一次性无菌医疗器械验收中存在的问题及相关对策  

Inspection of Disposable Sterile Medical Appliances and Their Related Problems

作　　者：刘新明[1] 杜显峰[1] 卢光泽[1] 

机构地区：[1]解放军总医院器械处,北京100853

出　　处：《中华医院感染学杂志》2009年第16期2139-2140,共2页Chinese Journal of Nosocomiology

摘　　要：目的分析一次性无菌医疗器械进入医院验收过程中出现的质量问题,提示医疗机构应重视医疗器械的验收。方法采用回顾性分析近5年来对一次性无菌医疗器械进入医院验收过程中出现的不合格产品。结果一次性无菌医疗器械主要存在着产品环氧乙烷残留量超标,无合格证明产品灭菌合格,包装破损,失效期不清晰,产品型号内外不符,医疗器械产品注册证号与产品分类目录不符等。结论以上存在的问题与国家颁布的法律法规、规章及相关技术指标不相符合,医疗机构验收中发现类似的问题,应及时采用有效的措施杜绝进入临床,这样才能达到一次性无菌医疗器械安全有效的使用。OBJECTIVE To analyze the quality of the disposable sterile medical appliances befoure used and give suggestions for managements. METHODS The acceptance process of the disosable sterile medical appliances during the past five years wes restropectively analyzed and the unqualified products were found out. RESULTS After examination of the sterile medical devices, the main problems were more ethylene oxide residues, packaging damaged, expiry date not clear, both within and outside the Model not matching the registration of medical device product number. Categories not matching the product and so on. CONCLUSIONS The above problems are not meet the national laws and regulations, and should be timely and effective monitored to achieve safety use of medical device.

关 键 词：一次性无菌医疗器械 灭菌合格 残留量 存在问题 

分 类 号：R187[医药卫生—流行病学]