徐汇区医疗器械经营企业质量管理现况和监管对策研究

发布时间：2018-06-01 04:35

本文选题：医疗器械经营企业 + 质量　；参考：《复旦大学》2014年硕士论文

【摘要】：研究背景医疗器械是在医疗中广泛使用,是疾病的诊断和治疗重要的物质基础,其发展水平高低、质量保证的好坏,对临床诊断和治疗有着非常大的影响。医疗器械经营企业是联系医疗器械生产企业和医疗机构的桥梁,承担着医疗器械的保存、运输、售后维修等保证医疗器械安全有效的重要职责。在发达国家,医疗器械生产许可控制和产品的市场准入均被作为保证质量的重点,医疗器械生产企业将产品通过物流公司配送至医院。在我国,医疗器械生产企业将市场进行区域分隔,然后通过产品代理商分销至医院,这些医疗器械经营企业数量多,但规模往往较小,质量保障能力较弱,这就为医疗器械的质量安全带来风险。目前医疗器械经营企业的许可、监管,是按二000年颁布的《医疗器械监督管理条例》和按二00四年颁布的《行政许可法》、《医疗器械经营企业许可证管理办法》等法津法规要求执行,具体标准是依据《上海市医疗器械经营企业检查验收标准(试行)》等规范性文件,重点对人员、场地、质量管理制度、及采购与验收、储存与保管、出库与运输以及销售与售后服务各过程等质量管理方面提出了要求。研究目的通过现场调查,了解徐汇区医疗器械经营企业质量管理的现状,查找医疗器械经营企业质量管理中存在的薄弱环节和主要问题,通过关键知情人士访谈分析原因和对策,为加强对徐汇区医疗器械经营企业监管,促进医疗器械经营企业质量管理水平提高,提供必要的参考。研究方法本研究采用定性研究与定量研究相结合的方法,研究对象为徐汇区内已取得《医疗器械经营企业许可证》的559家企业,资料来自于现场调查和关键知情人访谈,均为一手资料。现场收集的定量资料用Excel软件建立数据库并录入,使用SPSS 17.0进行统计分析,对定性访谈资料现场记录,Word模块输入,采用分类归纳总结的方法,对调查发现的问题进一步分析。研究结果从质量管理人在位、设施设备这些结构方面的因素比较,所调查的医疗器械经营企业中,大型医疗器械经营企业与中小型企业、代理经营企业与医院分销企业无明显差异。但是,从过程方面的因素比较,如质量管理制度是否执行,质量管理人是否履职,产品资质审核,入库验收、出库复核及销售记录、追溯性管理、售后服务与质量跟踪、从业人员培训等,大型企业明显优于小型企业,代理经营企业明显优于医院分销企业。将体外诊断试剂经营企业进行比较发现,在冷链验证方面,大型企业明显优于小型企业,代理经营企业明显优于医院分销企业。将角膜接触镜零售企业进行比较发现,在过程管理制度的执行方面,连锁角膜接触镜零售企业明显好非连锁企业。对策建议通过本次研究发现,目前徐汇区医疗器械经营企业质量管理上存在企业领导对质量管理不重视、企业质量管理制度流于形式、质量管理人员形同虚设、各项管理记录内容信息不全、员工培训教育严重缺失等问题,在外部监管中存在监督管理法律法规体系有待完善、监管力量薄弱,监管无法有效覆盖,为此建议监管部门修订完善相关法律法规、加强监管力度、实施认证管理、创新监管模式,同时要加强宣传培训,强化企业自律意识和质量意识,加强行业协会建设。
[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.
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：F203

【参考文献】