THE IMPACT OF THE INFORMATION SYSTEM OF MEDICAL DEVICES IN PORTUGAL

Author(s)

Silva E, Inacio P, Figueira J
INFARMED_ National Authority for Medicines and health Products, Lisboa, Portugal

OBJECTIVES The Portuguese National Health System (NHS) identified the need to easily access information that allowed identification of all medical devices (MDs) with their respective manufacturers, distributors, characteristics, and purposes. The objective of the creation of an information system is to collect, store and analyze data of each MD and to provide NHS resources management, health technology assessment (HTA), as well as data about the Portuguese market. METHODS A system consisting of a database that is a repository, and an application system that stores the information was built. For the registry of information all MDs should disclose their respective instructions of use, labels and price. The concept of unique medical device and a process to assign a code to each device was designed, and tested by collecting data from NHS acquisitions.The prescription of medical devices is made by code, with all information online. A model for communication between the health regulatory agency and market operators was also devised, as well as rules and codes of procedure. RESULTS The creation of this system in 2011 allowed for the coding of 20% of all registered MDs (n=838000) up to June 2014. This has allowed for the elimination or withdrawal of 16% (n=136000) of references, thus keeping the registries up to date. The coding permitted the comparison of devices and the management of total expenditure in MDs by hospitals of the NHS. CONCLUSIONS The system provides solid information about available MDs in the market, their respective manufacturer, distributor and pricing to which they are sold to the NHS. The system is a support for decision makers, payers, and HTA processes. It facilitates the management and traceability of medical devices in hospitals and has impact on reimbursement, access and pricing varies by market.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP56

Topic

Economic Evaluation, Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment, Real World Data & Information Systems

Topic Subcategory

Approval & Labeling, Cost/Cost of Illness/Resource Use Studies, Decision & Deliberative Processes, Health & Insurance Records Systems, Hospital and Clinical Practices, Pricing Policy & Schemes, Quality of Care Measurement

Disease

Multiple Diseases

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