北京生物醫(yī)學(xué)工程

中國(guó)醫(yī)療器械不良事件報(bào)告現(xiàn)狀

Status of medical device adverse event reporting in China

作者：郭柯磊歐陽(yáng)昭連杜然然池慧

單位：中國(guó)醫(yī)學(xué)科學(xué)院北京協(xié)和醫(yī)學(xué)院醫(yī)學(xué)信息研究所(北京100020)

關(guān)鍵詞：醫(yī)療器械; 不良事件；監(jiān)管；報(bào)告

分類號(hào)：

出版年·卷·期（頁(yè)碼）：2012·31·5（518-523）

摘要：

目的分析中國(guó)醫(yī)療器械不良事件報(bào)告的現(xiàn)狀及存在問題，提出建議，為促進(jìn)科學(xué)監(jiān)管、保證用械安全提供參考。方法在萬方、CNKI等數(shù)據(jù)庫(kù)及FDA、SFDA等醫(yī)療器械監(jiān)管機(jī)構(gòu)網(wǎng)站搜集醫(yī)療器械不良事件監(jiān)測(cè)方面的數(shù)據(jù)，在文獻(xiàn)評(píng)閱的基礎(chǔ)上，比較中、美醫(yī)療器械不良事件監(jiān)管報(bào)告的現(xiàn)狀及采取的措施。結(jié)果通過與美國(guó)比較，發(fā)現(xiàn)中國(guó)醫(yī)療器械不良事件報(bào)告存在報(bào)告數(shù)占發(fā)生數(shù)比例較低、生產(chǎn)企業(yè)報(bào)告數(shù)最少及相同問題重復(fù)上報(bào)等問題，影響產(chǎn)業(yè)創(chuàng)新。進(jìn)一步分析認(rèn)為，主要存在監(jiān)管不力、各方認(rèn)識(shí)不足、技術(shù)評(píng)價(jià)難度大及信息上報(bào)渠道不暢通等方面原因。結(jié)論建議逐步完善法規(guī)、扭轉(zhuǎn)“重審批，輕監(jiān)管”的傾向，不斷提高監(jiān)管方、制造方和使用方的認(rèn)識(shí)，促進(jìn)醫(yī)、企共同評(píng)價(jià)，拓寬上報(bào)渠道并及時(shí)反饋，以改善中國(guó)醫(yī)療器械不良事件報(bào)告的狀況。

Objective We analyzed the status and problems of medical device adverse event reporting in China and provided the recommendations in order to offer references for promoting scientific supervision and ensuring the safe use of medical devices. Methods We retrieved the information on medical device adverse event monitoring in the databases of Wanfang and CNKI and the webs of FDA and SFDA, compared the status and measurements of medical device adverse event reporting between China and America on the basis of literature review. Results The problems of medical device adverse event reporting, such as repeated reporting, the less reporting number than the real, the lest reporting number from manufactures, affected the innovation of medical device industry in China. The reasons were analyzed as lack of supervision, inadequate awareness of medical device adverse events, huge difficulties in the technical evaluation, imperfect channels to report the information. Conclusions We should gradually improve the laws, reverse the mode of “tight registration and loose regulation”, continuously enhance the awareness of the parties about medical device adverse events, evaluate the reports together, broaden the reporting channels and provide the feedbacks timely, in order to improve the status of medical device adverse event reporting in China.

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