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目的对行政机关关于医疗机构使用过期医疗器械案件的认定进行法理分析。探讨应如何正确认定医疗机构使用过期医疗器械案件中的使用行为、过错推定及违法所得等问题。方法根据《医疗器械监督管理条例》,针对某辖区内某诊所使用过期医疗器械案件及其认定过程进行法理分析,思考行政机关对该类案件的合理认定依据。结果案件认定过程中,执法人员对如何理解和认定过期医疗器械的使用行为,以及如何认定违法所得产生了争议。结论分析认为,医疗机构若在医疗器械过期后未及时区分放置或销毁处理,却有储存、养护等失当行为和管理疏漏,存在危害公众生命健康隐患,则应认定存在过期医疗器械的使用行为。执法人员若在合格区发现不合格药品、医疗器械,则可直接依照过错推定原则予以行政处罚。医疗机构违法经营后,违法所得的认定应既考虑到计算标准的统一性、简捷性和操作性,又考虑到具体案例的丰富性、具体性和特殊性。
Objective To carry out the jurisprudential analysis of the accusations of administrative agencies regarding the use of expired medical devices by medical institutions. To explore how to correctly identify the use of medical devices in medical institutions in the past cases of use behavior, presumption of fault and illegal income and other issues. Methods According to the Regulations on the Supervision and Administration of Medical Devices, a legal analysis is made on the cases of expired medical devices and the process of their identification in a clinic in a certain jurisdiction, and the basis for the reasonable identification of such cases by administrative agencies is considered. As a result, cases of lawsuits were disputable to law enforcement officials on how to understand and recognize the use of expired medical devices and how to identify illegal gains. Conclusions The analysis shows that if the medical institutions do not differentiate placement or destruction after the expiration of medical devices in time, there are some omissions and omissions in storage and maintenance, which may endanger the public health and life, then the use of expired medical devices should be considered. If law enforcement officials found substandard drugs and medical devices in the qualified area, they may directly be punished according to the principle of presumption of fault. After the illegal operation of a medical institution, the determination of the illegal gains shall take into account the unity, simplicity and operability of the calculation criteria, taking into account the richness, specificity and particularity of the specific cases.