Andrea Garcia-Ibarra Biomedical engineer - MoHSP consultant Colombia

Transcription

1 Third WHO Global Forum on Medical Devices NETWORKING FROM COLOMBIAN CLINICAL ENGINEER Present by: Andrea Garcia-Ibarra Biomedical engineer - MoHSP consultant Colombia

2 Disclosure My name is Andrea Garcia-Ibarra, I am biomedical engineer and I have worked external contracts with the Colombian Ministry of Health and Social Protection (MoHSP) since june 2013, with the objective to support Colombian medical equipment regulations development. I have no actual or potential conflict of interest in relation to this presentation 2

3 Population Colombia Estimates in Brief 49 Million (2017. DANE) Population Growth Rate 1.1% ( DANE) Average Life Span Male: 71 Female: 78 Infant Mortality Rate 20.1 (2015. OMS) (2012. OPS) Health care providers hospitals: ( private/ public) Professionals (Doctors, therapists and others) Total Expenditure on Health as % of GDP 7.2 (2014. OMS) A land full of magic, where everything is possible. Colombia is a place of dreamers, where the ocean and the snow lives at the same place, the landscapes of the greatest books come alive and the rivers are pieces of art. 3

4 COLOMBIA KEY ACCOMPLISHMENTS 1. MoHSP has an unit: Direction of Drugs and Health Technologies, its role is to design decrees, resolutions, policy documents, recommendations and guidelines regarding health technologies 2. Public health care providers must spend 5% of their budget 1 on infrastructure and hospital equipment maintenance, including medical equipment. However, there are no recommendations for these expenditures. Private health care providers do not have a specific percentage requirement to spend on maintenance. 3. The maintenance of the medical equipment is mandatory in order to be a licensed 2 as healthcare provider, but other requirements of medical equipment management are not included. 4. Establishment of a Health Technology Assessment Institute (IETS). 5. Incorporation of HTA in the definition of priorities (Health Benefits Package) 6. Price regulation of coronary stents: ntrol-precios-dispositivos-medicos.aspx 7. Regulatory of medical devices: Premarket regulatory, medical devices classification of risk (I-IIA-IIB-III) All devices need permission for marketing (INVIMA) All human resources for maintenance of medical equipment need a registration in sanitary agency (INVIMA) Technovigilance program Control of medical equipment donation 4

5 OUR PROBLEM OUR SOLUTION Our system is DECENTRALIZED, each health care provider has autonomy and administrative independence for medical equipment management, so in Colombia, MoHSP is not in charge of procurement and maintenance of medical equipment. Only some high complexity hospitals has ACCESS to information and the resources for management, so only they can do it very well. But any of us can be patient in any type of hospital, not only in high complexity ones. For example, when you are traveling and an accident happens. Therefore, the information access and optimization of their resources is very important for all types of hospital. In 2015, while I was working in the Drug and Health Directorate of the MoHSP, I supported a launched an initiative for establishing a CLINICAL ENGINEERING NETWORK oriented to improve medical equipment management countrywide. Including small and distant hospitals. Currently I have continued supporting this network, which covers 40% of the national territory, wich is divided into six nodes or regions. The Network includes 120 hospital and 10 universities. 5

6 HOW WE CAN DO IT 1st step 2nd step We assure the MoHSP is the leader of the project and a person in MoHSP who is responsible for coordinated the network. We identified the best and most recognized hospitals in the country and we invited the clinical engineers of those hospitals, in different region, to make a working group. We based on a study conducted by the business magazine América Economía to obtain the 2016 Ranking of the Best Hospitals and Clinics of Latin America where of the 100% of hospital institutions that were part, 48% are clinics and hospitals of Colombia. All these institutions are part of our network. 3rd step We support the engineers of these hospitals to lead and keep work groups or technical meetings, in the region where they come from. 6

7 WHAT ARE WE DOING? In order to prepare projects on Medical Equipment Management (MEM) and share information and experiences, the members of the Network meet every two months in one of the nodes. Some of the accomplishments and outcomes of the meetings are: Continuous training in Colombian regulations. Linking between participants. Institutional referencing to improve processes Positioning the Biomedical Engineers as the key stakeholders in MEM. Institutional strengthening of the MoHSP in the Health Technology field. 7

8 WHO ARE OUR LEADERS? There are 12 clinical engineers from 8 high complexity hospitals, those hospitals with high quality standards as national and JCI accreditations and successful experiences in medical equipment management. They are leadering and keeping 6 regional nodes for medical equipment management: R1: Antioquia R2 : Southwest Colombia R3: Santanderes R4: Coffee triangle area R5: Caribbean cost R6: Bogota and central zone 8

9 REGIONAL NODE 1 OUR TEAM REGIONAL NODE 4 REGIONAL NODE 2 REGIONAL NODE 5 REGIONAL NODE 3 REGIONAL NODE 6 9

10 O U R N E T W O R K REGION CE LEADERS 200 CLINICAL ENGINNER 120 HOSPITALS 10 UNIVERSITIES R1: Antioquia R2 : Southwest Colombia R3: Santander R4: Coffee region R5: Caribbean coast R6: Bogota and central zone

11 OUR GOALS The main outcome is a better healthcare service to the patients. The interaction among the members of the participant institutions has facilitated a successful knowledge and best practices transference in MEM, from the eight high-complexity university hospitals to almost 120 regional and local hospitals. These regional and local hospitals have limited access to resources and operation of the Network has contributed to improve the efficiency in the equipment managing process. One of the priority projects of the Network is the collaboration with the MoHSP in the validation of the Equipment Maintenance and Obsolescence Assessment Manual. The document should be ready by the end of We made, together with the network, a proposal of mandatory requirements for medical equipment management for public and private hospitals, blood banks and public health laboratories. 11

12 NEXT STEPS Strengthening of the Network Next step: Colombian Clinical Engineering Association Increasing the membership and the motivation of members and institutions. Supporting to Health Technology Assessment Institute (IETS) in medical equipment management projects. Work with ACCE international committee projects in Colombia Interacting with professional engineering societies and health technology organizations worldwide. Seeking support and improving communication with health authorities, hospital directors, and administrators for the expansion of the Network. Improving our communication, webex or other platforms are necessary for our meeting and we need a sponsor or similar for it. Getting a website for share our experiences, knowledge and documents. 12

13 Gracias Andrea Garcia-Ibarra COLOMBIA 13