外来医疗器械管理现状及管理对策研究

Current status of management of loaned medical instruments and countermeasures

目的通过调查金华市外来医疗器械管理现状,找出可能发生隐患的环节,为提高外来器械管理与使用质量提供可靠的基线资料,针对问题提出解决方案与对策。方法选取金华市所有使用外来医疗器械的医院为调查对象,根据相关行业规范,自行设计调查问卷方案,对外来器械的准入管理、组织管理、流程管理等全程质量控制进行全面调查,将所得数据用SSPS19.0软件进行统计分析。结果在接受调查的26所医院中,相应的管理制度基本完备,但只有11所医院(38.46%)对外来器械管理制度执行情况定期组织督查考核;26所(100.00%)医院允许厂商跟台人员上手术台,13所(50.00%)医院跟台人员培训与准入考核;12所(46.15%)医院外来器械到位及时;2所(7.69%)医院对医护人员进行培训;19.23%外来器械使用后清洗消毒后取走。医院级别不同,差异有统计学意义(P<0.05),三级医院在流程管理、外来器械处理能力、器械跟台人员管理上更优于二级医院。结论外来器械管理存在安全隐患,加强制度监管与人员的培训、规范流程,为患者提供合格的医疗器械,保证医疗质量与医疗安全。

OBJECTIVE To investigate the current status of management of loaned medical instruments in Jinhua and find out the links at hidden risks so as to provide baseline data for improvement of management of the loaned medical instruments and use quality and put forward＆#183;solutions and countermeasures.METHODS The hospitals in Jinhua that used the loaned medical instruments were recruited as the study objects.According to the industry standards,the questionnaire were designed by ourselves to fully investigate the whole-course quality control of access management,organization management and process of management of the loaned medical instruments,and the obtained data were statistically analyzed by using SPSS19.0 software.RESULTS Of all the 26 surveyed hospitals,all had the basically completed management systems,only 11 （38.46%） conducted regular supervision and assessment of implementation of the management systems of loaned medical instruments,26 （100.00%） allowed manufacturers onto the operating table,13 （50.00%） carried out the training and admittance examination for the persons who were on the operating table,12 （46.15%） had timely placement of the loaned medical instruments,and 2 （7.69%） conducted the training for the health care workers.19.23% of the loaned medical instruments were withdrawn after cleaning and disinfection.There was significant difference among the different grades of hospitals （P〈0.05）.The process management,processing ability of.loaned medical instruments,and management of personnel onto the table were better in tertiary hospitals than in the secondary hospitals.CONCLUSION The management of the loaned medical instruments are at hidden risk.It is necessary to strengthen the system supervision and training of personnel and standardize the process so as to provide the qualified medical instruments and ensure the medical quality and safety.