title: Serious adverse event reporting in a medical device information system.
abstract: The paper describes the design of a module that manages Serious Adverse Events (SAEs) reporting within a Clinical investigation on Medical devices. This module is integrated in a Medical Device Information System (MEDIS) that collects data and documents exchanged between applicants and the National Competent Authority during the clinical investigation lifecycle. To improve information sharing among different stakeholders and systems MEDIS design and developed were based on the HL7 v.3 standards. The paper provides a conceptual model on SAEs based on HL7 RIM that underlines Medical Device characteristics.
authors: Institute for Research on Population and Social Policies (IRPPS), National Research Council, Rome, Italy.
authors: Fabrizio
authors: F
authors: Pecoraro
authors: Daniela
authors: D
authors: Luzi
mesh_terms: D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000009:adverse effects* / Q000592:standards*; D057208:Health Level Seven; D006801:Humans; D007558:Italy; D008962:Models, Theoretical; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012042:Registries; D012985:Software Design; D013673:Technology Assessment, Biomedical / Q000379:methods*