Abstract
BackgroundThe vigilant observation of medical devices during post-market surveillance (PMS) for identifying safety-relevant incidents is a non-trivial task. A wide range of sources has to be monitored in order to integrate all accessible data about the safety and performance of a medical device. PMS needs to be supported by an efficient search strategy and the possibility to create complex search queries by domain experts.ResultsWe use ontologies to support the specification of search queries and the preparation of the document corpus, which contains all relevant documents. In this paper, we present (1) the Search Ontology (SON) v2.0, (2) an Excel template for specifying search queries, and (3) the Search Ontology Generator (SONG), which generates complex queries out of the Excel template. Based on our approach, a service-oriented architecture was designed, which supports and assists domain experts during PMS. Comprehensive testing confirmed the correct execution of all SONG functions. The applicability of our method and of the developed tools was evaluated by domain experts. The test persons concordantly rated our solution after a short period of training as highly user-friendly, intuitive and well applicable for supporting PMS.ConclusionsThe Search Ontology is a promising domain-independent approach to specify complex search queries. Our solution allows advanced searches for relevant documents in different domains using suitable domain ontologies.
Highlights
The vigilant observation of medical devices during post-market surveillance (PMS) for identifying safety-relevant incidents is a non-trivial task
According to the provisions of the current European Medical Device Directive 93/42/EEC [1, 2] and the new European Medical Device Regulation [3], each manufacturer of medical devices has to set up a comprehensive system in order to identify, evaluate and integrate clinical data derived from the field application of a medical device after market access during post-market surveillance (PMS)
Search Ontology (SON) v2.0 The Search Ontology (SON) provides a general structure for all Domain-specific Search Ontologies (dSON)
Summary
The vigilant observation of medical devices during post-market surveillance (PMS) for identifying safety-relevant incidents is a non-trivial task. A wide range of both internal (own quality management and compliant system) and external (scientific databases, medical congresses, internet-based knowledge & experiences, PMS by competent authorities) sources have to be monitored in order to integrate all accessible data about a medical device’s safety and performance These detailed, continuous searches are still performed manually with a high input of time and personnel resources, making PMS a daunting task. An employee has to type all search queries (e.g., “safety AND coronary stent”) into the input fields of a large number of different databases, congress sites and public search engines in order to gain a broad, unspecific hit list, interspersed with single, relevant content This strategy of data retrieval reaches its limits assuming that several search strings have to be applied in order to monitor a whole range of medical devices, each featured by a variety of decisive search questions. This incompatibility between databases and the amount of different search tasks combined with the manual application to a multitude of databases results in low efficiency and a high potential for human error
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