{"id":"https://openalex.org/W75567118","doi":"https://doi.org/10.3233/978-1-60750-806-9-834","title":"Serious Adverse Event Reporting in a Medical Device Information System","display_name":"Serious Adverse Event Reporting in a Medical Device Information System","publication_year":2011,"publication_date":"2011-01-01","ids":{"openalex":"https://openalex.org/W75567118","doi":"https://doi.org/10.3233/978-1-60750-806-9-834","mag":"75567118","pmid":"https://pubmed.ncbi.nlm.nih.gov/21893864"},"language":"en","primary_location":{"id":"doi:10.3233/978-1-60750-806-9-834","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-60750-806-9-834","pdf_url":null,"source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5061292206","display_name":"Fabrizio Pecoraro","orcid":"https://orcid.org/0000-0001-5718-4240"},"institutions":[{"id":"https://openalex.org/I4210117484","display_name":"Institute for Research on Population and Social Policies","ror":"https://ror.org/01n1ayq61","country_code":"IT","type":"facility","lineage":["https://openalex.org/I4210117484","https://openalex.org/I4210155236"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Pecoraro Fabrizio","raw_affiliation_strings":["Institute for Research on Population and Social Policies (IRPPS), National Research Council, Rome, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute for Research on Population and Social Policies (IRPPS), National Research Council, Rome, Italy","institution_ids":["https://openalex.org/I4210117484"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5010067486","display_name":"Daniela Luzi","orcid":"https://orcid.org/0000-0003-3404-3271"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Luzi Daniela","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":3.0756,"has_fulltext":false,"cited_by_count":4,"citation_normalized_percentile":{"value":0.91208791,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":94},"biblio":{"volume":"169","issue":null,"first_page":"834","last_page":"8"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9939000010490417,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9939000010490417,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13280","display_name":"Biomedical and Engineering Education","score":0.9427000284194946,"subfield":{"id":"https://openalex.org/subfields/2204","display_name":"Biomedical Engineering"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T13295","display_name":"Safety Systems Engineering in Autonomy","score":0.934499979019165,"subfield":{"id":"https://openalex.org/subfields/2213","display_name":"Safety, Risk, Reliability and Quality"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.593591570854187},{"id":"https://openalex.org/keywords/medical-information","display_name":"Medical information","score":0.5873732566833496},{"id":"https://openalex.org/keywords/event","display_name":"Event (particle physics)","score":0.5281591415405273},{"id":"https://openalex.org/keywords/adverse-effect","display_name":"Adverse effect","score":0.4962924122810364},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.47702643275260925},{"id":"https://openalex.org/keywords/patient-safety","display_name":"Patient safety","score":0.44844797253608704},{"id":"https://openalex.org/keywords/data-sharing","display_name":"Data sharing","score":0.44236382842063904},{"id":"https://openalex.org/keywords/information-sharing","display_name":"Information sharing","score":0.4407682716846466},{"id":"https://openalex.org/keywords/medical-emergency","display_name":"Medical emergency","score":0.3543449342250824},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.33334171772003174},{"id":"https://openalex.org/keywords/knowledge-management","display_name":"Knowledge management","score":0.3086601495742798},{"id":"https://openalex.org/keywords/world-wide-web","display_name":"World Wide Web","score":0.19423627853393555},{"id":"https://openalex.org/keywords/biomedical-engineering","display_name":"Biomedical engineering","score":0.09876564145088196},{"id":"https://openalex.org/keywords/alternative-medicine","display_name":"Alternative medicine","score":0.09769943356513977},{"id":"https://openalex.org/keywords/health-care","display_name":"Health care","score":0.08906921744346619}],"concepts":[{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.593591570854187},{"id":"https://openalex.org/C3019150057","wikidata":"https://www.wikidata.org/wiki/Q92779279","display_name":"Medical information","level":2,"score":0.5873732566833496},{"id":"https://openalex.org/C2779662365","wikidata":"https://www.wikidata.org/wiki/Q5416694","display_name":"Event (particle physics)","level":2,"score":0.5281591415405273},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.4962924122810364},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.47702643275260925},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.44844797253608704},{"id":"https://openalex.org/C2779965156","wikidata":"https://www.wikidata.org/wiki/Q5227350","display_name":"Data sharing","level":3,"score":0.44236382842063904},{"id":"https://openalex.org/C2776854237","wikidata":"https://www.wikidata.org/wiki/Q6031064","display_name":"Information sharing","level":2,"score":0.4407682716846466},{"id":"https://openalex.org/C545542383","wikidata":"https://www.wikidata.org/wiki/Q2751242","display_name":"Medical emergency","level":1,"score":0.3543449342250824},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.33334171772003174},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.3086601495742798},{"id":"https://openalex.org/C136764020","wikidata":"https://www.wikidata.org/wiki/Q466","display_name":"World Wide Web","level":1,"score":0.19423627853393555},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.09876564145088196},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.09769943356513977},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.08906921744346619},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.0},{"id":"https://openalex.org/C62520636","wikidata":"https://www.wikidata.org/wiki/Q944","display_name":"Quantum mechanics","level":1,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0},{"id":"https://openalex.org/C50522688","wikidata":"https://www.wikidata.org/wiki/Q189833","display_name":"Economic growth","level":1,"score":0.0},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004868","descriptor_name":"Equipment Failure","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004868","descriptor_name":"Equipment Failure","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004868","descriptor_name":"Equipment Failure","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007558","descriptor_name":"Italy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007558","descriptor_name":"Italy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007558","descriptor_name":"Italy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008962","descriptor_name":"Models, Theoretical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008962","descriptor_name":"Models, Theoretical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008962","descriptor_name":"Models, Theoretical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012985","descriptor_name":"Software Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012985","descriptor_name":"Software Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012985","descriptor_name":"Software Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013673","descriptor_name":"Technology Assessment, Biomedical","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D013673","descriptor_name":"Technology Assessment, Biomedical","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D013673","descriptor_name":"Technology Assessment, Biomedical","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D057208","descriptor_name":"Health Level Seven","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D057208","descriptor_name":"Health Level Seven","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D057208","descriptor_name":"Health Level Seven","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.3233/978-1-60750-806-9-834","is_oa":false,"landing_page_url":"https://doi.org/10.3233/978-1-60750-806-9-834","pdf_url":null,"source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},{"id":"pmid:21893864","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/21893864","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in health technology and informatics","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W1591534803","https://openalex.org/W4306630407","https://openalex.org/W3095507586","https://openalex.org/W2884487111","https://openalex.org/W3007390702","https://openalex.org/W4392527860","https://openalex.org/W2468455523","https://openalex.org/W4240341494","https://openalex.org/W2354453123","https://openalex.org/W2363838410"],"abstract_inverted_index":{"The":[0,71],"paper":[1,72],"describes":[2],"the":[3,42,47,67],"design":[4,61],"of":[5],"a":[6,16,27,74],"module":[7,23],"that":[8,33,83],"manages":[9],"Serious":[10],"Adverse":[11],"Events":[12],"(SAEs)":[13],"reporting":[14],"within":[15],"Clinical":[17],"investigation":[18,49],"on":[19,66,77,80],"Medical":[20,28,85],"devices.":[21],"This":[22],"is":[24],"integrated":[25],"in":[26],"Device":[29,86],"Information":[30],"System":[31],"(MEDIS)":[32],"collects":[34],"data":[35],"and":[36,41,58,62],"documents":[37],"exchanged":[38],"between":[39],"applicants":[40],"National":[43],"Competent":[44],"Authority":[45],"during":[46],"clinical":[48],"lifecycle.":[50],"To":[51],"improve":[52],"information":[53],"sharing":[54],"among":[55],"different":[56],"stakeholders":[57],"systems":[59],"MEDIS":[60],"developed":[63],"were":[64],"based":[65,79],"HL7":[68,81],"v.3":[69],"standards.":[70],"provides":[73],"conceptual":[75],"model":[76],"SAEs":[78],"RIM":[82],"underlines":[84],"characteristics.":[87]},"counts_by_year":[{"year":2024,"cited_by_count":1},{"year":2021,"cited_by_count":1},{"year":2014,"cited_by_count":1},{"year":2012,"cited_by_count":1}],"updated_date":"2026-06-11T09:08:48.828518","created_date":"2025-10-10T00:00:00"}
