UNIQUE DEVICE IDENTIFIER SYSTEM- THE IMPACT OF THE PORTUGUESE EXPERIENCE
Author(s)
alves Da Silva E, Figueira J, 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: 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 (unique device identifier), 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 44% of all registered MDs (n=1000000) up to June 2015. This has allowed for the elimination or withdrawal of 21% (n=215000) of references, thus keeping the registries up to date. The coding (unique device identifier), 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
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PMD165
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
Multiple Diseases