Abstract:This paper introduced the qualification documents that should be submitted by the suppliers
of each kind of medical equipment and the information that ought to be verified before procurement
and during the acceptance of medical equipment. Then, application of the logistics management system
was suggested for informatization management of qualification documents of medical equipment,
which can ensure the compliance, effectiveness and security of various medical equipment in its clinical
applications. Additionally, this practice contributed to effective reduction of medical disputes and
sustainable development of the hospital.
马超琼,冯刚,陈江山. 医疗器械资质的审核及信息化管理[J]. 中国医疗设备, 2015, 30(3): 145-147.
医疗器械广泛应用于疾病预防、诊断、治疗、保健和康复。由于医疗器械直接或间接的作用于人体,其安全性和有效性需要严格控制,因此实验论证和审核的周期较长。有些生产厂家和经销商在利益的驱使下销售无证产品,如果医疗单位未经严格审核使用无证产品,一旦出现医疗事故,不但可能给患者带来严重后果,也可能让医疗机构面临经济损失和行政处罚,甚至追究刑事责任。因此,如何审核医疗器械资质证件,保证产品的安全性和有效性显得尤为重要;此外,近几年来医疗器械行业迅猛发展,医疗器械的种类越来越多,这就加大了医院对医疗器械资质证件审核和管理的难度。. Verification and Informatization Management for Qualification of Medical Equipment. China Medical Devices, 2015, 30(3): 145-147.