Clinical engineering in Paraguay

Chapter 11

Clinical engineering in Paraguay Pedro Galvan Biomedical Engineering Department, Health Sciences Research Institute, San Lorenzo, Paraguay

Healthcare technology (HCT) development plays an essential role today in promoting health and developing health systems and services. Clinical engineers must be able to work with patients and with a range of professional staff, including technicians and clinicians, and with medical device providers. They have to keep up-to-date with fast-­moving scientific and medical research in the field and be able to develop laboratory, design, workshop, and management skills. Traditionally, in developing countries, nonfunctional equipment and facilities impede the adequate delivery of appropriate health services. Furthermore, a proper health technology management (HTM), which includes HCT policy, sufficient financial resources, adequate human resources, and a comprehensive maintenance system, is crucial to guaranteeing the development of a sustainable health service. This chapter provides an overview of the clinical engineering practice in Paraguay and its impact on the care HCT management system for the public health sector. A feasible and sustainable HCT model is included in the management plan, which is based on a development of the healthcare infrastructure in the last decade. The HCT management (HCTM) plan focuses on issues such as HCT policy, financial resources, human resource development, and maintenance system to promote a sustainable clinical engineering practice in the country in the framework of an adequate health service delivery policy. Together, a well-structured and organized HCTM with the experiences made in this field can help to establish a comprehensive clinical engineering practice in healthcare systems.

Introduction One of the results of globalization and efforts to improve healthcare systems worldwide has been the recognition that increasingly complex healthcare technology (HCT) plays a vitally important role in all health systems.

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In the last decade, the majority of countries in the Americas, including Paraguay, has been reforming their health systems and services to promote equity in health and universal access to health services through improved HCTM. Improved HCTM will result in increased efficiency in the allocation, use, and maintenance of resources; improved effectiveness and quality of care; ensured financial sustainability, and encouraging community participation and intersectoral action (PAHO, 2001). In Latin America and the Caribbean, there are approximately 50% of the medical devices in public hospitals out of service or is functioning at a level that is out of compliance with manufacturer safety specifications. The problem of malfunctioning equipment is complex and it involves issues such as the capital and recurrent cost of equipment; the low level of development of maintenance systems; the lack of standardization; the donation of medical equipment; weak after-sale support service; uncoordinated processes for infrastructure development; a lack of technical capacity; and a shortage of professional and technical staff in public sector hospitals. In Paraguay, the hospital infrastructure lists 1207 hospitals with 6966 hospital beds. Of these hospitals, 68.6% are located in the public sector and comprise 62.2% of the hospitals beds. The state of the physical and technological infrastructure in the health sector is similar to that in Latin America. A survey of HCT maintenance practices taken in 18 regions in the country (Galvan and Isaacs, 1999) showed that 48.9% of existing medical equipment and devices were out of service or malfunctioning, mainly due to a lack of managerial capacity and a shortage of professional and technical maintenance staff. Finally, as in most developing countries, technology development plays an essential role in promoting health and in developing health systems and services. A well-conceived and well-implemented biomedical or clinical ­engineering

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service can make an important contribution to health technology assessment (HTA), to the proper distribution of resources, to the selection of cost-effective technology, to greater efficiency and more effective services, to quality assurance in HCT, and to the facilitation of decision-making regarding HCT policy in hospitals and other healthcare services. This chapter expands the information about the status of clinical engineering in Paraguay and its contribution in improving regulation and the appropriate use and maintenance of HCT.

Healthcare infrastructure As in most developing countries, technological development in the healthcare system of Paraguay has been based on the transfer of technologies designed for developed countries (PAHO, 2001). In many cases, this technology transfer was incomplete, as it was not contextualized (organizational, economic, social, and cultural settings) to the country. In the past two decades, some of the common problems in the healthcare system were the following: • Scarcity of many basic technologies • Excessive and indiscriminate use of expensive HCT • Lack of policies and standards to regulate the introduction and use of HCT • Underdevelopment of support technologies • Inequalities in access to available HCT • Scarce human and financial resources • A shortage of professional and technical staff [i.e., clinical engineers (CEs) and biomedical equipment technicians (BMETs)] Problems such as a lack of HCT policies and standards; uncoordinated donor programs; shortages of, and inadequately qualified, human resources; and suboptimal managerial capacities are consequences of scarce resources, institutional weaknesses, and insufficient capacity to absorb and maintain new technology in the country (Galvan and Isaacs, 1999). Regarding the field of HCT and physical infrastructures management, it is common to find that medical devices and facilities are frequently out of service or malfunctioning (Galvan and Isaacs, 1999) for various reasons, such as the following: • Lack of infrastructure, equipment, and human resources for maintenance • Lack of resource planning and management • Low efficiency and weak after-sale support service • Low levels of standardization, leading to a high degree of diversity of medical devices and physical plant • Inadequate training of medical device operators and maintenance technicians • Lack of managerial and financial capacity to improve HCT maintenance

Survey reports (Galvan and Isaacs, 1999) showed that only 51.1% of basic medical devices of selected health facilities, 10 of the secondary care hospitals (second referral level), and 48 of primary care hospitals (first referral level), were in proper working condition. This situation is a direct consequence of the absence of a maintenance program and shortage of, as well as inadequate training, maintenance technicians. For performing maintenance in the selected hospitals, only BMETs (13%) and self-taught technicians (87%) were available but no clinical or biomedical engineers.

Sustainable clinical engineering practice A sustainable and strengthened organization and structure of clinical engineering services in the healthcare centers is of vital importance and implies a challenge for all stakeholders and decision makers (particularly for HCT, as its rate of change has increased considerably faster, in recent years, outpacing the evolution in the management and organization of national health care). To develop a comprehensive clinical engineering practice in Paraguay, the Biomedical Engineering and Imaging Department of the “Instituto de Investigaciones en Ciencias de la Salud-UNA” (Health Sciences Research Institute) proposed a feasible and sustainable strategy based on survey results (Galvan and Isaacs, 1996, 1997), with the key focus on HCT policy, financing, and human resource development, as well as maintenance system development. The final outcome will only be as successful and strong as the quality of effort and skill applied to the key issues.

HCT policy In December 1994, the Summit of the Americas reaffirmed the interest of the governments of the region in promoting reforms in their health systems that would guarantee equal access to basic health services. The summit charged Pan American Health Organization (PAHO), the International Development Bank (IDB), and the World Bank with organizing a special meeting on health sector in the Americas (PAHO, 2001). In this regard, and within the framework of transformation of the health sector, the Ministry of Health of Paraguay has been working since 1994 (Vidovich et al., 1998) on the reorganization of health systems, including health technology, to achieve a higher level of equity, quality, efficiency, and universal access to health care. In the last decade, decisions on new construction, the purchase, or replacement of HCT, and the approval of new applications were made through specialists like physicians and nurses but without participation of clinical or biomedical engineers. Consequently, in most cases, it is common to find that for complex HCT, what was chosen was what was

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technically possible instead of what is really necessary and useful for each health service (PAHO, 2001). This unsatisfactory situation contributed to inadequate procurement and operational strategies and impacted adversely on the ­healthcare system. In order to improve the overall situation, in particular HCTM and HTA issues, the Ministry of Health defined a strategy (Galvan, 2001) wherein a basic health technology policy (HTP) is an integral part of its overall national health policy and development plans (i.e., contingency, short-, mid-, and long-term plans). One essential part of the strategy is the assumed health technology development framework, which includes two important components: 1. HTA (PAHO, 2001) 2. Health technology management (HTM) In order to guarantee ownership and sustainability of the HTM policy, the Ministry of Health includes all national stakeholders in the formulation and implementation of the policy. In this regard, it created alliances with the following: • • • •

Health sciences research institutes (basic and applied) Scientific organizations and universities Multilateral organizations International agencies

In addition, in April 1996, a meeting of ministers of health of MERCOSUR (the commercial alliance among Argentina, Brazil, Paraguay, and Uruguay) was held to address quality and HCT. Since 1997, MERCOSUR has started a technical subgroup 11, which is in charge of promoting HCT and HTA issues, among other things. In this regard, the technical subgroup is working on multilateral cooperation, facilitating cooperation with international agencies and networks (e.g., PAHO/WHO, HTAi, RedETSA, EUnetHTA, INAHTA, CCOHTA, etc.), identifying relevant groups and national institutions in HCTM and HTA fields, and emphasizing that the clinical engineer is pivotal in the proper implementation of such issues. More recently, the Ministry of Health of Paraguay began creating a critical mass of personnel trained in HTA methodology and practice (Galvan et al., 2017) who have appropriate access to national and international information sources. To establish an appropriate HCT system and its management, the Ministry of Health created an HCTM Department with three specific objectives: • Strengthening policy and programs in clinical engineering, maintenance, technology management, and regulation • Optimal use of the resources assigned to the clinical engineering and maintenance programs

• Improvement in quality, efficiency, and safety of the operation of equipment, utilities, and physical plant, adapting to economic realities The HCTM Department has implemented the divisions of planning, procurement, and management to achieve the specific objectives and to guarantee health services delivery with equity, quality, efficacy, and safety, and to protect the HCT investment. A short evaluation report (Galvan et al., 2017) showed that the impact of the implementation of the HCT development plan was focused on acceptable improvement of the healthcare referral system, giving access to curative services with appropriate technology to deliver a basic package of essential diagnosis, treatment, and rehabilitation, with increased delegation of responsibilities at the district level. Furthermore, viewed from a practical perspective, this preliminary country analysis showed that, over the implementation period of HCTM, the evidence gathered demonstrates that 90% of the contingency plan of the HTP for the period 2013–17 has been achieved with the general improvement in the state of HCT. In general, improvement of planning system focusing on an appropriate HCT system and its management was reached at the Ministry of Health through the implementation of the HCT development plans.

Telemedicine Through technological innovations based on information and communication technologies (ICT), advantageous telemedicine systems can be developed to improve the health care of remote populations that do not have access to specialist physicians (Basogain et  al., 2010). In the context of universal coverage and the efficient use of available resources in public health which should be directed toward greater equity in the provision of services, greater concern for the effectiveness and usefulness of health technologies, there is a favorable opportunity to develop telemedicine toward an integrated ecosystem to improve health care in remote locations without access to specialists. Telemedicine activities require knowledge of telecommunications technology, networking technology, and medical device technology. In this sense, clinical and biomedical engineers can expand their horizons to a more diverse application of their engineering and management skills. In Paraguay, the first telemedicine experience was made in 2000 at the Biomedical Engineering and Imaging Department (Galvan et  al., 2008) with a live pregnancy echography transmission from the gynecology rooms at the Regional Hospital of Fuerte Olimpo (800 km north from Asuncion) to the Ministry of Health in the capital city of Asuncion, utilizing satellite transmission. But, the connection with remote rural communities was not attempted u­ ntil

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FIG. 1  National telemedicine network of the Ministry of Public Health.

2008, when sufficient experience had accumulated with ­ultrasound, electrocardiography, and nuclear medicine image transmission at the Biomedical Engineering Department with the available internet services. The National Telemedicine Program of the Ministry of Public Health (MoH), the first nationwide telemedicine program implemented in 2013 in Paraguay, as shown in Fig. 1, focused on tele-electrocardiography, tele-­tomography, teleechography, and tele-­electroencephalography, is the result of a collaborative pilot project between the Biomedical Engineering Department at the Health Sciences Research Institute of the National University of Asunción (IICS-UNA) and the University of the Basque Country (UPV/EHU). The telemedicine experience in Paraguay (Galvan et al., 2017) between 2013 and 2017 shows that technological innovation in public hospitals through telediagnosis can facilitate the universal coverage of diagnostic services at a relatively low cost, the economic sustainability of the public telediagnosis system, and the development of systems resilient in rural and isolated communities of the country, where these are not available.

Financial resources According to World Bank reports (World Bank, 1996), it is recommended that up to US$12 per capita is required to

comply with current healthcare demands. The reality of the developing countries demonstrates that such targets are difficult to achieve and that they must make tremendous efforts to comply and meet their healthcare demands (Heimann et al., 2001). In the case of Paraguay, the per capita spending on health in 2015 was US$317.00, and the public spending was 7.8% of the gross domestic product (GDP) (Ministry of Public Health, Dirección de Economía de la Salud, 2017). The poor financial resources for public health are mirrored in the area of HCT, with <5% of the overall national health budget dedicated to upkeep and maintenance. Consequently, the financial needs far exceed the resources available. In order to improve the available financial resources, a process of decentralization with increased delegation of responsibilities at the district level could prove to be one of the key responses.

Human resource development A sustainable and strengthened HCTM can be achieved only if an appropriate human resource development plan is included in the HTP. To establish an appropriate HCT system and its management, human resource availability based on clinical engineers, BMETs, managers, and secretaries as staff members is required.

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TABLE 1  Task distribution by job classes (Bauld, 1987). Job Task

BMET

Clinical engineer

Manager

In-service training

✶

✶

✶

Equipment evaluation

✶

✶

✶

Periodic inspection

✶

✶ ✶

Preacquisition planning

Secretary

Repair

✶

Design services

✶

✶

Rounds

✶

✶

Parts ordering

✶

✶

Data analysis

✶

✶

Such qualified staff should perform activities as listed in Table 1 (Bauld, 1987). Task distribution by job classes and the total work effort by all of the staff must be included to account for productivity. The clinical engineer is the manager of a Clinical or Biomedical Engineering Department. The department will be responsible for technology management and at least part of the safety management program. With this variety of responsibilities, several different job roles are required, and each of these may have different educational requirements. In Paraguay, the main problem with HCTM in the 1980s and 1990s was defined as inadequately qualified human resources and suboptimal managerial capacity. Survey reports (Galvan and Isaacs, 1999) showed that, regarding human resources, the main institutional weaknesses were focused on the following for upkeep and maintenance of HCT: • The absence of a clinical or biomedical engineer to manage the Clinical Engineering Department • Shortage of technical staff (2.5% CE, 13% low-qualified BMET, and 84.5% self-taught) • Inadequate training of maintenance technicians • Low managerial capacity • Lack of staff in new technical areas To improve the HCTM and, in particular, human resource development, a training strategy for BMET and CE was defined. Additionally, another key goal of professional development will be the formation of certification programs for CEs and BMET, with the cooperation and support of the American College of Clinical Engineering (ACCE). To overcome the critical situation of scarce qualified staff for HTM in the country, the Biomedical Engineering Department of the Health Science Research Institute (IICS/ National University of Asuncion) has played an essential

✶

✶ ✶ ✶

✶

role for the development and implementation of the education program for clinical engineers, BMETs, and master in biomedical engineering. Regarding the training of BMETs, since 2008 a 2-year polyvalent basic training program was instituted at the National Institute of Health of the Ministry of Health. Such qualified staff has received a further 1-year training on medical electronics of biomedical equipment to enable them to fulfill their roles. Thus, today it is estimated that more than 60 licensed BMETs are working in the hospital field. The clinical engineering (CE) training program includes a 5-year polyvalent training at the National University of Asunción (Polytechnics Faculty). Furthermore, a 1-year training practicum at hospitals (in Clinical Engineering Departments) or in industry is necessary to enable the clinical engineers to fulfill their roles. Education of clinical engineers started in Paraguay in 2000. Thus, today it is estimated that more than 65 specialized professionals are working in the field of clinical engineering. In addition to the clinical engineering and BMET training program, since 2011 exist a Master Course Program in Biomedical Engineering developed between the Basque Country University (Europe) and the National University of Asuncion (Paraguay) with 60 European Credit Transfer System (ECTS). Thus, today it is estimated more than 15 masters working in the field of research, academy, and clinical engineering. After fulfilling the education and training program the BMET, CE, and Master in Biomedical Engineering get a 5-year valid license from the Ministry of Public Health for registration and permission to work as health staff at the hospitals and health research centers. Today, there are more than 200 clinical technicians working in hospitals, and service companies in Paraguay (32.5% CE, 30% qualified BMET, and 37.5% self-taught).

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Regular, continuous training courses for staff and clinical equipment users should be implemented, and career opportunities should be explored. Furthermore, specialized courses have been designed and instituted for specific topics, for example, X-ray, CT scanners, lab analyzers, surgery equipment, and ventilators in the annual training program of the Ministry of Health with the cooperation and support of the Senior Experten Service (SES) of Germany. Moreover, managerial skills are also required at the administrative level (private and public sector) to comply with the needs of a maintenance system and future advances and developments in HCT.

HCT maintenance A full clinical engineering service should cover the entire life cycle of a medical device within a quality assurance system. Maintenance infrastructure should be designed and established at all hospitals and reference centers that have at least 100 beds. Then, in general, at this level there are operating theaters, intensive care units, radiology departments, maternity services, and functional laboratories, all of which need in-house maintenance services. The list of duties includes maintaining the inventory, device records, and schedule of maintenance, safety checks, and calibrations. In Paraguay, the maintenance system situation is similar to that in Latin America. Survey reports (Galvan and Isaacs, 1999) showed that 48.9% of the existing medical equipment and devices of selected hospitals were out of service or malfunctioning, and that one of the main reasons for this situation was lack of infrastructure, tools, equipment, and information systems for maintenance. To overcome this situation and to improve the HCT maintenance system in the country, the Ministry of Health has designed, and is seeking financial resources to implement, an HCTM Network for national hospitals as well as all regional/district hospitals as reference centers. The HCTM Network comprises a central workshop, located in Asuncion; three regional workshops distributed according to the demand of the involved hospitals in main provincial towns; and three mobile workshops to maintain hospitals in rural and remote areas. According to the assigned capabilities, the HCTM network should cover up to 85% (depending on volume of complex repair) of the daily scope of maintenance activities. Further, the more complex repair and maintenance work (15%) should be performed by private services (i.e., manufacturers and agents). However, to achieve an acceptable level of efficiency in the HCTM system, a good collaboration should exist among the administration, hospital managers, and workshop personnel.

Paraguayan Society of Biomedical Engineering The society was established in 2014 and now has 55 members. The majority (38) are clinical engineers and 17 students of clinical engineering. Thus, today it is estimated that 28 professionals found jobs in the private sector (medical device providers, CE services) and 10 are working in public hospitals. Eight members are working in the field of CE education and 4 members in CE research.

Recommendations Clinical engineering services should be installed close to the problem areas in a sustainable and cost-effective manner. This implies that such departments must have competent human resources (CEs and BMETs), adequate infrastructure, sufficient financial resources, and adequate management for the scope of responsibilities. Furthermore, such CE services would not be available at rural and remote levels, given the lack of critical mass of HCT. In Paraguay, the majority of rural and remote hospitals have between 5 and 20 beds, with a lack of critical mass of HCT. To compensate for the absence of such CE services in rural and remote areas, the use of mobile workshops incorporated into the clinical engineering maintenance system is recommended. In order to achieve a well-organized and well-­structured clinical engineering service, an HCTM plan developed according to the criteria of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) called “equipment management” (EM) should be established to comply with the HCTM’s mission and vision.

Conclusion Clinical engineering practice in Paraguay does not differ significantly from the practice made in other Latin America countries. Proper HCTM, including performing maintenance, is crucial for adequate health service delivery. But local settings differ from region to region in the same country, and appropriate solutions are not easy to find. In order to guarantee health service delivery with equity, quality, efficacy, and safety and to protect the physical plant investment, governments need to improve the availability and management of HCT at hospitals in rural and remote areas for the more deprived population. Sustainable maintenance systems at an affordable cost contribute substantially toward improving the health system. The establishment of an adequate HCT policy, improvement of financial resources, investment in local human resources, and alliances with relevant groups and national institutions to create common positions to solve problems are of vital importance to guarantee a sustainable system.

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World experiences show that in-house maintenance services at the local, regional, or national level can save the scarce financial resources if driven by a clinical engineering concept and cost-effective considerations. Investment in continuing education courses for clinical engineers and BMETs is important but is only beneficial if the other key components like sufficient financial resources, adequate infrastructure, and appropriate supply of spare parts are available. In conclusion, well-structured and well-organized Clinical Engineering Departments to manage and maintain HCT are absolutely necessary at healthcare facilities where a critical mass of HCT and utilities is available.

References Basogain, X., Cane, V., Galván, P., Cabral, M., Olabe, M.A., Gómez, M.A., et al., 2010. Epidemiological surveillance using information technologies in Paraguay. Biomed. Instrum. Technol. (2), 159–165. Bauld, T., 1987. Productivity: standard terminology and definitions. J. Clin. Eng. 12 (2), 139. Galvan, P., 2001. Technology Development in Health Systems and Services in Paraguay. Instituto de Investigaciones en Ciencias de la Salud, Asunción. Galvan, P., Isaacs, J., 1996. Evaluación del Estado de los Equipos y Sus Respectivos Programas de Mantenimiento en las 5 Regiones Sanitarias del Proyecto BID “Reforma de la Atención Primaria de Salud”. Pan American Health Organization/World Health Organization (PAHO/ WHO), Asunción.

Galvan, P., Isaacs, J., 1997. Evaluación del Estado de los Equipos y sus respectivos Programas de Mantenimiento en las 6 Regiones Sanitarias del Proyecto BIRF “Salud Materna y Desarrollo Integraldel Niño/a”. Pan American Health Organization/World Health Organization (PAHO/WHO), Asunción. Galvan, P., Isaacs, J., 1999. Evaluación del estado de los equipos y sus respectivos programas de mantenimientoen 11 Regiones Sanitarias de Paraguay. Instituto de Investigaciones en Ciencias de la Salud, Asunción. Galvan, P., Cabral, M.B., Cane, V., 2008. Implementation of a Telemedicine/Telehealth system at the Institute of Research in Health Sciences. Mem. Inst. Investig. Cienc. Salud 1817-46204 (1), 20–27. Galvan, P., Velázquez, M., Benítez, G., Ortellado, J., Rivas, R., Barrios, A., et al., 2017. Impacto en la salud pública del sistema de telediagnóstico implementado en hospitales regionales y distritales del Paraguay. Rev. Panam. Salud Pública 40 (4), 250–255. Heimann, P., Porter, D., Schmitt, R., et al., 2001. Sustainable health care technology management systems for the public health sector in developing countries. Medizintechnik 1, 22. Ministerio de Salud Pública y Bienestar Social, Dirección General de Planificación y Evaluación, Dirección de Economía de la Salud, 2017. Pan American Health Organization/World Health Organization (PAHO/ WHO), 2001. Developing Health Technology Assessment in Latin America and the Caribbean. Pan American Health Organization/World Health Organization (PAHO/WHO), Asunción. Vidovich, A., Avila, R., Echeverría, A., 1998. Análisis del Sector Salud del Paraguay. Pan American Health Organization/World Health Organization (PAHO/WHO), Asunción. World Bank, 1996. Health Report. Washington, DC.