F.J. de Ranitz
Abstract
A Database on medical devices, to be used in the member countries has been developed. The structure developed enables the users to introduce and present data on makes, models, most important properties, local standards, local regulations, a short description, hazards, alerts, literature, etc. Procedures are developed to gather the data in a concerted action with experts from other member countries.
By using this program a considerable time can be saved compared with local, individual activities on the setting up of a national database on medical devices in the member countries.
The contents and structure of the database can easily be modified to fulfil the requirements of the users, hospital staff, suppliers, governmental or European organizations.
Evaluation reports and quality guidelines have been distributed and made accessible in all the member countries.
Procedures and protocols have been exchanged to enable the institutions to use the same methods in testing and evaluating equipment. The methods are used in comparative studies, acceptance testing or even in maintenance programs in hospitals.