BIOMAT Database Logo BIOMAT Database Logo

EDI system definition for a European medical device vigilance system. 1996

G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Department of Informatics, Athens University of Economics and Business, Greece.

EDI is expected to be the dominant form of business communication between organizations moving to the Electronic Commerce era of 2000. The healthcare sector is already using EDI in the hospital supply function as well as in the clinical area and the reimbursement process. In this paper, we examine the use of EDI in the healthcare administration sector and more specifically its application to the Medical Device Vigilance System. Firstly, the potential of this approach is examined, followed by the definition of the EDI System Reference Model and the specification of the required system architecture. Each of the architecture's components are then explained in more detail, followed by the most important implementation options relating to them.

UI MeSH Term Description Entries
D008421 Materials Management, Hospital The management of all procurement, distribution, and storage of equipment and supplies, as well as logistics management including laundry, processing of reusables, etc. Hospital Materials Management,Storeroom,Storerooms,Management, Hospital Material,Management, Hospital Materials,Hospital Material Management,Hospital Material Managements,Managements, Hospital Material,Material Management, Hospital,Material Managements, Hospital
D011358 Product Surveillance, Postmarketing Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D003195 Computer Communication Networks A system containing any combination of computers, computer terminals, printers, audio or visual display devices, or telephones interconnected by telecommunications equipment or cables: used to transmit or receive information. (Random House Unabridged Dictionary, 2d ed) Cognitive Radio,Computer Network Management,Databases, Distributed,Distributed Systems,Extranets,Intranets,Network Communication Protocols,Telecommunication Networks,Cognitive Radios,Communication Network, Computer,Communication Networks, Computer,Communication Protocol, Network,Communication Protocols, Network,Computer Communication Network,Database, Distributed,Distributed Database,Distributed Databases,Distributed System,Extranet,Intranet,Management, Computer Network,Network Communication Protocol,Network Management, Computer,Network, Computer Communication,Network, Telecommunication,Protocol, Network Communication,Radio, Cognitive,System, Distributed,Telecommunication Network
D003628 Database Management Systems Software designed to store, manipulate, manage, and control data for specific uses. Data Base Management Systems,Management System, Data Base,Management Systems, Data Base,System, Data Base Management,Systems, Data Base Management,Database Management System
D004864 Equipment and Supplies Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures. Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D004868 Equipment Failure Failure of equipment to perform to standard. The failure may be due to defects or improper use. Defects, Equipment,Device Failure,Failure, Equipment,Malfunction, Equipment,Medical Device Failure,Misuse, Equipment,Device Failure, Medical,Device Failures, Medical,Failure, Medical Device,Failures, Medical Device,Defect, Equipment,Device Failures,Equipment Defect,Equipment Defects,Equipment Failures,Equipment Malfunction,Equipment Malfunctions,Equipment Misuse,Equipment Misuses,Failure, Device,Failures, Device,Failures, Equipment,Malfunctions, Equipment,Misuses, Equipment
D005060 Europe The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN. Northern Europe,Southern Europe,Western Europe
D001330 Electronic Data Processing Applications that store and process large quantities of data. Automatic Data Processing,Bar Codes,Computer Data Processing,Data Processing, Automatic,Information Processing, Automatic,Optical Readers,Information Processing,Automatic Information Processing,Bar Code,Codes, Bar,Data Processing, Computer,Data Processing, Electronic,Optical Reader,Processing, Automatic Data,Processing, Automatic Information,Processing, Computer Data,Processing, Electronic Data,Processing, Information
D012308 Risk Management The process of minimizing risk to an organization by developing systems to identify and analyze potential hazards to prevent accidents, injuries, and other adverse occurrences, and by attempting to handle events and incidents which do occur in such a manner that their effect and cost are minimized. Effective risk management has its greatest benefits in application to insurance in order to avert or minimize financial liability. (From Slee & Slee: Health care terms, 2d ed) Hospital Incident Reporting,Incident Reporting, Hospital,Hospital Incident Reportings,Incident Reporting,Incident Reportings, Hospital,Management, Risks,Reporting, Hospital Incident,Reportings, Hospital Risk,Voluntary Patient Safety Event Reporting,Hospital Risk Reporting,Hospital Risk Reportings,Incident Reportings,Management, Risk,Reporting, Hospital Risk,Reporting, Incident,Reportings, Hospital Incident,Reportings, Incident,Risk Reporting, Hospital,Risk Reportings, Hospital,Risks Management
D012984 Software Sequential operating programs and data which instruct the functioning of a digital computer. Computer Programs,Computer Software,Open Source Software,Software Engineering,Software Tools,Computer Applications Software,Computer Programs and Programming,Computer Software Applications,Application, Computer Software,Applications Software, Computer,Applications Softwares, Computer,Applications, Computer Software,Computer Applications Softwares,Computer Program,Computer Software Application,Engineering, Software,Open Source Softwares,Program, Computer,Programs, Computer,Software Application, Computer,Software Applications, Computer,Software Tool,Software, Computer,Software, Computer Applications,Software, Open Source,Softwares, Computer Applications,Softwares, Open Source,Source Software, Open,Source Softwares, Open,Tool, Software,Tools, Software

Related Publications

G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
[The European monitoring system for medical products (vigilance system)].
January 1997, Biomedizinische Technik. Biomedical engineering,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
The Australian Medical Device Vigilance System.
January 1996, Studies in health technology and informatics,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Requirements specification for a harmonized medical device vigilance information exchange system.
January 1996, Studies in health technology and informatics,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Early experience of the European Medical Devices Vigilance System.
December 1997, Australasian physical & engineering sciences in medicine,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Vigilance to Medical Device Failures.
January 2016, Regional anesthesia and pain medicine,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Medical device vigilance at FDA.
January 1996, Studies in health technology and informatics,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Security aspects for medical device vigilance information exchange.
January 1996, Studies in health technology and informatics,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Insights into the definition of terms in European medical device regulation.
October 2016, Expert review of medical devices,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Medical devices vigilance: the European approach.
January 1996, Studies in health technology and informatics,
G Doukidis, and N Pallikarakis, and G Pangalos, and G Vassilacopoulos, and K Pramataris
Quality analysis of medical device vigilance reports.
January 2003, Technology and health care : official journal of the European Society for Engineering and Medicine,
Copied contents to your clipboard!