中国医疗器械杂志
中國醫療器械雜誌
중국의료기계잡지
CHINESE JOURNAL OF MEDICAL INSTRUMENTATION
2014年
1期
65-67
,共3页
医疗器械%不良事件%评价%问题%建议
醫療器械%不良事件%評價%問題%建議
의료기계%불량사건%평개%문제%건의
medical device%adverse event%evaluation%deficiency%suggestion
医疗器械不良事件的上报数量逐年增加，但上报系统还存在不足之处，导致对不良事件的评价和判定产生困惑。该文根据我国上报的医疗器械不良事件的特点，对上报系统的评价流程提出修订建议，以期实现对不同类型的不良事件以监管目标为导向及时进行有效管理。
醫療器械不良事件的上報數量逐年增加，但上報繫統還存在不足之處，導緻對不良事件的評價和判定產生睏惑。該文根據我國上報的醫療器械不良事件的特點，對上報繫統的評價流程提齣脩訂建議，以期實現對不同類型的不良事件以鑑管目標為導嚮及時進行有效管理。
의료기계불량사건적상보수량축년증가，단상보계통환존재불족지처，도치대불량사건적평개화판정산생곤혹。해문근거아국상보적의료기계불량사건적특점，대상보계통적평개류정제출수정건의，이기실현대불동류형적불량사건이감관목표위도향급시진행유효관리。
The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system stil existed some deficiencies which resulting in confusion when fil ing the forms, especial y those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
