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Clinical engineering in Albania
Chapter 25
Clinical engineering in Albania Ledina Picari Medical Devices and Systems Unit, Ministry of Health of Albania, Tirana, Albania
This is a brief summary of the organization and functioning of the clinical engineering in Albania. The issues addressed in this chapter include Albania’s healthcare system infrastructure and organization, the role and responsibilities of the organizational structures, regulatory framework of medical devices, maintenance policies, clinical engineering education, and activities at hospitals and other issues related to the health technology management in Albania.
Demographics and geography Albania is a country in Southeastern Europe, located in the Southwestern part of the Balkan Peninsula. Albania spans 28748 km2 with a population of almost 2.9 million according to the 2016 census data. Coastlines: Adriatic and Ionian seas. Neighbors: Kosovo, Italy, Greece, North Macedonia, and Montenegro. Tirana is the capital, with almost 1million people. Language: Albanian, a separate branch of IndoEuropean symbolic tree of world languages.
History The first independent Albanian state was established in 1912. After World War II, the Communist Party came to power. Albania experienced the most severe dictatorial regime compared to other countries of the Communist Camp. Therefore, it has had significantly more turbulent progress along the path of economic and structural transition than most of the other ex-communist European countries. Today Albania has established a constitutional democracy. It is a member of NATO and is in the process of becoming a member of the European Union (EU). This commitment is a key factor contributing to regional stability and further cooperation between the Republic of Albania and the European Union. Due to radical changes, there has been two major disruptions: the disruption of effective working of the existing health infrastructure, particularly a loss of qualified staff because of migration, and the Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00025-0 Copyright © 2020 Elsevier Inc. All rights reserved.
disruption of a number of early initiatives in economic reform, specifically, the initiatives in the field of healthcare reform and development. Despite these difficulties, the Ministry of Health has continuously strived to develop programs and policies to redevelop and realign the healthcare system into a more effective structure and more responsive to population needs.
Albania’s healthcare system Healthcare facilities ● ● ● ● ●
413 primary healthcare centers 5 university hospitals 11 regional hospitals 23 district hospitals 10 polyclinics in Tirana
Organization and budget allocation Albania’s healthcare system, before 1990, was completely public. It is still very centralized and the central government controls almost all aspects of the system. Primary health care covers all population through family doctors. The referral system is organized into three hospital levels: district, regional, and tertiary. Problems related to this system are mainly due to the concentration of the “best doctors in capital” and the lack of trust in the expertise in primary health care and small hospitals. The “Fund” is the only Insurance Health Institute in the country financing health services. To support the access to health care, Albania is using the universal healthcare system. Almost all the healthcare providers work as government employees and the government acts as the single payer for all health services. Aiming to provide the healthcare coverage for all population, the system is under pressure due to rising costs. The private sector covered initially pharmaceutical, dental, and diagnostic services but in the last 5 years, four private hospitals have covered almost all healthcare services. Big investments (medical devices and buildings) are mainly planned and procured by the Ministry of Health (MoH). Running costs are managed by hospitals upon the approval of MoH. 151
152 SECTION | 2 Worldwide clinical engineering practice
Budget allocaon (mln USD) 6 5 4 3 2 1 0
1994 New MD
2000
2004 Consumable MD
2011
2017
Maintenance cost
FIG. 1 Health technology budget allocation.
documentation, and training. The progress in the integration process to European Union, the government priorities, and the new competence in biomedical engineering in the decision-making levels have brought to light the need for a great reform in this field. The last 15 years have achieved more than what was achieved in the last 50 years and these achievements were because of the strong aspiration of the country to join the European Union, the technical and financial supports provided by the international experts and institutions, and the strong commitment of the new clinical engineers.
Medical devices and systems unit at MoH In the last 5 years, the government policy has encouraged private-public partnership (PPP) mainly in: - laundry and food services - dialysis - sterilization of the medical instruments (used in surgery departments) - checkup age 40–70 - laboratory services For the past 15 years, millions of Euros were invested in new medical devices. This has contributed to increased cost efficiency and better access to health care. Total health expenditure in 2017 exceeded the highest historical value of 3% of GDP from public funding, which was around US$470 million and 2.3% of GDP from private funding. Investments in health technology followed the same trend (Fig. 1).
Health technology management After the collapse of the communism in 1990, Albania emerged as a poor country with a poor healthcare system. There were a limited number of medical devices (MDs) mainly imported from China and other ex-communist countries. Very old analog technology was in use in hospitals providing poor diagnosis and healthcare treatment. For several years, loads of hospital medical devices were donated by various countries and organizations. Some of them were never put to work; some were out of service soon after installation because of the lack of spare parts and consumables or lack of user’s competence. From 2000 on, the Albanian government has paid more attention in procuring new medical devices, several new hospitals were built and other hospitals were renovated. Even though new, modern devices were procured every year and new medical facilities were build or renovated, the importance of the health technology management throughout the medical device life cycle was not the focus of the healthcare reforms because of low awareness of the high-level decision makers. There were no proper standardized routines for planning, procurement, installation, acceptance testing, maintenance, repair,
Structural organization at Ministry of Health of Albania did not have any department or unit for medical devices before 2010. There was one electronic engineer in the Department of Procurement and Investment as procurement specialist dealing mainly with the preparation of technical specifications for medical devices and the evaluation of bids to define technical compliance. In 2007, the Ministry of Health developed the National Strategy for Management of Medical Devices. This document was used for strategic, long-term decisions regarding the management of medical devices in compliance with the European Medical Device Directives. In 2009, a biomedical engineer was employed at the Hospital Department, a health policy department of MoH. Main tasks included: - defining priorities and planning the supply of hospitals with medical devices, - preparing technical specifications, - participation in the evaluation committees, - distribution of medical devices, donated by various philanthropic associations, based on hospital needs, - designing regulatory documents for medical devices. Due to continuous increasing investments in health technology and the need for planning, prioritizing, evaluation, and regulation design, in 2010, the first dedicated Management and Standardization of Health Technologies Unit, later Medical Devices and Systems Unit (Unit) was established, having for the first time, in high levels of public healthcare sector, a decision-making unit with a high competence in this area. The head of the unit was a biomedical engineer.
Duties and responsibilities The unit was responsible for the overall supervision and monitoring of medical devices in the healthcare sector. Its mission was to increase patient and user safety when medical devices are used. The unit was directly involved in legal framework preparation and its implementation:
Clinical engineering in Albania Chapter | 25 153
- Design of laws and sublaws, orders of the Minister, policy documents, recommendations, and guidelines regarding the use, management, and maintenance of medical devices as part of policy-making process. - Preparation and/or approval of technical specifications, for medical devices aiming the standardization of the health technology used in public hospitals in the country. - Wholesale and retail distribution authorization provision for economic operators. - Management and participation in the process of the adverse event reporting process. - Monitoring of legislation and guidelines for implementation of national policies on medical devices. - Preparation of the process for medical device recalls or limitations in their use when incidents related to safety are encountered. - Participation in working groups for health technology budget planning. - Participation in procurement procedures when high and sophisticated technology is procured centrally (CTs, MRIs, etc.) at MoH. - Participation in working groups of the Ministry of European Integration regarding European legislation approximation for medical devices, customer protection, and market surveillance, leading the process in this field on behalf of MoH. - Representation in international organization, e.g., WHO, World Bank, etc., for medical device-related issues.
Clinical engineering structures District(small) hospitals do not have any in-house clinical engineer. There is a technician (electric, mechanical, or IT) performing the duties. Due to the government priority for the informatization of the healthcare systems in Albania, in regional hospitals, clinical engineering and information technology departments were integrated and are part of the same unit. These units are composed of two to four technical staff. Since there is a lack of clinical engineers in Albania, the information technologist, in some hospitals, performs the clinical engineer duties and responsibilities.These inhouse structures of clinical engineering in regional hospitals can only perform simple repairs and everyday safety routine for medical devices. The replacement of spare parts, updates, and maintenance of big and complex medical devices are provided by third-party contractors. The biggest hospital in the country, “Mother Theresa” University Hospital of Tirana, with around 1200 beds, has a unit of clinical engineering (CE) composed of the head of the unit, four clinical engineers, four information technologists, and five technicians. When problems arise, each of the three levels of hospitals (district, regional, and tertiary), address the problem to the Biomedical National Center (Centre).The center is a
small workshop with a bunch of engineers and technicians. It existed since 1960s, taking care of small repairs mainly analog devices. It was thought as a reference center when the CE unit of each hospital was unable to fix the problem. Because of the lack of continuous training and complexity of modern devices, the center did lose importance and was unable to manage the process and answer the increasing need for technical support.
Actual legislation The Law 89/2014 “For Medical Devices,” the first law for medical devices in Albania: - regulates the circulation of medical devices in Albanian market; - improves the safety of the patients and users; - defines the legal responsibilities of the responsible structures; - defines the role and functioning of the State Agency for Drugs and Medical Devices. The Law 89/2014 “For Medical Devices” and three sub-laws: The Decision of Council of Ministers (DCM) No. 508 date 10.06.2015, Technical regulation “On Essential Requirements, conformity evaluation and CE marking of active implantable medical devices”, DCM No. 731 date 02.09.2015, Technical regulation “On Essential Requirements, conformity evaluation, classification and CE marking of medical devices” and DCM No. 189 date 09.03.2016, Technical regulation “On Essential Requirements, conformity evaluation, CE marking of in- vitro medical devices”, prepared by the unit in collaboration with the law department, approximate the three European directives: - Directive 93/42/EEC concerning medical devices. - Directive 98/79/EEC on in vitro diagnostic medical devices. - Directive 90/385/EEC on active implantable medical devices. To complete the legal framework, three orders of the Minister were prepared as well: “For the authorization of the wholesales traders of medical devices” (No. 86/2015), “On procedures and rules for the registration of medical devices” (No. 360/2016), and “On the inspection of medical devices” (No. 150/2017), starting for the first time the market surveillance for medical devices. The unit was directly involved in these regulatory documents preparation.
Harmonized standards All the European standards referred by European Directives for MD were adopted by Albanian Standards Institute. Head
154 SECTION | 2 Worldwide clinical engineering practice
of unit of MoH is the head of the Technical Committee 205 (Non-active MD); another biomedical engineer is the head of the Technical Committee 140 (in vitro diagnostic MD). Since there is no domestic production, the focus is to guarantee the quality of the imported MD and market surveillance. The implementation of the regulations made possible for the first time the following: - Only medical devices bearing CE mark are placed on the Albanian market. - Database of the economic operators trading medical devices in Albania was created. - The registration of the medical devices placed on the Albanian market is a continuing process. - Market surveillance as part of the national action plan for consumer protection 2014–2020 has started. Head of the unit was a member of the governmental working group for the Consumer Protection Strategy design.
has drastically reduced, increasing patients' access to diagnostic imaging services. This policy has provided the following outcomes: - improvement in the service - lower price: from approx. 12% (of the purchase price) to 8% annually - standardization of prices and procedures - shorter downtimes - better partnership with distributors - no more gaps between contracts - better budget planning from both sides (hospital and service provider) - efficient use of public funds - better planning - budget guaranteed due to fixed price - open procedure for international participation to avoid speculation of a monopoly situation
Safety and adverse events
Maintenance of medical devices Before 2014, the maintenance of medical devices was managed by each hospital. No standard procurements and maintenance procedures even for the same devices were applied and no standard terms and conditions were used in binding contracts. Due to the increase in the investments in high and sophisticated technology, in-house engineers and technicians were unable to repair and maintain them and the hospitals were facing higher costs due to the frequent interventions, difficult relationships with the service providers and long waiting times for the patients and delay in the diagnosis. Because of the lack of management policies, the big and complex devices were very often out of service. The long downtimes were related to long procedures for public procurements of spare parts and service company selection. Gradually the private companies increased in number and competencies. Since Albania is a small country, usually, manufacturers assign “country authorized distributors” for repairs and maintenance. Being a small market, often only one company was authorized for each brand, creating a monopoly situation and providing a very highcost service. In order to gain and preserve the status, the distributors are obliged to systematically train their engineers ensuring higher competencies compared to the public staff where training programs for continuing education are not available. This situation led to a new policy: the procurement of the maintenance services for CT scans, MRIs, angiographers, etc., was organized centrally by the Ministry of Health. The actions taken were the centralization of the procedures, negotiation with the country authorized distributors and manufacturers regarding the price and contract terms and conditions. Thanks to this policy, the downtime
No proper system for the registration of human errors is in place. Although some efforts have been made, no proper analyses for the evaluation of the malfunctions and adverse events associated with medical devices are performed.
Development of human resources dealing with medical devices The lack of knowledge and competence was identified as one of the problems during the life-cycle management of the medical devices. Not many educational and training programs for the people dealing with medical devices in health centers, hospitals, or other health institutions have been organized.
University program in Biomedical/Clinical Engineering In order to ensure a long-term solution in having qualified clinical engineers, negotiations with the Ministry of Education and Tirana Polytechnic University were undertaken to establish a Biomedical/Clinical Engineering Programs at the Engineering School. A master's program in clinical engineering was completed in 2014. In all 10 students graduated and some of them are working with medical devices in the private and public sector. Even though there is a great need for qualified people, they have struggled to find a job at any public hospitals and some of them are not working with medical devices. Still, the system is suffering from the lack of awareness of the need for qualified people. Often other professionals are hired instead of clinical engineers in hospitals to take care of health techno logy. Low salary in the public sector is another obstacle for hiring qualified engineers and technicians.
Clinical engineering in Albania Chapter | 25 155
Education at hospital level The staff working with medical devices in hospitals do have a diploma in biomedical, clinical, electronics, information technology, electrical, or mechanical engineering. Most of them have some knowledge mainly due to the experience gained by working with medical devices. Not many possibilities to attend training courses have been made available.
Medical device information system as an important tool of management The number of medical devices being used in hospitals and healthcare organizations continues to grow demanding the setup of a medical devices information system for proper management. There have been several local attempts by the hospitals to list all the medical devices in use. Several various programs were created. It was difficult to make these systems compatible with each other and the information was impossible to be merged into a central national list. Ministry of Health intervened and registered all the medical devices of the public hospitals in a central system administered by commercial software. In 2014, the Ministry of Health of Albania started the informatization reform in health care. This process has improved the access to the system and health service delivery. Key projects were the introduction of the personal health card, nationwide electronic health records, e-prescription, hospital management information system, e-signature and e-examination, administration of medical drugs, registration system, management of human resource, and medical assets system. Clinical engineers are being charged to extend their scope as communicators, problem solvers, and experts in integrating high technology systems. With medical devices becoming more software-based and connected to networks, the role and responsibilities of CE have increased, demanding new skills and competencies in order to make the technology connected. The Telemedicine and e-Health Program are operating in 18 hospitals. Telemedicine center is merged with Biomedical National Center to create and to put in operation a remote care program for tele-trauma, tele-stroke, tele-radiology, etc. These achievements and other smaller complementary successes in the last years were attained as a result of the commitment of the local staff and the foreign experts who have assisted the Albanian health sector with their knowledge and financial support through various international bilateral and regional projects. World Bank, WHO, USAID, Italian Cooperation Agency, JICA, etc., projects have brought the best of international experiences to Albania and have supported successfully the local attempts in the development of healthcare technologies.
Albanian Society of Biomedical Engineering Albanian Society of Biomedical Engineering was founded in 2005. The mission was to promote the role and i mportance of biomedical engineering in health care, to represent the
professional interests of biomedical and clinical engineers, and to promote the safe use of the technology by establishing standards of practice in clinical engineering. Since there is a small community of people involved in health technology in Albania and due to the lack of economic and political stability, challenges have been faced over the years to get full recognition. As the awareness to recognize the important role of biomedical and clinical engineering in health care is increasing internationally, the collaboration of Albanian Society of Biomedical Engineering with other international societies and organizations and the involvement of its members in international forums are playing a crucial role in strengthening this organization and its contributions in healthcare delivery.
Clinical engineering challenges in Albania The challenges facing clinical engineering in Albania are as follows: Raising awareness of the importance of biomedical and clinical engineering within the health system. Establishing national health technology assessment in order to support management, clinical, and policy decisions. Establishing collaboration and partnerships with healthcare providers, industry, patient’s societies, and scientific and technical organizations. Implementation of national regulations and strengthening of the human resources. Development of the university programs in biomedical and clinical engineering and training programs for a high professional profile. Enhance patient safety in healthcare delivery. Strengthening market surveillance for medical devices to ensure regulatory compliance and public health protection.
Further reading Calil, S.J., 2016. The evolution of clinical engineering: history and the role of technology in health care. In: Clinical Engineering, From Devices to Systems. Council of Ministers of Albania, 2017. National plan for European integration, 2016-2020. Decision of the Council of Ministers of Albania, No. 42. Hernandez, A., Judd, T., 2017. ACCE Webinar: Global Health Technology Equity: How Emerging CE-HTM Leaders Can Help. Ministry of Health of Albania, 2007. National Policy for Management of Medical Devices. Statistics Institute of Albania, 2007. Population of Albania, www.instat.gov.al. Velazquez, A., 2017. World Health Organization, The role of health technology management in WHO, to support access to medical devices for Universal Health Coverage and achievement of SDGs. World Health Organization, Sixtieth World Health Assembly, WHO Resolutions: WHA60.29, Health technologies. http://158.232.12.119/ health systems/WHA60_29.pdf. Yadin, D., 2013. Second WHO Global Forum on Medical Devices, Global Perspectives on Clinical Engineering Trends, Geneva, Switzerland.
Clinical engineering in Albania Ledina Picari Medical Devices and Systems Unit, Ministry of Health of Albania, Tirana, Albania
This is a brief summary of the organization and functioning of the clinical engineering in Albania. The issues addressed in this chapter include Albania’s healthcare system infrastructure and organization, the role and responsibilities of the organizational structures, regulatory framework of medical devices, maintenance policies, clinical engineering education, and activities at hospitals and other issues related to the health technology management in Albania.
Demographics and geography Albania is a country in Southeastern Europe, located in the Southwestern part of the Balkan Peninsula. Albania spans 28748 km2 with a population of almost 2.9 million according to the 2016 census data. Coastlines: Adriatic and Ionian seas. Neighbors: Kosovo, Italy, Greece, North Macedonia, and Montenegro. Tirana is the capital, with almost 1million people. Language: Albanian, a separate branch of IndoEuropean symbolic tree of world languages.
History The first independent Albanian state was established in 1912. After World War II, the Communist Party came to power. Albania experienced the most severe dictatorial regime compared to other countries of the Communist Camp. Therefore, it has had significantly more turbulent progress along the path of economic and structural transition than most of the other ex-communist European countries. Today Albania has established a constitutional democracy. It is a member of NATO and is in the process of becoming a member of the European Union (EU). This commitment is a key factor contributing to regional stability and further cooperation between the Republic of Albania and the European Union. Due to radical changes, there has been two major disruptions: the disruption of effective working of the existing health infrastructure, particularly a loss of qualified staff because of migration, and the Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00025-0 Copyright © 2020 Elsevier Inc. All rights reserved.
disruption of a number of early initiatives in economic reform, specifically, the initiatives in the field of healthcare reform and development. Despite these difficulties, the Ministry of Health has continuously strived to develop programs and policies to redevelop and realign the healthcare system into a more effective structure and more responsive to population needs.
Albania’s healthcare system Healthcare facilities ● ● ● ● ●
413 primary healthcare centers 5 university hospitals 11 regional hospitals 23 district hospitals 10 polyclinics in Tirana
Organization and budget allocation Albania’s healthcare system, before 1990, was completely public. It is still very centralized and the central government controls almost all aspects of the system. Primary health care covers all population through family doctors. The referral system is organized into three hospital levels: district, regional, and tertiary. Problems related to this system are mainly due to the concentration of the “best doctors in capital” and the lack of trust in the expertise in primary health care and small hospitals. The “Fund” is the only Insurance Health Institute in the country financing health services. To support the access to health care, Albania is using the universal healthcare system. Almost all the healthcare providers work as government employees and the government acts as the single payer for all health services. Aiming to provide the healthcare coverage for all population, the system is under pressure due to rising costs. The private sector covered initially pharmaceutical, dental, and diagnostic services but in the last 5 years, four private hospitals have covered almost all healthcare services. Big investments (medical devices and buildings) are mainly planned and procured by the Ministry of Health (MoH). Running costs are managed by hospitals upon the approval of MoH. 151
152 SECTION | 2 Worldwide clinical engineering practice
Budget allocaon (mln USD) 6 5 4 3 2 1 0
1994 New MD
2000
2004 Consumable MD
2011
2017
Maintenance cost
FIG. 1 Health technology budget allocation.
documentation, and training. The progress in the integration process to European Union, the government priorities, and the new competence in biomedical engineering in the decision-making levels have brought to light the need for a great reform in this field. The last 15 years have achieved more than what was achieved in the last 50 years and these achievements were because of the strong aspiration of the country to join the European Union, the technical and financial supports provided by the international experts and institutions, and the strong commitment of the new clinical engineers.
Medical devices and systems unit at MoH In the last 5 years, the government policy has encouraged private-public partnership (PPP) mainly in: - laundry and food services - dialysis - sterilization of the medical instruments (used in surgery departments) - checkup age 40–70 - laboratory services For the past 15 years, millions of Euros were invested in new medical devices. This has contributed to increased cost efficiency and better access to health care. Total health expenditure in 2017 exceeded the highest historical value of 3% of GDP from public funding, which was around US$470 million and 2.3% of GDP from private funding. Investments in health technology followed the same trend (Fig. 1).
Health technology management After the collapse of the communism in 1990, Albania emerged as a poor country with a poor healthcare system. There were a limited number of medical devices (MDs) mainly imported from China and other ex-communist countries. Very old analog technology was in use in hospitals providing poor diagnosis and healthcare treatment. For several years, loads of hospital medical devices were donated by various countries and organizations. Some of them were never put to work; some were out of service soon after installation because of the lack of spare parts and consumables or lack of user’s competence. From 2000 on, the Albanian government has paid more attention in procuring new medical devices, several new hospitals were built and other hospitals were renovated. Even though new, modern devices were procured every year and new medical facilities were build or renovated, the importance of the health technology management throughout the medical device life cycle was not the focus of the healthcare reforms because of low awareness of the high-level decision makers. There were no proper standardized routines for planning, procurement, installation, acceptance testing, maintenance, repair,
Structural organization at Ministry of Health of Albania did not have any department or unit for medical devices before 2010. There was one electronic engineer in the Department of Procurement and Investment as procurement specialist dealing mainly with the preparation of technical specifications for medical devices and the evaluation of bids to define technical compliance. In 2007, the Ministry of Health developed the National Strategy for Management of Medical Devices. This document was used for strategic, long-term decisions regarding the management of medical devices in compliance with the European Medical Device Directives. In 2009, a biomedical engineer was employed at the Hospital Department, a health policy department of MoH. Main tasks included: - defining priorities and planning the supply of hospitals with medical devices, - preparing technical specifications, - participation in the evaluation committees, - distribution of medical devices, donated by various philanthropic associations, based on hospital needs, - designing regulatory documents for medical devices. Due to continuous increasing investments in health technology and the need for planning, prioritizing, evaluation, and regulation design, in 2010, the first dedicated Management and Standardization of Health Technologies Unit, later Medical Devices and Systems Unit (Unit) was established, having for the first time, in high levels of public healthcare sector, a decision-making unit with a high competence in this area. The head of the unit was a biomedical engineer.
Duties and responsibilities The unit was responsible for the overall supervision and monitoring of medical devices in the healthcare sector. Its mission was to increase patient and user safety when medical devices are used. The unit was directly involved in legal framework preparation and its implementation:
Clinical engineering in Albania Chapter | 25 153
- Design of laws and sublaws, orders of the Minister, policy documents, recommendations, and guidelines regarding the use, management, and maintenance of medical devices as part of policy-making process. - Preparation and/or approval of technical specifications, for medical devices aiming the standardization of the health technology used in public hospitals in the country. - Wholesale and retail distribution authorization provision for economic operators. - Management and participation in the process of the adverse event reporting process. - Monitoring of legislation and guidelines for implementation of national policies on medical devices. - Preparation of the process for medical device recalls or limitations in their use when incidents related to safety are encountered. - Participation in working groups for health technology budget planning. - Participation in procurement procedures when high and sophisticated technology is procured centrally (CTs, MRIs, etc.) at MoH. - Participation in working groups of the Ministry of European Integration regarding European legislation approximation for medical devices, customer protection, and market surveillance, leading the process in this field on behalf of MoH. - Representation in international organization, e.g., WHO, World Bank, etc., for medical device-related issues.
Clinical engineering structures District(small) hospitals do not have any in-house clinical engineer. There is a technician (electric, mechanical, or IT) performing the duties. Due to the government priority for the informatization of the healthcare systems in Albania, in regional hospitals, clinical engineering and information technology departments were integrated and are part of the same unit. These units are composed of two to four technical staff. Since there is a lack of clinical engineers in Albania, the information technologist, in some hospitals, performs the clinical engineer duties and responsibilities.These inhouse structures of clinical engineering in regional hospitals can only perform simple repairs and everyday safety routine for medical devices. The replacement of spare parts, updates, and maintenance of big and complex medical devices are provided by third-party contractors. The biggest hospital in the country, “Mother Theresa” University Hospital of Tirana, with around 1200 beds, has a unit of clinical engineering (CE) composed of the head of the unit, four clinical engineers, four information technologists, and five technicians. When problems arise, each of the three levels of hospitals (district, regional, and tertiary), address the problem to the Biomedical National Center (Centre).The center is a
small workshop with a bunch of engineers and technicians. It existed since 1960s, taking care of small repairs mainly analog devices. It was thought as a reference center when the CE unit of each hospital was unable to fix the problem. Because of the lack of continuous training and complexity of modern devices, the center did lose importance and was unable to manage the process and answer the increasing need for technical support.
Actual legislation The Law 89/2014 “For Medical Devices,” the first law for medical devices in Albania: - regulates the circulation of medical devices in Albanian market; - improves the safety of the patients and users; - defines the legal responsibilities of the responsible structures; - defines the role and functioning of the State Agency for Drugs and Medical Devices. The Law 89/2014 “For Medical Devices” and three sub-laws: The Decision of Council of Ministers (DCM) No. 508 date 10.06.2015, Technical regulation “On Essential Requirements, conformity evaluation and CE marking of active implantable medical devices”, DCM No. 731 date 02.09.2015, Technical regulation “On Essential Requirements, conformity evaluation, classification and CE marking of medical devices” and DCM No. 189 date 09.03.2016, Technical regulation “On Essential Requirements, conformity evaluation, CE marking of in- vitro medical devices”, prepared by the unit in collaboration with the law department, approximate the three European directives: - Directive 93/42/EEC concerning medical devices. - Directive 98/79/EEC on in vitro diagnostic medical devices. - Directive 90/385/EEC on active implantable medical devices. To complete the legal framework, three orders of the Minister were prepared as well: “For the authorization of the wholesales traders of medical devices” (No. 86/2015), “On procedures and rules for the registration of medical devices” (No. 360/2016), and “On the inspection of medical devices” (No. 150/2017), starting for the first time the market surveillance for medical devices. The unit was directly involved in these regulatory documents preparation.
Harmonized standards All the European standards referred by European Directives for MD were adopted by Albanian Standards Institute. Head
154 SECTION | 2 Worldwide clinical engineering practice
of unit of MoH is the head of the Technical Committee 205 (Non-active MD); another biomedical engineer is the head of the Technical Committee 140 (in vitro diagnostic MD). Since there is no domestic production, the focus is to guarantee the quality of the imported MD and market surveillance. The implementation of the regulations made possible for the first time the following: - Only medical devices bearing CE mark are placed on the Albanian market. - Database of the economic operators trading medical devices in Albania was created. - The registration of the medical devices placed on the Albanian market is a continuing process. - Market surveillance as part of the national action plan for consumer protection 2014–2020 has started. Head of the unit was a member of the governmental working group for the Consumer Protection Strategy design.
has drastically reduced, increasing patients' access to diagnostic imaging services. This policy has provided the following outcomes: - improvement in the service - lower price: from approx. 12% (of the purchase price) to 8% annually - standardization of prices and procedures - shorter downtimes - better partnership with distributors - no more gaps between contracts - better budget planning from both sides (hospital and service provider) - efficient use of public funds - better planning - budget guaranteed due to fixed price - open procedure for international participation to avoid speculation of a monopoly situation
Safety and adverse events
Maintenance of medical devices Before 2014, the maintenance of medical devices was managed by each hospital. No standard procurements and maintenance procedures even for the same devices were applied and no standard terms and conditions were used in binding contracts. Due to the increase in the investments in high and sophisticated technology, in-house engineers and technicians were unable to repair and maintain them and the hospitals were facing higher costs due to the frequent interventions, difficult relationships with the service providers and long waiting times for the patients and delay in the diagnosis. Because of the lack of management policies, the big and complex devices were very often out of service. The long downtimes were related to long procedures for public procurements of spare parts and service company selection. Gradually the private companies increased in number and competencies. Since Albania is a small country, usually, manufacturers assign “country authorized distributors” for repairs and maintenance. Being a small market, often only one company was authorized for each brand, creating a monopoly situation and providing a very highcost service. In order to gain and preserve the status, the distributors are obliged to systematically train their engineers ensuring higher competencies compared to the public staff where training programs for continuing education are not available. This situation led to a new policy: the procurement of the maintenance services for CT scans, MRIs, angiographers, etc., was organized centrally by the Ministry of Health. The actions taken were the centralization of the procedures, negotiation with the country authorized distributors and manufacturers regarding the price and contract terms and conditions. Thanks to this policy, the downtime
No proper system for the registration of human errors is in place. Although some efforts have been made, no proper analyses for the evaluation of the malfunctions and adverse events associated with medical devices are performed.
Development of human resources dealing with medical devices The lack of knowledge and competence was identified as one of the problems during the life-cycle management of the medical devices. Not many educational and training programs for the people dealing with medical devices in health centers, hospitals, or other health institutions have been organized.
University program in Biomedical/Clinical Engineering In order to ensure a long-term solution in having qualified clinical engineers, negotiations with the Ministry of Education and Tirana Polytechnic University were undertaken to establish a Biomedical/Clinical Engineering Programs at the Engineering School. A master's program in clinical engineering was completed in 2014. In all 10 students graduated and some of them are working with medical devices in the private and public sector. Even though there is a great need for qualified people, they have struggled to find a job at any public hospitals and some of them are not working with medical devices. Still, the system is suffering from the lack of awareness of the need for qualified people. Often other professionals are hired instead of clinical engineers in hospitals to take care of health techno logy. Low salary in the public sector is another obstacle for hiring qualified engineers and technicians.
Clinical engineering in Albania Chapter | 25 155
Education at hospital level The staff working with medical devices in hospitals do have a diploma in biomedical, clinical, electronics, information technology, electrical, or mechanical engineering. Most of them have some knowledge mainly due to the experience gained by working with medical devices. Not many possibilities to attend training courses have been made available.
Medical device information system as an important tool of management The number of medical devices being used in hospitals and healthcare organizations continues to grow demanding the setup of a medical devices information system for proper management. There have been several local attempts by the hospitals to list all the medical devices in use. Several various programs were created. It was difficult to make these systems compatible with each other and the information was impossible to be merged into a central national list. Ministry of Health intervened and registered all the medical devices of the public hospitals in a central system administered by commercial software. In 2014, the Ministry of Health of Albania started the informatization reform in health care. This process has improved the access to the system and health service delivery. Key projects were the introduction of the personal health card, nationwide electronic health records, e-prescription, hospital management information system, e-signature and e-examination, administration of medical drugs, registration system, management of human resource, and medical assets system. Clinical engineers are being charged to extend their scope as communicators, problem solvers, and experts in integrating high technology systems. With medical devices becoming more software-based and connected to networks, the role and responsibilities of CE have increased, demanding new skills and competencies in order to make the technology connected. The Telemedicine and e-Health Program are operating in 18 hospitals. Telemedicine center is merged with Biomedical National Center to create and to put in operation a remote care program for tele-trauma, tele-stroke, tele-radiology, etc. These achievements and other smaller complementary successes in the last years were attained as a result of the commitment of the local staff and the foreign experts who have assisted the Albanian health sector with their knowledge and financial support through various international bilateral and regional projects. World Bank, WHO, USAID, Italian Cooperation Agency, JICA, etc., projects have brought the best of international experiences to Albania and have supported successfully the local attempts in the development of healthcare technologies.
Albanian Society of Biomedical Engineering Albanian Society of Biomedical Engineering was founded in 2005. The mission was to promote the role and i mportance of biomedical engineering in health care, to represent the
professional interests of biomedical and clinical engineers, and to promote the safe use of the technology by establishing standards of practice in clinical engineering. Since there is a small community of people involved in health technology in Albania and due to the lack of economic and political stability, challenges have been faced over the years to get full recognition. As the awareness to recognize the important role of biomedical and clinical engineering in health care is increasing internationally, the collaboration of Albanian Society of Biomedical Engineering with other international societies and organizations and the involvement of its members in international forums are playing a crucial role in strengthening this organization and its contributions in healthcare delivery.
Clinical engineering challenges in Albania The challenges facing clinical engineering in Albania are as follows: Raising awareness of the importance of biomedical and clinical engineering within the health system. Establishing national health technology assessment in order to support management, clinical, and policy decisions. Establishing collaboration and partnerships with healthcare providers, industry, patient’s societies, and scientific and technical organizations. Implementation of national regulations and strengthening of the human resources. Development of the university programs in biomedical and clinical engineering and training programs for a high professional profile. Enhance patient safety in healthcare delivery. Strengthening market surveillance for medical devices to ensure regulatory compliance and public health protection.
Further reading Calil, S.J., 2016. The evolution of clinical engineering: history and the role of technology in health care. In: Clinical Engineering, From Devices to Systems. Council of Ministers of Albania, 2017. National plan for European integration, 2016-2020. Decision of the Council of Ministers of Albania, No. 42. Hernandez, A., Judd, T., 2017. ACCE Webinar: Global Health Technology Equity: How Emerging CE-HTM Leaders Can Help. Ministry of Health of Albania, 2007. National Policy for Management of Medical Devices. Statistics Institute of Albania, 2007. Population of Albania, www.instat.gov.al. Velazquez, A., 2017. World Health Organization, The role of health technology management in WHO, to support access to medical devices for Universal Health Coverage and achievement of SDGs. World Health Organization, Sixtieth World Health Assembly, WHO Resolutions: WHA60.29, Health technologies. http://158.232.12.119/ health systems/WHA60_29.pdf. Yadin, D., 2013. Second WHO Global Forum on Medical Devices, Global Perspectives on Clinical Engineering Trends, Geneva, Switzerland.