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During the last decade, biomedical technology and medical devices are proved to be a crucial factor in healthcare (Pallikarakis & Moore, 2007; Iakovidis et al., 2007). An essential requirement for the healthcare environment, where the free movement of medical devices is a substantial part of world trade, is the attainment of the highest possible level of patient safety, through strict certification criteria, rules and limitations on medical devices released in the European Market. The introduction of the EU New Approach Directives (MDD93/42/EEC, IVDD 98/79/EEC and AIMDD 90/385/EEC) has stated the legal framework for medical device certification and circulation in EEU and highlighted the need of a common reference platform. On this common platform, medical devices could be correctly identified, and all the related data could safely be exchanged both between the EU member states for certification or vigilance issues (Notified Bodies, Competent Authorities, manufacturers, suppliers, healthcare organizations, hospitals, etc.) and other international bodies/markets, (bilateral mutual recognition agreements have been set up by the European Union with many countries, each incorporating the exchange of regulatory information).
The National Legislation for medical supplies in the Greek public healthcare sector addresses the legal framework for healthcare procurement (Law 3580/2007). According to the Law 3580/2007 a Greek registry of approved medical Devices and approved suppliers had to be developed, maintained and function as a source database for market monitoring, procurement, management and strategic planning of medical devices in Greece. “Registry of Medical Devices” is a web application which has been developed to confront the infrastructure requirements derived from EU Directives and National Legislation, in terms of recording, classification, management, strategic planning, procurement and market monitoring of medical devices available, or potentially available, in the Greek market. It is addressed to all practitioners of Health, including Public and Private Health Infrastructure, specifically procurement and I.T. services in healthcare, medical device suppliers and manufacturers, as well as the overall public.
EKAPTY’s contribution focuses on e-Health infrastructure by expressing solutions, depicting efficient methodologies and by producing software applications that simplify and rationalize procedures (See Figure 1). Transparency, effectiveness and re-establishment are the main axis in which the design and implementation of the proposed solutions were politically and technically supported on.
Figure 1. EKAPTY’s envision of e-Health
The three pillar applications of e-Health promoted by EKAPTY include:
- 1.
A registry for medical devices;
- 2.
A software tool for the production of specifications of medical devices;
- 3.
A healthcare needs estimation system.
These applications combined under a centralized web services system can act as the basis for an e-Health infrastructure that exchanges and routes information between healthcare institutions, the government and the market, as shown in Figure 2.
Figure 2. e-Health systems relationships
The lack of comparable data has proven to be one of the major issues throughout the procurement procedure of medical devices in the Greek public hospitals. The hospitals were unable to provide reliable data, in a common reference format. The main reason for this inadequacy was the lack of common and nationally approved nomenclature and coding system for the medical devices.