{"title":"The Role of Healthcare Technology Management Professionals in Adverse Event Reporting","authors":"A. S. Silva Ferreira, S. Waheed","doi":"10.1097/jce.0000000000000588","DOIUrl":null,"url":null,"abstract":"Healthcare technology management professionals play a key role in the medical device environment. By sharing their insights and expertise on medical devices issues with the US Food and Drug Administration, healthcare technology management professionals help the agency resolve medical device safety concerns and help improve patient safety. This article presents two real-world case study examples in which medical device reports containing critical healthcare technology management input were submitted to the US Food and Drug Administration's MedSun (Medical Product Safety Network) reporting program and helped contribute to 2 recalls. The details in the reports, provided by the hospital reporting team, offer a unique perspective for identifying the device concern and greatly contribute to the investigation and resolution of the reported device safety issue.","PeriodicalId":77198,"journal":{"name":"Journal of clinical engineering","volume":"48 1","pages":"103 - 106"},"PeriodicalIF":0.0000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical engineering","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/jce.0000000000000588","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Healthcare technology management professionals play a key role in the medical device environment. By sharing their insights and expertise on medical devices issues with the US Food and Drug Administration, healthcare technology management professionals help the agency resolve medical device safety concerns and help improve patient safety. This article presents two real-world case study examples in which medical device reports containing critical healthcare technology management input were submitted to the US Food and Drug Administration's MedSun (Medical Product Safety Network) reporting program and helped contribute to 2 recalls. The details in the reports, provided by the hospital reporting team, offer a unique perspective for identifying the device concern and greatly contribute to the investigation and resolution of the reported device safety issue.