Analysis of 519 Reports of Suspicious Adverse Events Associated with In Vitro Diagnostics(IVD) Medical Devices
Author(s): LI Yao, WANG Xin-min, BIAN Rong-rong, SUN Jun, ZHANG Su-lin, Center for ADR Monitoring of Jiangsu, Center for Certification & Evaluation, Jiangsu Food and Drug Administration
Pages: 593-595
Year: 2015 Issue: 6
Journal: Jiangsu Pharmacertical and Clinical Research
Keyword: In Vitro diagnostics; Medical device adverse events monitoring; Risk factor; Analysis;
Abstract: A retrospective case study was conducted, to analyze 519 reports of suspicious adverse events in last three years on in vitro diagnostics(IVD) medical devices. Reporting of IVD suspicious adverse events is mostly neglected by users. Reports on class Ⅱ IVD are more than the others. The risk signals of using IVD are subtle. IVD monitoring is suggested to be strengthened consciously and institutionally to promote public safety.
Pages: 593-595
Year: 2015 Issue: 6
Journal: Jiangsu Pharmacertical and Clinical Research
Keyword: In Vitro diagnostics; Medical device adverse events monitoring; Risk factor; Analysis;
Abstract: A retrospective case study was conducted, to analyze 519 reports of suspicious adverse events in last three years on in vitro diagnostics(IVD) medical devices. Reporting of IVD suspicious adverse events is mostly neglected by users. Reports on class Ⅱ IVD are more than the others. The risk signals of using IVD are subtle. IVD monitoring is suggested to be strengthened consciously and institutionally to promote public safety.
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