目的 了解宣城市医疗机构医疗器械卫生行政处罚案件情况,为更好地开展执法监督检查提供参考依据。方法 收集国家卫生健康监督信息平台中宣城市各级卫生健康监督机构2019—2023年上报的医疗机构医疗器械卫生行政处罚案件信息,对行政处罚案件基本情况、处罚种类、案件来源、违法主体、案件案由等进行统计分析。结果 宣城市2019—2023年医疗机构医疗器械行政处罚案件共81件,处罚种类以普通程序为主(70件,占86.42%);案件来源以卫生机构监测报告为主(45件,占55.56%);违法主体以个体诊所和村卫生室为主(50件,占61.74%);处罚案由以传染病防治专业中“对重复使用的医疗器械未按照消毒和管理的规定进行处理”为主(54件,占66.67%)。结论 宣城市医疗机构医疗器械卫生行政处罚逐步趋于规范化,但也存在案件来源较单一,查处力度有所下降,基层医疗机构违法行为较多等问题,应加强卫生监督执法能力建设,加大查处力度,构建长效监管机制。

Objective To understand the situation of health administrative penalties cases for medical device in medical institutions in Xuancheng City,and provide reference basis for better law enforcement and inspection. Methods Information of health administrative penalties cases for medical device reported by various levels of health supervision institutions in Xuancheng City from 2019 to 2023 were collected from National Health Supervision Information Platform.Basic situation of health administrative penalties,punishment type,case sources,punishment subject and punishment cause were analyzed,retrospectively. Results From 2019 to 2023,there were a total of 81 health administrative penalties cases for medical device in medical institutions in Xuancheng City.The types of penalties were mainly based on general procedures(70 cases,accounting for 86.42%).The sources of the cases were mainly health institution monitoring reports(45 cases,accounting for 55.56%).The main subject of punishment were individual clinics and village clinics(50 cases,accounting for 61.74%).The main reason for the penalties was "failure to handle reusable medical devices in accordance with disinfection and management regulations" in the infectious disease(54 cases,accounting for 66.67%). Conclusion The health administrative penalties for medical device in medical institutions in Xuancheng City are gradually becoming standardized,but there are also problems such as a relatively single source of cases,a decrease in punishment efforts,and a high number of illegal behaviors in basic medical institutions.It is necessary to strengthen the construction of health supervision and law enforcement capabilities,increase punishment efforts,and establish a long-term regulatory mechanism.