期刊文献+

关于市级中心应用国家药品不良反应监测系统之器械平台的思考 被引量:9

Investigation on Application of the Medical Device Platform of National Adverse Drug Reaction Monitoring System in the Municipal Center
暂未订购
导出
摘要 目的通过分析系统的功能特点,为市级监测机构的用户合理、高效地利用该系统开展工作提供参考,并对系统建设和发展提出建议。方法分析我国医疗器械不良事件监测工作现状,对系统进行研究,对其功能特点进行归纳,立足市级监测机构开展医疗器械不良事件监测业务的特点和应用需求,分析系统存在的优势和不足。结果与结论国家药品不良反应监测系统的建立及应用,为医疗器械不良事件监测工作提供了有效的技术手段;随着市级相关工作不断广泛和深入发展,在系统应用层面需要进一步加强。 Objective To use the system efficiently and reasonably in the municipal center and provide reference and suggestions for the system construction and development by analyzing the functions and features of the information system. Methods The current status of the medical device adverse event monitoring was analyzed. By studying the information system, the technical features of the system were analyzed and summarized. Based on the work characteristics and application requirements of the municipal agencies, the advantages and disadvantages existing in the system were analyzed. Resalts and Conclusion The construction and application of the system is helpful for MDAE monitoring. With the development of the MDAE monitoring in the municipal center, the system application need to be further strengthened.
出处 《中国药事》 CAS 2014年第2期209-214,共6页 Chinese Pharmaceutical Affairs
关键词 监测系统 器械平台 市级中心 monitoring system medical device platform the municipal center
  • 相关文献

参考文献8

二级参考文献42

共引文献48

同被引文献105

  • 1张素敏,曹立亚,曾光.世界各国医疗器械不良事件监测现状比较[J].中国医疗器械信息,2005,11(6):52-56. 被引量:29
  • 2纪立伟,李可欣,傅得兴.222份药品不良反应报告表质量评价[J].药物不良反应杂志,2005,7(6):458-460. 被引量:11
  • 3王晓瑜,杜文民,王宏敏,徐建龙.2005年上海市药品不良反应自发报告质量评价[J].中国临床药学杂志,2006,15(5):331-333. 被引量:23
  • 4陈新谦,金有豫,汤光.新编药物学[M].17版.北京:人民卫生出版社,2011:3465.
  • 5US FDA. Ensuring the safety of marketed medical devices -CDRH's medical device postmarket safety program[R]. [2006-01- 18].
  • 6FDA: Medical Device Reporting (MDR) [EB/OL]. (2014- 04-16). [2014 -06 -20].http ://www.fda.gov/MedicalDevices/ Safety/ReportaProblern/defauh.htm.
  • 7FDA. MAUDE Information Available to the Public [EB/OL]. ( 2014-03 -24).[2014-06-20].http://www.fda.gov/downloads/ Training/CDRHLearn/UCM234355.pdf.
  • 8FDA. Manufacturer and User Facility Device Experience Database - ( M AU DE ) [E B/OL]. (2014-03 - 12 ). [2014 -06- 20].http ://www:fda.gov/MedicalDevices/DeviceRegulationand Guidance/PostmarketRequirements/ReportingAdverseEvent s/ucm127891.htm.
  • 9FDA. MAUDE - Manufacturer and User Facility Device Experience (Simple Search) [EB/OL]. (2014 -05 -31 ). [2014-06-20]. http ://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfMAUDE/TextSearch.cfm.
  • 10FDA. MAUDE-Manufacturer and User Facility Device Experience (Advanced Search) [EB/OL]. (2014-05 -31 ). [2014-06-20]. http ://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfMAUDE/Search.cfm.

引证文献9

二级引证文献70

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部