發(fā)布時間：2018-06-01 04:35

  本文選題：醫(yī)療器械經(jīng)營企業(yè) + 質(zhì)量　； 參考：《復(fù)旦大學(xué)》2014年碩士論文

【摘要】：研究背景醫(yī)療器械是在醫(yī)療中廣泛使用,是疾病的診斷和治療重要的物質(zhì)基礎(chǔ),其發(fā)展水平高低、質(zhì)量保證的好壞,對臨床診斷和治療有著非常大的影響。醫(yī)療器械經(jīng)營企業(yè)是聯(lián)系醫(yī)療器械生產(chǎn)企業(yè)和醫(yī)療機(jī)構(gòu)的橋梁,承擔(dān)著醫(yī)療器械的保存、運(yùn)輸、售后維修等保證醫(yī)療器械安全有效的重要職責(zé)。在發(fā)達(dá)國家,醫(yī)療器械生產(chǎn)許可控制和產(chǎn)品的市場準(zhǔn)入均被作為保證質(zhì)量的重點(diǎn),醫(yī)療器械生產(chǎn)企業(yè)將產(chǎn)品通過物流公司配送至醫(yī)院。在我國,醫(yī)療器械生產(chǎn)企業(yè)將市場進(jìn)行區(qū)域分隔,然后通過產(chǎn)品代理商分銷至醫(yī)院,這些醫(yī)療器械經(jīng)營企業(yè)數(shù)量多,但規(guī)模往往較小,質(zhì)量保障能力較弱,這就為醫(yī)療器械的質(zhì)量安全帶來風(fēng)險。目前醫(yī)療器械經(jīng)營企業(yè)的許可、監(jiān)管,是按二000年頒布的《醫(yī)療器械監(jiān)督管理?xiàng)l例》和按二00四年頒布的《行政許可法》、《醫(yī)療器械經(jīng)營企業(yè)許可證管理辦法》等法津法規(guī)要求執(zhí)行,具體標(biāo)準(zhǔn)是依據(jù)《上海市醫(yī)療器械經(jīng)營企業(yè)檢查驗(yàn)收標(biāo)準(zhǔn)(試行)》等規(guī)范性文件,重點(diǎn)對人員、場地、質(zhì)量管理制度、及采購與驗(yàn)收、儲存與保管、出庫與運(yùn)輸以及銷售與售后服務(wù)各過程等質(zhì)量管理方面提出了要求。研究目的通過現(xiàn)場調(diào)查,了解徐匯區(qū)醫(yī)療器械經(jīng)營企業(yè)質(zhì)量管理的現(xiàn)狀,查找醫(yī)療器械經(jīng)營企業(yè)質(zhì)量管理中存在的薄弱環(huán)節(jié)和主要問題,通過關(guān)鍵知情人士訪談分析原因和對策,為加強(qiáng)對徐匯區(qū)醫(yī)療器械經(jīng)營企業(yè)監(jiān)管,促進(jìn)醫(yī)療器械經(jīng)營企業(yè)質(zhì)量管理水平提高,提供必要的參考。研究方法本研究采用定性研究與定量研究相結(jié)合的方法,研究對象為徐匯區(qū)內(nèi)已取得《醫(yī)療器械經(jīng)營企業(yè)許可證》的559家企業(yè),資料來自于現(xiàn)場調(diào)查和關(guān)鍵知情人訪談,均為一手資料�，F(xiàn)場收集的定量資料用Excel軟件建立數(shù)據(jù)庫并錄入,使用SPSS 17.0進(jìn)行統(tǒng)計(jì)分析,對定性訪談資料現(xiàn)場記錄,Word模塊輸入,采用分類歸納總結(jié)的方法,對調(diào)查發(fā)現(xiàn)的問題進(jìn)一步分析。研究結(jié)果從質(zhì)量管理人在位、設(shè)施設(shè)備這些結(jié)構(gòu)方面的因素比較,所調(diào)查的醫(yī)療器械經(jīng)營企業(yè)中,大型醫(yī)療器械經(jīng)營企業(yè)與中小型企業(yè)、代理經(jīng)營企業(yè)與醫(yī)院分銷企業(yè)無明顯差異。但是,從過程方面的因素比較,如質(zhì)量管理制度是否執(zhí)行,質(zhì)量管理人是否履職,產(chǎn)品資質(zhì)審核,入庫驗(yàn)收、出庫復(fù)核及銷售記錄、追溯性管理、售后服務(wù)與質(zhì)量跟蹤、從業(yè)人員培訓(xùn)等,大型企業(yè)明顯優(yōu)于小型企業(yè),代理經(jīng)營企業(yè)明顯優(yōu)于醫(yī)院分銷企業(yè)。將體外診斷試劑經(jīng)營企業(yè)進(jìn)行比較發(fā)現(xiàn),在冷鏈驗(yàn)證方面,大型企業(yè)明顯優(yōu)于小型企業(yè),代理經(jīng)營企業(yè)明顯優(yōu)于醫(yī)院分銷企業(yè)。將角膜接觸鏡零售企業(yè)進(jìn)行比較發(fā)現(xiàn),在過程管理制度的執(zhí)行方面,連鎖角膜接觸鏡零售企業(yè)明顯好非連鎖企業(yè)。對策建議通過本次研究發(fā)現(xiàn),目前徐匯區(qū)醫(yī)療器械經(jīng)營企業(yè)質(zhì)量管理上存在企業(yè)領(lǐng)導(dǎo)對質(zhì)量管理不重視、企業(yè)質(zhì)量管理制度流于形式、質(zhì)量管理人員形同虛設(shè)、各項(xiàng)管理記錄內(nèi)容信息不全、員工培訓(xùn)教育嚴(yán)重缺失等問題,在外部監(jiān)管中存在監(jiān)督管理法律法規(guī)體系有待完善、監(jiān)管力量薄弱,監(jiān)管無法有效覆蓋,為此建議監(jiān)管部門修訂完善相關(guān)法律法規(guī)、加強(qiáng)監(jiān)管力度、實(shí)施認(rèn)證管理、創(chuàng)新監(jiān)管模式,同時要加強(qiáng)宣傳培訓(xùn),強(qiáng)化企業(yè)自律意識和質(zhì)量意識,加強(qiáng)行業(yè)協(xié)會建設(shè)。
[Abstract]:Background medical instruments are widely used in medical treatment. It is an important material basis for the diagnosis and treatment of diseases. The level of development and quality assurance have a great influence on clinical diagnosis and treatment. Medical equipment business enterprise is a bridge linking medical equipment production enterprises and medical institutions and bears medical instruments. In the developed countries, the medical instrument production license control and the market access of the products are the key to guarantee the quality in developed countries. The medical instrument production enterprises deliver the products to the medical hospital through the logistics company. In our country, the medical instrument production enterprise will carry out the market. Regional separation, and then distributed through product agents to the hospital, the number of these medical equipment business enterprises, but the size is often small, the quality assurance ability is weak, which is a risk for the quality and safety of medical equipment. The license and supervision of medical equipment management enterprises, which are promulgated in two 000 years, "medical equipment supervision and Management Regulations > and According to the "administrative licensing law" promulgated in two 00 and four years, the law and regulations of the management of medical equipment management enterprises and other laws and regulations are required to be carried out. The specific standard is according to the standard documents such as the inspection and acceptance standards (Trial) of the medical equipment management enterprises in Shanghai, and the emphasis on the personnel, the site, the quality management system, the purchase and acceptance, the storage and storage. The requirements for the quality management of the storage and transportation as well as the process of sale and after-sales service are put forward. The purpose of this study is to find out the current situation of the quality management of Xuhui District medical equipment management enterprises through field investigation, find out the weak links and main problems in the quality management of medical equipment management enterprises, and analyze the original information through interviews with key insiders. In order to strengthen the supervision of Xuhui District medical equipment management enterprises and promote the improvement of quality management level of medical equipment management enterprises, the research methods used the method of combining qualitative and quantitative research. The research object is the 559 enterprises in Xuhui District which have obtained the license of the medical equipment management enterprise. The data from the field survey and the key lovers interview are all one hand data. The quantitative data collected on the spot are set up by Excel software and recorded with SPSS 17. The field records of the qualitative interview data, the input of the Word module and the classification method are used to further analyze the problems found in the investigation. The results of the research are compared with the factors such as the reign of the quality manager and the structure of the facilities and equipment. There is no obvious difference between the large medical equipment management enterprises and the small and medium enterprises, the agency business enterprises and the hospital distribution enterprises. However, the factors from the process are compared, such as the implementation of the quality management system. Whether the quality managers perform their duties, the audit of the product qualification, the acceptance of the products, the review and sales records, the traceability management, the after-sale service and quality tracking, the training of the employees, and so on, the large enterprises are obviously superior to the small enterprises, and the agency business enterprises are obviously superior to the hospital distribution enterprises. In the aspect of chain verification, large enterprises are obviously superior to small enterprises, and the agency business enterprises are obviously superior to the hospital distribution enterprises. The corneal contact lens retail enterprises are compared and found that the chain contact lens retail enterprises are obviously good non chain enterprises in the implementation of the process management system. The Countermeasures and suggestions are found to be in Xuhui District at present. There are some problems in the quality management of medical equipment management enterprises, such as the lack of attention to the quality management of enterprise leaders, the flow of quality management system in the form, the deficiency of the quality management personnel, the incomplete information of various management records, the serious lack of staff training and education, and the supervision and administration of laws and regulations in the external supervision. The regulatory force is weak and the supervision can not be effectively covered. Therefore, it is suggested that the regulatory authorities revise and improve the relevant laws and regulations, strengthen supervision, implement certification management, innovate the mode of supervision, and strengthen the publicity and training, strengthen the self-discipline consciousness and quality consciousness of the enterprises, and strengthen the construction of the industry association.
【學(xué)位授予單位】：復(fù)旦大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：F203

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相關(guān)期刊論文 前1條

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本文編號：1962857