Systematization of information for identifying similar cardiovascular implantable devices

ABSTRACT

Introduction The lack of a terminology to compare medical devices together with the arbitrary and opaque nature of product registration systems are major obstacles to a more informed decision process regarding the use and acquisition of new medical devices. This paper describes the systematization of information to help in the identification of similar cardiovascular implantable devices. Methods The systematization was developed in four stages definition of the technical attributes of each device group; classification of a sample of devices; implementation of the proposed systematization in Protégé; and evaluation of the application. The systematization dealt with a set of common attributes – indication of use, anatomic location, manufacturer, device model and lifetime; and a set of attributes specific for each type of device. Results The systematization was performed by means of a hierarchy of classes with the respective properties in Protégé, which support three basic functions data entry, query, and maintenance. 38 queries were designed to allow the identification of similar devices according to their technical characteristics. The users’ evaluation showed that the application fulfilled the requirements to monitor the price of these devices on the market. Conclusions Protégé was a useful tool for the systematization of cardiovascular implantable devices that can be used for the post-market vigilance of medical device safety. To better fulfill this aim, other attributes may be incorporated to better characterize the safety aspects of these devices.