Systematization of information for identifying similar cardiovascular implantable devices
نویسندگان
چکیده
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 identifi cation of similar cardiovascular implantable devices. Methods: The systematization was developed in four stages: defi nition of the technical attributes of each device group; classifi cation 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 specifi c 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 identifi cation of similar devices according to their technical characteristics. The users’ evaluation showed that the application fulfi lled 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 fulfi ll this aim, other attributes may be incorporated to better characterize the safety aspects of these devices.
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