the need for a formal high-level academic as well as training program for CEs in the country, in 2008, three premier academic institutes, namely, Indian Institute of Technology Madras, Christian Medical College Vellore and Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum, jointly launched Masters in Technology program in Clinical Engineering, the first of its kind in the country. In addition to conventional academic courses in Biomedical Engineering, two unique training modules in the form of “Clinical Attachment” and “Clinical Engineering Internship” were introduced into the curriculum. This provided students ample time to immerse themselves in the clinical environment and thus, understand important practical aspects of patient care. They could closely interact with the clinical professionals in various clinical departments as well as get involved in the management of medical equipment through all stages of its life cycle from procurement to disposal. They also got a unique opportunity to identify “unmet clinical needs” and propose innovative technology-oriented solutions.
Training avenues for Biomedical Equipment Technicians Training for Biomedical Equipment Technicians has been made available by many institutions across the country in private as well as public sector. These training programs include hands-on repair and maintenance of most commonly used medical equipment. These programs have been either short courses up to 6-month duration or 3-year state government recognized Diploma in Engineering Courses with specialization in Medical Electronics. Organizations such as HLL (formerly Hindustan Latex Limited) Lifecare Limited, Trivandrum, Center for Advanced Computing, Mohali, Center for Development of Imaging Technology, Trivandrum, and Kerala Institute of Medical Sciences, Trivandrum have been offering certificate courses of 6 months to 1-year duration. Some Universities offer an M.Sc. (Biomedical Instrumentation) which allow successful candidates to take up positions as senior BMETs or even CEs in hospitals.
Clinical engineering professional activities Clinical engineering community in India has remained professionally unorganized. On the other hand, recent widespread use of social media through smartphones has made
it possible for them to unite on such platforms. One such platform is FORCE Biomedical, which has been recently registered with the government as nonprofit organization and has about 1000 members. Similarly, CEs and BMETs have formed informal social media groups, which they use for exchanging technical information.
Future of clinical engineering in India Clinical engineering profession in India has been slow in gaining recognition for all these years. However, recent initiatives have provided momentum for its growth and in order to sustain this growth, innovative approaches need to be adopted. One such approach could be providing CE exposure to undergraduate engineering students by offering them long term, that is, up to 6 months, internships in hospitals. These internships would be compulsory and made part of their engineering curriculum. This would open up an opportunity for these young engineers to gain the first-hand experience of clinical medicine and witness how advances in technology have revolutionized today’s medical practice. Regulation of CE profession through Certification by a statutory body such as the Clinical Engineering Council of India would help in ensuring that quality of this profession is maintained. A system for assessment of knowledge and competency levels of existing CEs and BMETs working in hospitals will have to be worked out. In the same way formal periodic assessments by this body would help in achieving continuous professional development. These efforts will lead to ensuring that only best and competent CE professionals remain in service.
Conclusion The crucial role of CEs in providing effective and safe health care is acknowledged world over, especially when modern medicine continues to increasingly depend on use of advanced medical technology. Clinical engineers are capable of addressing multiple issues in relation to the use of advanced medical technology, thus can effectively complement the efforts of clinical professionals in providing highest standards of care. In India, in spite of having highly trained clinical professionals, less attention is being directed toward the needs of education, training, credentialing, and continuing professional development of CEs. This is perhaps reflected in the appearance of multiple media reports on equipment associated with patient safety incidents. It is obvious that urgent steps need to be taken toward developing a strong CE Profession in the country. Recent renewed efforts described in this chapter have helped in creating awareness and triggered interest among the authorities in the healthcare systems by closely i nvolving
136 SECTION | 2 Worldwide clinical engineering practice
them in various events. These efforts need to be sustained if the required change has to happen in near future. Many more avenues for education and training of the CEs to the highest and internationally accepted standards are needed to satisfy the need of the country. A policy-level change is warranted at the highest level of governance to trigger this process.
References APAC-VHS/Shiva Consultants, 2011. Utilisation of medical equipment in public health facilities in Tamil Nadu: a pilot study. Unpublished Report. India Today, 2012. AERB’s sloppiness leads to flouting of radiation norms. Kartikeya Sharma, New Delhi, September 10, 2012. http://indiatoday. intoday.in/story/radiation-norms-aerb-diagnostic-units/1/216718. html. (Accessed October 3, 2012). Indian Express, 2009. Five infants burnt alive as incubator catches fire. http://www.indianexpress.com/news/five-infants-burnt-alive-as-incubator-catche/417449/. (Accessed January 10, 2010). Jacobson, Murray, A., 2011. Medical Devices: Use and Safety, Elsevier, India. Khambete, N., and Sable, S., 2012. Neonatal incubators: are new born babies really safe? IFMBE Proceedings 2013; 39. World Congress on Medical Physics and Biomedical Engineering, Beijing. Khambete, N., Kelkar-Khambete, A., Desurkar, V., Murray, A., 2010 .Safety of medical equipment: a review of hospital safety testing in the Indian City of Pune, In: Appropriate Healthcare Technologies for Developing Countries, Institution of Engineering and Technology, London, pp 1–4. Khambete, N., Kelkar-Khambete, A., Desurkar, V., Murray, A., 2012. Safety testing of medical equipment in hospitals and its implications for patient care in India. World Congress in Medical Physics and Biomedical Engineering, Beijing.
Maya, 2013. Life-saving machines in medical colleges get no check-up. The Hindu, http://www.thehindu.com/todays-paper/lifesavingmachines-in-medical-colleges-get-no-checkup/article5337476.ece. (Accessed November 2, 2019). Mehta, J., 2000. Why are our hospitals sick?. The Tribune, https://www. tribuneindia.com/2000/20000308/health.htm#4. (Accessed November 2, 2019). Nagarajan, R., 2015. 30-63% of Rs 10,000 crore medical devices faulty. The Times of India. https://timesofindia.indiatimes.com/india/3063-of-Rs-10000-crore-medical-devicesfaulty/articleshow/46037018. cms. (Accessed November 2, 2019). National Accreditation Board for Hospitals and Healthcare Systems, 2015. Accreditation Standards for Hospitals, fourth ed. National Health Systems Resource Centre. NHRC Introductory Brochure. n.d. http://nhsrcindia.org/sites/default/files/NHSRC_Introductory_Brochure. pdf (Accessed November 2, 2019). Sonawane, U., Singh, M., Sunil Kumar, J.V., Kulkarni, A., Shirva, V.K., Pradhan, A.S., 2010. Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India. J. Med. Phys. 35 (4), 229–234. The Hindu, 2008. Dismal state of medical X-ray safety. http://www.thehindu. com/thehindu/seta/2008/06/05/stories/2008060550081400.htm. (Accessed October 3, 2012). The Hindu, 2008. Two tragic deaths in two incubators. http://www.thehindu.com/2008/03/13/stories/2008031360440100.htm. (Accessed January 10, 2010). The Hindu, 2012. Editorial. Regulating hospitals is healthy. http://www. thehindu.com/opinion/editorial/regulatinghospitals-is-healthy/article2889880.ece. (Accessed November 2, 2019).
Clinical engineering in India Niranjan D. Khambete Department of Clinical Engineering, Deenanath Mangeshkar Hospital and Research Centre, Pune, India
Introduction Advanced medical technology has revolutionized modern medical practice making it possible to effectively deliver high quality and safe health care to patients. Effectiveness of healthcare delivery is closely linked to the efficient management of this medical technology and clinical engineers (CEs), who manages the medical technology, play a key role along with other clinical professionals in this h ealthcare delivery process. Therefore, for any country, it is essential to ensure that sufficient efforts are directed toward developing and strengthening of the CE profession. This chapter begins by outlining the current form of healthcare delivery systems in India and the current situation of healthcare technology management (HTM). It then goes on to describe historical as well as recent initiatives aimed at development of the CE profession in India. It provides details regarding training avenues for CEs and their professional activities and concludes with some suggestions for further development of this profession in the country.
Healthcare delivery systems in India India is the second most populated country in the world and in order to cater to the healthcare needs of such a large population, it needs to have an effective and safe healthcare delivery system. In its current form, the country’s healthcare delivery system has evolved into a mix of government-funded network of healthcare organizations and a large number of charitable and corporate healthcare organizations. Highly qualified and well-trained clinical professionals are indeed a strength of these organizations and by acquiring advanced medical technology they have brought its benefits to a large number of patients. Initiatives such as the establishment of National Accreditation Board for Hospitals and Healthcare Systems in 2006 and passing of Clinical Establishment Act by the Indian Parliament in 2010 have provided a suitable framework for quality enhancement and regulation of the h ealthcare delivery systems. Furthermore, various activities of the advisory bodies such as National Health Systems Resource Center, 132
have initiated policy-level changes for increasing the effectiveness of healthcare delivery in the country (National Accreditation Board for Hospitals and Healthcare Systems, 2015; National Health Systems Resource Centre, n.d.).
Concerns regarding current state of healthcare technology management In spite of the strengths mentioned above, one aspect that seems to have received less attention from the leaders and policymakers of healthcare system is the need to have effective systems for management of medical technology. This is evident from the literature and media reports published in recent years. A survey aimed at reviewing the status of medical equipment in one of the largest public hospitals in South India reported that out of 3790 pieces of medical equipment, 30% were found to be “out of service.” This situation was attributed to the absence of efficient procedures for equipment and vendor management, suboptimal user training and insufficient efforts toward carrying out preventive maintenance (APAC-VHS/Shiva Consultants, 2011). Another pilot survey of medical equipment safety conducted in Central India revealed that out of 41 clinicians surveyed, 39 reported that they had witnessed medical equipment-related patient safety incidents. These incidents involved various types of medical equipment such as electrosurgery units, motorized operation tables, patient monitors, surgical lamps, suction pumps, and infusion pumps (Khambete et al., 2010, 2012). Reports of serious injuries and death due to malfunction of neonatal intensive care equipment such as baby incubators and warmers have appeared in media at an alarmingly high rate. A study of these reports revealed that 15 such cases from eight different states of India were reported in the media between 2003 and 2011, and burn injuries and death due to fire were reported in 13 of them (Indian Express, 2009; The Hindu, 2008; Khambete and Sable, 2012). Concerns regarding the safety of medical X-ray equipment have also been raised more than once in newspaper reports (The Hindu, 2008; India Today, 2012; Sonawane et al., 2010). Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00020-1 Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in India Chapter | 20 133
A few reports have also highlighted issues related to medical device regulation and periodic medical device checks and raised concerns over suboptimal maintenance of medical equipment in public hospitals (The Hindu, 2012; Maya, 2013; Nagarajan, 2015). These reports, though anecdotal in nature, cannot be ignored as they do point at major gaps in the management and safe use of medical technology. Efforts have been underway historically as well as in recent years to address these issues by encouraging discussion among stakeholders and emphasizing the need to promote CE profession. An account of these early efforts is presented below followed by details of more recent initiatives.
Early efforts in establishing clinical engineering As reported by Mehta JC in 2000, efforts to establish clinical engineering profession in India were initiated as early as 1969 (Mehta, 2000). Subsequently, in the year 1970, senior medical professionals working at Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, along with the Ministry of Health, Government of India, took an initiative in forming a working group to identify the engineering needs in hospitals. These findings were implemented in PGIMER by establishing preventive maintenance protocols for the medical equipment. Bio-Medical Engineering Society of India (BMESI) was also established in the 1960s with a mission to encourage interaction between scientist, engineers, and clinicians and thus, promote research and development in all aspects of Biomedical Engineering. A similar initiative in Bangalore led to the formation of Clinical Engineering Society of India in 1997. However, in spite of achieving an initial breakthrough in bringing interdisciplinary professionals on a common platform, it appears that these societies could create limited impact on development of CE profession in India. As a consequence, the CE profession and HTM practices seem to have lagged behind other developments in the healthcare system.
Recent efforts for revival of clinical engineering These media reports highlighting the limitations in HTM practices and raising concerns about medical equipment safety have led to a feeling of urgency among professionals for reviving and strengthening the CE profession in India. Many conferences, workshops, and focus group meetings have been organized in recent past, building up consensus to speedily act and overcome these limitations through concerted action. Inputs from international experts have been sought during these events and participation of leaders of healthcare systems and health policymakers have been
e nsured to achieve maximum impact. The following overview of these initiatives highlights their key points.
Advanced Clinical Engineering Workshop (ACEW—India, 2009) The Advanced Clinical Engineering Workshop (ACEW— India, 2009), was organized in October 2009 by Sree Chitra Tirunal Institute for Medical Sciences and Technology at Trivandrum, Kerala, India and can be considered as the first major event in recent past for revival of interest in CE profession. The faculty to this Workshop included five experienced CEs from the United States of America along with senior clinicians and hospital managers from leading hospitals of India. CEs, teaching faculty, hospital managers, and students were the participants in this Workshop. The sessions covered all the important topics related to HTM with a special emphasis on training and competency requirements for certification of CEs, use of information technology in modern HTM practices and adverse event investigation. After a long time gap, this workshop provided a valuable opportunity to CE professionals from India to interact with those from abroad and compare their practices. Participants from distinct disciplines such as engineering, medicine, and management used this platform to exchange their experiences and share their concerns about the current CE practices in the country leading to a clear consensus that urgent action was needed to strengthen the CE profession in India.
International Clinical Engineering Workshop (ICEW—India, 2011) In order to sustain the momentum generated by ACEWIndia (2009), second ICEW-India (2011) was organized jointly by the College of Engineering, Pune and Sree Chitra Tirunal Institute for Medical Sciences and Technology in Pune in February 2011. Active involvement of CEs and medical device experts from the UK was the main feature of this event. A talk by the Senior Advisor to World Health Organization, Geneva, on Medical Devices and Healthcare Technology, was another important highlight of this Workshop. It also received formal endorsements from some of the country’s leading healthcare organizations, namely the Armed Forces Medical College, Fortis Healthcare Ltd, Max Healthcare Institute, and Deenanath Mangeshkar Hospital and Research Center. “Medical Device Safety” was the central theme of this Workshop and keeping in line with this theme, a low priced Asian edition of the book titled “Medical Devices: Use and Safety” by Jacobson and Murray (2011), was released during the inaugural session of this Workshop. The eminent personalities invited to the inaugural session mainly included clinicians occupying offices of high authority in
134 SECTION | 2 Worldwide clinical engineering practice
renowned healthcare organizations. The purpose behind giving them prominence was to attract their attention to the current status of CE profession in India and seek their involvement in its development. The experts equivocally acknowledged that there was a need to employ trained and certified CEs in hospitals to reduce medical device safety incidents. They also emphasized the need for setting up a National Certification Body for CEs in India and assured help and complete support to this initiative.
Impact of these workshops and follow-up activities The talks and discussions on good HTM Practices and medical equipment safety, which took place at the two main events described above seemed to generate significant interest among other medical professionals. Their impact in spreading this message beyond the cities was evident from an invitation to conduct a similar workshop for staff of Government Medical College, in Latur, a small town in the state of Maharashtra. Taking a cue from this invitation, two 1-day “Regional Clinical Engineering Workshops” (RCEWs) were organized in Latur and Mumbai in May and June of 2011, respectively. These RCEWs also provided an opportunity to the Workshop’s faculty members in gaining insight into challenges faced in implementing HTM practices in places located away from the major cities. The discussions at these RCEWs also led to the preparation of a report recommending establishment of “Department of Clinical Engineering” with full academic status in each of the Medical Colleges run by the state of Maharashtra. This report was presented to the Health Education Ministry of the state government for further consideration.
Clinical engineering conclave—2012 In order to further strengthen advocacy in support of CE profession, a roundtable meeting of experts was called in February 2012 at King Edward Memorial Hospital, Mumbai. The invitees included individuals in leadership positions in public health sectors, experts in senior positions in charitable and private healthcare sectors, representatives of medical equipment procurement agencies, accreditation bodies (National Accreditation Board for Hospitals & Healthcare Providers, NABH), Medical Council of India, Army Medical Corps, and academic institutions. International experts from the UK and from WHO were special invitees and they shared their experiences and gave valuable suggestions. The action points that emerged from these discussions identified the need for: ●
An Adverse Event Reporting System, initially in selected hospitals and then at the national level.
●
●
●
Systematic surveys on existing HTM practices in different healthcare sectors and identifying the gaps. Formation of a professional body for CEs and Biomedical Equipment Technicians (BMETs) and certification requirements. Continued advocacy at various levels of government for policies on HTM and medical device safety.
Medical Equipment Safety Workshop Series—2013 and 2014 Medical Equipment Safety Workshop Series—India, 2013 and 2014 was a continuation of efforts toward engaging healthcare authorities and professionals with problems related to medical equipment safety and initiate necessary changes. This initiative involved conducting 1-day seminar on Medical Equipment Safety in about 20 medical colleges and renowned hospitals across the country. During these seminars, information on the current situation of medical equipment safety practices was also sought from the participants through a questionnaire.
Achieving sustainability in the long run These renewed efforts in the form of Workshops and consultation meetings helped in achieving the first step toward creating an overall awareness regarding the need for good HTM practices, safe use of medical devices and development of the CE profession in India. It was also an important step forward in acknowledging that there were substantial challenges associated with the management of healthcare technology, the availability of clinical engineers and their training and establishing effective medical device incident reporting in the country.
Training of clinical engineers: Barriers and opportunities Almost throughout India, it is an established norm to provide engineering and medical education in separate educational institutions. This perhaps has led to the creation of a knowledge barrier between these two professions. On the one hand, healthcare systems, which are led by medical professionals, have been rapidly adopting modern medical technology, but on the other hand, realization for its effective management also requires a strong back up of highly trained in-house CE professionals and this has been coming up only lately. Thus, in the absence of significant demand for formally trained CE professionals, the education and training avenues for them have taken a long time to come up. Undergraduate and postgraduate programs in Biomedical Engineering have remained focused on biomedical engineering research
Clinical engineering in India Chapter | 20 135
rather than CE training because the ‘engineering’ institutions offering these opportunities have remained distant from the clinical environment.
High-level academic and training of Clinical Engineers In order to address the need for a formal high-level academic as well as training program for CEs in the country, in 2008, three premier academic institutes, namely, Indian Institute of Technology Madras, Christian Medical College Vellore and Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum, jointly launched Masters in Technology program in Clinical Engineering, the first of its kind in the country. In addition to conventional academic courses in Biomedical Engineering, two unique training modules in the form of “Clinical Attachment” and “Clinical Engineering Internship” were introduced into the curriculum. This provided students ample time to immerse themselves in the clinical environment and thus, understand important practical aspects of patient care. They could closely interact with the clinical professionals in various clinical departments as well as get involved in the management of medical equipment through all stages of its life cycle from procurement to disposal. They also got a unique opportunity to identify “unmet clinical needs” and propose innovative technology-oriented solutions.
Training avenues for Biomedical Equipment Technicians Training for Biomedical Equipment Technicians has been made available by many institutions across the country in private as well as public sector. These training programs include hands-on repair and maintenance of most commonly used medical equipment. These programs have been either short courses up to 6-month duration or 3-year state government recognized Diploma in Engineering Courses with specialization in Medical Electronics. Organizations such as HLL (formerly Hindustan Latex Limited) Lifecare Limited, Trivandrum, Center for Advanced Computing, Mohali, Center for Development of Imaging Technology, Trivandrum, and Kerala Institute of Medical Sciences, Trivandrum have been offering certificate courses of 6 months to 1-year duration. Some Universities offer an M.Sc. (Biomedical Instrumentation) which allow successful candidates to take up positions as senior BMETs or even CEs in hospitals.
Clinical engineering professional activities Clinical engineering community in India has remained professionally unorganized. On the other hand, recent widespread use of social media through smartphones has made
it possible for them to unite on such platforms. One such platform is FORCE Biomedical, which has been recently registered with the government as nonprofit organization and has about 1000 members. Similarly, CEs and BMETs have formed informal social media groups, which they use for exchanging technical information.
Future of clinical engineering in India Clinical engineering profession in India has been slow in gaining recognition for all these years. However, recent initiatives have provided momentum for its growth and in order to sustain this growth, innovative approaches need to be adopted. One such approach could be providing CE exposure to undergraduate engineering students by offering them long term, that is, up to 6 months, internships in hospitals. These internships would be compulsory and made part of their engineering curriculum. This would open up an opportunity for these young engineers to gain the first-hand experience of clinical medicine and witness how advances in technology have revolutionized today’s medical practice. Regulation of CE profession through Certification by a statutory body such as the Clinical Engineering Council of India would help in ensuring that quality of this profession is maintained. A system for assessment of knowledge and competency levels of existing CEs and BMETs working in hospitals will have to be worked out. In the same way formal periodic assessments by this body would help in achieving continuous professional development. These efforts will lead to ensuring that only best and competent CE professionals remain in service.
Conclusion The crucial role of CEs in providing effective and safe health care is acknowledged world over, especially when modern medicine continues to increasingly depend on use of advanced medical technology. Clinical engineers are capable of addressing multiple issues in relation to the use of advanced medical technology, thus can effectively complement the efforts of clinical professionals in providing highest standards of care. In India, in spite of having highly trained clinical professionals, less attention is being directed toward the needs of education, training, credentialing, and continuing professional development of CEs. This is perhaps reflected in the appearance of multiple media reports on equipment associated with patient safety incidents. It is obvious that urgent steps need to be taken toward developing a strong CE Profession in the country. Recent renewed efforts described in this chapter have helped in creating awareness and triggered interest among the authorities in the healthcare systems by closely i nvolving
136 SECTION | 2 Worldwide clinical engineering practice
them in various events. These efforts need to be sustained if the required change has to happen in near future. Many more avenues for education and training of the CEs to the highest and internationally accepted standards are needed to satisfy the need of the country. A policy-level change is warranted at the highest level of governance to trigger this process.
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