Innovative practice of auditing qualification documents of disinfectant, disinfection devices and disposable medical devices_West China Medical Journal

Authors：

HUANG Jing , QIAO Fu , FU Xueqin , KANG Xia , ZONG Zhiyong ,  YIN Weijia

Department of Nosocomial Infection Management, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

YIN Weijia, Email: 525989261@qq.com

Keywords：

Disinfectant and disinfection devices; Disposable medical devices; Audit

DOI：

10.7507/1002-0179.201711105

Video：

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Abstract Full text Figures/Tables Video References Cited by

The quality of disinfectant, disinfection devices and disposable medical devices is closely related to the patients' safety. Hospital infection management department must carry out the audit responsibilities for qualification documents of disinfectant, disinfection devices and disposable medical devices, to guarantee legality, safety and effectiveness of products used in hospital. This paper mainly introduces the implementation of qualification documents audit in West China Hospital, Sichuan University, including system construction, process reengineering, documents audit scope and key points, and document management.

Citation： HUANG Jing, QIAO Fu, FU Xueqin, KANG Xia, ZONG Zhiyong, YIN Weijia. Innovative practice of auditing qualification documents of disinfectant, disinfection devices and disposable medical devices. West China Medical Journal, 2018, 33(3): 271-274. doi: 10.7507/1002-0179.201711105 Copy

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1. 中华人民共和国国家卫生和计划生育委员会. 中华人民共和国卫生部令(第 48 号)——医院感染管理办法. (2006-07-06)[2017-11-10]. http://www.nhfpc.gov.cn/mohyzs/s3576/200804/29294.shtml.
2. 中华人民共和国国务院. 国务院关于取消和下放 50 项行政审批项目等事项的决定. (2013-07-13)[2017-11-10]. http://www.gov. cn/zwgk/2013-07/22/content_2452368.htm.
3. 丁方然, 程薇, 王宗武, 等. 我国消毒产品生产企业卫生监督现状. 中国预防医学杂志, 2017, 18(8): 635-637.
4. 周世红, 胡晓玲, 曹韵, 等. 成都市消毒产品生产企业现状及监管建议. 中国消毒学杂志, 2016, 33(6): 555-558.
5. 朱丹. 新形势下对消毒产品监管的思考与建议. 中国卫生产业, 2014(2): 28-29.
6. 于丽丽. 消毒产品市场监管中存在的" 真空地带”及完善对策. 中国卫生法制, 2017, 25(1): 60-62.
7. 中华人民共和国国家卫生和计划生育委员会. 消毒产品卫生安全评价规定. (2014-06-27)[2017-11-10]. http://www.nhfpc.gov. cn/zhjcj/s9139/201407/9798bda61e9b4b028a679d2c9b9a3202.shtml.
8. 中华人民共和国国家食品药品监督管理总局. 医疗器械注册管理办法, 2014. (2014-07-30)[2017-11-10]. http://www.gov.cn/ gongbao/content/2014/content_2758500.htm.

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