Clinical engineering in Venezuela

Clinical engineering in Venezuela

Chapter 13 Clinical engineering in Venezuela Ricardo J. Silvaa,b, Noel C. Castrob,c a Foundation for Living, Wellness, and Health, Orlando, FL, Unit...

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Chapter 13

Clinical engineering in Venezuela Ricardo J. Silvaa,b, Noel C. Castrob,c a

Foundation for Living, Wellness, and Health, Orlando, FL, United States, bMontenegro Institute for Cognitive Disabilities, Guayaquil, Ecuador, cDepartment of Electronics and Circuits, Simon Bolivar University, Caracas, Venezuela

The present chapter is an update to the Clinical Engineering Handbook chapter about Clinical Engineering in Venezuela (Silva and Lara-Estrella, 2004) and is written in honor of Prof. Luis Lara-Estrella who has since passed away. This new version recovers and updates the historical background from that chapter updates all health-related information and reorganizes the content, according to the systems model developed by Dr. Roemer (Kleczkowski et al., 1984).

The Bolivarian Republic of Venezuela The Bolivarian Republic of Venezuela (916,446 km2) is organized into 23 states and a district capital. According to the latest data available from the Global Health Observatory (Table 1), Venezuela counts with a population of 31,108,000, 93.5% of whom live in urban areas (Moya, 2017). According to the Constitution of the Bolivarian Republic of Venezuela (Asamblea Nacional Constituyente, 1999), health care is a fundamental social right, and the government has the obligation to guarantee it (Article 83). In order to do this, there is a National Public Health System, controlled by the Ministry of Health and Social Development, based on the principles of free service, universality, integrity, equity, social integration, and solidarity (Article 84). Finally, the constitution states that financial support for the National Public Health System is a responsibility of the state (Article 85) and that everyone has the right to social security as a public, nonlucrative service that warrants health and protection against different contingencies (Article 86). There are 296 public hospitals; 214 of which are integrated into the National Public Health System and the rest are integrated into several different public organizations. There are 344 private hospitals, of which 29 are nonprofit organizations. By the year 2000, there were 40,675 hospitalization beds integrated into the National Public Health Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00013-4 Copyright © 2020 Elsevier Inc. All rights reserved.

System (17.6 beds per 10,000 inhabitants), with more than 50% of those in the five most developed states.

Historical perspective The first attempts at organizing clinical engineering-related activities were begun during the 1960s when the Centro Nacional de Mantenimiento (National Maintenance Center) was created within the Ministry of Health with a grant from WHO-PAHO (VEN 24/U.N.D.P/P.A.H.O.-4862) (Lara Estrella, 1992). This center was a pioneer in the development of maintenance standards and guidelines for hospital engineering in Latin America. Although it was a good start, the economic welfare of the nation was about to change, and these initiatives were short-lived. During the 1970s, Venezuela had an impressive economic boom; oil prices were high, and the government had money to spare. The money seemed limitless, and everything could be acquired new. Major investment projects were begun, new hospitals were built, new equipment was bought, everything was overpriced, and there was a lack of government control to avoid excess. At this time it was felt that there was no need for maintenance. Therefore, maintenance organizations were dismantled and clinical engineering was considered unnecessary. The National Maintenance Center was the basis for what later became known as the Dirección General de Mantenimiento de Infraestructura Física y Equipos (DIFE) (General Direction for Physical Plant and Equipment). DIFE’s functions were planning, construction, and maintenance of the physical plant and equipment for all of the institutions within the Ministry of Health. In 1987, in conjunction with DIFE, the Fundación para el Mantenimiento de la Infraestructura Médico-Asistencial para la Salud Pública (FIMA) (Foundation for Maintenance of Medical Infrastructure for Public Health), was created. FIMA was created with the aim of organizing and ­optimizing the 101

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TABLE 1  World Health Organization, Global Health Observatory, latest data for Venezuela (2017) (Moya, 2017). Total population (2015)

31,108,000

Gross national income per capita (PPP international $, 2013)

17

Life expectancy at birth m/f (years, 2015)

70/78

Probability of dying between 15 and 60 years m/f (per 1000 population, 2015)

208/103

Total expenditure on health per capita (Intl $, 2014)

923

Total expenditure on health as % of GDP (2014)

5.3

response time for the maintenance of medical infrastructure and equipment. The headquarters were located in Caracas, but FIMA had offices in each of the 23 states. FIMA was a civil nonprofit organization, overseen by the Ministry of Health, with direct income from the central government (Lara Estrella, 1992). Both FIMA and DIFE were centralized structures in charge of all of the technological responsibilities for the whole country. The area of competence for the first one was hospitals, while that of the second was small clinics and ambulatory care units. These organizations selected and acquired technology, determined technical specifications, provided maintenance, installed equipment, and supervised service contracts. This proved to be a great failure because acquired equipment did not necessarily respond to a real technological need; response time for repair of damaged and defective equipment was high and preventive maintenance was almost nonexistent. Moreover, customer (hospital clinical personnel) satisfaction was very low. Since 1976, clinical engineering has been studied at the Simon Bolivar University (USB) as part of the bioengineering studies program; however, it was not until 1996 that clinical engineering activities were established in a Venezuelan hospital. Clinical engineering is commonly associated with the management of medical equipment, while hospital engineering concerns with the physical plant. In Venezuela, this distinction of activities was impossible because many of the equipment-related problems are the direct result of physical plant problems and vice versa. Therefore, in 1997, Mijares and Lara-Estrella redefined clinical engineering for Venezuela as “the sum of all the engineering and management processes that, as a whole, allows the optimization of the hospital’s technological aspects, guaranteeing an overall efficient technological management, with high availability and to the satisfaction of physicians, paramedics, and patients” (Seminario and Lara-Estrella, 1997). In 1996, the Master of Science program in Biomedical Engineering was established ­

within USB and the Unidad de Gestión de Tecnología en Salud (UGTS) (Health Technology Management Group) was created to provide research and funding for clinical ­engineering-related activities. That same year, a technical assistance agreement was signed between the USB and the J.M. de Los Ríos Children’s Hospital. The objective of the project was to endow the institution with an integral technological management system through the establishment of a clinical engineering department that allowed effective management of all technology available in the institution (Seminario and Lara-Estrella, 1997). The project was begun in March 1996 and lasted for 10  months. A new organizational structure that considered the technological aspects was proposed. Consequently, the clinical engineering department, structured at a staff level, modified the traditional organization of the hospital to include the Clinical Engineering Department at an executive level. Many Clinical Engineering projects followed the implementation at the Children’s Hospital. After2  years, in 1998, Centro Médico Loira, a private hospital in the city of Caracas, requested the establishment of a clinical engineering department. This project was significant since Clinical hospitality was incorporated for the first time as part of a Clinical Engineering Department. Clinical Hospitality was defined as the management of infrastructure and accommodation in order to increase customer (patients, medical doctors, and staff) satisfaction, within a clinical/hospital environment. This concept proved to be a significant improvement in clinical engineering management since customer satisfaction became an essential managerial component. In 1999, a project was begun to establish a clinical engineering department within Dr. Carlos Arvelo Military Hospital, the head hospital for Military Health Service (SM). This project incorporated training of clinical engineering staff for the other military hospitals and introduced the concept of clinical engineering networking and coordination at a national level. That project was renewed in two opportunities and allowed for the constitution of the Clinical Engineering Division at SM. That same year (1999), the Ministry of Health decided to change their Technology Management Practices and Procedures, and a New Technology Management General Direction (TMGD) was created within the Ministry. FIMA and DIFE were integrated, and their technological, and some human, resources were incorporated into this new structure. TMGD is responsible for policy manager and supervisor of Good Clinical Engineering Practice and operative processes at the national level. TMGD is also responsible for establishing and controlling usefulness, accessibility, and quality of new technology introduced into the country, and for supervising regional activities. However, the operation of technology needs assessment, maintenance, and operative procedures will be managed locally by clinical engineering departments created in every hospital.

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In 2001, the Venezuelan Social Services Institute (IVSS), established the central maintenance direction (DGE) for Medical Technologies, with similar responsibilities to those of the TMGD. With all these major clinical engineering structures in place, UGTS at USB devoted to the creation of a new Clinical Engineering Specialization Program. Also, in 2001 a new National System for Science Technology and Innovation was developed via specific Law (Nacional A, 2010). This law defines science technology and innovation as a matter of public interest and in its fourth article promotes technology transfer from research institutes to private and public industries. Besides that, it creates a national fund for that purpose and requires large industries to invest a minimum of 0.5% of their gross income into activities related to this law. Based on the spirit of the law the National Center for Technology Innovation (CENIT) was created. CENIT’s mission is to contribute with the strengthening and development of science, technology, education, production and social appropriation of technology, through the conformation of a network of research development and innovation, articulated with the National System for Science Technology and Innovation. CENIT partnered up with UGTS in 2006, in order to develop technology for the automation of Health Institutes. CENIT was aiming to develop dedicated computer systems for specific applications. The result was Medicar, a sturdy movable device, with its own uninterruptible power supply (UPS), a local information storage unit, a convenient Man-Machine Interface (MMI), and wireless communication to a broad area network (Silva, 2010). Venezuelan Ministry of Science and Technology partnered up with the Ministry of Health to define an electronic medical record (EMR) system for the Venezuelan Health Sector. The Ministry of Health developed a Standardized Basic Clinical Record, to serve as a base for the EMR. The Standardized Basic Clinical Record includes many categories that are not usual in other EMR. For example, geographic and ethnic origins of ancestral indigenous groups, the relation of the patient with various government organizations, specific obligatory report for various contagious deceases and others. The team decided to create a new software-based over Care2X platform. The new software was called Sinapsis, being this an acronym for National Public Health System for Social Inclusion (Sistema Nacional Publico de Salud para la Inclusión Social) (Silva, 2010). Sinapsis Software was presented to the public January 12, 2009, during the transference of the Venesat-1, Venezuela’s first communication satellite from the Chinese Space Agency, which launched the satellite, to the Venezuelan Space Agency. Sinapsis was used as a mean of interconsultation between MD. Huascar Tejera, who was in a rural ambulatory at San Francisco de Guayos, on the Orinoco Delta

and MD. Francisco Gonzales a Pediatric Dermatologist at Universidad Central de Venezuela, University Hospital in Caracas.

Clinical engineering in Venezuela In order to understand the organization of Clinical Engineering in Venezuela and in order to compare it with other health systems, the Roemer’s Model is utilized (Kleczkowski et al., 1984). Roemer’s Model divides health system into five components: (1) systems organization, (2) how services are delivered, (3) programs and their management, (4) sources of economic support, and (5) production of resources that support the system.

Systems organization According to the Constitution of the Bolivarian Republic of Venezuela (Asamblea Nacional Constituyente, 1999), the National Public Health System is based on the principles of free service, universality, integrity, equity, social integration, and solidarity (article 84). Venezuela’s health services system is a mixture of public or government sector, private sector, and voluntary or charitable services. The government’s role in health is that of major care provider through large public-sector programs such as the Ministry of Public Health (MPPS), The Venezuelan Social Security Institute (IVSS), SM, and other area-specific government providers. Under the late Hugo Chavez, Venezuela developed a primary public healthcare system for the poor, The Barrio Adentro Foundation, working in what are called missions set up in the poorest areas (Venezuela Gaceta Oficial, 2006).

How services are delivered The Venezuelan MPPS counts with three Deputy Ministries. The Office of the Deputy Minister of Health Resources is in charge of: Planning, formulating, coordinating, and evaluating policies, strategies, plans, programs, and projects at the national level, aimed at ensuring the production, maintenance and supply of equipment, medicines, and other resources and inputs to the establishments that make up the National Public Health System.

Programs and their management Management of the Venezuelan health services system, which includes planning, administration, legislation, and regulation, is the responsibility of the MPPS, although, the IVSS, SM, and even the Missions have certain autonomy to determine health provision and services. Clinical Engineering provision and management is under the supervision of the Foundation of Buildings and Hospital Equipment (FUNDEEH), created in 2006 (Salud

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MdPPpl, 2006). Institutional Mission: Support the promotion, planning, maintenance, and construction of buildings of the National Public Health System; the coordination, management, financing, administration, execution, and supervision of Projects related to equipment and Health Services Network. FUNDEEH was assigned by the MPPS with the responsibility to “establish Clinical Engineering units in all hospitals.” The IVSS has a central maintenance direction (DGE) and the SM has a Clinical Engineering Direction (DIG). The Barrio Adentro Foundation has the autonomy to manage resources allocated for the provision of human resources and adequate infrastructure for health facilities, the Barrio Adentro I, II Mission and Integral Dental Care, as well as the development of other projects and special programs, with the participation of qualified personnel, applying the principles of efficiency, efficiency, transparency, and speed in the processes; reflecting the values of respect, honesty, responsibility, solidarity, social justice, teamwork, to contribute to the sustainability of health services and improve health quality of life of the entire Venezuelan population (Venezuela Gaceta Oficial, 2006).

Sources of economic support Financial support for the National Public Health System is a responsibility of the state (article 85), and everyone has the right to social security as public, no lucrative service that warrants health and protection against different contingencies (article 86) (Asamblea Nacional Constituyente, 1999). However, Economic support depends on the type of health services organizations—those in the public, the private, and the voluntary or charitable sectors—influence the ways in which health services are financed. In the case of The Barrio Adentro Foundation this is largely supported by PDVSA. Venezuela’s public petroleum corporation.

Production of resources that support the system In addition to financial support, the provision of health services requires resources, such as a trained workforce. Due to the experience accumulated at the USB, a project for the

creation of a Graduate Program in Clinical Engineering was carried out. This Graduate Program was accredited by the National Universities Council (CNU) (Gaceta Oficial No. 38.508, August 25, 2006). The Specialization Program was structured with subjects that conformed to the professional profile required in Venezuela. The curriculum is structured in three components: basic (principles of biophysics and bioengineering, principles of clinical engineering, and medical bases of bioengineering); specialized (medical equipment management, management of physical plant and facilities, networks and communications, and clinical hospitality); management (hospital security, maintenance management, organizational design, and business administration). Clinical Engineering Specialization has received a multiplicity of students from public institutions and also international students from Mexico and Colombia.

References Asamblea Nacional Constituyente, 1999. Constitución de la República Bolivariana de Venezuela. Gaceta Oficial de la República de Venezuela. Kleczkowski, B.M., Roemer, M.I., van der Werff, A., 1984. National Health Systems and Their Reorientation Towards Health for All: Guidelines for Policy-Making. World Health Organization, Geneva. Lara Estrella, L., 1992. El Mantenimiento como parte Integrante de la Gerencia y Gestión Tecnológica en el Ámbito Hospitalario. GBBAUSB. Senado de la República de Venezuela, Comisión de Asuntos Sociales, Caracas. Moya, D.J.G., 2017. Venezuela (Bolivarian Republic of) [Online]. Available from: http://www.who.int/countries/ven/en/. (cited 11 October 2017). Nacional A, 2010. Ley Orgánica de Ciencia, Tecnología e Innovación. Gaceta Oficial. Salud MdPPpl, 2006. Fundación de Edificaciones y Equipamiento Hospitalario (FUNDEEH). Gaceta Oficial. Seminario, R.M., Lara-Estrella, L.O., 1997. Establishment of a clinical engineering department in a Venezuelan national reference hospital. J. Clin. Eng. 22 (4), 239–248. Silva, R., 2010. Venezuela makes medical IT a national priority. Biomed. Instrum. Technol. 44 (5), 409–413. Silva, R., Lara-Estrella, L., 2004. Clinical engineering in Venezuela. In: Dyro, J.F. (Ed.), Clinical Engineering Handbook. Elsevier Academic Press, Burlington, pp. 89–91. Venezuela Gaceta Oficial, 2006. Decreto Presidencial No. 4382. Gaceta Oficial.