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輸注器具鉛鎘含量能力驗證

Proficiency testing program lead and cadmium content in infusion apparatus

作者: 盧大偉  陳鴻波  孫雪  楊昭鵬 
單位:<span style="font-size:14px;font-family:宋體">中國食品藥品檢定研究院(北京</span><span style="font-size:14px;font-family:&#39;Times New Roman&#39;,serif"> 102629</span><span style="font-size:14px;font-family:宋體">)</span>
關(guān)鍵詞: 醫(yī)療器械;  能力驗證;  質(zhì)量管理;  實驗室間比對 
分類號:R318.04
出版年·卷·期(頁碼):2018·37·3(311-314)
摘要:

目的 通過輸注器具鉛鎘含量能力驗證計劃評價醫(yī)療器械檢驗機構(gòu), 為提高實驗室檢測能力提供指導。方法 依據(jù)CNAS-CL03:2010《能力驗證提供者認可準則》策劃并實施本次能力驗證。采用模擬輸注器具溶出液作為樣品, 根據(jù)隨機原則發(fā)放給參加者, 要求參加者按照作業(yè)指導書規(guī)定的步驟采用原子吸收分光光度法測定樣品中鉛鎘含量。通過計算專家實驗室公儀值獲得指定值, 計算上一輪次結(jié)果的散度作為能力評定標準差。結(jié)果 全國共有30個省的58家實驗室參加, 其中39家結(jié)果滿意, 18家不滿意, 1家退出。通過結(jié)果分析參加者應在3個方面提高檢驗能力, 一是設(shè)備核心部分加強維護保養(yǎng), 二是按照SOP進行試驗操作, 三是加強環(huán)境監(jiān)控避免干擾。結(jié)論 客觀準確地評價了全國醫(yī)療器械檢驗機構(gòu)鉛鎘含量項目的檢驗能力, 發(fā)現(xiàn)并分析了問題, 為實驗室提高檢驗能力提供指導。

Objective The content of lead cadmium in infusion apparatus is an important test item. This paper aims to improve the laboratory 's ability through the proficiency testing program of lead and cadmium content in Infusion apparatus. Methods According to CNAS-CL03: 2010 Accreditation Criteria for Proficiency Testing Providers, we made lead and cadmium solution as proficiency samples, and provided to every labs who had participated this proficiency testing. The expert laboratory value was the assigned value. The result of last turn was the standard deviation for proficiency. Results A total of 58 laboratories from 30 provinces nationwide participated in this proficiency testing program, including 39 laboratories with satisfactory results, and 18 laboratories unsatisfactory. Three problems were found, first was strengthen instrument maintenance, the second was conduct test operation according to SOP, the third was strengthen environmental control.Conclusions In this paper, the ability of labs in lead and cadmium content experiment is evaluated, and problems are found. This paper can guide the labs to improve the ability of lead and cadmium content in Infusion apparatus.

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